1.0 PURPOSE:
2.0 SCOPE:
This procedure for microbiological analysis of primary packaging material is applicable to analysis of primary packaging material and accessories used in (Company name).
3.0 DEFINITIONS:
4.0 RESPONSIBILITY:
4.1 Analyst /Microbiologist: The Analyst/microbiologist is responsible for:
4.1.1 Execution of the procedure specified in this document.
4.2 Executive /designee: Executive or designee is responsible for:
4.2.1 Ensuring that, the procedure followed as specified in this document.
4.2.2 Initiation for the investigation and necessary corrective and preventive action in case of failure as per concerned procedure.
4.3 Head Quality Control: The Head Quality control is responsible for:
4.3.1 Ensuring that, the overall compliance to procedure specified in this document.
4.4 Quality assurance: The QA is responsible for:
4.4.1 Ensuring that, the overall compliance to procedure specified in this document.
5.0 PROCEDURE:
5.1 Sampling:
5.1.1 Sample using sterile poly bags or container. Take necessary precautions to prevent contamination of the sample during sampling.
5.1.2 Use sterile forceps wherever applicable.
5.2 PET bottles:
5.2.1 Sampling quantity: 05 numbers.
5.2.2 Give a rinsing of not more than 100ml of sterile 0.1% peptone to the inner surface of 05 units. The rinsing volume should be such that the rinse of the complete inner surface taken. Filter this rinsing solution through a sterile 0.45 p membrane filter 47 mm in diameter.
5.2.3 Rinse the filter with 03×100 ml of sterile 0.1% peptone.
5.2.4 Place the membrane filter aseptically on the surface of the pre incubated soybean casein digest agar plate.
5.2.5 Incubate the plates at 20-25 0C for the first 3 days then at 30-35 0C for 2 days in the inverted position.
5.2.6 Count the number of colony forming units observed on the membrane filter at end of the incubation. i.e, 5th day and record the observations in respective log.
5.3 PVC film/Aluminum foil/poly bags:
5.3.1 For PVC film/Aluminum foil carefully remove initially 1meter of the foil/film and discard. Sample approximately 0.5 meter of the foil /film. For poly bags randomly sample one poly bag.
5.3.2 Determine the bio burden on PVC film/Aluminum foil/poly bags by carrying out swab test using soybean casein digest agar contact plates on the inner surface of the PVC film/Aluminum foil/poly bags. After Sampling wipe with mop dipped in disinfectant.
5.3.3 Incubate the plates at 20-25 0C for the first 3 days then at 30-35 0C for 2 days in the inverted position.
5.3.4 Count the number of colony forming units observed on the plate at end of the incubation. i.e, 5th day.
5.3.5 Record the observations in respective log.
5.4 Cotton:
5.4.1 Sample quantity: 2gms.
5.4.2 Take 1gms of cotton add 99 ml of sterile 0.1%peptone with 1% tween 80.
5.4.3 Swirl the container.
5.4.4 Squeeze the cotton with a sterile forceps.
5.4.5 Plate out 1ml of each in duplicate.
5.4.6 Within 20 min of adding the sample add 15-20 ml of soybean casein digest agar which is at 45 0C to the plates. Mix well by rotating the plates.
5.4.7 Incubate the plates at 20-25 0C for the first 3 days then at 30-35 0C for 2 days in the inverted position.
5.4.8 Count the number of colony forming units observed on the membrane filter at end of the incubation. i.e, 5th day.
5.4.9 Take average of two plates apply the dilution factor i.e. multiply with 100. Record the observations in respective log.
5.5 Silica gels:
5.5.1 Sample quantity: 05 units.
5.5.2 Dip the silica gels in 100 ml of sterile 0.1%peptone.
5.5.3 Swirl the container and mix well.
5.5.4 Plate out 1mI of each in duplicate.
5.5.5 Add 15-20 ml of soybean casein digest agar which is at 45 0C to the plates. Mix well by rotating the plates.
5.5.6 Incubate the plates at 20-25 0C for the first 3days then at 30-35 0C for 2 days in the inverted position.
5.5.7 Record the observations in respective log.
6.0 ABBREVIATIONS:
QA :Quality Assurance
QC :Quality control
No. :Number
SOP :Standard operation procedure
Gms :grams