ORAL DOSAGE FORM SOPs

1.0 PURPOSE

The purpose of this SOP is to provide the procedure for review of microbiological monitoring results and evaluation of state of control including initiation of additional corrective actions if  any, in order to enhance over-all practices and maintenance.

2.0 SCOPE:

This procedure is applicable for trend analysis of microbiological monitoring of air, surfaces and personnel, water, compressed gases, bio burden carried out in Microbiological laboratories.

5.0 PROCEDURE:                       

5.1 Monitoring Data Review:

5.1.1 Perform microbial monitoring of air, surface, personnel, water, compressed gases, bio burden etc. - Refer location specific procedures.

5.1.2 Review the results against the set levels.

5.1.3 If results are complying, approve the report.

5.1.4 When the specified microbial level is exceeded, a documentation review and/ or investigation should occur.

5.2 Data Trending:

5.2.1 Visualize trends through the construction of statistical control charts that include alert and action levels.

5.2.2 Monthly, Quarterly or Yearly trends can be prepared based on frequency of monitoring. For eg: Monthly and yearly trends for Environmental monitoring, Quarterly trend compressed gases and identification of isolates etc.

5.2.3 The trend analysis shall include rolling data of at least previous three months including the current month’s data.

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1.0 PURPOSE

To describe the procedure for Destruction of Microbial waste by Autoclave.

2.0 SCOPE: 

This SOP is to be applied at the time of Destruction of Microbial waste by Autoclave in Microbiology laboratory.

5.0 PROCEDURE:                   

5.1 Wear a protective garment, nose mask and hand gloves prior to start the destruction of Microbial waste.

5.2  Collect and transfer all used microbiological media, cultures and contaminated Glassware’s to Washing area.

5.3  Remove the liquid media and agar media in a waste destruction container with the help of Spatula.

5.4  Add a disinfectant solution. half quantity of the waste media and plug with cotton and finally wrap with aluminium foil.

5.5  For pipettes, spatula, forceps and spreader soak in disinfectant solution for 30 minutes and proceed for cleaning of glassware’s for Microbiological testing SOP.

5.6 Leave the waste media and glassware’s for half an hour at room temperature to facilitate the reaction of disinfectant solution.

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