sop for treated RO water

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3 years ago

sop for treated RO water

STORAGE REQUIREMENTS
Store at room temperature in a well closed stainless steel or glass container.
a) Analysis samples drawn for chemical analysis within 24 hours after sampling.
b) Analysis samples drawn for microbiological analysis within 8 hours after sampling. Refrigerate the samples (between 2°C to 8°C) until testing is commenced.
SAMPLING:

A) For Chemical Analysis:
Collect the sample in clean, glass stopper bottle of 800 ml capacity from DM Water plant / usage point with utmost care to ensure that no contamination occurs at the time of collection or prior examination. Remove the stopper of the bottle and handle carefully to avoid contamination (preferably hold in hand). While collecting samples allow the sample to run to Water for sufficient time as per validated drain time to permit clearing of service line. The glass bottles must be thoroughly rinsed three times with the same Water before sampling. Restrict the flow from the tap so that the bottle can be filled without splashing. During sampling, hold the bottle near the base, do not touch the stopper and the neck of the bottle. Replace the stopper immediately.
For conductivity test sample as above but by collecting the sample in a tight container with minimum head space and test in a timely manner to minimize the impact of organic contamination on the closure and container.

B) For Microbiological Analysis :
Sampling bottles : Collect the sample in non –reactive borosilicate screw capped glass bottles of 200ml capacity that have been cleaned and rinsed carefully ,i.e. final rinse with RO Water and sterilized by using a steam sterilized by using a steam sterilizer at 121°C for validated time period.
SAMPLING:
Sampling Procedure: Collect the sample from DM Water plant / usage point with utmost care to ensure that no contamination occurs at the time of collection or prior to analysis. Remove the cap of the bottle and handle carefully to avoid contamination (preferably hold in hand). While collecting samples allow the sample to run to waste for sufficient time as per validated drain time to permit clearing of service line. Restrict the flow from tap so that the bottle can be filled without splashing. During sampling, hold the bottle near the base and fill without rinsing. Do not touch the cap and the neck of the bottle. Replace the cap immediately.
Note : Do not open the sampling bottle except at the time of sampling.

QUANTITY OF SAMPLE FOR ANALYSIS
For Chemical analysis : About 800ml
For Microbiological analysis : About 200ml

QUANTITY OF RESERVE SAMPLE:
Not applicable

CATEGORY
Pharmaceutical aid (Solvent)
.

Description: A Clear, colorless, tasteless &, odorless liquid.

pH: Not less than 5.0 and not more than 7.0

Conductivity: Not more than 5.1 µS/cm at 25°C

Chlorides: Shall be free from chlorides.

Total Dissolved Solids: Not more than 0.001% (1mg).

MICROBIOLOGICAL CONTAMINATION:
Total viable count:
Not more than 500 cfu/ml
Test for Pathogens:
Escherichia coli : Should be Absent / 100ml
Salmonella : Should be Absent / 100ml
Pseudomonas aeruginosa : Should be Absent / 100ml
Staphylococcus aureus : Should be Absent / 100ml

Description: Examine the sample for clarity, color and odour.
Reporting: Report as Complies / does not comply
pH: Take 100ml of the sample and determine the pH with previously calibrated pH meter.
Reporting: Report as Complies / does not comply
Limit: Between 5.0 and 7.0.
Conductivity: The Water conductivity can be determined by the following procedure:
1. Transfer a sufficient amount of water (100ml or more to a suitable container, and stir the test specimen. Adjust the temperature, if necessary, and while maintaining it at 25°C (+/-) 1°C, begin vigorously agitating the test specimen while periodically observing the conductivity. When the change in conductivity (due to uptake of atmospheric carbon dioxide) is less than a net of 0.1µS/cm per 5 minutes, note the conductivity.
2. If the conductivity is not greater than 5.1µS/cm , the Water meets the requirements of the test for conductivity.
3. Perform this test within approximately 5 minutes of the conductivity determination, while maintaining the sample temperature at 25°C (+/-) 1°C.
If either the measured conductivity is greater than this value or the pH is outside the range of 5.0 to 7.0, the Water
does not meet the requirement of the test for conductivity.
Reporting: Report as a value in µS/cm (micro Siemen per centimeter) along with the respective pH value.

Chlorides: Take 10ml sample add 1ml of 2M Nitric acid and 0.2ml of 0.1M Silver Nitrate solution, the appereance of solution does not change for at least 15 mibnutes.
Reporting: Report as Complies / does not comply

Revision No.	Changes
00	First Time Prepare.