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Day of Observation Test Sample Negative Control Positive Control

This document summarizes sterility testing results for a product batch. It includes the product name and batch details, test method used, incubation conditions, 14-day observation results for test samples, negative controls, and positive controls in two media, and a conclusion on whether the batch complies with sterility requirements. The document is signed off by the tester, checker, and approver.

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56 views1 page

Day of Observation Test Sample Negative Control Positive Control

This document summarizes sterility testing results for a product batch. It includes the product name and batch details, test method used, incubation conditions, 14-day observation results for test samples, negative controls, and positive controls in two media, and a conclusion on whether the batch complies with sterility requirements. The document is signed off by the tester, checker, and approver.

Uploaded by

sagor sagor
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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Lab Reference No:

Name of the Product / Materials :

Batch/Lot No Mfg. Date

Batch Size Exp. Date

Tested Quantity Date of test

Origin Date of result

Test Method : Membrane Filtration Direct Inoculation


Terminal Sterilization Aseptic Process Gama Irridation
Sterilization Method
Sterilization Dry Heat Sterilization

Media Preparation Ref. No. FTM - SCDB -


For Fluid Thioglycolate Medium (FTM) 30oC-35oC
Incubation Condition14 days
For Soybean -Casein Digest Medium (SCDM) 20°C-25°C

Day of Test Sample Negative Control Positive Control


Observation FTM SCDM FTM SCDM FTM SCDM
1st Day
2nd Day
3rd Day
4th Day
5th Day
6th Day
7th Day
8th Day
9th Day
10th Day
11th Day
12th Day
13th Day
14th Day

Legend: P= Presence of Growth. A= Absence of Growth

Disposition: Complies Not Complies

Remarks (If any):

Tested by Checked by Approved by

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