Current Regulatory Thinking on Cleaning and Disinfection

Date/Time: MARCH 25, 2021 | 11:00 AM – 12:00 PM PST


Why should you attend – Why is it important to learn about the topic

The selection of disinfectants to be used to control microbial contamination in a cleanroom is a complex decision as there is no single disinfectant that is effective against all microorganisms and has cleaning capability with surfactant activity. Choosing the best disinfection program involves not just the choice of the chemical agents, but also practical considerations such as safety, compatibility, storage and application methods. The validation of agents for sanitizing and disinfecting seems like a major undertaking but does not need to be. Poorly executed disinfectant qualification study may have an overall bearing on the bioburden in the cleanroom.

Cleanroom cleaning procedures should address both the chemical kill of the target organisms by effective disinfectants and adequate physical removal by appropriate cleaning supplies.
The changes to EU Annex 1, provide a glimpse into the current regulatory thinking related to cleaning, disinfection and residue removal.

Areas covered in the session:

  • The science behind cleaning and disinfection-common errors
  • Discussion on the changes in Draft EU Annex 1, 2020 related to cleaning and disinfection
  • Impact of the changes to cleaning, disinfectant and residual removal strategy
  • Disinfectant efficacy studies- most subjective test
  • Implementing Annex 1 changes to cleaning and disinfection SOPs
  • Case studies-what practices have led to contamination issues

Which industries does this webinar apply to?

Pharmaceuticals, Biotechnology, Medical Device, Cell/Gene Therapies, and Pharmacies

Who will benefit?

Quality Assurance, Quality Control, Microbiology, Manufacturing, Facilities, Validation, and Training Personnel