validation protocol cg ta

IQ / OQ Documentation

For

MAS 100 CG Ex Compressed Gas Sampler

Supplied by

Merck KGaA

THIS PAGE TO BE REMOVED AND REPLACED WITH A

DIVIDER TITLEDAPPROVALS

Validation Protocol Approval Sheet

Title: MAS-100 CG Ex Compressed Gas Micriobial Sampler

Supersedes: Revision 0

Original Issue Date: 11/18/09

Effective Date:

Revision Number: 0

Serial No: Page Number: 1 of 1

This following individuals have reviewed the attached validation protocol for the

MAS-100 CG Ex Compressed Gas Sampler and their signature indicates approval of

the completed protocol after a review of all data, deviation and discrepancy

reports. Revisions to this document require a new approval sheet.

Protocol Approved By: Name:

Title:

Signature:

Date:


Title:

Signature:

Date:


Title:

Signature:

Date:


Title:

Signature:

Date:

Validation Protocol Approval Sheet

Title: MAS-100 CG Ex Compressed Gas Micriobial Sampler

Supersedes: Revision 0

Original Issue Date: 11/18/09

Effective Date:

Revision Number: 0

Serial No: Page Number: 1 of 1

This following individuals have reviewed the proposed validation protocol for the

MAS-100 CG Ex Compressed Gas Sampler. Revisions to this document require a

new sign-off sheet. Review of this document doesn’t imply approval of the

completed validation protocol as discrepancies could exist.

Protocol Reviewed By: Name:

Title:

Signature:

Date:


Title:

Signature:

Date:


Title:

Signature:

Date:


Title:

Signature:

Date:


DIVIDER TITLEDPROTOCOL

A. Validation Protocol Revision History Sheet

Title: MAS-100CG EX Microbial Sampler

RevisionNumber

Issue Date Issued By Revision Description

0 11/18/2009 TA Original Issuance of Validation Protocol

Installation and Operational Qualification Merck KGaA: MAS-100 CG EX Compressed Gas Microbial Sampler Protocol Revision: 0 18/11/09 B. OBJECTIVE

The objective of the Installation Qualification (IQ) of the Merck KGaA MAS-100 CG EX Compressed Gas Sampler is to assure that the instrument has been correctly supplied and installed according to the purchase order and Merck KGaA installation guidelines.

The objective of the Operational Qualification (OQ) of the Merck KGaA MAS-100 CG Ex Compressed Gas Sampler is to assure that the instrument operates correctly over the entire operating range according to defined procedures.

B. BACKGROUND INFORMATION, DESCRIPTION, AND FUNCTION

The MAS-100 CG Ex, Compressed Gas Sampler, is an easy to use instrument for precise monitoring of microorganisms in compressed gasses. The MAS-100CG EX is a sieve impaction type of instrument based upon the principles described by Andersen [1]. Gas is aspirated through a perforated lid (300 X 0.6mm holes). The resulting gas stream, which contains particles, is directed onto the agar surface of a standard Petri dish (90 mm diameter). The instrument can be programmed for total collection volumes of up to 2000 liters, however most firms will run 1000 liter volumes. The MAS-100CG EX operates with two integrated sensors, one for mass flow and the other for pressure. These sensors continuously regulate gas flow to provide an accurate sample collection. The gas flow rate is regulated at a constant rate 50 liters/min or 100 liters/minute which is determined by the flow requirements of the gas system being sampled. The MAS-100CG EX is pre programmed for compressed air, nitrogen, carbon dioxide, argon and Oxygen. Up to 10 gasses can be programmed and stored in the instrument. The instrument operates over pressure range of 1.5 to 10 bar. The MAS-100CG EX compensates for all factors which could influence gas flow, like the volume of agar in the Petri dish or the variation in the Petri dish diameter. The impaction speed of the microorganisms on the agar surface is approximately 11 meters/second which corresponds to stage 5 in the Andersen-Sampler at 50 liters per minute.This velocity assures that all particles > 1 m are collected. After a collection cycle, the Petri dish is incubated and the colonies are counted and expressed as colony forming units (cfu/m3) using the correction table from Feller (positive hole conversion table).

