1.0 OBJECTIVE:To lay down a procedure for the preparation and bioburden monitoring of 70% IPA.
2.0 SCOPE:This SOP shall be applicable for the preparation and bioburden monitoring of 70 % IPA in microbiology section.
4.0 ACCOUNTABILITY:Head QC, HOD QA & QC
5.0 PROCEDURE:5.1 Measure the required quantity of Isopropyl Alcohol in a clean measuring cylinder.
5.2 Use freshly collected distilled water for preparation of IPA solution.
5.3 Prepare IPA solution in a proportion of 70:30, isopropyl alcohol: water.
5.4 Assemble the filtration assembly; insert sterilized 0.45µ, 47 mm dia. membrane filter.
5.5 Connect the assembly to vacuum pump.
5.6 Turn ‘ON’ switch of vacuum pump.
5.7 Filter the prepared IPA solution.
5.8 Transfer the prepared IPA in the sterilized glass bottle.
5.9 Affix the label on the bottle with following information.
i) Name of reagent ii) strength iii) batch number iv) date of preparation v) use before date & vi) prepared by.
5.10 Batch numbering procedure shall be as follows :
Where, XX - shall be current month, A – shall be sequential number of preparation in current month and YYYY shall stand for the current year. Enter preparation activity in format.
5.11 Prepared Isopropyl Alcohol solution shall be used within 7 days from the date of preparation.
6.0 ABBREVIATIONS:6.1 QA : Quality Assurance
6.2 QC : Quality Control
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.
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