company name: tender description: request ......6 tender for freezer dryer obp02/21/pd1 doc. no.:...

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Tender for Freezer Dryer OBP02/21/PD1 DOC. NO.: OBP02/21/PD1 (EDITION 3)

COMPANY NAME:

TENDER DESCRIPTION: REQUEST FOR BID FOR PURCHASE OF FREEZE DRYER

EQUIPMENT AND INSTALLATION AT

ONDERSTEPOORT BIOLOGICAL PRODUCTS SOC LTD

COMPULSORY BRIEFING SESSION: NONE

CLOSING DATE: 15 April 2021

CLOSING TIME: 13H00

RESPONSES MUST BE HAND

DELIVERED/COURIERED TO:

ONDERSTEPOORT BIOLOGICAL PRODUCTS SOC LTD

100 OLD SOUTPAN ROAD, ONDERSTEPOORT

PRETORIA

NO FAXED OR E-MAILED PROPOSALS WILL BE

CONSIDERED

ATTENTION: THE SUPPLY CHAIN MANAGER

N.B. ALL TENDERERS MUST ENSURE THAT THEY SIGN THE TENDER SUBMISSION REGISTER THAT

WILL BE KEPT AT THE RECEPTION AREA AT OBP UPON SUBMISSION OF THEIR PROPOSAL

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TENDERING STRUCTURE Indicate the type of Bidding Structure by marking with an ‘X’:

Individual Bidder

Joint Venture

Consortium

Using sub-contractors

Other

If individual bidder, indicate the following:

Name of bidder

Registration Number

VAT Registration Number (If applicable)

Contact Person

Telephone Number

Fax Number

E-mail address

Postal Address

Physical Address

If Joint Venture/Consortium, indicate the following:

Name of prime contractor

Registration Number


Contact Person

Telephone Number

Fax Number

E-mail address

Postal Address

Physical Address

If Joint Venture/Consortium, indicate the following: (To be completed for each JV/Consortium Member)

Name of Joint Venture/Consortium

Registration Number


Contact Person

Telephone Number

Fax Number

E-mail address

Postal Address

Physical Address

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If using subcontractors, indicate the following:

Name of prime contractor

Registration Number


Contact Person

Telephone Number

Kindly Note that: 1. Should all of these documents not be included, the bidder may be disqualified on the basis of non-compliance.

2. The same documents must be submitted for all other companies that are involved in the tender in case of a

consortium.

ABREVIATIONS

• BBBEE Broad Based Black Economic Empowerment

• OBP Onderstepoort Biological Products

• RFB Request for BID

• ID Identification

• AO/AA Accounting Officer/ Accounting Authority

• DALRRD Department of Agriculture, Land Reform and Rural Development

• SARB Service Approval review Board

• VAT Value Added Tax

• SABS South African Bureau of Standards

• NPA National Prosecuting Authority

• SBD Standard Bidding Document

• SHE Safety Health and Environment

• EMO Environmental Management Office

• OSH Occupational Safety and Health

• NEM National Environment Management

• EMU Engineering Maintenance unit

• CU Clinical Unit

• UP University of Pretoria Onderstepoort Faculty

• VPF Vector Protected Facility

• GCP Good Clinical Practice

• SACPCMP South African Council for the Project and Construction Management Professions

• CIDB Construction Industry Development Board

• COID Compensation for Occupational Injuries and Diseases

• CSD Central Suppliers Data (National Treasury) Definitions

• Panel Number of suppliers between 2 and more

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Checklist of compulsory documents to be submitted - Please tick in the relevant block below.

YES NO Compulsory Documents

One original tender document and 3 copies

Proof that the service provider is registered with CSD must be tax compliant. or International Bidders comply with Country Tax or any

required documents by SARS

List and letters of references for past and present clients (Company Name, Department, Contact person, Telephone Number and e-mail address)

Company profile

COID letter of good standing

Conformity as per the user requirement and technical specification document

Technical quotation and detailed proposal

Equipment /system fact sheets

Technical and layout drawings Requirements for installation and Qualification Commercial proposal /quotation

Signed: Name in Print:

_________________________ ____________________________

Capacity: Date:

_________________________ ____________________________

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TABLE OF CONTENTS FOR THIS TENDER

•

No Contents Page number

1 CONDITIONS AND UNDERTAKINGS BY TENDERER 6

2 TENDER CONDITIONS 8

3 SPECIFICATION 12

4 BRIEFING SESSION 14

5 PRICING SCHEDULE 14

6 DECLARATION OF INTEREST BY TENDERER SBD 4 14

7 PREFERENTIAL POINTS CLAIM FORM IN TERMS OF

PREFERENTIAL PROCUREMENT REGULATIONS 2017 SBD

6.1

18

8 DECLARATION CERTIFICATE FOR LOCAL PRODUCTION

AND CONTENT FOR DESIGNATED SECTORS SBD 6.2

20

9 DECLARATION OF INTEREST FOR PAST SUPPLY CHAIN

MANAGEMENT PRACTICES SBD 8

25

10 CERTIFICATE OF INDEPENDENT SBD 9 26

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1. CONDITIONS AND UNDERTAKINGS BY TENDERER

1.1 The Tender forms should not be retyped or redrafted, but photocopies may be prepared and used.

However, only documents with the original signature in black ink shall be accepted.

1.1.1 Black ink should be used when completing Bid documents.

1.1.2 Bidders should check the numbers of the pages to satisfy themselves that none is missing or duplicated.

OBP will accept NO liability in regard to anything arising from the fact that pages are missing or

duplicated.

1.2 I/We hereby tender to supply all or any of the supplies and/or to procure all or any of the services

described in the attached documents to OBP on the terms and conditions and in accordance with the

specifications stipulated in the Tender documents (and which shall be taken as part of, and incorporated

into, this Tender) at the prices inserted therein.

1.3 I/We agree that -

1.3.1 The offer herein shall remain binding upon me/us and open for acceptance by OBP during the validity

period indicated and calculated from the closing hour and date of the Tender.

1.3.2 the laws of the Republic of South Africa shall govern the contract created by the acceptance of my/our

Tender and that I/we choose domicilium citandi et executandi in the Republic as indicated below; and

1.4 I/We furthermore confirm that I/we have satisfied myself/ourselves as to the correctness and validity of

my/our Tender that the price(s) and rate(s) quoted cover all the work/item(s) specified in the Tender

documents and that the price(s) and rate(s) cover all my/our obligations under a resulting contract and

that I/we accept that any mistakes regarding price(s) and calculations will be at my/our risk.

1.5 I/We hereby accept full responsibility for the proper execution and fulfillment of all obligations and

conditions devolving on me/us under this Tender as the Principal(s) liable for the due fulfillment of this

contract.

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Signature(s) of Tenderer or assignee(s) Date

Name of signing person (in block letters)

Capacity

Are you duly authorized to sign this

Tenderer?

Name of Tenderer [company name] (in

block letters)

Postal address (in block letters)

Domicilium citandi et executandi in the RSA (full street address of this place) (in block letters)

………………………………………………………………………………………………………………………………………………

………………………………………………………………………………………………………………………………………………

………………………………………………………………………………………………………………………………………………

………………………………………………………………………………………………………………………………………………

Telephone Number: ................................................ FAX Number..............................................

Cell Number.…………………………….

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2. TENDER CONDITIONS

2.1 Tenderers shall provide full and accurate answers to all questions posed in this document, and, are

required to explicitly state either "Comply” or “Not Comply” or “Partial” (with a )" regarding compliance

with the requirements. Where necessary, the tenderer shall substantiate their response to a specific

question.

2.2 A “” under “Accept” will be interpreted as full compliance/acceptance to the applicable paragraph. A

“” under “Accept” will be interpreted that the tenderer/s has/have read and understood the paragraph,

but the tenderer does not accept the content of the applicable paragraph.

2.3 The following Tender conditions will govern the contract between the OBP and the successful tenderer:

Requirement ACCEPT NOT ACCEPT

2.3.1

Tenderers are invited to offer the Services/Products in

accordance with the attached Specifications and the

conditions within this document.

2.3.2

Fully comprehensive service documentation shall be supplied

in English by each Tenderer, which shall explicitly and detail,

describe the service/s offered. This documentation shall

include sufficient detail to clearly give the reader a precise

and unambiguous description of the service/s offered.

Incomplete or incomprehensive service documentation will

result in rejection of the offer.

2.3.3

Tenderer’s name and address should clearly appear on the

outside of tender documents and on envelope.

2.3.4

OBP reserves the right to evaluate and consider any Tenders

that do not comply strictly to this RFB.

2.3.5

Acceptance of any Tenders will only indicate, without any

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obligations on the part of either OBP and/or a Tenderer, the

willingness of such parties to enter into negotiations, which

may or may not result in a contract/order as the case may be.

2.3.6

OBP reserves the right to make a selection solely on the

information received in the Tenders or to negotiate further

with one or more Tenderer/s.

2.3.7

The Tenderer/s selected for further negotiations, if any, will

be chosen on the basis of the greatest benefit to OBP and

not necessarily on the basis of lowest price or any other

criteria.

2.3.8

Should OBP consider it necessary, the Tenderer/s shall agree

to an inspection of the resources and works of the Tenderer,

if so required?

2.3.9

Should OBP consider it necessary, OBP will visit the

Tenderer/s customer sites.

2.3.10

OBP reserves the right:

- to cancel this Request at any time.

- not to accept any Tender.

- to accept one or more Tenders for further negotiation and.

- to contact any Tenderer during the evaluation period, to

clarify information only, without informing any other

Tenderer.

2.3.11

The specifications are the intellectual property of OBP.

2.3.12

The Procuring of the Services shall not take place until OBP

has given final approval of all procedures.

2.3.13

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In the event that modifications, clarifications or additions to

the RFB become necessary, all Tenderers will be notified, in

writing, addenda to this RFB.

2.3.14

All costs incurred in the preparation, presentation and

demonstration of the response shall be for the account of the

Tenderer. All supporting documentation and manuals

submitted with RFB will become OBP property unless

otherwise stated by the Tenderer/s at the time of submission.

2.3.15

Any material submitted by the Tenderer/s, which is

confidential in nature, must be clearly marked as such.

2.3.16

OBP will evaluate the bids against the following criteria:

• Compliance to the Specifications

• Compliance to the Functionality

• Price

• BBBEE

• Compliance to Bid Condition

2.3.17

Payments of services rendered will be done 30 days after

receipt of statement(s)

Payments will be made as agreed by the two parties

2.4 REASONS FOR DISQUALIFICATION

2.4.1 OBP reserves the right to disqualify any Tenderer which does any one or more of the following, and

such disqualification may take place without prior notice to the offending tenderer, however the

tenderer shall be notified in writing of such disqualification:

- Tenderers who are blacklisted.

