1.0 PURPOSE: To provide methods for microbiological analysis of primary packaging material to determining the bio burden (i.e. total bacterial and fungal count) of primary packaging material. 2.0 SCOPE: This procedure for microbiological analysis of

1.0 PURPOSE: To provide a procedure for cleaning and sterilization / depyrogenation of glassware / accessories. 2.0 SCOPE: This SOP is applicable for cleaning and sterilization / depyrogenation of glassware / accessories at Microbiology laboratory

1.0 PURPOSE: This procedure elaborates the methods of labeling, incubation and observation of microbial media filled Petri plate / glassware that are used in microbiological analysis. 2.0 SCOPE: This SOP is applicable for labeling, incubation

1.0 PURPOSE: To lay down a procedure for the preparation of 10-100 cfu/ml culture suspension. 2.0 SCOPE: This procedure is applicable to preparation of 10-100 cfu/ml culture suspension prepared in Quality Control Department at (Company

1.0 PURPOSE: To define the procedure for cleaning of glassware for microbiological testing purposes to avoid any cross contamination. 2.0 SCOPE: This procedure is applicable for cleaning of glassware for microbiological testing used in Quality

1.0 PURPOSE: To lay down the procedure for Operation and Maintenance of Infrared sterilizer. 2.0 SCOPE: This SOP for Operation and Maintenance of Infrared sterilizer is applicable in Microbiology Laboratory, at (Company name). 3.0 DEFINITION:

1.0 PURPOSE: To define the procedure for spore staining. 2.0 SCOPE: The procedure for spore staining is applicable to Microbiology department at (Company name). 3.0 DEFINITION: Not Applicable 4.0 RESPONSIBILITY: 4.1 Trainee/officer is responsible to

1.0 PURPOSE: To describe the procedure for cleaning of equipments and instruments in Microbiology Laboratory. 2.0 SCOPE: This procedure is applicable to cleaning of equipments and instruments like Autoclave, incubators, hot air oven and refrigerator

1.0 PURPOSE: To define the gram staining procedure to identify the purity of culture by checking the Gram characteristics and to differentiate unknown colony forming units found during microbiological testing. 2.0 SCOPE: This Gram staining

1.0 PURPOSE: To define the procedure for cleaning of laboratory glassware used for analytical purpose, to avoid any cross contamination which results in erratic values. 2.0 SCOPE: The procedure for cleaning of laboratory glassware is

1.0 PURPOSE: To define the procedure for total viable spore count determination of Biological indicator. 2.0 SCOPE: This procedure for total viable spore count determination of biological indicators is applicable to Quality Control Department, at

1.0 PURPOSE: To define the procedures for performing lacto phenol cotton blue staining technique for identification of fungi. 2.0 SCOPE: This SOP for lacto phenol cotton blue staining for identification of fungi is applicable for