A computer interface cable is included with the system to allow communication between the MAS-100CG Ex and a compatible computer. Software is available from Merck KGaA. Validation of the PC software is separate from the MAS-100 instrument validation.

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Installation and Operational Qualification Merck KGaA: MAS-100 CG EX Compressed Gas Microbial Sampler Protocol Revision: 0 18/11/09 Reference

[1] New Sampler for the Collection, Sizing, and Enumeration of Viable Airborne Particles,A. Anderson, U.S. Army Chemical Corps Proving Ground, Dugway, Utah, 1958


Installation and Operational Qualification Merck KGaA: MAS-100 CG EX Compressed Gas Microbial Sampler Protocol Revision: 0 18/11/09

C. INSTALLATION AND OPERATIONAL QUALIFICATION

1. SUPPLY VERIFICATION

Verify that the component supply is complete and undamaged. Fill-in the appropriate boxes of the table, sign and date each entry. Complete a discrepancy report for each missing or damaged component.

Supply Verification Pass/CompleteNot Applicable

Discrepancy/Incomplete Damaged

Signature and Date

Verify that the following standard components have been supplied.MAS-100 CG EX sampler with roller case. Cat. No. 1.09327.0001

(1) Battery charger with mains cable and appropriate power cable for wall outlet.Sampling head, low flow 50 to 100 L/min flow rate:

(1) Sampling cover (300 X 0.6 mm holes) , (1) bottom plate

with adjustable Petri dish holder, (1) O Ring.

(1)Tri-Clamp (1), Rapid male coupling attached to Tri-clover flange coupling. (1) gasket

(1) Grounding cable

(1) Allen key, (1) extra O Ring for sampling head, (1) extra O ring for rapid male coupling (1) Laminated positive hole conversion table. (Feller conversion table)(1) Calibration Certificate

Supply Verification reviewed by: _______________________________ Date: ________________



Supply Verification(Continued)

Pass/CompleteNot Applicable

Discrepancy/Incomplete Damaged

Signature and Date

Verify that the following optional accessories have been supplied for the MAS-100CG EX Compressed Gas Sampler, if purchased. Reference the purchase order.

Extra sampling head, for 50/100 L/min flow rate: (1) Sampling cover (300 X 0.6 mm holes) , (1) bottom plate with adjustable Petri dish holder, (1) O Ring.

Cat. No. 1.09237.0001

Supply Verification reviewed by: _______________________________ Date: ________________



2. SET-UP VERIFICATION

Verify that the instrument is properly set-up for operation. Complete a discrepancy report for any activity that fails this test. Complete a deviation report for any test that is modified.

Set-Up Verification Pass/CompleteNot Applicable

Discrepancy/Fail Signature and Date

1. Place the MAS-100 CG EX on a solid base such as a table so it doesn’t topple over during set-up.

2. Serial No.______________

3. Verify the firmware version to the calibration certificate.

Firmware Version___________4. Calibration Verification:

Certificate not older than 24 months.

Calibration Date:___________Expiration Date:____________5. Set Time and Date

6. Plug in battery charger an charge battery for 2.5 hrs.

7. Preset Standard Volume: Volume 1 = 50 L8. Preset Standard Volumes: Volume 2 = 100 L9. Preset e Standard

Volumes: Volume 3 = 250 L10. Preset Standard Volumes: Volume 4 = 500 L11. Preset Standard Volumes: Volume 5 = 1000 L12. Activate/Deactivate Delay

Time

13. Set Operation Mode:Verify the system is set to Manual mode.Check instrument selects automatically correct Flow-rate 50/100 Liters/minute (depends on pressure of gas supply).


Installation and Operational Qualification Merck KGaA: MAS-100 CG EX Compressed Gas Microbial Sampler Protocol Revision: 0 18/11/09 Set-Up Verification (cont.) Pass/Complete

Not ApplicableDiscrepancy/Fail Signature and Date

14. Petri dish support jaw check:

Remove sampling head cover by loosening clamp screws and removing the four clamps. Press down on the clamps with the red dots to lift sampling head cover. Place a Petri dish on to the dish support. Adjust the blue jaw clamps with the Allen key so the Petri dish is held snug in place. 15. Reinstall the sampling

head cover and evenly tighten the four clamps in place.