- Tenderers who are not registered on Central Supplier Database. /Does not comply to international

Companies

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- Tenderers who submitted incomplete information and documentation according to the requirements

of this RFB.

- Tenderers who submitted information that is fraudulent, factually untrue, or inaccurate, for example

memberships that do not exist, BBBEE credentials, experience, etc.

- Tenderers who received information not available to other vendors through fraudulent means.

- Tenderers who in the past abused OBP’s procurement system:

- Tenderers who failed to perform on their previous contracts with OBP or any of their references

2.4.2 No Tenders from any Tenderer with offices within the RSA shall be accepted if sent via the Fax or e-mail.

However, Tenders from international bidders with no office or representation in the RSA shall be

accepted if received via the Fax or e-mail before the closing date and time. Such Tenders shall not be

made available for evaluation until the original signed documentation is received within three (3)

working days after the closing date, otherwise the proposal shall be disqualified. International bidders

must submit proof that they do not have any offices or representation in South Africa.

2.5 ENQUIRIES

Enquiries regarding this Request for Proposal should be submitted via e-mail to :

[email protected]. Such queries must be sent at least Four (4) working days before the closing

date. OBP cannot guarantee that queries received after that date can be answered before the Tender

closing date.

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3.SPECIFICATIONS: 3.1 See Appendix 1 full specification document of Freezer Dryer.

3.1.1

The supply of new freeze dryer will be a turnkey project, Bidders must ensure that all items below are followed

• Remove Current freeze dryer, need to be decommissioning and, new freezer dryer must be installed and

commissioned.

• Must include all cost i.e. removal, rigging, all service connections

• Manufacturer of freezer dryer must have an approved agent or office with technical support in South Africa.

3.2 Evaluation criteria

The request for this service will be evaluated based on the following stages.

3.2.1 Compulsory documents

Stage 1: Check for compulsory documents

All documents indicated on page 4 shall be submitted, might lead to automatic disqualification, unless a written

explanation can accompany this application.

3.2.2 Functionality

Stage 2: Evaluation for functionality

Interested service provider must obtain a minimum score of 70% of functionality to be eligible for evaluation in stage

two. The following will be used as a criteria and the minimum points of each criteria which are indicated in the table

below:

Aspects Functionality Weight Means of verification

Previous experience Confirmation of experience in

manufacturing production scale

freeze dryer for pharmaceuticals

application (as required by OBP):

Less than 5 Freeze Dryer build =Nil

• Above 5 Freeze Dryer build = 20 points

• Above 10 Freeze Dryer build = 50 points

Over a period of 10 years

50

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List of contactable references

successfully undertaken in

manufacturing production scale

freeze dryer for pharmaceuticals

application:

• No list of references: Nil

• List of above 3 positive contactable references =20 points

20 References letters from

customers

Complete Technical Offer (Equipment Description offered as per appendix full specification)

10 Letter

After sales services plan approved agent or office with technical support in South Africa 2 years =10 Points Above 2 years =20 Points

20 Proposal

Total 100

3.2.3 Stage 3: Price and BBBEE

The evaluation for Price and BBBEE shall be based on the 80/20 PPPFA principle and the points for evaluation criteria are as follows:

Evaluation Criteria Points

1. Price 80

2. Black Economic Empowerment 20

3. Total 100

BBBEE Status Level of Contributor Number of Points

1 20

2 18

3 16

4 12

5 8

6 6

7 4

8 2

Non-compliant contributor 0

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4. Validity of Proposals

The prospective tenderer is required to confirm that it will hold its proposal valid for __90_ Days from

the closing date of the submission of proposals. All the proposals shall be quoted in South African

Rand and remain valid for 90 days after closure of the tender.

5.0 PRICING SCHEDULE –

All pricings must be fixed amounts and should be in Rand

1.1. Provide a complete Price Schedule with detailed breakdown

1. Description Price (Excl. Vat)

1

2

3

4

TOTAL COST

VAT at 15%

TOTAL COST INCLUDING VAT

Signed Name in Print:

_________________________ _____________________________

Capacity: Date:

_________________________ _____________________________

6. DECLARATION OF INTEREST BY TENDERER SBD4

6.1. Any legal person, including persons employed by the state¹, or persons having a kinship with persons employed by the

state, including a blood relationship, may make an offer or offers in terms of this invitation to bid (includes a price quotation, advertised competitive bid, limited bid or proposal). In view of possible allegations of favouritism, should the resulting bid, or part thereof, be awarded to persons employed by the state, or to persons connected with or related to them, it is required that the bidder or his/her authorised representative declare his/her position in relation to the evaluating/adjudicating authority where-

- The bidder is employed by the state; and/or

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- the legal person on whose behalf the bidding document is signed, has a relationship with persons/a person who are/is involved in the evaluation and or adjudication of the bid(s), or where it is known that such a relationship exists between the person or persons for or on whose behalf the declarant acts and persons who are involved with the evaluation and or adjudication of the bid.

6.2. To give effect to the above, the following questionnaire must be completed and submitted with the bid. 6.2.1 Full Name of bidder or his or her representative: …………………………………………………………. 6.2.2 Identity Number: ………………………………………………………………………………………………… 6.2.3 Position occupied in the Company (director, trustee, shareholder²): ……………………………………. 6.2.4 Company Registration Number: ……………………………………………………………………….……. 6.2.5 Tax Reference Number: ………………………………………………………………………………….……… 6.2.6 VAT Registration Number: ………………………………………………………………………………....

6.2.6.1 The names of all directors / trustees / shareholders / members, their individual identity numbers, tax reference numbers and, if applicable, employee / persal numbers must be indicated in paragraph 3 below.

¹“State” means – (a) Any national or provincial department, national or provincial public entity or constitutional institution within the

meaning of the Public Finance Management Act, 1999 (Act No. 1 of 1999); (b) Any municipality or municipal entity. (c) Provincial legislature. (d) National Assembly or the national Council of provinces; or (e) Parliament. ²” Shareholder” means a person who owns shares in the company and is actively involved in the management of the enterprise

or business and exercises control over the enterprise. 6.2.7 Are you or any person connected with the bidder YES / NO Presently employed by the state? 6.2.7.1 If so, furnish the following particulars:

Name of person / director / trustee / shareholder/ member: ……....……………………………… Name of state institution at which you or the person connected to the bidder is employed: ……………………………………… Position occupied in the state institution: ……………………………………… Any other particulars: ……………………………………………………………… ……………………………………………………………… ………………………………………………………………

6.2.7.2 If you are presently employed by the state, did you obtain YES / NO

The appropriate authority to undertake remunerative Work outside employment in the public sector?

6.2.7.3 If yes, did you attach proof of such authority to the bid YES / NO

Document?

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(Note: Failure to submit proof of such authority, where Applicable, may result in the disqualification of the bid.

6.2.7.4 If no, furnish reasons for non-submission of such proof:

……………………………………………………………………. ……………………………………………………………………. …………………………………………………………………….

6.2.8 Did you or your spouse, or any of the company’s directors / YES / NO Trustees / shareholders / members or their spouses conduct Business with the state in the previous twelve months?

6.2.8.1 If so, furnish particulars:

………………………………………………………………….. ………………………………………………………………….. …………………………………………………………………...

6.2.9 Do you, or any person connected with the bidder, have YES / NO any relationship (family, friend, other) with a person employed by the state and who may be involved with the evaluation and or adjudication of this bid?

6.2.9.1 If so, furnish particulars. ……………………………………………………………... …………………………………………………………..….

………………………………………………………………

6.2.10. Are you, or any person connected with the bidder, YES/NO aware of any relationship (family, friend, other) between

any other bidder and any person employed by the state who may be involved with the evaluation and or adjudication of this bid?

2.10.1 If so, furnish particulars.

……………………………………………………………… ……………………………………………………………… ………………………………………………………………

6.2.11 Do you or any of the directors / trustees / shareholders / members YES/NO

of the company have any interest in any other related companies whether or not they are bidding for this contract? 6.2.11.1 If so, furnish particulars:

……………………………………………………………………………. ……………………………………………………………………………. …………………………………………………………………………….

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6.3. Full details of directors / trustees / members / shareholders.

Full Name Identity Number Personal Tax Reference Number

State Employee Number / Persal Number

6.4 DECLARATION

I, THE UNDERSIGNED (NAME)………………………………………………………………………

CERTIFY THAT THE INFORMATION FURNISHED IN PARAGRAPHS 2 and 3 ABOVE IS CORRECT. I ACCEPT THAT THE STATE MAY REJECT THE BID OR ACT AGAINST ME IN TERMS OF PARAGRAPH 23 OF THE GENERAL CONDITIONS OF CONTRACT SHOULD THIS DECLARATION PROVE TO BE FALSE. ………………………………….. ..…………………………………………… Signature Date …………………………………. ……………………………………………… Position Name of bidder

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7. PREFERENCE POINTS CLAIM FORM IN TERMS OF THE PREFERENTIAL PROCUREMENT REGULATIONS 2011 SBD6.1

This preference form must form part of all bids invited. It contains general information and serves as a claim form for preference points for Broad-Based Black Economic Empowerment (BBBEE) Status Level of Contribution NB: BEFORE COMPLETING THIS FORM, BIDDERS MUST STUDY THE GENERAL CONDITIONS, DEFINITIONS AND DIRECTIVES

APPLICABLE IN RESPECT OF B-BBBEE, AS PRESCRIBED IN THE PREFERENTIAL PROCUREMENT REGULATIONS, 2017.

1. GENERAL CONDITIONS

1.1 The following preference point systems are applicable to all bids:

- the 80/20 system for requirements with a Rand value of up to R50 000 000 (all applicable taxes included); and - the 90/10 system for requirements with a Rand value above R50 000 000 (all applicable taxes included).

1.2

a) The value of this bid is estimated to exceed/not exceed R50 000 000 (all applicable taxes included) and therefore the preference point system shall be applicable; or

b) Either the 80/20 or 90/10 preference point system will be applicable to this tender (delete whichever is not applicable for this tender).

1.3 Points for this bid shall be awarded for:

(a) Price; and

(b) BBBEE Status Level of Contributor.

1.4 The maximum points for this bid are allocated as follows:

POINTS

PRICE

BBBEE STATUS LEVEL OF CONTRIBUTOR

Total points for Price and B-BBBEE must not exceed 100

1.5 Failure on the part of a bidder to submit proof of BBBEE Status level of contributor together with the bid, will be interpreted to mean that preference points for BBBEE status level of contribution are not claimed.

1.6 The purchaser reserves the right to require of a bidder, either before a bid is adjudicated or at any time subsequently, to substantiate any claim in regard to preferences, in any manner required by the purchaser.

2. DEFINITIONS

(a) “BBBEE” means broad-based black economic empowerment as defined in section 1 of the Broad-Based Black Economic Empowerment Act.

