Cleaning Efficiency of Production Equipment for Parenterals

SUBJECT Cleaning Efficiency of Production Equipment for Parenterals 

To describe the procedure to ensure effective cleaning of parenteral manufacturing equipment to minimize the chances of cross-contamination and unacceptable viable count 

The validation manager and quality control manager are responsible for following the procedure. The quality assurance manager is responsible for SOP compliance. 

At the end of approval cleaning, the equipment should be rinsed with sterile water for injection. The water for hnal rinse shall be tested for its conductivity. As an alternative, run a placebo batch after a production batch and subsequent cleaning. Analyze the samples of placebo batch for the active ingredients of the previous run batch to ensure that there is no cross-contamination. 

Three times for each piece of equipment and each different product 

---