Pharmaceutical Guidelines

Factory Acceptance Test Protocol

Document No : Equipment :
Page No : 1 of 6
PG/FAT/001 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.
2. FAT is successfully completed or not

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 Pharmaceutical Guidelines
Factory Acceptance Test Protocol

Document No : Equipment :
Page No : 2 of 6
PG/FAT/001 Tray Dryer (96 Trays)

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. Item/ Expectation Actual Remarks
No. Parameter
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  Air Deflectors
Chamber  Excess pressure flap
comprising  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  Feed Blower
system  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

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 Pharmaceutical Guidelines
Factory Acceptance Test Protocol

Document No : Equipment :
Page No : 3 of 6
PG/FAT/001 Tray Dryer (96 Trays)

 Motor : Reputed
 HP : 3
 Qty. 1 No.
10 Pre Filter  Filtration : 5 & 10 µ
(Combination  Make : Fine Airsys
type)  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  Make : Paan Fabriwork Engineering
Blower  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  Type : RTD
Sensor  Make : Trister
 Model : PT - 100
 Qty. 5 Nos.
19 Air Velocity  Make : Microset
Sensor  Model : HD403TS1
 Qty. 1 No.

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 Pharmaceutical Guidelines
Factory Acceptance Test Protocol

Document No : Equipment :
Page No : 4 of 6
PG/FAT/001 Tray Dryer (96 Trays)

20 % RH Sensor  Make : Microset

 Model : RHT-DM
 Qty. 1 No.
21 Operation PLC should Switch ON/ OFF by turning
 Selector the switch to ON / OFF position
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 When pressed should stop the machine.
STOP Push
button Start the machine & check.
24 Safety Should be suitably covered under
Features replaceable guards or box
 All moving Should be appropriately numbered and
parts identified and covered with suitable
 All electrical guard.
connections
25 Documents Should be available
 Machine
Manual
 MOC Should be available
Certificates
 Calibration Should be available
Certificates
 Test and Should be available for Blower, motors &
Guarantee Filters
Certificates
7. Observed Deviation
Details of Deviation/ s :

Investigation:

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Factory Acceptance Test Protocol

Document No : Equipment :
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PG/FAT/001 Tray Dryer (96 Trays)

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:

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 Pharmaceutical Guidelines
Factory Acceptance Test Protocol

Document No : Equipment :
Page No : 6 of 6
PG/FAT/001 Tray Dryer (96 Trays)

Name:
___________________________

9. Approval
Name & Designation Department Signature Date
Prepared By
Checked By
Approved By

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