(b) “BBBEE status level of contributor” means the B-BBBEE status of an entity in terms of a code of good practice on black economic empowerment, issued in terms of section 9(1) of the Broad-Based Black Economic Empowerment Act;

(c) “bid” means a written offer in a prescribed or stipulated form in response to an invitation by an organ of state for the provision of goods or services, through price quotations, advertised competitive bidding processes or proposals.

(d) “Broad-Based Black Economic Empowerment Act” means the Broad-Based Black Economic Empowerment Act,

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2003 (Act No. 53 of 2003);

(e) “EME” means an Exempted Micro Enterprise in terms of a code of good practice on black economic empowerment issued in terms of section 9 (1) of the Broad-Based Black Economic Empowerment Act.

(f) “functionality” means the ability of a tenderer to provide goods or services in accordance with specifications as set out in the tender documents.

(g) “prices” includes all applicable taxes less all unconditional discounts.

(h) “proof of BBBEE status level of contributor” means:

1) BBBEE Status level certificate issued by an authorized body or person.

2) A sworn affidavit as prescribed by the BBBEE Codes of Good Practice.

3) Any other requirement prescribed in terms of the BBBEE Act.

(i) “QSE” means a qualifying small business enterprise in terms of a code of good practice on black economic empowerment issued in terms of section 9 (1) of the Broad-Based Black Economic Empowerment Act;

(j) “rand value” means the total estimated value of a contract in Rand, calculated at the time of bid invitation, and includes all applicable taxes.

3. POINTS AWARDED FOR PRICE

3.1 THE 80/20 OR 90/10 PREFERENCE POINT SYSTEMS

A maximum of 80 or 90 points is allocated for price on the following basis: 80/20 or 90/10

−−=

min

min180

P

PPtPs or

−−=

min

min190

P

PPtPs

Where

Ps = Points scored for price of bid under consideration

Pt = Price of bid under consideration

Pmin = Price of lowest acceptable bid

4. POINTS AWARDED FOR B-BBBEE STATUS LEVEL OF CONTRIBUTOR

4.1 In terms of Regulation 6 (2) and 7 (2) of the Preferential Procurement Regulations, preference points must be awarded to a bidder for attaining the BBBEE status level of contribution in accordance with the table below:

BBBEE Status Level of Contributor

Number of points

(90/10 system)

Number of points

(80/20 system)

1 10 20

2 9 18

3 6 14

4 5 12

5 4 8

6 3 6

7 2 4

20


8 1 2

Non-compliant contributor 0 0

5. BID DECLARATION

5.1 Bidders who claim points in respect of BBBEE Status Level of Contribution must complete the following:

6. BBBEE STATUS LEVEL OF CONTRIBUTOR CLAIMED IN TERMS OF PARAGRAPHS 1.4 AND 4.1

6.1 BBBEE Status Level of Contributor: . = ……… (maximum of 10 or 20 points)

(Points claimed in respect of paragraph 7.1 must be in accordance with the table reflected in paragraph 4.1 and must be substantiated by relevant proof of B-BBBEE status level of contributor.

7. SUB-CONTRACTING

7.1 Will any portion of the contract be sub-contracted?

(Tick applicable box)

YES NO

7.1.1 If yes, indicate:

i) What percentage of the contract will be subcontracted............……………?………% ii) The name of the sub-contractor………………………………………………………….. iii) The BBBEE status level of the sub-contractor......................................…………….. iv) Whether the sub-contractor is an EME or QSE

(Tick applicable box)

YES NO

v) Specify, by ticking the appropriate box, if subcontracting with an enterprise in terms of Preferential Procurement Regulations,2017:

Designated Group: An EME or QSE which is at last 51% owned by: EME √

QSE √

Black people

Black people who are youth

Black people who are women

Black people with disabilities

Black people living in rural or underdeveloped areas or townships

Cooperative owned by black people

Black people who are military veterans

OR

Any EME

Any QSE

8. DECLARATION WITH REGARD TO COMPANY/FIRM

8.1 Name of company/firm:…………………………………………………………………….

8.2 VAT registration number:…………………………….…………………………………

8.3 Company registration number:……….……………………….…………………………….

8.4 TYPE OF COMPANY/ FIRM

Partnership/Joint Venture / Consortium

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One-person business/sole propriety

Close corporation

Company

(Pty) Limited [TICK APPLICABLE BOX]

8.5 DESCRIBE PRINCIPAL BUSINESS ACTIVITIES

………………………………………………………………………………………………………………………………………………………………………………………

………………………………………………………………………………………………………………………………………………………………………………………

…………………………………………..

8.6 COMPANY CLASSIFICATION

Manufacturer

Supplier

Professional service provider

Other service providers, e.g. transporter, etc. [TICK APPLICABLE BOX]

8.7 Total number of years the company/firm has BBBEE in business:………………

8.8 I/we, the undersigned, who is / are duly authorised to do so on behalf of the company/firm, certify that the points

claimed, based on the BBBEE status level of contributor indicated in paragraphs 1.4 and 6.1 of the foregoing

certificate, qualifies the company/ firm for the preference(s) shown and I / we acknowledge that:

i) The information furnished is true and correct.

ii) The preference points claimed are in accordance with the General Conditions as indicated in paragraph 1 of this form.

iii) In the event of a contract being awarded as a result of points claimed as shown in paragraphs 1.4 and 6.1, the contractor may be required to furnish documentary proof to the satisfaction of the purchaser that the claims are correct.

iv) If the BBBEE status level of contributor has BBBEE claimed or obtained on a fraudulent basis or any of the conditions of contract have not BBBEE fulfilled, the purchaser may, in addition to any other remedy it may have –

(a) disqualify the person from the bidding process.

(b) recover costs, losses or damages it has incurred or suffered as a result of that person’s conduct.

(c) cancel the contract and claim any damages which it has suffered as a result of having to make less favourable arrangements due to such cancellation.

(d) recommend that the bidder or contractor, its shareholders and directors, or only the shareholders and directors who acted on a fraudulent basis, be restricted by the National Treasury from obtaining business from any organ of state for a period not exceeding 10 years, after the audi alteram partem (hear the other side) rule has BBBEE applied; and

(e) forward the matter for criminal prosecution.

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8.0 DECLARATION CERTIFICATE FOR LOCAL PRODUCTION AND CONTENT FOR DESIGNATED SECTORS SBD 6.2

This Standard Bidding Document (SBD) must form part of all bids invited. It contains general information and serves as a declaration form for local content (local production and local content are used interchangeably).

Before completing this declaration, bidders must study the General Conditions, Definitions, Directives applicable in respect of Local Content as prescribed in the Preferential Procurement Regulations, 2017, the South African Bureau of Standards (SABS) approved technical specification number SATS 1286:2011 (Edition 1) and the Guidance on the Calculation of Local Content together with the Local Content Declaration Templates [Annex C (Local Content Declaration: Summary Schedule), D (Imported Content Declaration: Supporting Schedule to Annex C) and E (Local Content Declaration: Supporting Schedule to Annex C)].

1. General Conditions

1.1. Preferential Procurement Regulations, 2017 (Regulation 8) make provision for the promotion of local production and

content.

1.2. Regulation 8.(2) prescribes that in the case of designated sectors, organs of state must advertise such tenders with the specific bidding condition that only locally produced or manufactured goods, with a stipulated minimum threshold for local production and content will be considered.

1.3. Where necessary, for tenders referred to in paragraph 1.2 above, a two-stage bidding process may be followed, where the

first stage involves a minimum threshold for local production and content and the second stage price and B-BBBEE.

1.4. A person awarded a contract in relation to a designated sector, may not sub-contract in such a manner that the local production and content of the overall value of the contract is reduced to below the stipulated minimum threshold.

1.5. The local content (LC) expressed as a percentage of the bid price must be calculated in accordance with the SABS approved

technical specification number SATS 1286: 2011 as follows: LC = [1 - x / y] * 100

Where

x is the imported content in Rand y is the bid price in Rand excluding value added tax (VAT)

Prices referred to in the determination of x must be converted to Rand (ZAR) by using the exchange rate published by South African Reserve Bank (SARB) on the date of advertisement of the bid as indicated in paragraph 3.1 below. The SABS approved technical specification number SATS 1286:2011 is accessible on http:/www.thedti.gov.za/industrial development/ip.jsp at no cost.

……………………………………….

SIGNATURE(S) OF BIDDERS(S)

DATE: …………………………………..

ADDRESS …………………………………..

…………………………………..

…………………………………..

WITNESSES

1. ……………………………………..

2. …………………………………….

23


1.6. A bid may be disqualified if this Declaration Certificate and the Annex C (Local Content Declaration: Summary Schedule) are not submitted as part of the bid documentation.

2. The stipulated minimum threshold(s) for local production and content (refer to Annex A of SATS 1286:2011) for this bid

is/are as follows: Description of services, works or goods Stipulated minimum threshold.

_______________________________ _______%

_______________________________ _______% _______________________________ _______%

3. Does any portion of the goods or services offer have any imported content? (Tick applicable box)

YES NO

3..1 If yes, the rate(s) of exchange to be used in this bid to calculate the local content as prescribed in paragraph 1.5 of the

general conditions must be the rate(s) published by SARB for the specific currency on the date of advertisement of the bid.

The relevant rates of exchange information are accessible on www.resbank.co.za

Indicate the rate(s) of exchange against the appropriate currency in the table below (refer to Annex A of SATS 1286:2011):

Currency Rates of exchange

US Dollar

Pound Sterling

Euro

Yen

Other

NB: Bidders must submit proof of the SARB rate (s) of exchange used.

4. Where, after the award of a bid, challenges are experienced in meeting the stipulated minimum threshold for local content

the dti must be informed accordingly in order for the dti to verify and in consultation with the AO/AA provide directives in this regard.

LOCAL CONTENT DECLARATION

(REFER TO ANNEX B OF SATS 1286:2011)

LOCAL CONTENT DECLARATION BY CHIEF FINANCIAL OFFICER OR OTHER LEGALLY RESPONSIBLE PERSON NOMINATED IN WRITING BY THE CHIEF EXECUTIVE OR SENIOR MEMBER/PERSON WITH MANAGEMENT RESPONSIBILITY (CLOSE CORPORATION, PARTNERSHIP OR INDIVIDUAL)

IN RESPECT OF BID NO. ................................................................................. ISSUED BY: (Procurement Authority / Name of Institution): ......................................................................................................................... NB

http://www.resbank.co.za/

24


1 The obligation to complete, duly sign and submit this declaration cannot be transferred to an external authorized representative, auditor or any other third party acting on behalf of the bidder.