16. Adjust the sampling head so that it is in a vertical position.

17. The unit may be operated from a solid base such as a table or trolly.

Set-Up Verification reviewed by: _______________________________ Date: ________________


Installation and Operational Qualification Merck KGaA: MAS-100 CG EX Compressed Gas Microbial Sampler Protocol Revision: 0 18/11/09 3. BASIC OPERATION VERIFICATION

Verify that the instrument performs the following basic operations. Complete a discrepancy report for any activity that fails this test. Complete a deviation report for any test that is modified.

Basic Operation Verification Pass/CompleteNot Applicable

Discrepancy/Fail Signature and Date

1. Press the yes button when the MAS-100CG EX is in sleep mode. The gas type and last volume used will then be displayed.

2. Press no then the “change gas” prompt will be displayed.

3. Press yes to select a different gas. Contimue to press yes until desired gas type is displayed (Air, Nitrogene, CO2, Argon, Oxygene)

4. Press no and “select other volumes” is displayed.

5. Press no then “select volume” is displayed.

6. Press yes to modify volume, if more than one volume is programmed, it must be possible to choose among the programmed volumes. Contimue to press yes until desired sampling volume is displayed.

7. Press no then display shows the gas type and sample collection volume chosen.

8. Without connecting the gas supply press yes and the “Start?” prompt is displayed.

9. Push yes and the MAS-100 CG Ex will start to run. The green “run” LED is lit.

10. After the MAS-100CG Ex has started to run press no, the “Failed Repeat Test” message must be displayed. “Close gas supply and decompress” is then



displayed. At the same time the run and stop LED’s are flashing.

11. Push yes then “Press Release Running” is displayed. After a few seconds ”Open sampling head now” is displayed. The red stop LED is now on.

12. Push yes and the gas type and sampling volume will be displayed.

13. Press yes again and “Start?” will be displayed. Press yes again and the MAS-100 CG EX will begin to run. The green run LED will be on.

14. After a few seconds the “Failed Repeat Test” message must be displayed, followed by “Gas flow too low”. At the same time the run and stop LED’s are flashing.

15. Press yes then “Close gas supply and decompress” is then displayed. At the same time the run and stop LED’s are flashing.

16. Push yes then “Press Release Running” is displayed. After a few seconds ”Open sampling head now” is displayed. The red stop LED is now on.

17. Push yes and the gas type and sampling volume will be displayed.

18. Wait for 5 minutes then the MAS-100CG Ex will go into sleep mode, nothing on display.

Results of tests reviewed by: _______________________________ Date: ________________


Installation and Operational Qualification Merck KGaA: MAS-100 CG EX Compressed Gas Microbial Sampler Protocol Revision: 0 18/11/09 4. DOCUMENTATION AND MAINTENANCE VERIFICATION

Complete the following table for the documentation and maintenance of the MAS-100 air sampler w/ data port.

Description AvailableYes/No orNot Applicable

Document Located

DocumentNumber(s)

Signature and Date

Purchase Order

Technical Specification

Operation Manual

PM and Calibration Program (optional)Spare Parts List

Cleaning and Usage LogbookOperating SOP

Cleaning SOP

Training Records

Documentation and records reviewed by: _______________________________ Date: ________________


Installation and Operational Qualification Merck KGaA: MAS-100 CG EX Compressed Gas Microbial Sampler Protocol Revision: 0 18/11/09 Comments

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D. CONCLUSION

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Signature: ____________________________________ Date: ______________________________



DIVIDER TITLEDAPPENDICES

Appendix A.

(1) Purchase Order(2) Technical Specification (Vendor Literature)(3) Operation Manual(4) PM and Calibration Program Datasheet(5) Spare Parts List(6) Operating SOP(7) Cleaning and Usage Logbook(8) Cleaning SOP(9) Training Records

Appendix B.

