OBJECTIVE
To lay down the procedure for the sampling and testing of equipment wash water and swab sampling
SCOPE
This SOP is applicable to all incoming wash water and swab samples.
RESPONSIBILITY
Execution : Lab Attendant – QC department.
Checking : Chemist and above – QC department.
PROCEDURE
- Sampling Procedure
- Take a clean glass bottle with a lid
- Take a pretreated hydrophilic swab and immerse the swab part in 10 ml of purified water present in a clean glass tube and close the tube with the lid.
- Take 10 ml of purified water into a clean stoppered glass test tube.
- Take precautions while collecting the wash water and swab sampling
- Wear hand gloves and nose masks during wash water collection.
- Take a clean bottle and collect the wash water from a predefined location and label the bottle with the sample name and location
- Take the pre prepared swab and swab at pre-defined location at an area of 10 x 10 cm2 surface area of the equipment in a defined fashion. Care should be taken while taking swab; swab should not touch other than 10 x 10 cm2 area.
2. Testing Procedure
- Prepare the standard solution of the substance being examined as per respective test procedure.
- Set the instruments at described wavelength with respect to sample being analyzed.
- Perform the blank correction of the instruments by using water in 1 cm cell.
- After the blank correction put the sample solutions being examined in the 1 cm cell and measure the Absorbance.
- Similarly measure the standard solution absorbance.
- Note down the sample and standard absorbance readings and calculate the contents in the sample solution in ppm
Sample absorbance
Calculation = ------------------------------------ x Concentration of standard sol. = ppm
Standard absorbance
REFERENCE(s)
Nil.
ABBREVIATION(s)
Nil
PEOPLE ALSO READ FOR: Cleaning Validation - Guide for Pharmaceutical Industries
0 Comments