PURPOSE: 

To lay down procedure for Vial washing.

SCOPE:  

This procedure applies for washing of all vials.

 RESPONSIBILITY:

            1. Production Chemist

2. Q.A. Chemist

PROCEDURE:

Introduction :  As the vials get contaminated with the lint, dirt, fibers and particulate matter, it becomes essential to adopt a well defined procedure to wash & clean them to make them free from particulate matter.

REQUIREMENTS : –

                        1.         4 Head brushing machine

                        2.         Brushes of required sizes

                        3.         0.2 % Teepol solution.

                        4.         Plastic Crates for storage of vials during washing process

                        5.         Potable water supply

• Purified water IP supply
• Water for Injection supply

                        8.         Vial washing machine

                        9.         Steel & Aluminium Cabinets to store vials.

                        10.       Water for injection IP.

PROCEDURE :

1.         Take a plastic crate, fill 0.2%, Teepol Solution and dip vials in it.

2.         Carefully brush the vials on brushing machine both internally & externally.

3.         Rinse the vials with potable water

4.         Load the vials in  jet washing machine

5.         Switch on jet washing machine & vials will be washed by 2 cycle of Purified

Water & one cycle of Water for Injection.

6.         Remove vials from the vial washing machine and place in vial storage cabinets.

7.         After washing every 10,000 vials visually inspect 20 vials for particulate matter. 

Not more than 1 vial shall be rejected.

8.         Note down details like date & time of commencement & washing, quantity issued

for washing, Quantity washed, quantity broken during washing, AR No. of

Purified water IP in the batch manufacturing record.

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