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Microbial Limit Test for Raw Materials and Active Pharmaceutical Ingredients

Microbial Limit Test for Raw Materials and Active Pharmaceutical Ingredients

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Description

1.    APPARATUS
1.1    Autoclave
1.2    BOD - Incubator
1.3    Bacteriological Incubator
1.4    pH – meter
1.5    Hot air Oven
1.6    Laminar Air flow
1.7    Analytical Balance
1.8    Spirit Lamp / Bunsen Burner
1.9    Water Bath 
1.10    Micropipette
1.11    Petri dishes 
1.12    Test tubes
1.13    Media bottles    
2.    REAGENTS   AND  MEDIAS
3.    Prepare the media as per Respective GTP. 
4.    PROCEDURE
      4.1    As per USP Microbial limit are as follows
              4.1.1    Total Microbial count.  – Perform as per Respective GTP. 

              4.1.2    Specified Microorganisms 

                          4.1.2.1    E .coli                              - Perform as per Respective GTP. 
                          4.1.2.2    Salmonella                       - Perform as per Respective GTP.
                          4.1.2.3    Pseudomonas                  - Perform as per Respective GTP.
                          4.1.2.4    Staphyococcus aureus      - Perform as per Respective GTP.
   4.2    As per EP Microbial limit are as follows
           4.2.1    Total Microbial count.  – Perform as per Respective GTP.
           4.2.2    Specified Microorganisms 
                       4.2.2.1    E .coli                               - Perform as per Respective GTP.
                       4.2.2.2    Salmonella                        - Perform as per Respective GTP.
                       4.2.2.3    Pseudomonas                   - Perform as per Respective GTP.
                       4.2.2.4    Staphyococcus aureus      - Perform as per Respective GTP.

 

Tags

Autoclave, general testing procedure, laminar air flow, bod - incubator

References

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