Factory Acceptance Test of Automatic Capsule Filling Machine
Table of Contents
- System Information
- Protocol Details
- Protocol Approval from Customer
- The objective of this protocol
- Scope of this Protocol
- Definition of FAT and SAT
- Acceptance Criteria
- Responsibility
- Customer Requirements
- Performance Check Points & Testing
- Machine Sr. number details AF T Lab
- Factory Acceptance Report Approval
- Final Report
System Information
Supplier: Pam Pharmaceutical & Allied Machinery Co. Pvt. Ltd.
The objective of this Protocol
To test the equipment before dispatch as per URS / Customer’s requirements.
Scope of this Protocol
Functional Tests with placebo & or actual material.
Safety Functions verification
Reporting of results and deviations
Equipment inspection & acceptance by the customer
Definition of FAT and SAT
Factory Acceptance Tests (FAT)
The FAT protocol is an inspection that includes both static and dynamic exhaustive testing of systems or major system components to support the qualification of equipment or a system. The tests must verify that all functionality detailed in the User Requirements Specification (URS) is embodied and performs as specified. It is written by the manufacturers and executed by the client or client representative.
Site Acceptance Tests (SAT)
The SAT is related to the FAT and also entails the inspection and dynamic testing of systems or major system components to support the qualification of equipment. This is written by the client and verifies that the installed functionality of the equipment meets or exceeds the operational requirements as specified in the equipment URS. The SAT is executed on completion of all commissioning tasks; but before the start of Installation Qualification execution.
Acceptance Criteria
FAT Protocol shall be referred for final Inspection of the equipment.
The Inspection Team shall note down their findings in the protocol after discussion with the vendor as per the details given in this protocol.
The inspection team may suggest the implementation of minor points at the vendor’s site.
On completion of FAT, the inspection team/vendor gives technical clearance of the equipment/system.
Responsibilities
Inspection
The customer is responsible for visiting the vendor’s site and completing the inspection based on this FAT Protocol.
Customer Requirements
Automatic Capsule filling Machine Model AF- T Lab
Change parts for powder Size # 4
Change parts for powder Size # 5
Change parts for powder Size # 0 (AF 25T)
Change parts for powder Size # 1 (AF 25T)
Change parts for pellet Size # 00 (AF 25T)
Vacuum Pump
Air displacement Unit Model ADU-100
Compact Air Displacement unit, Model CADU-100
Sorter Elevator Model SE-100
Interchangeable section for size 00
Interchangeable section for size 0
Interchangeable section for size-1
Interchangeable section for size-4
Interchangeable section for size-5
Automatic De-dusting and polishing machine Model DP-100
Empty capsule sorter Model ECS-100
Mini capsules sorter, Model MCS-100
Interchangeable section for size 00
Interchangeable section for size 0
Interchangeable section for size-1
Interchangeable section for size-4
Interchangeable section for size-5
Metal Detector, Model MD- 2000
Checkweigher, Model CW- 10
Product Conveying System, PCS 200
Performance check Points & Testing
Automatic Capsule Filling Machine Model: AF- T Lab
Machine specification & details
Voltage – Three phase 415 v 50 Hz
Single phase 220 v 50 Hz
Machine dimension
Output
Powder filling: 6000 capsules / hr. (AF T lab)
Powder filling: 25000 capsules / hr. (AF25T)
Pellet filling: 23,000 capsules / hr. (AF25T)
MMI –
Door – Acrylic
Machine mount –
Performance of the machine
Loading station
Check all the capsules get loaded in the bushes.
Separation of Cap / Body
Check cap/body gets separated after loading
Powder filling
Check that the slug is delivered into the body of the capsule without cutting.
Unopen ejection
Check all non-separated capsules get collected on an unopen collection box
Closing of filled capsule
Check all the capsules are closed and the lock length of the capsule is within +/- 0.2 mm of
# 00 – 23.5 mm, # 0 – 21.8 mm
# 1 – 19.5 mm , # 4 -14.5 mm
# 5 – 11.0 mm.
Ejection of capsules
Check all the filled are ejected without getting damaged
Total no. of capsules filled –Capsule size/Colour/No. of capsule filled
Filled capsule check – Denting/Telescoping/Unlocked/Folded
% Weight variation –Name of Powder / Pellet: Weight variation (Individual) 50 capsules, Weight variation (Group of 10 capsules)
Bush cleaning
Check for proper airflow from bush cleaning pins
Check for proper suction from bush-cleaning housing
The function of line machines
Sorter Elevator ( SE 100 )
No abnormal noise was observed.
Check that the sorter elevator sorts diametrically defective capsules & elevates empty capsules in the Automatic capsule-filling machine hopper
Check the function of the upper & lower-level sensor
Finish & aesthetics of the machine after final cleaning
Air Displacement Units (ADU 100)
No abnormal noise.
Check the direction of rotation of ADU & check for suction
Finish & aesthetics after final cleaning.
Compact Air Displacement Units ( CADU 100 )
No abnormal noise.
Check the direction of rotation of ADU & check for suction
Finish & aesthetics after final cleaning.
Dedusting & polishing (DP 100)
No abnormal noise.
Proper De dusting & polishing of the filled capsules
Finish & aesthetics after final cleaning.
Metal Detector ( MD 2000 )
Detection of Ferrous & Non-Ferrrous filled capsules.
Sorting of Ferrous & Non-Ferrous capsules in a separate box.
Checkweigher (CW 10 )
Sampling – Stroke base / Time base/manual.
Weight of capsule at intervals & alarms.
Weight variation report.
Empty Capsule Sorter ( ECS 100 )
No abnormal noise.
Check sorting of empty capsules from filled capsules.
Finish & aesthetics after final cleaning.
Mini Capsule Sorter (MCS 100)
- Check the proper assembly of change parts for the correct size of capsules.
- No abnormal noise.
- Function of the vibrator controller.
- Complete inspection of functional aspects (with filled capsules) & adjustment of critical settings.
- Check for the following diametrical defective 1) telescopic & heavy notches and 2) Loose capsules.
- Finish & aesthetics after final cleaning.
Product Conveying System (PCS 200)
Check, when the vacuum is on – proper suction of powder & intake gate is closed.
Check, when the vacuum is off – open the hopper gate & drop the powder.
Check, when PMM is on – Cycle stops.
Finish & aesthetics after final cleaning.
Alarms/interlocks verification
- Door open
- Air pressure low
- Line machines not working
- Overload of the main motor
- Metal detected in capsule
- Hand wheel “IN”
- Powder level low
- Pellet level low
- Capsule level low
- Individual Weight out of limit
- Average weight out of limit
- Over speed of the main motor.
Machine serial number details
Machine Details
Automatic Capsule Filling Machine Model: AF T Lab.
Vacuum pump
Air Displacement Unit, ADU 100
Compact Air displacement unit, CADU 100
De-dusting & polishing machine, DP 100
Empty Capsule Sorter, ECS 100
Mini Capsule Sorter, MCS 100
Sorter Elevator Unit, SE 100
Metal Detector, MD 2000
Check weigher, CW 10
Product Conveying System, PCS 200
Factory Acceptance Report
Final Report
