1.0 PURPOSE: To lay down the Standard Operating Procedure for Preparation of 70 percentage v/v Isopropyl Alcohol Solution.
2.0 SCOPE: This SOP applies to the preparation of 70 percentage v/v Isopropyl Alcohol Solution.
3.1 Requisition for Isopropyl Alcohol 70 percentage Solution:
3.1.1 Prepare the Material Requisition for Isopropyl Alcohol, mentioning required Quantity as per Annexure-II “Item Requisition Slip.”
3.1.2 Get the Requisition Approved from Head Production and Authorised from Head Quality Assurance.
3.1.3 Handover Authorised Material Requisition Slip to Warehouse Department.
3.2 Transfer and Storage of Isopropyl Alcohol Solution:
3.2.1 Ensure that the Stainless steel Container is Closed Properly.
3.2.2 Keep the SS Container on SS Trolley.
3.2.3 Transfer the Isopropyl Alcohol in SS Container to Wash Room through Dispensed RM Store Tablet.
3.3 Preparation of 70 % v/v Isopropyl Alcohol Solution:
3.3.1 Frequency: Whenever Required (At the Time of Product Change Over, Serial Cleaning, Recleaning, or At the Time of Qualification and Requalification of Dies and Punches).
3.3.2 Put on Safety Goggles, Nose Mask, and Hand Gloves.
3.3.3 Avoid any Spillage of Isopropyl Alcohol during Solution Preparation.
3.3.4 Take IPA and water in 70:30 ratio for example for the preparation of 3 liters of IPA take 0.900 Liters of Purified Water (use fresh purified water) in a Clean Stainless Steel Container and Add 2.100 liters of Isopropyl Alcohol.
3.3.5 Transfer the total quantity prepared of 70 % v/v Isopropyl Alcohol Solution to the specified Area in closed condition.
3.3.6 Consume Total Quantity of 70% v/v Isopropyl Alcohol solution on the Same Day.
3.3.7 Record the details of Solution Prepared as per Annexure “Preparation of 70 percentage v/v Isopropyl Alcohol Solution Record”.
3.3.8 Filter IPA 70% with sterilized 0.45 micron and 47 mm dia. membrane and pass through the vacuum pump assembly then store it in SS containers.
- SOP – Standard operating procedure
- SS – Stainless steel
- v/v – volume by volume
- No. – Number
- Pg. – Page
- % -Percentage • Limited
annexure -I Preparation of 70 % isopropyl alcohol solution
Annexure -II Item Requisition Slip