Standard Operating Procedure For Glass Ampoule Washing

by Pharmadocx Consultants


To lay down procedure for Ampoule washing.


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


1.Production Chemist

2. Q.A. Chemist


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.


 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.

Author: (GM Production)Checked by: (QA Manager)Authorised by: (Director Technical)
Date:Date :Date :

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

Written by Anmol Singh

Anmol Singh Completed his Bachelors in Field of Mechanical and Automation Engineering. He has over 2 Years of experience in field of Pharmaceuticals, Medical Devices, Cosmetics Manufacturing.

10 June 2023

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