Friday, January 30, 2009

COLLECTION OF SWAB FOR CLEANING VALIDATION - SOP

1.0 PURPOSE:
To provide a written procedure for collection of swab for cleaning validation.
2.0 SCOPE:
Applicable to sample from hard to clean area of cleaned equipments.
3.0 RESPONSIBILITY:
Executive Manufacturing, Executive QA, Assistant Manager QA.
4.0 ACCOUNTABILITY:
Manager Quality Assurance.
5.0 DEFINITIONS:
Nil
6.0 PROCEDURE:
6.1 Check the area / part of the equipment which is hard to clean.
6.2 Select 4 x 4 square inch area of the hard surface to clean.
6.3 Swab the marked area using Readymade Swab in four direction as shown below
[swab1.bmp]

6.4 Collect the swab sample as per the sampling plan.
6.5 Collect the swab in clean glass bottle labeled properly.
7.0 REFERENCES:
Nil
8.0 ENCLOSURES:
Nil
9.0 ABBREVIATION:
9.1 QA : Quality Assurance

2 comments:

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