Calibration CertificateCalibration Certificate of Instrument used to Calibrate the MAS-100CG EXCalibration Certificate of Instruments used for Validation

Appendix C.

Summary of Cleanroom Classification StandardsPositive Hole Conversion Table CalculationAnderson Report – New Sampler for the Collection, Sizing, and Enumeration of Viable Airborne ParticlesSwiss Pharma Paper, “Detection of Microorganisms in Compressed Gasses”, Validation of the MAS-100CG Using Compressed Gasses.

C. Appendix D: References

Firmware Revision History Sheet

Title: MAS-100 CG EX Compressed Gas Sampler

RevisionNumber

Issue Date Issued By Revision Description

As Delivered


DIVIDER TITLEDDEVIATION REPORTS

DISCREPANCY REPORT

Validation Deviation Report

Part I. Deviation Identification. (Completed by Initiator)

System Name: MAS-100 CG Ex Compressed Gas Microbial Sampler

Validation Protocol Section Number: ______________________________________

Deviation Number: _____________________________________________________

Provide Short Description of the Deviation:__________________________________

_____________________________________________________________________

_____________________________________________________________________

_____________________________________________________________________

_____________________________________________________________________

Identified by: __________________________________________________________ Initiator’s Signature and Date

Part II. Impact on Protocol. (Completed by Person Resolving the Deviation)

Indicate the Impact the Deviation has on the System Protocols: __________________

_____________________________________________________________________

_____________________________________________________________________

_____________________________________________________________________

_____________________________________________________________________

_____________________________________________________________________

Resolved by: _________________________ Date: ___________________________

Reviewed by: _________________________ Date: ___________________________

Attach to the applicable validation protocol.

Validation Discrepancy Report

Part I. Discrepancy Identification. (Completed by Initiator)

System Name: MAS-100CG EX Compressed Gas Microbial Sampler____


Discrepancy Number: ___________________________________________________

Provide Description of the Discrepancy Found and Possible Causes:_______________

_____________________________________________________________________

_____________________________________________________________________

_____________________________________________________________________

_____________________________________________________________________


Part II. Corrective Action. (Completed by Person Resolving the Discrepancy)

Describe the Corrective Action Taken: _____________________________________

_____________________________________________________________________

_____________________________________________________________________

_____________________________________________________________________

_____________________________________________________________________

_____________________________________________________________________

Resolved by: _________________________ Date: ___________________________

Verified by: _________________________ Date: ___________________________

Was the Corrective Action Taken Satisfactory? _______________________________ Initiator’s Signature/Date

Attach to the applicable validation protocol.Validation Discrepancy Report

Part I. Discrepancy Identification. (Completed by Initiator)

System Name: MAS-100CG EX Compressed Gas Microbial Sampler____


Discrepancy Number: ___________________________________________________

Provide Description of the Discrepancy Found and Possible Causes:_______________

_____________________________________________________________________

_____________________________________________________________________

_____________________________________________________________________

_____________________________________________________________________


Part II. Corrective Action. (Completed by Person Resolving the Discrepancy)

Describe the Corrective Action Taken: _____________________________________

_____________________________________________________________________

_____________________________________________________________________

_____________________________________________________________________

_____________________________________________________________________

_____________________________________________________________________

Resolved by: _________________________ Date: ___________________________

Verified by: _________________________ Date: ___________________________

Was the Corrective Action Taken Satisfactory? _______________________________ Initiator’s Signature/Date

Attach to the applicable validation protocol.


DIVIDER TITLEDEXECUTIVE SUMMARY

Validation Protocol Execution Summary Sheet

System Name: MAS-100 CG EX Validation Protocol Executed: IQ/OQQualification Completed On (Date):Number of Deviation Reports Issued:Number of Discrepancy Reports Issued: #Resolved:

Remaining Corrective Action, Comments, and Recommendations:

What Corrective Action is remaining and provide timing for the completion of each so that follow-up can be scheduled?

If Corrective Action is remaining,is there a quick fix in place until Corrective Action is completed?

Comments and Recommendations:

Signed ________________________ Title ____________________________ Date _________________

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