PROCEDURE FOR MICROBIAL CONTAMINATION IN BULK / FINISH PRODUCTS

1. OBJECTIVE:

To lay down a procedure for microbial contamination in bulk / finish products.

• SCOPE:

This procedure is applicable for procedure for microbial contamination in bulk / finish products.

• RESPONSIBILITY:

Microbiologist

• ACCOUNTABILITY:

QC Manager.

•  PROCEDURE:
  • After received the sample note down of detail of products in bulk / finish products inward register.
  • Analysis the sample as respect parameter:
  • Microbial contamination
  • Total bacterial contamination
  • Total Fungal Contamination
  • Pathogen – E. coli
  • Preparation of Enrichment Sample: Take 10.0 g of Sample in 100 ml of sterile saline / peptone water.
  • Total Bacterial Contamination: Take 1 ml from enrichment sample by sterile pipette in sterilized Petri dishes 90 mm. Pour 15 – 20 ml of SCDA, mix and incubate at 30°C to 35°C for 5 days. (Acceptance criteria: NMT 1000 cfu/gm)
  • Total Fungal Contamination: Take 1 ml from enrichment sample by sterile pipette in sterilized Petri dishes 90 mm. Pour 15 – 20 ml of SDA, mix and incubate at 20°C to 25°C for 5 days. (Acceptance criteria: NMT 100 cfu/gm)
  • Pathogen: E. coli:
  • Take 1 ml from enrichment sample and incubate with 100 ml soyabean casein digest broth at 30 – 35⁰C for 18 -24 hours.
  • After incubation shake the broth and transfer 1 ml to 100ml of MacConkey Broth, incubate at 42 – 44⁰C for 24-48 hours.
  • After completion of incubation, subculture on a plate of MacConkey agar and incubate at 30 – 35⁰C for 18 -72 hours.
  • ACCEPTANCE CRITERIA:
  • If Growth of pink, non-mucoid colonies indicates the presence of Escherichia coli.
  • Maintain the record.
  • Acceptance Criteria: Should be absent in per gm.

• TRAINING:

Trainer   : Manager – Quality Control

Trainees : Staff of the microbiology departments

• DISTRIBUTION:

Master Copy                  :           QA Department

Controlled Copy            :           Microbiology Department

Display Copy                 :           Microbiology Department (If Required)

• REFERENCES:

In-House

1. ABBREVIATIONS:

Abbreviations	Extended Form
SOP	Standard Operating Procedure
NA	Not Applicable
MB	Microbiology
Sr. No.	Serial Number
QA	Quality Assurance
DEPT.	Department
IPA	Isopropyl Alcohol
%	Percentage