SOP on Sampling of Wash Water
Objective : To lay down a procedure for sampling of Wash Water of equipments.
Scope : This Standard Operating Procedure is applicable for formulation plant.
Responsibility
Executive/ Officer – IPQA shall be responsible for the implementation of the procedure as per this SOP.
Head- QA/ designee shall be responsible for compliance of this SOP.
Abbreviations and Definitions
Procedure ‘A’ – Cleaning with the help of potable / purified water (Wet Cleaning). Procedure ‘A’ follows every product to product changeover and after eight consecutive batches of the same product 0.5 % SLS shall be used as cleansing agent in case of product containing Nimesulide and product of soft gel department.
Procedure ‘B’ – Cleaning with the help of Clean, dry cloth (Dry Cleaning). Procedure ‘B’ follows every batch to batch changeover
Procedure :
Wash water sampling shall be performed after cleaning the equipment for every product to product changeover e.g. after cleaning of Procedure ‘A’ and after eight consecutive batches of the same product.
Officer / Executive- IPQA shall receive request for Sampling / Analysis of Wash Water of equipment used in production department.
Officer / Executive-IPQA shall collect the wash water sample in clean, dry sampling bottle.
Take required quantity of purified water in clean SS container for particular equipment as specified. Pour into cleaned equipment (contact part of equipment) and rinse the equipment with purified water.
Then collect wash water from equipments in clean, dry glass bottle and label the bottle, duly filled and signed.
Sample for the microbial analysis shall be taken by Microbiologist in sterile, clean glass bottle.
Submit the sample to QC department for Wash water Analysis.
QC shall analysis the sample, prepare the analysis report and same shall be sent to production department.
After receiving wash water analysis report for its compliance, Production department shall affix ‘CLEANED’ label on the equipments duly filled and signed.
IPQA person shall prepare the wash water sampling procedure with respect to equipment and submit to QA.
QA person shall review the wash water sampling procedure with respect to equipment, which is submitted by IPQA, prepare Master and same shall be distributed to all concerned department.