2 Guidance on the Calculation of Local Content together with Local Content Declaration Templates (Annex C, D and E) is accessible on http://www.thedti.gov.za/industrial_development/ip.jsp. Bidders should first complete Declaration D. After completing Declaration D, bidders should complete Declaration E and then consolidate the information on Declaration C. Declaration C should be submitted with the bid documentation at the closing date and time of the bid in order to substantiate the declaration made in paragraph (c) below. Declarations D and E should be kept by the bidders for verification purposes for a period of at least 5 years. The successful bidder is required to continuously update Declarations C, D and E with the actual values for the duration of the contract.

I, the undersigned, …………………………….................................................... (full names), do hereby declare, in my capacity as ……………………………………… ……….. of ...............................................................................................................(name of bidder entity), the following:

(a) The facts contained herein are within my own personal knowledge.

(b) I have satisfied myself that:

(i) the goods/services/works to be delivered in terms of the above-specified bid comply with the minimum local content requirements as specified in the bid, and as measured in terms of SATS 1286:2011; and

(c) The local content percentage (%) indicated below has BBBEE calculated using the formula given in clause 3 of SATS 1286:2011, the rates of exchange indicated in paragraph 3.1 above and the information contained in Declaration D and E which has BBBEE consolidated in Declaration C:

Bid price, excluding VAT (y) R

Imported content (x), as calculated in terms of SATS 1286:2011 R

Stipulated minimum threshold for local content (paragraph 3 above)

Local content %, as calculated in terms of SATS 1286:2011

If the bid is for more than one product, the local content percentages for each product contained in Declaration C shall be used instead of the table above. The local content percentages for each product have BBBEE calculated using the formula given in clause 3 of SATS 1286:2011, the rates of exchange indicated in paragraph 3.1 above and the information contained in Declaration D and E.

(d) I accept that the Procurement Authority / Institution has the right to request that the local content be

verified in terms of the requirements of SATS 1286:2011.

(e) I understand that the awarding of the bid is dependent on the accuracy of the information furnished in this application. I also understand that the submission of incorrect data, or data that are not verifiable as described in SATS 1286:2011, may result in the Procurement Authority / Institution imposing any or all of the remedies as provided for in Regulation 14 of the Preferential Procurement Regulations, 2017 promulgated under the Preferential Policy Framework Act (PPPFA), 2000 (Act No. 5 of 2000).

SIGNATURE:_________________________ WITNESS No. 1 DATE: ___________ WITNESS No. 2 DATE: ___________

http://www.thedti.gov.za/industrial_development/ip.jsp

25


9. DECLARATION OF INTEREST FOR PAST SUPPLY CHAIN MANAGEMENT PRACTICES SBD 8

1 This Standard Bidding Document must form part of all bids invited. 2 It serves as a declaration to be used by institutions in ensuring that when goods and services are being procured, all

reasonable steps are taken to combat the abuse of the supply chain management system.

3 The bid of any bidder may be disregarded if that bidder, or any of its directors have-

a. abused the institution’s supply chain management system. b. committed fraud or any other improper conduct in relation to such system; or c. failed to perform on any previous contract.

4 In order to give effect to the above, the following questionnaire must be completed and submitted with the bid.

Item Question Yes No

4.1 Is the bidder or any of its directors listed on the National Treasury’s Database of Restricted Suppliers as companies or persons prohibited from doing business with the public sector? (Companies or persons who are listed on this Database were informed in writing of this restriction by the Accounting Officer/Authority of the institution that imposed the restriction after the audi alteram partem rule was applied). The Database of Restricted Suppliers now resides on the National Treasury’s website(www.treasury.gov.za) and can be accessed by clicking on its link at the bottom of the home page.

Yes

No

4.1.1 If so, furnish particulars:

4.2 Is the bidder or any of its directors listed on the Register for Tender Defaulters in terms of section 29 of the Prevention and Combating of Corrupt Activities Act (No 12 of 2004)? The Register for Tender Defaulters can be accessed on the National Treasury’s website (www.treasury.gov.za) by clicking on its link at the bottom of the home page.

Yes

No


4.3 Was the bidder or any of its directors convicted by a court of law (including a court outside of the Republic of South Africa) for fraud or corruption during the past five years?

Yes

No


4.4 Was any contract between the bidder and any organ of state terminated during the past five years on account of failure to perform on or comply with the contract?

Yes

No

http://www.treasury.gov.za/

http://www.treasury.gov.za/

26



SBD 8

CERTIFICATION

I, THE UNDERSIGNED (FULL NAME)………………………………………………… CERTIFY THAT THE INFORMATION FURNISHED ON THIS DECLARATION FORM IS TRUE AND CORRECT. I ACCEPT THAT, IN ADDITION TO CANCELLATION OF A CONTRACT, ACTION MAY BE TAKEN AGAINST ME SHOULD THIS

DECLARATION PROVE TO BE FALSE. ………………………………………... ………………………….. Signature Date

………………………………………. ………………………….. Position Name of Bidder

10. CERTIFICATE OF INDEPENDENT BID DETERMINATION SBD 9

1 This Standard Bidding Document (SBD) must form part of all bids¹ invited.

2 Section 4 (1) (b) (iii) of the Competition Act No. 89 of 1998, as amended, prohibits an agreement between, or

concerted practice by, firms, or a decision by an association of firms, if it is between parties in a horizontal relationship

and if it involves collusive bidding (or bid rigging).² Collusive bidding is a pe se prohibition meaning that it cannot be

justified under any grounds.

3 Treasury Regulation 16A9 prescribes that accounting officers and accounting authorities must take all reasonable steps to prevent abuse of the supply chain management system and authorizes accounting officers and accounting authorities to:

a. disregard the bid of any bidder if that bidder, or any of its directors have abused the institution’s supply chain

management system and or committed fraud or any other improper conduct in relation to such system.

b. cancel a contract awarded to a supplier of goods and services if the supplier committed any corrupt or fraudulent act during the bidding process or the execution of that contract.

4 This SBD serves as a certificate of declaration that would be used by institutions to ensure that, when bids are

considered, reasonable steps are taken to prevent any form of bid-rigging.

5 In order to give effect to the above, the attached Certificate of Bid Determination (SBD 9) must be completed and

submitted with the bid:

¹ Includes price quotations, advertised competitive bids, limited bids and proposals.

27


² Bid rigging (or collusive bidding) occurs when businesses, that would otherwise be expected to compete, secretly conspire to

raise prices or lower the quality of goods and / or services for purchasers who wish to acquire goods and / or services through

a bidding process. Bid rigging is, therefore, an agreement between competitors not to compete.

CERTIFICATE OF INDEPENDENT BID DETERMINATION I, the undersigned, in submitting the accompanying bid:

________________________________________________________________________

(Bid Number and Description)

in response to the invitation for the bid made by:

______________________________________________________________________________

(Name of Institution)

do hereby make the following statements that I certify to be true and complete in every respect:

I certify, on behalf of:_______________________________________________________that:

(Name of Bidder)

1. I have read and I understand the contents of this Certificate.

2. I understand that the accompanying bid will be disqualified if this Certificate is found not to be true and complete in

every respect.

3. I am authorized by the bidder to sign this Certificate, and to submit the accompanying bid, on behalf of the bidder.

4. Each person whose signature appears on the accompanying bid has BBBEE authorized by the bidder to determine the

terms of, and to sign the bid, on behalf of the bidder;

5. For the purposes of this Certificate and the accompanying bid, I understand that the word “competitor” shall include any

individual or organization, other than the bidder, whether or not affiliated with the bidder, who:

(a) has BBBEE requested to submit a bid in response to this bid invitation;

(b) could potentially submit a bid in response to this bid invitation, based on their qualifications, abilities

or experience; and

(c) provides the same goods and services as the bidder and/or is in the same line of business as the bidder

6. The bidder has arrived at the accompanying bid independently from, and without consultation, communication,

agreement, or arrangement with any competitor. However, communication between partners in a joint venture or

consortium³ will not be construed as collusive bidding.

7. In particular, without limiting the generality of paragraphs 6 above, there has BBBEE no consultation, communication,

agreement, or arrangement with any competitor regarding:

(a) prices;

(b) geographical area where product or service will be rendered (market allocation)

(c) methods, factors or formulas used to calculate prices;

28


(d) the intention or decision to submit or not to submit, a bid.

(e) the submission of a bid which does not meet the specifications and conditions of the bid; or

(f) bidding with the intention not to win the bid.

8. In addition, there have BBBEE no consultations, communications, agreements or arrangements with any competitor

regarding the quality, quantity, specifications and conditions or delivery particulars of the products or services to which

this bid invitation relates.

9. The terms of the accompanying bid have not BBBEE, and will not be, disclosed by the bidder, directly or indirectly, to any

competitor, prior to the date and time of the official bid opening or of the awarding of the contract.

³ Joint venture or Consortium means an association of persons for the purpose of combining their expertise, property, capital, efforts, skill and knowledge in an activity for the execution of a contract.

10. I am aware that, in addition and without prejudice to any other remedy provided to combat any restrictive practices

related to bids and contracts, bids that are suspicious will be reported to the Competition Commission for investigation

and possible imposition of administrative penalties in terms of section 59 of the Competition Act No 89 of 1998 and or

may be reported to the National Prosecuting Authority (NPA) for criminal investigation and or may be restricted from

conducting business with the public sector for a period not exceeding ten (10) years in terms of the Prevention and

Combating of Corrupt Activities Act No 12 of 2004 or any other applicable legislation.

………………………………………………… …………………………………

Signature Date

…………………………………………………. …………………………………

Position Name of Bidder

PROJECT NUMBER: C17155

PROJECT DESCRIPTION: FREEZE DRYER EQUIPMENT

PURCHASES INSTALLED AND

COMMISSIONED

DOCUMENT NUMBER: 2189-420-P-0015

DOCUMENT TITLE: FREEZE DRYER TECHNICAL

SPECIFICATION

REVISION HISTORY

C 4/02/2021 Reviewed section 4,5,6,7,8,9,10 4,6,7,9,10,15,17 I Naryan

B 13/03/2019 Reviewed sections 8.1, 8.5 & 16 10, 12, 20 S. Ntombela

A 08/03/2018 Issued for Review ALL S Dale

REV. DATE DESCRIPTION AFFECTED

PAGES ORIGINATOR

ii

Document: 2189-420-P-0015 Rev C Page ii Onderstepoort Biological Products Printed Date: 11/03/2021 REF: OBP-GMP-URS-005 freeze dryer equipment purchases installed and commissioned

TABLE OF CONTENTS

1. INTRODUCTION ............................................................................................................................................. 1

1.1 SCOPE OF SPECIFICATION ................................................................................................................................. 1 1.2 ALTERNATIVE DESIGN AND/OR DEVIATIONS ......................................................................................................... 1 1.3 PROVEN EQUIPMENT ...................................................................................................................................... 1 1.4 SUPPLIER’S RESPONSIBILITY .............................................................................................................................. 1 1.5 CONFLICTING REQUIREMENTS ........................................................................................................................... 1 1.6 LANGUAGE AND UNITS ..................................................................................................................................... 2 1.7 CONFIDENTIALITY ........................................................................................................................................... 2

