Standard Operating Procedure Inspection Of Garments Used In The Sterile Filling Room

by Pharmadocx Consultants

PURPOSE:  In order to prevent viable and non viable particle shedding, as well as to keep the levels of both viable and non viable particles low, it is absolutely necessary to wear dedicated garments while working in the sterile filling area. These garments are made from sterilizable lint free material and a set comprises of snoods, overall and booties in a sterilization bag.

Due to regular laundering, sterilization and use, these garments either get worn out, torn or their stitches come off. Hence it is necessary to carefully inspect these garments before putting them through the sterilization cycle so that only good set of garments are available for use in the sterile area.

RESPONSIBILITY  : Production Manager.


1. Receive laundered garments in sets.

2. Remove the set from the bag and separate out snood, overall and booties.

3. Check the set and bag for any residual detergent powder or stains.

4. Take the snood and check carefully the stitches and inspect for any worn out patches or torn areas; also check whether the tying ribbon is in tact.

5. Take the booties and check carefully the stitches and inspect for any worn out or torn areas especially around the toes, heels and bottom portion; also check whether the tying ribbons are intact.

6. Take the overall and check carefully the stitches, the buttons/Velcro and inspect for any torn or worn out patches especially around the armpits, elbows and seat and also check whether the waist ribbon is intact.

7. Similarly  check the sterilization bag and place the garment set inside the bag along with a sterilization indicator mentioning date of sterilization & expiry.

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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