Guest Blog: Re-Validation Following a Contamination Event
In this blog post, John, our Aftersales & Validation Lead, looks at how to get your cleanroom operational again following a contamination event.
When considering how to effectively revalidate a cleanroom’s performance following a contamination event, we look to ISO 14644 Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration.
It cites that “a risk assessment shall be undertaken in order to develop a monitoring plan by determining factors that may affect the ability to maintain the agreed air cleanliness by particle concentration of the cleanroom or clean zone, and determine the monitoring requirements to provide evidence of performance.”
If an operator falls ill or develops symptoms of a contagious illness, putting the health of other operators and the process at risk, it is likely that a deep clean is an essential course of action to remove any associated microbial contamination.
ISO 14644-2 warns that “events that may affect environmental conditions at monitoring locations” should be considered when developing a monitoring plan, such as “cleaning and reassembly of equipment, whether as part of the process cycle or as an element of maintenance work.”
If your cleanroom has required a deep clean, then your risk assessment may deem that it needs to be re-qualified before it comes operational again.
In this instance you may opt to use a particle counter to revalidate that it meets or exceeds the requirements of the particle concentration limits of its class. The other option is to contact your validation partner to arrange for them to perform validation testing. In both instances, testing should be undertaken using the correct test procedures according to the guidelines within ISO 14644 standards.
If you have any questions on this topic or need to talk to me about validations, please get in touch.
Thanks for reading,