2. SCOPE OF SUPPLY ......................................................................................................................................... 2

3. OPERATIONAL OVERVIEW ............................................................................................................................. 3

3.1 FACILITY ....................................................................................................................................................... 3 3.2 CONTAINMENT .............................................................................................................................................. 3

4. DESIGN AND MAIN CHARACTERISTICS OF THE EQUIPMENT .......................................................................... 4

4.1 OPERATIONAL REQUIREMENTS .......................................................................................................................... 4 4.2 GENERAL REQUIREMENTS ................................................................................................................................ 4

5. UTILITIES AND BATTERY LIMITS ..................................................................................................................... 6

5.1 GENERAL ...................................................................................................................................................... 6 5.2 ELECTRICAL POWER SUPPLY & REQUIREMENTS .................................................................................................... 7

6. MATERIALS OF CONSTRUCTION .................................................................................................................... 7

6.1 GENERAL ...................................................................................................................................................... 7 6.2 METALLIC MATERIALS ..................................................................................................................................... 7 6.3 NON-METALLIC CONTACT MATERIALS ................................................................................................................ 8 6.4 SURFACE FINISHES .......................................................................................................................................... 8 6.5 PASSIVATION ................................................................................................................................................. 9 6.6 INSULATION .................................................................................................................................................. 9

7. MECHANICAL DESIGN CONSIDERATIONS ...................................................................................................... 9

7.1 REMOVABLE EQUIPMENT ................................................................................................................................. 9 7.2 BEARINGS AND MECHANICAL SEALS ................................................................................................................... 9 7.3 LUBRICATION ................................................................................................................................................. 9 7.4 DRIVES ......................................................................................................................................................... 9 7.5 MAINTENANCE .............................................................................................................................................. 9 7.6 EQUIPMENT LABELLING AND MARKING............................................................................................................... 9 7.7 NOISE ........................................................................................................................................................ 10

8. CONTROL SYSTEM REQUIREMENTS ..............................................................................................................11

8.1 OVERVIEW .................................................................................................................................................. 11 8.2 FIELD CONTROL PANELS................................................................................................................................. 11 8.3 HMI .......................................................................................................................................................... 12 8.4 FIELD CONTROL PANEL HARDWARE ................................................................................................................. 13 8.5 SOFTWARE .................................................................................................................................................. 13 8.6 SECURITY .................................................................................................................................................... 14 8.7 REPORTING AND DATA RECORDING ................................................................................................................. 15 8.8 DATA INTEGRITY & DISASTER RECOVERY ........................................................................................................... 16 8.9 COMMUNICATION WITH OTHER SYSTEMS .......................................................................................................... 16

9. INSTRUMENTATION REQUIREMENTS ...........................................................................................................16

iii

Document: 2189-420-P-0015 Rev C Page iii Onderstepoort Biological Products Printed Date: 11/03/2021 REF: OBP-GMP-URS-005 freeze dryer equipment purchases installed and commissioned

9.1 GENERAL .................................................................................................................................................... 16 9.2 HYGIENIC REQUIREMENTS .............................................................................................................................. 17 9.3 ACCURACY REQUIREMENTS ............................................................................................................................ 17 9.4 SAFETY DEVICES ........................................................................................................................................... 17

10. STANDARDS, CODES AND REGULATIONS .....................................................................................................18

11. TRANSPORT .................................................................................................................................................19

12. DESIGN, MANUFACTURE, INSTALLATION, TESTING & COMMISSIONING ......................................................19

12.1 QUALITY PLAN ............................................................................................................................................. 19 12.2 PROGRESS REVIEWS ...................................................................................................................................... 20 12.3 INSPECTION DURING MANUFACTURE ................................................................................................................ 20 12.4 FACTORY ACCEPTANCE TESTS (FAT) ................................................................................................................ 20 12.5 INSTALLATION AND MECHANICAL COMPLETION .................................................................................................. 21 12.6 COMMISSIONING AND SITE ACCEPTANCE TESTS (SAT) ........................................................................................ 21

13. TRAINING .....................................................................................................................................................21

14. VALIDATION / QUALIFICATION ....................................................................................................................21

15. DOCUMENTATION & DRAWINGS .................................................................................................................22

LIST OF ACRONYMNS AND ABBREVIATIONS

ACRONYM DESCRIPTION

cGMP Current Good Manufacturing Practice

CIP Clean In Place

FAT Factory Acceptance Test

FDS Functional Design Specification

GAMP Good Automated Manufacturing Practice

HW Hardware

IQ Installation Qualification

OBP Onderstepoort Biological Products

OQ Operational Qualification

SAT Site Acceptance Test

SIP Sterilisation In Place

SW Software

URS User Requirement Specification

Table 1: Acronyms and Abbreviations

1

Document: 2189-420-P-0015 Rev C Page 1 of 22 Onderstepoort Biological Products Printed Date: 11/03/2021 REF: OBP-GMP-URS-005 freeze dryer equipment purchases installed and commissioned

1. INTRODUCTION

1.1 SCOPE OF SPECIFICATION

This specification defines the requirements for the design, manufacture, supply, inspection and FAT, delivery, installation, commissioning, SAT, user training and validation and documentation of the Freeze Dryer for Onderstepoort Biological Products.

1.2 ALTERNATIVE DESIGN AND/OR DEVIATIONS

This document should be read in conjunction with the User Requirement Specification (OBP-GMP-URS-005).

The supplier shall conform to the requirements outlined in the URS and this specification. Deviations (if any) shall be indicated and explained in detail. Alternative designs will also be considered but must be submitted as additional options.

1.3 PROVEN EQUIPMENT

The design and construction of the equipment supplied under this specification shall be the manufacturer's proven design for the pharmaceutical and biotech industry.

Unproven, prototype or “first off” equipment is not acceptable, only proven equipment may be used unless specifically indicated to and accepted by the Client.

1.4 SUPPLIER’S RESPONSIBILITY

Compliance with this specification does not relieve the supplier of the responsibility of furnishing equipment of proper and safe design, suitable to meet operating guarantees, cGMP regulatory compliance and all SAHPRA or PIC/S, European and US codes and regulations as mentioned in the URS.

All items/components that are necessary and essential to give the rated performance of the systems with qualification of complete installations are deemed to have been included in the scope of supply, irrespective of whether explicitly specified or not in the detailed description of works.

Any correction or additions required to the supply to conform to the basis of design cGMP codes and SAHPRA or PIC/S, European and US codes and regulations and guarantees specified will be under supplier responsibility and expenses.

Supplier shall provide, in advance, the equipment / devices / components vendor list for approval by OBP.

1.5 CONFLICTING REQUIREMENTS

Any conflicting requirements of this specification, data sheets, related specifications and drawings shall be referred to OBP for clarification before proceeding with manufacture or procurement of the affected item.

In the case of mutual conflict between documents attached to this specification, the following order of preference shall apply:

2


1. Laws and/or mandatory codes and regulations

2. Tender documentation, primarily this specification and the URS .

3. Other Specifications / Standards

4. Supplier Bid

1.6 LANGUAGE AND UNITS

English Language shall be used throughout all documents and drawings.

Documentation issued as built shall be in English.

The SI metric system of units shall be used, with the exception that pressure may be specified in bar or Pascal as the case may be.

1.7 CONFIDENTIALITY

1. This document was prepared by and for OBP and can be used exclusively for the purposes foreseen by the contract under which it was supplied. Any reproduction, assignment and in any case any use for different purposes are forbidden in the absence of a previous authorisation by OBP. The content of the document is protected by the norms on a copyright and intellectual property.

2. The Supplier will recognise that the said documents are communicated for the exclusive purpose of making an offer and possibly supplying equipment to the Client.

3. The Supplier will in no circumstances (promotion, sales or references) reuse these documents or the concepts contained within for any purpose, other than that outlined above.

4. Should the Supplier contemplate reusing these concepts or documents, in part or totally, they shall first of all inform OBP and shall not make any commitment without prior written permission.

2. SCOPE OF SUPPLY

The supplier’s scope of supply and responsibility shall include, but is not limited to:

• Detailed Design

• Meetings with OBP in Pretoria, South Africa, as required, all cost is for supplier’s account.

• Manufacture

• Complete pre-assembly in factory, OBP technical staff/artisan to be part of the supply as offsite training.

• Factory Acceptance Testing (FAT) of all aspects of supply user department, QA, Engineering to be represented. Aspect of supply to include review of functional &design specification approved by OBP engineering and GMP office and verify during FAT.

• Delivery to Onderstepoort Biological Products, including unloading and positioning.

• Installation

• Commissioning

3


• Site Acceptance Tests (SAT) Installation & Operational qualification compulsory. SAT protocol to be reviewed and signed off by OBP prior including test designs. Optional will be performance qualification.

• Documentation as detailed in Tender documentation, together with duplicate copies of standard documentation requirements (As Built Drawings, O&M Manuals, Spare Parts Lists, etc.)

• Functional Design Specification (FDS)

• Risk Assessment

• Validation Documentation: DQ / IQ /OQ Protocols, conforming to OBP Templates.

• Execution of relevant IQ / OQ Protocols and final reports

• Final Instrument Calibrations on site at OBP

• Operator Training

• Commissioning Spares

• Compulsory service level agreement for the term of warranty not less than two years post OQ. With 24-hour turnaround time on maintenance support preferable local supplier in South Africa.

• Adherence to local statutory rules & regulations

• Adherence to site rules & practices implemented by OBP during the length of the contract.

• Site safety management

• Supply of catalogues / warranty certificates / calibration certificates / inspection reports / test reports etc for the entire system / components / bought out items / local agent with full technical support and after sales services support minimum 5 years, based in south Africa.

3. OPERATIONAL OVERVIEW

3.1 FACILITY

The project includes the supply of systems and equipment that will be installed in the multipurpose animal vaccine facility at Onderstepoort Biological Products, Pretoria.

The Freeze Dryer will be used to freeze dry OBP animal vaccines, live attenuated.

3.2 CONTAINMENT

The containment level of the strains of the organisms handled is Level 2 and 3, according to “Council directive 98/81/EEC (26/10/98) amending Directive 90/219/EEC”, and the WHO Biosafety Manual. This is also consistent with the draft regulations in South Africa.

Design of the equipment / systems shall assure containment that is consistent with the above regulations.

4


4. DESIGN AND MAIN CHARACTERISTICS OF THE EQUIPMENT

4.1 OPERATIONAL REQUIREMENTS

Freeze Dryer will be used to freeze dry filled vaccine vial batches up to the following minimum specifications:

• Vial Size = 6R as per ISO 8362

• Fill Volume minimum 1.25ml

• Capacity of between minimum 75Lt-115Lt

• Minimum Number of Vials 60 000

Bidders need to confirm the sizing of the critical components i.e. Condenser, vacuum equipment refrigeration equipment and separation values must be communicated to OBP.

