PURPOSE: To lay down a procedure for the maintenance in case of ampoule filling machine.
1. Section Supervisor/Shift In-charge
2. Maintenance Engineer
- After complication of ampoule filling, close the valves related to LPG, nitrogen and oxygen gas.
- 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
- With dry sterile sponge remove all the glass pieces from the machine
- Remove the feeding roller and clean it free of any glass pieces with sterile sponge and sterile 70%
- 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
- Clean the feeding hopper spring clamps thoroughly with sterile 70%IPA
- .Clean complete body of the machine including hopper racks , tongs etc. with sterile 70% IPA
- 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)