Medisa SOP FOR MAKING 70% ISOPROPYL ALCOHOL

SIGN: SIGN: SIGN:

Initiated By Checked By Approved By

Department Q.C Manager. Technical Director.
ve
Incharge.
Pharmaceuticals Issue Date: 02.06.11 Revision N0: 00

DEPT: PRODUCTION

1.0 PURPOSE

This procedure has been established to provide the guidelines for making of mopping
solutions (70% IPA) for use in sterile area.
2.0 SCOPE

This SOP applies for the mopping of sterile area of production department.

3.0 RESPONSIBILITY

Sterile Area Officer / Assistant Supervisor Sterile Area / Quality Assurance

Inspector are responsible for the implementation of this procedure.

4.0 PROCEDURE

1. Put on protective goggles and gloves before working with any liquids

2. Identify the initial concentration of the 100 percent isopropyl alcohol, which is
the C1 variable in the equation. The variable C1=100.

3. Determine the desired concentration and volume of the final solution to obtain
C2 and V2. In this instance the final concentration C2 is 70 percent and final
volume V2 500 mL; So C2=70 and V2=500

4. Solve the equation C1*V1=C2*V2 for the unknown variable of V2.

Substitute known variables: 100*V1=70*500, V1=35000/100, V1= 350. It is
determined that 350 mL of 100 percent alcohol is needed for the preparation
 5. Add 350 mL of 100 percent isopropyl alcohol to a 500 mL graduated cylinder.
Ensure that the measurement is read at eye level with the meniscus, the
bottom of the curved liquid, at 350 mL.
6. Add an additional 150 mL of Distilled water to the graduated cylinder for a
total volume of 500 mL, again measured at eye level.

NOTE: Creating dilutions reduces the concentration of one liquid with the addition of
another. In order to create 70 percent isopropyl alcohol, a solution of isopropyl alcohol
with a concentration greater than 70 percent must be diluted by a calculated amount of
distilled water. The formula for this calculation is C1*V1=C2*V2, where C1 and V1 is
the starting concentration and volume of the solution and C2 and V2 is the final
concentration and volume of the dilution. For the purpose of this example, the initial
solution is 100 percent isopropyl alcohol, creating a final volume of 500 mL of 70
percent isopropyl alcohol.