sample fat protocol

Pharmaceutical Guidelines

Document No :

PG/FAT/001

Factory Acceptance Test

Protocol Page No : 1 of 6

Tray Dryer (96 Trays)

1. Purpose :

1. To ensure that the Tray Dryer (96 Trays) is manufactured as per designed

specification at manufacturer's site.

2. To check the basic performance of the machine at manufacturer's site.

2. Scope and References:

1. This protocol is applicable to the machine manufactured by M/S XYZ Pvt. Ltd.

3. Procedure:

1. Take out photocopy of the approved protocol for the FACTORY ACCEPTANCE

TEST to be carried at the manufacturer's site.

2. Carry out the below tests mentioned in Table Number 1 at manufacturer's site

& mention the observation in ACTUAL column of the protocol photocopy.

3. In case of any additional information or mode of checking mention in the

REMARKS column.

4. Check the basic operation of the machine.

5. In case any deviation observes during FAT, document it in Observed deviation

section.

6. Ensure that corrective action taken is meeting the user requirement

specification.

7. If deviation is acceptable, document in Observed Deviation section and provide

proper justification.

8. If deviation does not acceptable, inform to manufacturer for necessary action.

9. If deviation is acceptable, provide final conclusion.

10. Ensure that following listed documents are provided.

1. Operational and Maintenance manual

2. Electrical / mechanical schematics diagram

3. Process and utility diagram

4. Critical Spare part list

4. Documentation

All documentation work shall be completed concurrently during execution of the

FAT. However the protocol does not define the sequence of the test/

documentation to be carried out.

1. Use indelible black / blue ink for the recording.

2. Fill out complete information in the format provided.

3. Do not leave any blank space.

4. Correct the wrong entry by drawing single line through incorrect data,

recording the correct data and then signing and dating the change.

5. Enter NA in space that is not applicable. 6. During execution of the protocol any deviation must be implemented as per

defined procedure.

7. During protocol execution, report shall be prepared with following details.

1. Discussion of all study in observation column.

Pharmaceutical Guidelines

Document No :

PG/FAT/001

Factory Acceptance Test

Protocol Page No : 2 of 6

Tray Dryer (96 Trays)

2. FAT is successfully completed or not

3. Conclusion

4. Recommendation, if any

5. Acceptance criteria:

1. The Equipments shall fulfill the selection criteria & its purpose of application.

1. The Equipments shall be as per purchase order.

2. Accessories received shall be as per purchase order.

3. The Equipments shall meet Pre-selected design parameters.

6. Verification Sheet:

Sr.

No.

Item/

Parameter

Expectation Actual Remarks

1 Make M/s Precikot Pharma Pvt. Ltd.

2 Model Tray Dryer (96 Trays)

3 Capacity : Approx. 300.00 kg with 0.5 Bulk Density

4 Design: Should have basic four parts,

Process Chamber

Trolley

Trays

Air Filtration system

5 Process

Chamber

comprising

Air Deflectors

Excess pressure flap

Door lock

Trolleys & Trays

MOC SS 316

6 Trolley: MOC : SS 316

Qty. 2 Nos.

With PU Wheel

7 Trays : MOC : SS316

Qty. 96 Nos.

8 Air Filtration

system :

Feed Blower

Pre Filter

Cooling Coil

Steam Coil

HEPA Filter

DOP Test report

MOC: SS 304

9 Feed Blower Make : Paan Fabriwork Engineering

Pharmaceutical Guidelines

Document No :

PG/FAT/001

Factory Acceptance Test

Protocol Page No : 3 of 6

Tray Dryer (96 Trays)

Capacity: 1500 CFM

Qty. 1 No

Motor : Reputed

HP : 3

Qty. 1 No.

10 Pre Filter

(Combination

type)

Filtration : 5 & 10

Make : Fine Airsys

Qty. 1 Nos.

11 Cooling Coil Make : Precikot

Qty. 1 No

MOC : SS316

12

Steam Coil

Make : Precikot

Qty. 1 No

MOC : SS316

13 HEPA Filter Filtration : 0.3

Make : Fine Airsys

Qty. 1 Nos.

Effeciency : 99.97 %

14 Exhaust

Blower

Make : Paan Fabriwork Engineering

Capacity: 1000 CFM

Qty. 1 No

Motor : Reputed

HP : 2

Qty. 1 No.

15 Control Panel

:

Qty. 1 No.

Operation : Through Auto/ Manual

Mode

Emergency Stop

Manual ON/ OFF switch

16 PLC Make : Allen Bradly

Model : Micro Logix

Qty. 1 No

17 HMI Make : Allen Bradly

Model : PV 550 Touch display

Qty. 1 No

18 Temperature

Sensor

Type : RTD

Make : Trister

Model : PT - 100

Qty. 5 Nos.

Pharmaceutical Guidelines

Document No :

PG/FAT/001

Factory Acceptance Test

Protocol Page No : 4 of 6

Tray Dryer (96 Trays)

19 Air Velocity

Sensor

Make : Microset

Model : HD403TS1

Qty. 1 No.

20 % RH Sensor Make : Microset

Model : RHT-DM

Qty. 1 No.

21 Operation

Selector

switch

PLC should Switch ON/ OFF by turning

the switch to ON / OFF position

22 Timers &

temperature

When selected should able to run the m/c

for set period of time & temperature

within 10C of set value,

23 Emergency

STOP Push

button

When pressed should stop the machine.

Start the machine & check.

24 Safety

Features

All moving

parts

All electrical

connections

Should be suitably covered under

replaceable guards or box

Should be appropriately numbered and

identif ied and covered with suitable

guard.

25 Documents

Machine

Manual

Should be available

MOC

Certificates

Should be available

Calibrati

on

Certificates

Should be available

Test and

Guarantee

Certificates

Should be available for Blower, motors &

Filters

7. Observed Deviation

Details of Deviation/ s :

Pharmaceutical Guidelines

Document No :

PG/FAT/001

Factory Acceptance Test

Protocol Page No : 5 of 6

Tray Dryer (96 Trays)

Investigation:

Corrective action:

Acceptable : Yes / No

Deviation Approved by / Date:

8. Conclusion:

FAT CARRIED OUT BY: IN PRESENCE OF MANUFACTURER:

Sign : Date:

Name:___________________________

Name: Sign : Date:

Pharmaceutical Guidelines

Document No :

PG/FAT/001

Factory Acceptance Test

Protocol Page No : 6 of 6

Tray Dryer (96 Trays)

Sign : Date:

Name:

___________________________

Site address :-

9. Approval

Name & Designation Department Signature Date

Prepared By

Checked By

Approved By