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SOP for Sampling and Testing of Pure Steam


Standard operating procedure of collection and testing of pure steam samples.

1.0  PURPOSE

       To lay down the procedure for sampling of Pure steam for Microbiological and Chemical analysis.

2.0  SCOPE

       It is applicable to Microbiology Laboratory

3.0  RESPONSIBILITY

       Microbiologist

4.0  ACCOUNTABILITY

       Head of Department

5.0  PROCEDURE

5.1  Sampling of Pure Steam for Bacterial Endotoxin Testing

5.1.1  Samples for bacterial endotoxin evaluation should be collected in depyrogenated tubes / bottles.
5.1.2  Remove the cap from the bottle immediately prior to obtaining a sample.
5.1.3  While samplings avoid direct contact to the mouth of tubes / bottles, carry the sample tubes / bottles in the sampling kit.
5.1.4  Allow steam to flow for approximately 1 minute.
5.1.5  While sampling wear the gloves and open the sampling valve slowly so that the steam is converted into condensate.  
5.1.6  Take the holder and hold the sampling bottle from the neck of bottle.
5.1.7  Take the sampling bottle near the valve and collect the condensate
5.1.8  Obtain the sample by filling the bottle.
5.1.9  Do not allow the bottle or the water in the bottle to come in contact with the valve.
5.1.10  Fill the bottle, without overflowing the bottle.
5.1.11  Tighten the cap securely. Close the valve
5.1.13  Fill in the information on the face of the bottle, as required.
5.1.14  Collect all sample bottles as per the schedule and store in a dedicated refrigerated area (2-8°C) if bacterial analysis will not be initiated within 2 hours after sample collec­tion.

Related: Validation of Pure Steam

5.2  Shipment (if applicable)

5.2.1  If a contract laboratory is utilized, samples shall be sent by express service to arrive at the contract laboratory as soon as possible after sampling. Samples should be treated and incubation initiated within 24 h of sampling.
5.2.2  Sample container transfer boxes should include provi­sions for maintaining the sample temperature at approximately 2-8°C during shipment.
5.2.3  The sample temperature shall not exceed 25°C at any time after initial refrigeration.
5.2.4  Samples shall not be frozen or cooled to a temperature < 2°C.

5.3  Sampling of Pure steam for Chemical analysis

5.3.1  Samples for chemical analysis should be collected in a clean and dried bottle.
5.3.2  Remove the cap from the bottle just prior to obtaining a sample.
5.3.3  While samplings avoid direct contact to the mouth of tubes / bottles, carry the sample tubes / bottles in the sampling kit.
5.3.5  Allow water to flow to drain for approximately 1 minute.
5.3.6  While sampling wear the gloves and open the sampling valve slowly so that the steam is converted into condensate.  
5.3.7  Take the holder and hold the sampling bottle from the neck of bottle.
5.3.8  Take the sampling bottle near the valve and collect the condensate.
5.3.9  Rinse the bottle with the water to be sampled at least three times.
5.3.10  Do not allow the bottle or the water in the bottle to come in contact with the valve.
5.3.11  Fill the bottle and remove the bottle from the sample valve and place the cap on the bottle as quickly as possible and ensure that no air bubble is entrapped.
5.3.12  For TOC analysis take the sample in the separate TOC vials collect the sample by overflowing the vials and close with the lead immediately.
5.3.13  Tighten the cap securely.
5.3.14  Close the valve
5.3.15  Fill in the information on the face of bottle, as required
5.3.16  Collect all sample bottles per the schedule and analyze the sample within 2 hrs of sampling.
5.3.17  Ensure that testing in any case is initiated within 24 h after sampling.

5.4  Shipment

5.4.1  If a contract laboratory is utilized, samples should be sent by express service to arrive at the contract laboratory as soon as possible after sampling. Samples should be tested within 24 h of sampling.
5.4.2  Sample container transfer boxes should include provisions for maintaining the sample temperature below 25°C at any time.
5.4.3  Samples should not be frozen or cooled to a temperature < 2°C.

5.5  Testing of Pure Steam

5.5.1  Bacterial endotoxin test Refer SOP for bacterial endotoxin testing.

5.6  Conductivity

5.6.1  Take the 50 ml sample in a suitable container, and stir the test sample by maintaining the temperature 25°C ± 1°C, measure the conductivity with the help of calibrated conductivity meter.  
Temperature and the respective Conductivity.

6.0  ABBREVIATIONS

6.1  SOP - Standard operating procedure
6.2  °C - Degree Celsius
6.3  TOC - Total organic carbon
Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
Email: .moc.enilediugamrahp@ofni Need Help: Ask Question


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