Batches to be controlled with internal probes that monitor the parameters of the recipe and adjusted accordingly, recipe selectable via HMI.

4.2 GENERAL REQUIREMENTS

Full system to be supplied as a skid, with modular design if necessary, for shipping and installation on site. Skid to transmit minimum oscillations to connections and floor. Anti-vibration mountings to be supplied if necessary.

The chamber and condenser should be in-line, i.e. condenser to the rear of the chamber.

4.2.1 Chamber Design

Chamber must be 100% drainable and should be designed for ease of cleaning. The drain must have an easily accessible and removable strainer. The product chamber including shelves should be made of 316L stainless steel.

Validation ports shall be provided to facilitate validation in situ and must be of sufficient size to accept all probes necessary for validation.

Supplier to determine appropriate number of sensors for monitoring of process parameters. Product Temperature probes should be designed such that they could be located anywhere on any shelf.

Chamber and condenser to have their own pressure and vacuum gauges. Chamber and condenser vacuum monitoring mechanisms recommended to be independent.

4.2.2 Shelves and Loading

Freeze dryer will be loaded manually under Grade A UDAF via trolleys. There should be a mechanical means to prevent the crushing of vials especially when shelves are partially loaded. Also, there should be means to prevent vials from being pushed over the shelf edges during loading.

Shelf preference is 1250mm W x 1560mm D; 11 usable shelves with a clear spacing of 70mm. Supplier may consider alternate arrangements if necessary.

Design of shelves must facilitate uniform heating and cooling. The shelves should be preferably filled with heat transfer fluid to ensure a homogeneous temperature distribution in the shelf.

5


Shelf flatness to be ±0.5 mm across any 1m.

Shelves must facilitate closure of partially stoppered vials. Pressure for closure should be adjustable via recipe and suitable to prevent crushing. Stoppering operations must not in any way compromise the sterility of the product.

Supplier to specify expected shelf tolerance of temperature differentials and rigours of stoppering.

Offer to include option whereby Freeze dryer is designed to allow for future integration with filling line for automatic filling use of a conveyor system.

4.2.3 Door & Locking Mechanism

Sliding door is preferred supplier will give options before size and direction of door approval must be obtain first from OBP. The chamber door should be made of 316L stainless steel.

Door must have a loading slot to allow integration with a constant height loading system.

Door should contain a sight glass with a light.

Door should be operated by a single operator without force.

Door must be interlocked to ensure it cannot be opened under pressure. Differential pressure to be observed between end of cycle chamber parameters with current filling suite under HVAC.

4.2.4 Cleaning & Sterilisation

Freeze Dryer must be capable of recipe driven CIP & SIP. CIP must facilitate removal of any crushed glass and debris within the chamber.

End of cycle pressure in chamber must accommodate door opening under grade A with grade B clean room.

Chamber must be steam sterilisable between temperatures of 121 – 130°C, monitored by temperature probes. Suitable GMP monitoring system can be advise by supplier, market trend technology.

4.2.5 Condenser

Coldest operating temperature shall be -80°C.

Supplier to specify ice capacity suited to maximum product load.

Supplier to specify condenser style (coil/other) and defrosting time.

Condenser vessel must remain airtight to prevent contamination.

4.2.6 Vacuum Pumps

Vacuum Leak Rate should be no more than 0.02 mbar-L/sec.

Vacuum setpoint should be controllable.

4.2.7 Redundancy

There must be additional compressor capacity to ensure redundancy.

There must be additional vacuum pump capacity to ensure redundancy.

6


There should be N+1 redundancy for the refrigeration compressor system, vacuum pumps, and shelf heaters.

4.2.8 MOC

Material of construction: AISI 316L for metallic parts in contact with product, AISI 304L for other metallic parts.

4.2.9 Hygienic Filters

Filters shall be Steam sterilisable, Sanitary Hydrophobic, 0.22-micron PTFE double cartridge with bayonet lock type filters. Number and size of filters to be determined by Vendor. Vent filter housings to be trace heated. Filter Housings to be AISI 316L, Internal finishing Ra < 0,6-micron, external finishing satin, with clamped connections. Each filter shall be supplied with connections for in place water intrusion test with dedicated skid not included in scope of supply.

4.2.10 Piping and Valves

All product contact piping shall be ASME-BPE AISI 316L piping. Connections shall be Sanitary Tri-clamps. Piping arrangement shall be planned for ease of inspection, servicing, and removal of equipment. All dead legs must have a length no more than three times the internal diameter, and pipework shall be sloped and fully drainable. Steam traps to be allowed where necessary for SIP of pipework. Pipework support shall be the manufacturer’s proven design for the pharmaceutical industry.

Valves in contact with process shall be membrane type with mixproof arrangements; the body will be made of AISI 316L membrane will be PTFE or equivalent FDA approved material, suitable for design and operating conditions. Main valve type between condenser and chamber must be mushroom type.

5. UTILITIES AND BATTERY LIMITS

5.1 GENERAL

The Supplier shall include in his offer the following information:

• Required Utilities (the characteristics, including operating and design conditions)

• Average consumption per cycle for each utility

• Required Size and type of connection for each utility.

For each utility, including drain, Vendor will be provided with only one connection per skid with manual valve to plant distribution.

5.1.1 Mechanical Utilities

Connection to utilities headers (by other) in technical areas (above ceiling level - 4m) will be included in the scope. Connection to killing and neutralisation system will be at floor level beneath skid.

5.1.2 Pure Utilities

Vendor to indicate connection requirements for pure utilities.

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5.1.3 Electrical

The battery limit will be the power supply to the electrical/control board. The connections from electrical/control board to the user point and cable way is included in the scope of work.

5.1.4 Instrumental

The pneumatic and electrical/signal connections from the control board to the field instrumentation and cableway is included. The battery limit will be the power and pneumatic supply to the electrical/control board.

5.2 ELECTRICAL POWER SUPPLY & REQUIREMENTS

The available electric power supply is the following:

• 400/ 230 V - 50 Hz - 3 Phases + Neutral + Ground for power panel

Scope of electrical supply is a Panel, made in stainless steel, containing the electrical components provided by Vendor (as relays, contacts and other electrical components needed).

Vendor will include supply and installation of electrical motors, of electrical heating system (for vent filter heating, electrical heater) and all electrical connections to skid user points starting from power cabinet supplied. Power cabinet will also contain inverters for all motors.

ALL necessary overload, ground protection, relays, contacts and other electrical safety devices must be included in the freeze dryer scope of supply.

Enclosures shall be rated for a Protection degree IP65 minimum for parts installed in pharmaceutical areas, IP55 minimum for technical areas installation. Supplier to confirm.

The Supplier shall include in his offer the following information:

• Electric power installed.

• Electric power adsorbed.

• Operating Voltage: 230V single phase or 400V three-phases or 400/ 230V three-phases + neutral

6. MATERIALS OF CONSTRUCTION

6.1 GENERAL

1. Materials shall be identified.

2. Materials containing asbestos, lead, cadmium, mercury, or chromates shall not be used.

3. All equipment and materials shall be easily washable.

6.2 METALLIC MATERIALS

1. All materials in contact with product, cleaning and pure fluids shall conform to the requirements of the United States Code of Federal Regulations Title 21 (21CFR) and local SAHPRA requirements.

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2. All materials in contact with product, cleaning and pure fluids shall be AISI 316L. Material batch certificate to be provided.

3. Metallic materials of contact shall not in any way release any particles and contaminate the process.

4. Aluminium is not an acceptable construction material.

5. All stainless-steel components shall be passivated after welding and polishing.

6. All structural steels must be treated with appropriate corrosion protection systems to prevent deterioration by corrosion. Structural steels which are insulated must be designed and treated for 20 years maintenance free operation life.

7. The proposed refrigeration system must utilise low GWP refrigerants with availability horizon of at least 20 years. The refrigeration system must be appropriate for installation in non ATEX environments.

8. The Supplier shall indicate on his review drawings the material specification and grade number of all materials supplied.

6.3 NON-METALLIC CONTACT MATERIALS

Non-metallic materials in contact with the process and raw materials shall be pharmaceutical grade, sanitary construction in compliance with 21CFR, FDA approved material and shall conform to the following:

1. Materials shall be non-shedding (shall not release particles).

2. The level of extractives shall conform to the relevant sections of 21CFR and the European and British Pharmacopoeia.

3. Materials shall be generally of a closed cell type and shall not be porous.

4. Materials shall not in any way influence or contaminate the process system.

5. All elastomers should be suitable for exposure to relevant operating and CIP/SIP conditions.

6. The Supplier shall indicate on his review drawings the material specification and grade number of all materials supplied.

6.4 SURFACE FINISHES

6.4.1 External Surfaces

The preparation of the metal surfaces shall allow easy cleanability and shall have a satin finish with no more than 2µm Ra.

6.4.2 Metal Internal Contact Surfaces

All metallic contact surfaces shall be electro-polished with a final finish of no more than 0.6µm Ra.

6.4.3 Non-metallic Internal Contact Surfaces

Elastomeric and polymeric materials shall have a surface finish smooth enough to ensure the cleaning can be easily carried out.

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6.5 PASSIVATION

Stainless steel product contact parts shall be cleaned and passivated according to a written procedure for the vendor and that shall be approved by OBP before vendor commences the execution. A certificate of cleaning passivation shall be issued by Vendor. Vendor shall take care of supply and disposal of liquid effluents.

6.6 INSULATION

All hot pipes must be insulated so that the surface temperature will not exceed 40°C and cold pipes (below 15°C) must be insulated to prevent condensation (drip proof). Insulation material will be free of Asbestos or Chloride and shall be specified by the vendor in the offer.

In process areas the type of covering for pipe insulation will be pipe-in-pipe or similar which meets GMP requirements.

7. MECHANICAL DESIGN CONSIDERATIONS

7.1 REMOVABLE EQUIPMENT

Sub-assemblies shall be easily and quickly dismantled into components. All sub-assembly removable components shall have the same identification number as the sub-assembly.

7.2 BEARINGS AND MECHANICAL SEALS

All bearings and mechanical seals shall be designed to prevent any type of contamination into the product.

7.3 LUBRICATION

All moving parts shall be lubricated to ensure maintenance free operation. The design of the lubrication equipment shall ensure that the lubricant cannot leak into the process system or into the GMP area.

7.4 DRIVES

Direct drives are preferred, and belt or chain drives must be avoided where possible. Where belt or chain drives cannot be avoided, they shall be covered in a guard that can be easily cleaned and that is not removable without the use of tools.

7.5 MAINTENANCE

Equipment shall be designed in such a way that maintenance and assembly of all components can be access to all machine parts should be such that it is without interfering with the clean room. Vendor shall supply equipment maintenance requirements and schedules. Vendor shall also supply any bespoke/special maintenance equipment or tools required.

