Validation – Liquid Filler Loquid Filler for [name system/equipment here] XX(area)-IOQ (Installation and Operational Qualification)XXX(unique project number) Add Your Site Here
Ref: Val_________
Rev/Issue: 1
Page No 1 of 7
IOQ PROTOCOL AUTHORISATION Name/Title Prepared by
Your Name
Reviewed by
Quality Assurance
Reviewed by Reviewed by
Engineering Regulatory (If required)
Reviewed by
Other
Signature
Date
Signature
Date
IOQ PROTOCOL REPORT AUTHORISATION Name/Title Reviewed by
Quality Assurance
Reviewed by Reviewed by
Engineering Regulatory (If required)
Reviewed by
Other
Introduction The Liquid Filling machine on XXXX will be retrospectively validated and has been running historically with production history and data. This IOQ will cover the retrospective validation of the system and its components to GMP, MHRA Annex 15.
Brief System Description and IOQ Rationale The liquid filling machine on XXXX automatically fills 12 containers (change accordingly) at a time using a bottom up fill, neck location and heavy duty gating. Mounted on the base is a 12 (change accordingly) pump KT340/ K6x2 machine to deliver liquid to the containers. The XXX pump pumps the liquid product to the delivery nozzles which have air operated shut off nozzle outlets. When the outlets are open the nozzles direct the product into the 12 containers and then close again when the correct volume has been dispensed. When the containers are fitted they are gated out and fresh empty containers counted in to repeat the cycle. To accommodate the largest container special extended conveyor guides have been fitted and the support arms on the slide tube have been moved out on special fixing brackets. During the filling part of the cycle the nozzle support assembly is raised and lowered by the hydro/pneumatic cylinder. This can be done in either “Full” of “Part” mode. In Full mode the nozzles enter the containers and start to deliver product on the way down. The nozzles reach the bottom of the container and then retract at an adjustable controlled rate keeping the tip of the nozzle just above the level of the liquid. When the correct amount of liquid has been dispensed the nozzles will then retract at full speed to the top position. In most cases XXXX, the machine works on the principle of a “part” mode, where the nozzles enter the neck of the container and stop. Filling takes place until the correct amount of product has been dispensed from all nozzles. The nozzles retract then at full speed to the top position. The IOQ shall test the limits of the machine in this mode All systems shall be challenged in this protocol. Therefore it is imperative that checks are thoroughly documented according to cGMP recommendations. All testing will be performed retrospectively, and all tests will be in accordance with Your Company Name “Your SOP Here”.
Protocol Number: xxxxxx Page 22 of 15
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Index of IOQ XXX Liquid Filler on XXXX Test Reference
Test Name
IQ Section 1
Description and Reference Numbers
2
Mechanical, Electrical Checks
3
Critical Components
4
Maintenance and Calibration Checks
5
Availability of Software
6
Documentation Review
7
Health and Safety Checklist
8
cGMP Audit IQ Sign Off
OQ tests for execution 1
Test Counter
2
Test Gating
3
Sensor Checks
4
Single Shot
5
Test Modes
6
Bottle Jam
7
Power Failure and Air Droppage
8
Challenge Conveyor Speed
9
Product Challenge
10
Cleaning Verification
11
SOP Review
12
Training
Protocol Number: xxxxxx Page 32 of 15
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