SOP For swab test is described in this post which you can follow in the section of the Quality Assurance Department.

OBJECTIVE

This procedure has been established to provide the guidelines for performing the swab test to verify the cleanliness of machines after washing / cleaning by Production staff.

SCOPE

This SOP is applicable to Quality Assurance and Production Departments. 

RESPONSIBILITY

Q.A. Officer

ACCOUNTABILITY

Manager Quality Assurance

PROCEDURE     

After intimation by the Production Department for carrying out swab test, add 15 ml of the specific reagent for dilution (Table-1) in a test tube accordingly. Attach cotton loop at the end of aluminum / copper wire (swab) and dip in the test tube.

Close the test tube with aluminum foil.

Take out the cotton loop from test tube, wipe the defined surface area (25cm2) of the contact parts of the machine and return the cotton loop into the test tube and close it with aluminum foil.

Take Absorbance of the solution at specific wavelength by UV / visible spectrophotometer using blank having the same reagent used for dilution. The levels of residual product in each piece of equipment/ under tested substance should not be more than 1/1000 of the normal therapeutic dose that will be present per typical dose of the next product to be run in the equipment.

Limiting the level of product which could appear in the following Products.

Limits from 10ppm up to 0.1% (based on the ICH impurity document which indicates that up to 0.1% of an individual unknown or 0.5% total unknowns material may be present in the product being tested)

(FDA Statement on 0.1% impurities)

Logbook for recording the swab test analysis

Sr.#

Wavelength (nm)

Product Name

Active Ingredients

Reagents for Dilution