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Sample FAT Protocol

The document provides a protocol for conducting a factory acceptance test (FAT) of a 96-tray tray dryer at the manufacturer's site. The summary includes: 1) The protocol outlines tests to check that the tray dryer meets design specifications and performs basic functions as manufactured. 2) Tests listed in a verification sheet include checking components like the process chamber, trolleys, trays, air filtration system, sensors and documentation. 3) Any deviations observed during testing must be documented, investigated and corrective actions approved to ensure specifications are met.

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Umer Al-Faisal
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© © All Rights Reserved
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Download as PDF, TXT or read online on Scribd
10K views

Sample FAT Protocol

The document provides a protocol for conducting a factory acceptance test (FAT) of a 96-tray tray dryer at the manufacturer's site. The summary includes: 1) The protocol outlines tests to check that the tray dryer meets design specifications and performs basic functions as manufactured. 2) Tests listed in a verification sheet include checking components like the process chamber, trolleys, trays, air filtration system, sensors and documentation. 3) Any deviations observed during testing must be documented, investigated and corrective actions approved to ensure specifications are met.

Uploaded by

Umer Al-Faisal
Copyright
© © All Rights Reserved
Available Formats
Download as PDF, TXT or read online on Scribd
You are on page 1/ 6

Pharmaceutical Guidelines

Document No :

Factory Acceptance Test

PG/FAT/001

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 Refe rences:
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. Doc umentation
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 draw ing 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 :

Factory Acceptance Test


Protocol

PG/FAT/001

Page No : 2 of 6

Tray Dryer (96 Trays)


2. FAT is successfully completed or not
3. Conclusion
4. Recommendation, if any
5. Acceptance crite ria:
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/
Paramete r

Expectation

Make

M/s Precikot Pharma Pvt. Ltd.

Mode l

Tray Dryer (96 Trays)

Capacity :

Approx. 300.00 kg with 0.5 Bulk Density

Design:

Should have basic four parts,


Process Chamber
Trolley
Trays
Air Filtration system

Process
Chamber
comprising

Air Def lectors


Excess pressure flap
Door lock
Trolleys & Trays
MOC SS 316

Trolley:

MOC : SS 316
Qty. 2 Nos.
With PU Wheel

Trays :

MOC : SS316
Qty. 96 Nos.

Air Filtration
system :

Feed Blower
Pre Filter
Cooling Coil
Steam Coil
HEPA Filter
DOP Test report
MOC: SS 304

Feed Blowe r

Make : Paan Fabriwork Engineering

Actual

Rema rks

Pharmaceutical Guidelines
Document No :

Factory Acceptance Test


Protocol

PG/FAT/001

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

Make : Precikot
Qty. 1 No
MOC : SS316

12

Steam Coil

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 Pane l
:

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

Tempe rature
Sensor

Type : RTD
Make : Trister
Model : PT - 100
Qty. 5 Nos.

Pharmaceutical Guidelines
Document No :

Factory Acceptance Test


Protocol

PG/FAT/001

Page No : 4 of 6

Tray Dryer (96 Trays)


19

Air Ve locity
Sensor

Make : Microset
Model : HD403TS1
Qty. 1 No.

20

% RH Se nsor

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

21

Operation
Selector
switch

PLC should Sw itch ON/ OFF by turning


the switch to ON / OFF position

22

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

23

Emergency
STOP Push
button

When pressed should stop the machine.

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.

24

25

Start the machine & check.

Doc uments
Should be available

Machine
Manual

MOC
Certificates

Should be available

Calibrati Should be available


on
Certificates

Test and Should be available for Blower, motors &


Guarantee
Filters
Certificates

7. Observed Dev iation


Details of Deviation/ s :

Pharmaceutical Guidelines
Document No :

Factory Acceptance Test


Protocol

PG/FAT/001

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 MANUFAC TURER:

Sign : Date:
Name: Sign : Date:
Name:___________________________

Pharmaceutical Guidelines
Document No :
PG/FAT/001

Factory Acceptance Test


Protocol

Page No : 6 of 6

Tray Dryer (96 Trays)

Site address :Sign : Date:

Name :
___________________________

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

Depart ment

Signature

Date

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