SOP on Cleaning Procedure for Sterility Failure investigation

Learn About Standard Operating Procedure for Sterile failure investigation within sterile testing Areas including their, Aim, Scope, Responsibility, Procedure, and Definitions.

1.0 AIM: To lay down the cleaning procedure for the Sterility failure investigation.
2.0 SCOPE: This SOP applies to carry out the cleaning procedure for the Sterility failure investigation.
3.0 RESPONSIBILITY: Executive – Provide training for Cleaning procedure for the Sterility testing area applying GLP rules
3.1 Microbiologist – Preparation of SOP
3.2 Keep a document of the cleaning record based on GDP.

File with text title; Cleaning Procedure for Sterility failure investigation


4.1Master Copy: – Quality Assurance Department
4.2 Control Copy- Quality Control Department
4.3 Display copy – Quality Control Department (Microbiology Section)


5.1 During the sterility test of the product, if evidence of microbial growth is found in inoculated SCDM and FTGM tubes, then preserve the positive tube along with negative control till the complete investigation.
5.2 Immediately streak a loopful growth from the positive tube to the preincubated SCDA plate in duplicate.
5.3 If the growth of suspension is taken from the FTGM tube then incubated at 300℃ to 350℃ for 48 hrs and if it is taken from the SCDM tube then incubated at 200℃ to 250℃ for 72 hrs.
5.4 After incubation, observe the colony and find the unknown microorganisms per SOP No. “for Identification of unknown microorganisms”.

5.5 Check the sterilization details such as temperature, pressure, holding time, and status of indicator strip during sterilization of media, filtration assembly, and other materials used while performing the sterility test.
5.6 Check the cleaning details of the sterility testing area.
5.7 Check the results of environmental monitoring taken while performing the sterility.
5.8 Identify the colony as per SOP No. “The Identification of unknown microorganisms” in the plates exposed.
5.9 If the colony observed in LAF is the same as found in the positive tube, there are chances of contamination during testing. The test may be considered invalid.
5.10 After reviewing QC and production details, compile all the data and find the root cause.


SOP – Standard Operating Procedure
QA- Quality Assurance Department
QC- Quality Control Department
GLP- Good Laboratory Practices
GDP- Good Document Practices

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