sop of Microbiological assay
1.0 Objective
To lay down a procedure for microbiological assay of raw material and finished product by cup plate method
2.0 Scope
This Standard Operating Procedure is applicable for the Microbiological assay of raw material and finished
product by cup plate method at formulation plant of abc company.
3.0 Responsibility
3.1 Officer/Executive Quality Control shall be responsible for determination of microbiological assay.
3.2 Head Quality Control is responsible for the compliance of this SOP.
4.0 Abbreviations and Definitions
SOP : Standard Operating Procedure;
QA : Quality Assurance
LAF : Laminar Air Flow
DTH : Mean diameter of the sample dilution (Higher)
DTL : Mean diameter of the sample dilution (Lower)
DSH : Mean diameter of the standard dilution (Higher)
DSL : Mean diameter of the sample dilution (Lower)
° C : Degree Centigrade
SS : Stainless Steel
Hrs : Hours
Ml : Millilitre
DS : Dilution factor of standard solution
DT : Dilution factor of sample solution
P : Potency of vitamin Working standard (on as bases)
5.0 Procedure
5.1 Prepare microbiological assay medium as per specification given in monograph.
5.2 Requirements.
5.2.1 For standard cultures.
5.2.2 Micropipette 20µl to 200 µl, 1000 µl,
5.2.3 Sterile cork borer
5.2.4 Sterile measuring cylinder.
5.2.5 Sterile Petri dish.
5.2.6 Working Standard.
5.3 Preparation of inoculum:
5.3.1 Before starting antibiotic/vitamin assay, prepare fresh culture slant and incubate at 30 ºC to 35 ºC for 24 hrs.
5.3.2 Take one loop full culture from slant tube and inoculated in 10 ml of 0.9% normal saline solution and use it as inoculum.
5.4 Preparation standard and test dilution:
5.4.1 Make standard dilution with reference standard or working standard for DSH and DSL dilution.
5.4.2 In same manner make DTH dilution and DTL dilution as per requirements.
5.5 Assay method:
5.5.1 Aseptically transfer 10 ml (approx) of prepared culture inoculum into the vitamin assay medium.
5.5.2 After mixing of culture inoculum into media, aseptically pour 25 ml media in each of Petri plates.
5.5.3 After solidification make 4 holes in each media plates with the help of 6 to 8 mm SS borer.
5.5.4 Mark (DSH, DSL, DTH, and DTL) on the back side of media plate where respective dilution shall be poured.
5.5.5 Pour 100 µl of the test and standard dilution in their respective holes.
5.5.6 Keep the plates undisturbed at room temperature for about 15 min.
5.5.7 Incubate these plates in the incubator at 30 to 35º C for 24 hrs.
5.5.8 After incubation measure the zone of exhibition by vernier scale.
5.5.9 Calculate the Assay and record the results as per the current version of Annexure.
.
6.0 Forms and Records
6.1 Microbiological Assay Analysis record – Annexure-1
6.2 Vitamin B12 assay report for finished Product – Annexure-2
6.3 Vitamin B12 assay report for raw material – Annexure-3
7.0 Distribution
7.1 Master copy – Documentation Cell (Quality Assurance)
7.2 Control copy – Quality Control
8.0 History
| Revision Number | Details For Change |
Reason for Revision |
| 00 | New SOP | NA |
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