PURPOSE:

To lay down  procedure for operation , maintenance & cleaning of ampoule filling machine.

SCOPE:

This procedure applies to Ampoule Filling Machine

 RESPONSIBILITY :

Production Manager.

Machine Operator

PROCEDURE:

1.The operator performing the process shall wear sterile garments & gloves before entry to sterile area & dressing title.

2. A Laminar Air Flow unit shall cover the ampoule filling machine.

3. Syringes, solution needles, nitrogen needle, nitrogen filter, solution vessel and various pipes are clamped at the place specified for them as shown in the diagram attached & explained below.

a) Solution outlet nozzle of solution tank attached to the syringe [attached to a T in case of double head machine.

b) Nitrogen filling needle connected to dry nitrogen filter which is further connected to nitrogen control valve.

c) LPG & Oxygen are connected from the control valve to burner via a nylon plastic pipe valves have been provided on the ma­chine also to adjust flame intensity.

4.Open nitrogen control valve & adjust nitrogen.

Open LPG & oxygen control valve ignite flame with lighter & adjust if required.

6. Load ampoule in the hopper of ampoule filling machine.

7. Switch on the machine.

8. Sends 100 filled ampoules for visual inspection, total rejec­tion rate shall not be more than 5% during filling.

MAINTENANCE:

1. Do the greasing & oiling
2. Check & adjust the belt.
3. Replace or repair any damaged part

CLEANING:-

1. After completion of ampoule filling , close the valves related to LPG, nitrogen and oxygen gas.

2. Disconnect the syringes/tubes and place it in an SS tray and pass it out to non-sterile area through pass box for cleaning.

3. With dry sterile sponge, remove all the glass pieces from the machine.

4. Remove the feeding roller and clean it free of any glass pieces with sterile sponge and sterile 70% IPA.

5. 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.

6. Clean the feeding hopper, spring clamps thoroughly with sterile 70% IPA.

7. Clean complete body of the machine including hopper racks, tongs etc. with sterile 70% IPA.

8. 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.

9. Remove the deposits of the medicine by rubbing with a lint free cloth

dipped in 70 % I.P.A solution.          

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