INSTALLATION, OPERATIONAL QUALIFICATION PROTOCOL Installation, Operational, Qualification of the Capsule Filling Machine [details with location here]
Validation No.XX and Asset No.XX Your Site Here
Ref: XXXX
Rev: 1
Page No 1 of 3
Installation & Operational Qualification Protocol Capsule Fillers (Equipment No. – XXXXX)
Document Ref: VP-XX-IOQ-XX
Version: 1.0
Effective Date: XXXXX
IOQ PROTOCOL AUTHORISATION Name/Title
Signature
Date
Signature
Date
Prepared by Reviewed by Reviewed by Reviewed by
IOQ PROTOCOL REPORT AUTHORISATION Name/Title Reviewed by Reviewed by Reviewed by
Page 1 of 3
IOQ Capsule Fillers IOQ Line XX
Equipment No.XXXXX
Introduction The tablet & capsule counting machine on Line XX will be validated and has been running historically with production history and data. This IOQ will cover the validation of the system and its components to GMP, MHRA Annex 15.
Brief System Description and IOQ Rationale The XXXX, electronic multi channel tablet & capsule counting machine is part of the Line XX packaging line. The purpose of the counting machine is to count tablets and capsules as well as fill the tubs automatically to a pre-set quantity as they are filled. The XXXX consists of 4 major parts: 1. Feed System for all tablets and capsules 2. Electronic multi-channel counting system 3. Conveyor system with container alignment gate 4. Monitoring System The above systems shall all be challenged in this protocol. Tablets and capsules are loaded into a hopper manually or an automatic lifter. The speed variable vibrators feed the tablets to the counting zone. There are 12 channels feeding into a single filling funnel. Dust and chips are extracted in three points of a vibrating tray. Tablets drop into 12 tablet guides. Each guide has an infra red sensor system to count the tablets. There is an optical system covered by glass and an electronic program which compensates for the count or obstruction of dust. Counted tablets drop into a container through a funnel. The container alignment gate keeps the container position by means of sensor and pneumatic cylinders. The continuous counted tablets in the tablet guide by a shutter gate while the container feeds out after target fill. When the new container is positioned the closed individual shutter will be opened to pour down tablets through the funnel. The XXXX, electronic multi channel tablet & capsule counting machine is a critical process to product quality. The integrity of the XXXX, electronic multi channel tablet & capsule counting machine can affect the process and product risk if this is compromised. Therefore it is imperative that checks are thoroughly documented according cGMP recommendations.
Protocol Number: : VP-XX-IOQ-XXX Page 2 of 3
Version 1.0
IOQ Capsule Fillers IOQ Line XX
Equipment No.XXXXX
Operational Functional Tests Test Summary Start Machine as normal, following user manual and perform the following function checks:
Test No. OQ1
OQ3
Run product through conveyor and counter until sensor detects no bottle
OQ4
Overfill the line and run the machine as normal and simulate a jam
Acceptance Criteria Error Message should appear on screen for hopper empty and machine should stop Error message should appear on screen for dust on sensor and machine should stop Error message should appear on screen for no bottle and machine should stop Machine should stop with error message bottle jamming
OQ5
Power Failure Test- Run machine and isolate power safely.
The machine should stop and not be restarted until repowered
OQ6
Challenge the on board memory by entering details for 10 products
Close down, restart and ensure the details are saved.
OQ7
Tower Lamp – observe the lights at the following conditions – normal running, sensor obstruction, emergency stop
During normal operation the light should be green. Upon sensor obstruction the yellow light should illuminate. Upon Emergency Stop the red light should illuminate.
OQ2
Test Description Level Sensor Check – Fill Hopper and start machine as normal procedure run some tubs through until hopper is empty Run product through hopper and counter. Cover Dust sensor with dust or similar product
Protocol Number: : VP-XX-IOQ-XXX Page 3 of 3
Version 1.0
Pass/Fail
Initial/ Date