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
: Tray Dryer (96 Trays)
Page No : 2 of 6
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:
1 Make M/s Precikot Pharma Pvt. Ltd. 2 Model Tray Dryer (96 Trays)
4 Design Should have basic four parts,
Process Chamber
Trolley
Trays
Air Filtration system
5 Process Chamber comprising
6 Trolley
7 Trays
8 Air Filtration system
9 Feed Blower
Air Deflectors
Excess pressure flap
Door lock
Trolleys & Trays
MOC SS 316
MOC : SS 316
Qty. 2 Nos.
With PU Wheel
MOC : SS316
Qty. 96 Nos.
Feed Blower
Pre Filter
Cooling Coil
Steam Coil
HEPA Filter
DOP Test report
MOC: SS 304
Make : Paan Fabriwork Engineering
Capacity: 1500 CFM
Qty. 1 No
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
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
18 Temperature Sensor
Make : Allen Bradly Model : PV 550 Touch display Qty. 1 No
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 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 ± 10°C 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 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
7. Observed Deviation
Details of Deviation/ s :
Investigation:
Page No : 4 of 6
FACTORY ACCEPTANCE TEST PROTOCOL
Document No : PG/FAT/001
Corrective action:
Acceptable : Yes / No
Equipment : Tray Dryer (96 Trays)
Page No : 5 of 6
Deviation Approved by / Date:
8. Conclusion: FAT CARRIED OUT BY: IN PRESENCE OF MANUFACTURER:
