In previous issues, we covered the importance of cleaning surfaces to avoid microbial contamination. In this volume we will explore different types of cleaning that can occur and what it means to perform a cleaning validation.
It is important to clean our equipment, especially surfaces that directly touch product, to ensure they are free of contamination.
Cleaning ensures the product is free from contamination including:
Microbial contamination can cause adverse health effects such as cancer, autoimmune diseases and in serious cases can cause death.
manufacture multiple products. Cleaning prevents any leftover residue from one product to carry over into another product. Cross contamination can affect product stability and performance.
Cleaning in manufacturing is done with many different types of detergent. It is important to ensure all detergent is removed from equipment, so the residue does not affect the next product produced on that equipment.
There are a few different ways that equipment can be cleaned after manufacturing.
CIP is cleaning equipment without disassembling parts. The process is cleaned as a system by running heat, water and sanitizing chemicals through process equipment
COP is the cleaning of equipment with disassembling of parts. Cleaning equipment out of place is very similar to cleaning your dishes in your sink at your house!
Fact: Because contamination in the pharmaceutical industry can have so many adverse and even deadly consequences, you need to prove that your cleaning method works. Read on in the next page to see how we prove our cleaning works!
A cleaning validation is proof that the cleaning process removes all potential sources of contamination. It tests that all residues of the product that was manufactured prior and any cleaning agents used in the process have all been removed. Cleaning validation is critical to maintaining patient safety and mitigating cross contamination.
The first step in a cleaning validation is developing the instructions used for cleaning the equipment. These instructions should be equipment and product specific and include at a minimum:
A validation is done on the cleaning process. Once a cleaning process is created, a protocol for cleaning validation can be created. A robust validation protocol includes what equipment or products are impacted, and what results are needed to pass the validation.
In order to prove that your cleaning process removes all residue, you need to test that your cleaning worked. Two common methods are equipment swabbing and visual inspection
After a cleaning process is run equipment will be visually inspected prior for any soap or product residue. Sometimes blacklights or other techniques are used to help see the residue better.
Equipment will be swabbed in product contact locations to test if all soap and product residues have been removed. Swab sites and test methods for detection should be determined prior to performing the cleaning validation and specified in the protocol.
Before creating a cleaning procedure, you need to decide which detergent or sanitizing agent to use. In order to do this some companies will use Coupons. Coupons are disposable surfaces that mirror the properties of equipment surfaces that can be used to test removal of product residue with different detergents before the process is run on manufacturing equipment.
Fun Fact: Testing methods are needed to detect any product or detergent on the swabs taken from equipment. Coupons can also be used to develop these test methods.
