PURPOSE: 

To lay down procedure for Ampoule washing.

SCOPE: 

This procedure applies for washing of all types of glass ampoules.

 RESPONSIBILITY :

1.Production Chemist

2. Q.A. Chemist

PROCEDURE:

Introduction :-   

Ampoules are washed in the jet washing  machine . It connected  with purified water, compressed air and  electricity. Ampoules undergoes  3 cycles of  washing.

Cycle     1.          Purified water followed by air.

Cycle     2.          Purified water  followed by air .

Cycle     3.          Water for injection  Followed by air.

Ampoules are washed on the outside  by water jets on the  lid of the machine. Capacity of the machine :-    10,000 Ampoules /hour.

Requirements :–

1.         Jet washing machine .

2.         Approved purified water IP.

3.         Compressed air at  9 to 12 Kg/Cm²   pressure.

4.         Loading  trays for  Ampoules.

5.         Cabinets to store ampoules for DHS.

6.         Men power.

7.         Water for injection IP.

 PROCEDURE :-

 1.         Wear water proof garments & shoes.

 2.         Check water, air & electric supply.

 3.         Check that all needles of machine are intact.

 4.         Test fire machine to check that all  pressures of water go up to a height of minimum  3 foot.

 5.         Place ampoules to be washed on the loading  tray & load it in the  jetting chamber.

 6.         Switch on the machine, it will automatically stop after 3 cycle.

 7.         Remove loading tray, store washed ampoules in the storage cabinet.

  8.         Fill filtered  water in  20 ampoules & inspect visually to ensure that no glass, fiber,  Particles or particulate matter  is present  in the washed ampoules.

  9.         Repeat step 8  after  washing every 10,000 ampoules.

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