PURPOSE:  To lay down procedure for Washing, cleaning & storage of equipments, vessels &

machine parts for  Parenterals .

SCOPE: This procedure applies for the cleaning of equipments.

RESPONSIBILITY  :  Production Manager.

PROCEDURE:

REQUIREMENTS :-          

1.                     0.2% Teepol solution.

2.                     Scrubbing brush.

3.                     Potable water

4.                     Purified water

5.                     Water for injection.

6.                     Butter paper & rubber bands.

PROCEDURE :- Following steps are involved.

1.EQUIPMENT DISASSEMBLY :-  Equipment or machine parts like syringe should be

completely disassembled to render complete cleaning .

2. PRE WASH :- Collect all the vessels to be washed in the washing section & sprinkle hot water

over them.

3. SCRUBBING :- With a plastic brush soaked in 0.2% teepol solution, scrub all equipments to

                                 remove stains, medicine depositions etc.

4. INITIAL RINSE :- Rinse with potable water till they are  free from teepol.

5. FINAL RINSE :- Rinse all washed articles twice each with purified water  followed by water for  

                                   injection.

6. WASH WATER ANALYSIS :-   Request Q.C. Dept to  withdraw sample of wash water &

send their results for the  testing of detergent & last batch traces . Put clean equipment tag

after getting approval from Q.C Dept.

STORAGE OF CLEAN EQUIPMENTS.

After completion of washing , washed articles should be stored under conditions which minimize the risk of contamination by particulate matter & after sterilization by viable organisms . To the extent possible components should be covered with lid or with butter paper or aluminum foils.

(Review date on or before 12 months from date of authorization)