Follow
1.0 OBJECTIVE : To describe a generalized procedure for microbial limit tests of raw materials and finished products.
2.0 SCOPE : This SOP is applicable for analyzing microbial load and presence of specific pathogens in raw materials and finished products at the Microbiology Laboratory of Quality Control department of (Company Name).
3.0 RESPONSIBILITY
3.1 Microbiologist/ QC Officer should be responsible to ensure proper and timely execution.
3.2 Manager QC or his nominee shall be responsible for effective implementation and training of the procedure.
4.0 ACCOUNTABILITY
4.1 Head of Quality.
5.0 PRECAUTIONS
5.1 Care should be taken to avoid any kind of accidental contamination during sampling.
5.2 Only trained person should collect the samples.
6.0 PROCEDURE
6.1 Prerequisites
6.1.1 -Sterile sample bottle/ Polybags
-Sterilized petriplate
-Sterilized sampling tools
-Sterilized pippete
-Sterilized and preincubated media
-Nichrome wire loop
-Weighing balance
6.2 Sampling
6.2.1 Label the sampling bottle / poly bags.
6.2.2 Collect sample from different containers in the sterilized sampling bottle or polybags with sterilized/ sanitized sampling tools, so as to get representative sample from defferent container as per schedule.
6.2.3 Wear face mask and hand gloves during sampling to avoid any accidental contamination.
6.2.4 In case of Raw materials carry out sampling under sampling booth.
6.2.5 After sampling bring the sample in another closed polybag to the microbiology laboratory and make necessary entries in the register and allot a A.R. number as per SOP of Sample Management in QC laboratory (SOP No.: QC010)
6.3 Testing
6.3.1 Carry out the tests as per respective specification by following GTP: Test for Microbial Contamination ( GTP No.: GTP/007,GTP/008 & GTP/011).
6.3.2 Determine the bioload of a material or a product as per respective specification under the following headings:
Total Viable Aerobic Count
Total Aerobic Microbial Count/Total Aerobic Bacterial Count
Total Combined Mold and Yeast count/Total Fungal Count
Enterobacteria /bile tolerant gram negative bacteria.
6.3.3 Determine the presence or absence of specific pathogens as per following specification:
Absence of Escherichia coli in 1 ml/ gram of sample
Absence of Salmonella sp in 10 ml/ gram of sample
Absence of Pseudomonas aeruginosa in 1 ml/ gram of sample
Absence of Staphylococcus aureus in 1 ml/ gram of sample
Absence of bile-tolerant gram negative bacteria in 1 ml/gm of sample.
6.3.4 After analyzing the materials and products incubate the plates and culture bottles as mentioned in GTP: Test for Microbial Contamination ( GTP No.: GTP/007,GTP/008 & GTP/011).
6.4 Results
6.4.1 Following incubation count the number of colonies, observe the presence or absence of respective pathogens and produce the results by filling the specification formate of specific material or product.
6.4.2 If any abnormal results arise, immediately investigate the results and take necessary actions as per the SOP: Handling of Out of Specification (OOS) results in microbiological analysis (SOP No.: QC114).
