1.1 To lay down a procedure for sampling and analysis of Purified water analysis.
2.0 SCOPE
2.1 This procedure applies to the Pharmaceutical Manufacturing Facility of ___________________________________________________________
3.0 RESPONSIBILITY
3.1 Microbiologists.
4.0 Accountability
4.1 Head-Quality control
5.0 PROCEDURE
5.1 STERILISED GLASS BOTTLE PREPARATION :
5.1.1 For Purified water, wrap the stopper / screw cap with butter paper / parchment paper. Label the bottles. Autoclave the bottles.
5.2 STORAGE OF STERILIZED BOTTLE :
5.2.1 Autoclaved bottles should be stored below 25°C.The validity of the bottles is 15 days from the date of the sterilization.
5.3 WATER SAMPLING COLLECTION OF ACCESSSORIES :
5.3.1 The assigned Microbiologist should check the schedule and determine type, sampling point to collect the water.
5.3.2 Assemble all the type of bottles required to collect the water sample.
5.3.3 Take the SS Sampling kit. clean and disinfect the kit with suitable disinfectant. After drying the internal surface of the kit, place the bottles in the kit. Carry one calibrated stopwatch.
5.3.4 Carry the water sampling layout, specification and the sample collection SOP in the kit.
5.3.5 Carry the kit to the respective sampling location.
5.4 COLLECTION OF WATER SAMPLE :
5.4.1 FOR PURIFIED WATER:
5.4.1.1 Check the label of the Purified water sampling point. Check the sampling point to collect the sample as per the schedule.
5.4.1.2 Drain the sampling point for specified time as mentioned in respective specification. 5.4.1.3 Check the drain time with the help of stop watch.
5.4.1.4 After draining, adjust the flow to avoid splashing and take the bottle near to the sampling point. Open the stopper/ screw cap. Take the mouth of the bottle near to the sampling tap. Collect the water as per requirement or up to the level below the neck. Keep sufficient air space.
5.4.1.5 Close the bottle with stopper/ screw cap. Label the bottle. Keep the bottle in SS kit and carry to microbiology department carefully.
5.4.1.6 Sampled water should be analyzed within 2 hours after sampling. If delayed, store the sample at 2-8°C for a maximum of about 12 hours until analysis.
5.5 Quantity of water to be sampled for Analysis
5.5.1 100 ml for microbiological analysis.
5.5.2 250 ml for microbiological analysis.
5.6 Analysis of Purified water
5.3.1 Analyze the purified water sample
5.3.2 Incase purified water is not complying as per the specification inform the results to Head of the department/ Head –Quality Control.
5.7 Limits
5.7.1 Based upon the trends of phase I and Phase II of water validation, microbiological limit for purified water are as follows
5.7.2 Total microbial count
Alert limit : Not More Than 60 cfu / ml.
Action limit : Not More than 80 cfu / ml.
Maximum limit : Not More Than 100 cfu / ml.
5.7.3 Pathogens
E. Coli : Should be absent
Salmonella typhi : Should be absent
Pseudomonas aeruginosa : Should be absent
Staphylococcus aereus : Should be absent
4.1 Head-Quality control
5.0 PROCEDURE
5.1 STERILISED GLASS BOTTLE PREPARATION :
5.1.1 For Purified water, wrap the stopper / screw cap with butter paper / parchment paper. Label the bottles. Autoclave the bottles.
5.2 STORAGE OF STERILIZED BOTTLE :
5.2.1 Autoclaved bottles should be stored below 25°C.The validity of the bottles is 15 days from the date of the sterilization.
5.3 WATER SAMPLING COLLECTION OF ACCESSSORIES :
5.3.1 The assigned Microbiologist should check the schedule and determine type, sampling point to collect the water.
5.3.2 Assemble all the type of bottles required to collect the water sample.
5.3.3 Take the SS Sampling kit. clean and disinfect the kit with suitable disinfectant. After drying the internal surface of the kit, place the bottles in the kit. Carry one calibrated stopwatch.
5.3.4 Carry the water sampling layout, specification and the sample collection SOP in the kit.
5.3.5 Carry the kit to the respective sampling location.
5.4 COLLECTION OF WATER SAMPLE :
5.4.1 FOR PURIFIED WATER:
5.4.1.1 Check the label of the Purified water sampling point. Check the sampling point to collect the sample as per the schedule.
5.4.1.2 Drain the sampling point for specified time as mentioned in respective specification. 5.4.1.3 Check the drain time with the help of stop watch.
5.4.1.4 After draining, adjust the flow to avoid splashing and take the bottle near to the sampling point. Open the stopper/ screw cap. Take the mouth of the bottle near to the sampling tap. Collect the water as per requirement or up to the level below the neck. Keep sufficient air space.
5.4.1.5 Close the bottle with stopper/ screw cap. Label the bottle. Keep the bottle in SS kit and carry to microbiology department carefully.
5.4.1.6 Sampled water should be analyzed within 2 hours after sampling. If delayed, store the sample at 2-8°C for a maximum of about 12 hours until analysis.
5.5 Quantity of water to be sampled for Analysis
5.5.1 100 ml for microbiological analysis.
5.5.2 250 ml for microbiological analysis.
5.6 Analysis of Purified water
5.3.1 Analyze the purified water sample
5.3.2 Incase purified water is not complying as per the specification inform the results to Head of the department/ Head –Quality Control.
5.7 Limits
5.7.1 Based upon the trends of phase I and Phase II of water validation, microbiological limit for purified water are as follows
5.7.2 Total microbial count
Alert limit : Not More Than 60 cfu / ml.
Action limit : Not More than 80 cfu / ml.
Maximum limit : Not More Than 100 cfu / ml.
5.7.3 Pathogens
E. Coli : Should be absent
Salmonella typhi : Should be absent
Pseudomonas aeruginosa : Should be absent
Staphylococcus aereus : Should be absent
6.0 REFERENCES
6.1 Nil
END OF DOCUMENT
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