Sample FAT Protocol

FACTORY ACCEPTANCE TEST PROTOCOL Document No : PG/FAT/001

Equipment : Tray Dryer (96 Trays)

Page No : 1 of 6

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.

2. FAT is successfully completed or not

FACTORY ACCEPTANCE TEST PROTOCOL Document No : PG/FAT/001

Equipment : Tray Dryer (96 Trays)

Page No : 2 of 6

3. Conclusion 4. Recommendation, if any 5. Acceptance criteria: 1.

1.

2.

3.

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

The Equipments shall be as per purchase order.

Accessories received shall be as per purchase order.

The Equipments shall meet Pre-selected design parameters.

6. Verification Sheet: Sr. No.

Item/ Parameter

Expectation

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 Capacity: 1500 CFM Qty. 1 No

Actual

Remarks

FACTORY ACCEPTANCE TEST PROTOCOL Document No : PG/FAT/001

Equipment : Tray Dryer (96 Trays)   

Motor : Reputed HP : 3 Qty. 1 No.

10

Pre Filter (Combination type)

  

Filtration : 5 & 10 µ 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 µ 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.

19

Air Velocity Sensor

  

Make : Microset Model : HD403TS1 Qty. 1 No.

Page No : 3 of 6

FACTORY ACCEPTANCE TEST PROTOCOL Document No : PG/FAT/001

Equipment : Tray Dryer (96 Trays)

20

% RH Sensor

  

21

Operation  Selector switch

22

 Timers & When selected should able to run the m/c temperature for set period of time & temperature within ± 10°C of set value,

23

 Emergency STOP Push button

When pressed should stop the machine.

24

Safety Features  All moving parts  All electrical connections

Should be suitably covered under replaceable guards or box Should be appropriately numbered and identified and covered with suitable guard.

25

Documents  Machine Manual

Should be available

 MOC Certificates

Should be available

 Calibration Certificates

Should be available

 Test and Guarantee Certificates

Should be available for Blower, motors & Filters

PLC should Switch ON/ OFF by turning the switch to ON / OFF position

Start the machine & check.

7. Observed Deviation Details of Deviation/ s :

Investigation:

Make : Microset Model : RHT-DM Qty. 1 No.

Page No : 4 of 6

FACTORY ACCEPTANCE TEST PROTOCOL Document No : PG/FAT/001

Equipment : Tray Dryer (96 Trays)

Page No : 5 of 6

Corrective action:

Acceptable : Yes / No

Deviation Approved by / Date:

8. Conclusion:

FAT CARRIED OUT BY:

IN PRESENCE OF MANUFACTURER:

Sign : Date: Name: Sign : Date: Name:___________________________ Site address :Sign : Date:

FACTORY ACCEPTANCE TEST PROTOCOL Document No : PG/FAT/001

Equipment : Tray Dryer (96 Trays)

Page No : 6 of 6

Name: ___________________________

9. Approval Name & Designation Prepared By Checked By Approved By

Department

Signature

Date