Standard Operating Procedure   For Cleaning , Operation & Maintenance Of  Four  Head Ampoule Filling Machine

by Pharmadocx Consultants

PURPOSE:  To lay down a procedure for the maintenance in case of ampoule filling machine.


      1. Section Supervisor/Shift In-charge

      2. Maintenance Engineer



  1. After complication of ampoule filling, close the valves related to LPG, nitrogen and oxygen gas.
    1. Disconnect the syringe/ tube and  place  it in an SS tray  and pass it out to the non –sterile area through pass box for cleaning
    1. With dry sterile  sponge  remove all the glass pieces from the machine
    1.  Remove the feeding roller and clean it free of  any glass pieces  with sterile sponge  and sterile 70%
    1. During filling broken pieces of ampoules after sealing will be collected in the receiver. So open the receiver and collect all the broken glass pieces of ampoules in a tray and pass it out to non – sterile area.  clean the  inner part  and  outer part of the  receiver  with sterile  70% IPA
    1.  Clean the feeding hopper spring clamps thoroughly  with sterile 70%IPA
    1. .Clean  complete body of the  machine  including hopper racks  , tongs etc. with sterile 70% IPA
    1.  Before start up  of the  assembly  for filling  clean  various parts of machine  such as  feeding  hopper ,syringe clamps ,  waste  gases  extraction  assembly, barriers channels, moving and stationary racks, ampoule collecting rack with sterile 70% IPA solution.
        Author: (Production Manager)Checked by: (QA Manager)Authorized by: (Director Administration)
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.

16 June 2023

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