Preparation and Bio-Burden Monitoring of 70% IPA

1.0 Objective

To lay down a procedure for the preparation and bio-burden monitoring of 70% IPA.

2.0 Scope

This Standard Operating Procedure is applicable for preparation and bio-burden monitoring of 70% IPA.

3.0 Responsibility

3.1 All Microbiologists are responsible to follow the SOP.

3.2 Quality Control Head or his/her designee is responsible for compliance of this SOP.

4.0 Accountability

4.1 Department Head & QA Head shall be accountable for implementation of this SOP.

5.0 Abbreviations and Definitions

QC      :           Quality Control

IPA     :           Isopropyl Alcohol 

6.0 Procedure

6.1 Measure the required quantity of Isopropyl Alcohol in a clean measuring cylinder.

6.2 Use freshly collected distilled water for preparation of IPA solution.

6.3 Prepare IPA solution in proportion of 70:30, Isopropyl Alcohol: water.

6.4 Assemble the filtration assembly; insert sterilized o.45, 47 mm dia. Membrane filter.

6.5 Connect the assembly to vacuum pump.

6.6 Turn ON switch of vacuum pump.

6.7 Filter the prepare IPA solution.

6.8 Transfer the prepare IPA in the sterilized glass bottle.

6.9 Affix the label on the bottle with following information.

• Name of regent

• Strength

• Batch number

• Date of preparation

• Use before date

• Prepared by

6.10 Batch numbering procedure shall be as follows.

• XXA/YYYY.

• Where XX shall be current month

• A shall be Sequential number of preparation in current month and YYY shall stand for the current year.

• Enter preparation activity in format.

• Prepared Isopropyl Alcohol shall be used 7 days from date of preparation.

7.0 Forms and Records (Annexures)

NA

8.0 Distribution

8.1 Master copy –           Quality Assurance

8.2 Controlled copies- Quality Assurance, Quality Control

9.0 History