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SOP Forprocess Simulation Media Fill Request Form

This document outlines the process simulation (media fill) test that will be conducted to comply with SOP Val-1800.10. It specifies that three media fill runs are required for initial qualification or requalification in cases like a new filling room or major equipment changes. One media fill run is needed for minor changes like different filling assignments. Each line will also undergo large and small vial challenges once per year testing different fill volumes and machine speeds. The test details the specific challenge conditions and requests sign-off from listed quality managers.

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104 views2 pages

SOP Forprocess Simulation Media Fill Request Form

This document outlines the process simulation (media fill) test that will be conducted to comply with SOP Val-1800.10. It specifies that three media fill runs are required for initial qualification or requalification in cases like a new filling room or major equipment changes. One media fill run is needed for minor changes like different filling assignments. Each line will also undergo large and small vial challenges once per year testing different fill volumes and machine speeds. The test details the specific challenge conditions and requests sign-off from listed quality managers.

Uploaded by

Solomon
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd
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Humanwell Pharmaceutical Ethiopia PLC

Form No.: SOP/SL/013/F/01


Process Simulation (Media Fill) Test

From: Production Manager


To: List Vials/Ampoules
Date: ______________________________________________________________________
Size: ____________
Subject: Initial Qualification/Requalification
The media fill is scheduled from______ to _________ to comply with the SOP Val-1800.10 for
the following reason:

Check
applicable
box
Three media fill runs are required for the following (this list is not all
inclusive)
1. New filling room or machine h
2. Major room modification (such as wall or ceiling reconfigurations) h
3. New equipment or new machines that have product contact or affect product h
flow and are not an exact equivalent of the original equipment
4. Major mechanical or line configuration changes (such as new equipment h
additions or major preventive maintenance).
5. Major HVAC changes that may affect airflow patterns related to the critical h
filling area (class 100) (such as addition/removal of HEPA housings)
6. Exceeding the 6-month requalification interval h
7. A media fill failure with a conclusive nonpersonnel assignable cause h
(determined during the investigation process)
8. New product/process evaluation (number of runs to be determined on a case-by- h
case basis)
Check
applicable
box
One media fill run is required for the following (this list is not all inclusive)
1. Major modification to areas adjoining filling rooms (such as expanded core h
area)
2. Minor filling assignment (such as a different turntable) h
3. Filling areas that have not been in operation for a period of time not to exceed 6 h
months
4. Any other reason: ______________________________________ h
Humanwell Pharmaceutical Ethiopia PLC
Form No.: SOP/SL/013/F/01
Process Simulation (Media Fill) Test

Each of the following worst-case challenge conditions will be performed


on each line once per year
Large vial/slow speed challenge/fill volume:
The largest vial size with the largest opening run on a particular filling line h
The machine run at a speed lower than routine production h
Fill volume of approximately 50% of vial capacity h
Small vial/fast speed challenge/fill volume:
The smallest vial size with the smallest run on a particular filling line h
The machine run at a speed faster than routine production h
Fill volume of approximately 50% of vial capacity h
No. of units _______________ MFM No. _______________ h

List: QA Manager/QC Manager/Validation Manager/Microbiologist

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