7.6 EQUIPMENT LABELLING AND MARKING

All equipment and components shall be supplied with stainless steel nameplates (or tags) as necessary. Major equipment nameplates shall be submitted in advance to OBP for approval and shall include as a minimum:

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• Name of Client

• Equipment number and name

• Construction serial number

• Tare weight

• Design pressure (pressure equipment only) pressure certificate must be supplied based on the new safety law that is required for all pressure equipment.

Pressure Equipment Marking

• The Manufacturer shall cause a date plate to be permanently fixed in a conspicuous place with the following particulars.

o Name of Manufacturer

o Country of origin

o Year of manufacture

o Manufacturer serial number

o Reference number, date and edition of the health and safety standard

o Design pressure in units of pascal

o Design pressure for both minimum and maximum in degrees Celsius

o Capacity in cubic metres

o Unique mark of an approved inspection authority as applicable and

o The hazard category in accordance with the requirements of SANS347

• Design temperature

• Main characteristics (volume, rpm, G force, etc.)

Marking shall be legible with letters at least 5 mm high. Equipment shall be marked where required to indicate that it complies with the SABS 0140 or equivalent international requirements.

Installed instruments and valves should be uniquely identified with labels reporting items corresponding to drawings / P&IDs.

All wiring and pneumatic tubing shall be labelled. Piping shall be provided with suitable labels attached that shall include as a minimum:

• Fluid Type

• Pipe Size and/or Tag (with reference to P&ID)

• Flow Direction

7.7 NOISE

The maximum noise level shall not exceed 60 dBA at one meter from the equipment noise source and shall not be greater than a combined level of 80 dBA.

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8. CONTROL SYSTEM REQUIREMENTS

8.1 OVERVIEW

The system will be provided with all the devices needed for the control, monitoring, and recording operation of the systems.

The control system will manage instruments and controls of the system as designed by the vendor. The equipment must have a dedicated PLC Control system according to GAMP 5 to manage all the recipes.

The control system should provide for automated cycle optimisation

The equipment shall be supplied with a capability of a secured remote access for the system diagnosis/software upgrades via a network connection using appropriate security protocols. Secured remote access must be available for remote operation and cycle monitoring by OBP technicians.

The system shall be validated and shall be in compliance with GAMP 5 and CFR 21, part 11 recommendations.

The system will be equipped with sufficient devices (HW and SW) for connection and interface with a Central SCADA station (by other and OBP) which will be used to store critical data and as a Supervisor Station.

8.2 FIELD CONTROL PANELS

The Field Control Panel will have the following main features:

• Control system cabinet with dedicate PLC and PC (including solenoid valves, I/O rack)

• Communication bus, Power supply to control panel and HMI

• HMI touch screen panel (minimum size 15”)

• Production data management with data recorder (limited storage for 10 batches) and dedicated printer (for monitoring parameters)

• Storable product recipes (allow for 40)

• Operator interface Software should include graphical process displays.

• Interface with Central SCADA

• Panel UPS for PLC power backup in the event of a power failure

• Printer for batch report printing

The control panel must be located on the skid, construction material will be AISI 304, mechanical protection degree will be IP 65.

Included in the scope of supply are all electro-pneumatic cables and connections for instruments and valves required for the correct functioning of the system.

All electrical installations including and not limited to, panel building, panel modifications, trunking, cable trays, conduits, power/control cables, network/communication cables, and

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equipment and instrumentation termination must be supplied and installed according to SANS 10142, as-well as any Ex-requirements in accordance with SANS 10108 (and any accompanying Ex Zoning Drawings and/or reports).

All aspects associated with the supply of a new Panel must comply with the following standard: SANS 1973.

All the electrical components shall have CE stamps.

The whole installation shall be effectively earthed in accordance with SANS Standard Codes of Practice. On completion of the entire installation or any section thereof, as may be decided by the Engineer, tests shall be carried out in accordance with the appropriate rules, in the presence of the Engineer. External person will come for the Final FAT. Panels will be powered up and checked as part of FAT.

COC's and Supporting Test/Commissioning Certificates to be issued on completion of installation.

The cabinet shall be powered with 400V 3-phase supply 50Hz. Any transformer or rectifier shall be installed inside the cabinet with suitable circuit breakers.

The cabinet shall include a lockable isolator which prevents opening of the panel door when the power is on.

The cabinet requires an easily Accessible Emergency Stop.

Control cabinet will be equipped with integrated temperature monitoring to protect the installed components.

8.3 HMI

The Vendor shall supply one HMI installed in filling area. It will have mechanical protection IP 65, suitable for installation inside GMP production area must include graphical process display.

The colour touch screen HMI will have mechanical protection IP 65 flush-mounted type, suitable for installation inside pharmaceutical grade areas, designed for ease of cleanability. Operator Panels (HMI) should be installed in ergonomic position to allow operator to monitor process while performing manual operations.

From the HMI the responsible operator will monitor process parameters and will run production steps and sterilization cycles. Present recipe and locked as per access defined by OBP

All alarms set points and process parameters will be set by administrator including user profiles and accessibility levels.

It will be possible to visualise:

• Status

• Recipe Parameters

• Main Machine Parameters

• Operation Timers

• Actuated valves status

• Alarms

From touch screen panel, it will be possible to:

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• Set parameters.

• Start and stop recipes and or change modes. Recipe design should not hinder or push equipment above threshold, thus negatively affecting optimal functionality and control as per design.

8.4 FIELD CONTROL PANEL HARDWARE

All Field Control Panels The system shall have 20% spare IO capacity for future expansion.

The control panel shall be powered from the system electrical distribution panel must be included in the scope of supply.

In case of power failure, the system shall automatically reload the application software and remain in the idle state (except where automatic restart is required).

During idle state, the outputs shall be set to their safe conditions; the application program is stopped, and it will be restarted automatically or by the operator.

The UPS state shall be continuously monitored.

Control System should be provided with Analogue Input, Analogue output, Digital Input and Digital output cards with 20% spare for each. The Analogue PLC I/O cards will be specified as 4-20mA devices and all Digital Input / Output as 24VDC devices.

The cards will be equipped with an electronic device for the short-circuit protection.

External labels shall be used to identify the tag signals belonging to each I/O card.

Local Storage of critical parameters and measurements for the last 100 recipes is required and will be stored on a local data recorder per panel. All critical data will be stored by a central SCADA station (by other) on a higher level for a period of 5 years.

In any case the modification of recorded data will not be possible.

A printer will be included in scope of supply of Vendor.

Electrical Distribution panel must be supplied with the equipment.

8.5 SOFTWARE

8.5.1 General

It is intended that the PLC system for the package equipment shall be supplied complete with the application software and with the relevant documentation.

The installed application Software shall be supplied with a license valid for a minimum of 5 years including updating software when required. System to be upgradable and inn line with current IT systems at OBP or future OBP investments.

The basic concept that shall be taken into consideration by the Contractor of the package is that the software shall not only satisfy the operating and functional requirements of the relevant equipment but shall also be documented.

Standard Mode for equipment functioning will be automatic: in this case operator will choose predefined recipe and schedule the required recipe.

System should be capable of loading various stored recipes identified with codes and description.

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Data storage should be protected against losses in case of power failure or black-out, affording restore.

A dedicated database Must record all analogue a digital process values of automated components for diagnostic purposes.

on/off values of automated components. (important to advise what intervals)

Control system should manage equipment settings (set points, alarms threshold, process parameters).

Main Recipe and Values for parameters and alarms should be defined with supplier during SAT tests but it will be possible for the final user (supervisor) to modify values or create new recipes. All size-specific settings can be saved and retrieved at the HMI.

8.5.2 Alarm Management

Control system should manage all alarms related to the equipment (to be defined by vendor), in terms of thresholds, interlocks, signal to SCADA, and to operators (on HMI), acoustic and optical.

Alarms which take place during production should be recorded on a dedicated log and showed in a graphical page. It will be possible to print alarm report.

Alarms will be reported to the site centralized technical management system.

8.6 SECURITY

8.6.1 CFR 21 Section 11 Compliance

The control system must be compliant with CFR 21 Section 11 with features like system security, secure data management and reporting, electronic records and signatures, and the automated electronic recording of changes. Core system functions that support regulatory requirements:

• Access control

• Authentication and re-authentication

• Alarm and event management

• Audit trail

• Batch control and management

• Electronic recording

• Electronic signatures

• Event reports

• History and archiving

• Trends

• Redundancy

• Batch reports

• Infrastructure and network security

8.6.2 Access Control

The access to the control system will be possible according to the password level assigned to each user. Access control should define 4 password levels (administrator, supervisor, maintenance, operator). Capacities allowed to each level are listed in the following table:

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OPERATION ADMINISTRATOR Department MANAGER

SUPERVISOR OPERATOR

Password management X

Print out Configuration X X

Recipe definition/ modification

X X

Plant parameter Configuration

X X

Start Cycle manual mode X X X

Start predefined Cycle automatic mode

X X X X

In any case the Vendor will have to submit its final/standard solution to the Engineer/Owner for approval.

8.6.3 Electronic Signatures

The account of any user shall be constituted by two elements: user ID and password.

User ID shall be unique for each user and the password related to each user ID should be periodically changed. User ID / Password should be provided with automatic log-off (10 minutes). In case of password not periodically changed, the system should automatically deny access to users that did not change the password according to the predefined rules.

8.7 REPORTING AND DATA RECORDING

8.7.1 Reporting

Configured batch reports for the operations will be configured that will have all the specific real-time critical process data and audit information relating to that batch.

Historical trend chart facilities will be catered for to view all the process variables.

Alarm, event and audit trail viewing on the HMI must be part of the system.

Available in pdf format.

8.7.2 Trends

The ability to store, view, and retrieve process data and historical information is an integral function of the control system. All critical parameters must be able to be trended.

8.7.3 Audit Trail

The integrated system-wide audit trail lets authorized users view and filter:

• User login, logout and change events.

• Configuration changes

• Operator actions and inputs

• Alarm events

• System and device events

• Batch alarms and events

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• Signature events

All time-stamped audit trail events contain information about the object or file changed, the change itself and the action’s owner.

8.7.4 Local Data Recording

The system will be provided with a local data recorder and dedicated printer (for monitoring parameters, separated from control functions), which will display and record critical process parameters.

The system will be able to store at least the data for 100 batches.

For each batch, the following data (as a minimum) will be stored:

• Unit identification number

• Status

• Critical Process Parameters (Temperature, Pressure, etc.)

• Start and stop of operations (with time indication), including selected recipes and phases.

• Alarms (with time indication)

• Set-points modification (with name and time indications).

• Operator actions (with name and time indications).

• Operator overrides (with name and time indications).

