Cleaning Process Validation
BFK Solutions expedites the design and validation of your cleaning process.
“Cleaning validation” is a term frequently associated with medical device or pharmaceutical processes, where it is often associated with the concept of leachable residue. Validation also encompasses critical processes in any manufacturing industry. We help you to achieve cleaning validation that demonstrates and documents that residue is reduced to an acceptable level.
We work with you to design cleaning processes that can meet validation requirements, that can be scaled-up for high volume production, that are rugged, and that can be monitored to assure consistent, quality production. Steps include
Establish cleaning process goals, i.e. define “how clean is clean.” This can involve benchmarking to a well-established, acceptable product or cleaning process. It also involves setting goals in terms of residue level and surface attributes for new products, where benchmarking may not be possible.
Develop a validation protocol. This includes determining the analytical techniques to measure residue and surface quality.
Initiate a program to monitor the process. This may include continuous or periodic testing to insure that process limits are not exceeded. It may define a protocol for re-validation.
For more about cleaning validation, see our columns in Controlled Environments, Jan. and Feb., 2010.