Standard Operating Procedure Ampoule Filling Machine Operation, Cleaning & Maintenance

by Pharmadocx Consultants


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


This procedure applies to Ampoule Filling Machine


Production Manager.

Machine Operator


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.

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.

13 June 2023

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