8.8 DATA INTEGRITY & DISASTER RECOVERY

8.8.1 Redundancy

No equipment requires redundant hardware, but a list of critical spares is too be included in this scope of work for quick change out in the event of hardware failure.

8.8.2 Backups

No on-skid backups required, but allowance for critical parameters to be transmitted to central SCADA system for backup.

8.9 COMMUNICATION WITH OTHER SYSTEMS

Allow for future interface to higher level system (SCADA, ERP or MES)

9. INSTRUMENTATION REQUIREMENTS

9.1 GENERAL

The Supplier shall define and supply all instrumentation and controls (according to the released P&ID, to be provided by the vendor) required to ensure satisfactory operation under the conditions stated in this specification. This shall include all instrumentation required for start-up and shutdown and for safe operation in accordance with the applicable codes and standards.

The analogue instruments (e.g., Temp, Pressure etc) shall be supplied complete with manufacturer calibration certificate and procedure and material certificates.

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The certificates shall be available at FAT execution. All instrument loops shall be tested during FAT (if Applicable).

Instrument position should be clearly reported in equipment layout.

The Supplier shall indicate the accuracy of the process instruments selected.

Redundancy for critical instruments (shelf temperature, shelf vacuum, shelf pressure, condenser temperature) in addition require vacuum gauges on both shelf and condenser chambers.

9.2 HYGIENIC REQUIREMENTS

Material of Construction

Wetted Parts Certificate Standard Certificate Affiliation

Product Contact

S/S 316 L or FDA approved Material

Confirmation of Surface Roughness: Ra < 0.8 um

Inspection Certificate according to EN 10204-3.1 or Equivalent (with mill certificate including chemical analysis)

SANAS or traceable international accredited association

Non-Product Contact

Application Determined

Application Determined

Application Determined Application Determined

9.3 ACCURACY REQUIREMENTS

Level Type Accuracy

Requirement Calibration Certificate Certificate Standard

Certificate Affiliation

Example

0

Critical Process

Parameter (Onsite/In-

Situ)

< 0.1% of Range

Min 3-Point Calibration Test Over Full Range with Results and Design Accuracy Confirmation

Inspection Certificate according to EN 10204-3.1 or Equivalent

SANAS accredited

Weight Transmitter

1

Critical Process

Parameter (Factory)

< 0.1% of Range

3-Point Calibration Test Over Full Range with Results and Design Accuracy Confirmation



Manufacturing Tank Temperature Transmitter

2

Non-Critical Process

Parameter (Factory)

< 0.5% of Range

Test Report, Specific (Range, Accuracy, Manufacturing Standard)



CIP Level Transmitter

3

General Utility

Parameter (Factory)

< 1% of Range

Test Report, Non-Specific (Range, Accuracy, Manufacturing Standard)


Supplier

Pressure Indicators

9.4 SAFETY DEVICES

Machines will be supplied with all needed safety devices to guarantee control and interlocked actions in any condition.

In particular operator should be protected from the contact with hot surfaces and moving parts (proximity switch should stop equipment in case of accidental access).

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10. STANDARDS, CODES AND REGULATIONS

OBP aligns with the following guidance. Where guidance differ, compliance is first to South African GMP (SAHPRA), then PICS, WHO, ISO, European and other, in that order. Supplier shall ensure compliance with the most stringent condition from any of the listed guidelines.

GMP

SAHPRA 4.01 SA Guide to GMP Nov 19 V6.1

S A Guide to GMP for Medicines Products

PICS PE 009-14(2018) Guide to GMP for Medicinal Products: Part 1, 2, Annexes

WHO TRS 986 (2014) GMP for Pharmaceutical Companies

WHO TRS 999 (2016) GMP for Biological Products

WHO TRS 961 (2011) GMP for Sterile Pharmaceutical Products

UTILITIES

WHO TRS 929 Annex 3 (2005) Water for Pharmaceutical Use

WHO TRS 937 Annex 2 (2006) Supplementary Guidelines on GMP for HVAC systems for non-sterile pharmaceutical dosage forms

ISO 8573 Parts 1-9 Sterile Compressed Air

ISPE Baseline Guides Vol 4: Water and Steam Systems

ISPE Baseline Guides Vol 5: Commissioning and Qualification

ISPE Baseline Guides Vol 6: Biopharmaceutical Manufacturing Facilities

FACILITIES

SABS/ISO 14644-1 Parts 1-4 Cleanrooms and associated controlled environments

SABS 0140 Parts 1-5 Identification colour marking

ISPE Baseline Guides Vol 3: Sterile Manufacturing Facilities

EQUIPMENT

SANS 12469:2002 / EN12469:2000

Biotechnology – Performance criteria for microbiological safety cabinets.

ASME - BPE Bioprocessing Equipment

PICS Recommendation on Isolators used for Aseptic Processing

PICS Good Practices for Computerized Systems in GXP environments

ELECTRICAL

SANS 10142 The wiring of premises

SANS 10108 Hazardous area classifications

SANS 1973 Low-voltage switchgear and control gear assemblies

VALIDATION

WHO TRS 1019 Annex 3(2019) GMP: Guidelines on Validation

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GAMP 5 GAMP Guide for Validation of Automated Systems

PHARMACOPOEIAS

EP European Pharmacopoeia

BP British Pharmacopoeia

USP United States Pharmacopoeia

SAFETY

Act 85 of 1993 Occupational Health and Safety Act

WHO (2004) WHO Biosafety Manual

OTHER CODES AND REGULATIONS

Act 101 1961 and amendments Medicines and Related Substances Control Act

Act 53 1974 and amendments Pharmacy Act

Act 36 1947 and amendments Fertilizer, Farm feeds, seeds and remedies

IFPMA 2006 Code of Pharmaceutical Marketing Practices

SANS 347 Categorization and conformity assessment

criteria for all pressure equipment

CEI regulations for electrical equipment & installation

OBP Instrumentation Symbols and Identifications

11. TRANSPORT

Transportation will be at Vendor’s cost and responsibility. Transport up to the OBP site, unloading of the truck and including the transport up to the planned location in the rooms is vendor’s responsibility.

12. DESIGN, MANUFACTURE, INSTALLATION, TESTING & COMMISSIONING

12.1 QUALITY PLAN

The Supplier shall produce a quality plan that shall contain the following:

1. Brief introduction about the Project.

2. Definition of the deliverables with expected contents lists for all documentation.

3. Details of standards, quality, and audit requirements.

4. Schedule of progress review and inspections/ testing foreseen during the project; with indication of OBP witness requirements.

5. Project and implementation plans/programme

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12.2 PROGRESS REVIEWS

Progress review meetings and design walk-through meetings will be held at various stages throughout the Project. Exact details shall be defined and agreed during the Supplier co-ordination meeting. It is anticipated that the Project will be divided into the following phased activities:

1. Kick-off meeting at order placement

2. Project Inspection

3. System Definition

4. Detailed design

5. Risk Assessment

6. Manufacture

7. FAT (Factory Acceptance test)

8. Delivery / Installation will be conducted by approved supplier employees or agent that is fully skilled.

9. Commissioning and Site Acceptance Test (SAT)

10. IQ/OQ protocols

11. Decommissioning of current equipment

12.3 INSPECTION DURING MANUFACTURE

Materials and work in progress will be subject to inspection by OBP to ensure that the manufacture is in compliance with the agreed design and the required codes, standards and regulations. Waiver of any phase of inspection must be obtained in writing from the Contractor.

12.4 FACTORY ACCEPTANCE TESTS (FAT)

The complete system shall be fully built at the Supplier’s factory making use of such additional temporary steelwork as is necessary. The equipment will be connected to adequate utilities fluids and to the control system and a factory acceptance test (FAT) carried out.

The Supplier shall provide a complete FAT procedure and protocol two weeks before FAT execution. OBP shall review the test procedure and protocol. The FAT shall be carried out on the basis of OBP approved FAT procedure. Supplier is responsible of testing execution and test results’ record on FAT protocol.

This test must demonstrate that the equipment and control system is in compliance with this specification and relevant standard, codes etc. OBP will carry out an inspection and witness the testing.

Equipment will not be released for shipment until a satisfactory inspection; factory acceptance test (FAT) and document hand over has been achieved.

The FAT shall include mechanical (dimensional, material check, etc.), electrical (wiring test, etc.), instrumentation (DI/DO, AI/AO test, etc.), control and performance tests and documentation check.

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All the drawings needed for FAT execution shall be available in “as built” revision before FAT execution.

12.5 INSTALLATION AND MECHANICAL COMPLETION

The Supplier shall provide personnel and supervision for the installation.

A preliminary installation schedule shall be provided with the Supplier’s quotation indicating man-hours and the duration of each task required.

The Supplier shall specify any special requirements that may arise during the installation period.

The supplier shall fill a Mechanical Completion checklist for each package/ equipment after installation.

A certificate of Mechanical Completion shall be issued by Supplier after successful close out of all deviation/ pending points, for review/ approval of OBP.

12.6 COMMISSIONING AND SITE ACCEPTANCE TESTS (SAT)

The equipment will be fully commissioned by the Supplier to demonstrate that all the installed equipment functions correctly. The complete SAT shall demonstrate that the equipment and control system are in complete compliance with this specification. OBP will witness this testing.

Protocols for commissioning and the site acceptance test (SAT) shall be produced by the Supplier two weeks before SAT execution for review and approved by OBP.

At the end of the SAT execution the Supplier shall provide a copy of:

• Software licences

• Last back-up programme software edition (any change to be done between FAT & SAT shall be recorded and agreed with OBP)

13. TRAINING

The supplier shall include session training for client operators and maintenance staff and contractors. Supplier shall also indicate the length of training required and shall issue training certificate to trainees on successful completion of training. Inhouse training for Pre-Fat with inhouse refrigeration, mechanical and electrical artisans at OBP.

14. VALIDATION / QUALIFICATION

The supplier shall provide:

• FDS

• Risk Assessment – templates by OBP

• IQ & OQ Protocols – templates by OBP, Supplier should advise OBP on test protocols and OBP to review and approve pre-SAT.

• Executed IQ & OQ Protocols and final reports.QA include the performance qualification of at least one of the volumes 1.1,2.1,5.1 with supplier.

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15. DOCUMENTATION & DRAWINGS

The supplier shall provide documentation detailing the design, fabrication, testing and commissioning. The supplier shall provide as built drawings and documentation in both hard copy and soft copy standard formats.

• Documentation electronic formats to be in MS OFFICE formats.

• Drawing electronic formats to be in AUTOCAD format.

16. GUARANTEES AND WARRANTIES

The supplier shall undertake to offer warranties/guarantees for a minimum period of between 2 to 5 year from the date of installation acceptance certificate for minor components.

The supplier shall undertake to offer warranties/guarantees for a minimum period of between 6 to 10 year from the date of installation acceptance certificate for major components such as loading shelf chamber , Condenser .