PDA Southeast Chapter Dinner & Dialogue: Disinfectant Residues and their Implication to End Users

Presentation Overview:
One of the key areas for ensuring that cleanrooms remain within microbiological and particulate specifications as laid out in ISO 14644 or Annex 1 of GMP is routine cleaning and disinfection.

When selecting a cleanroom disinfection program there are many considerations in addition to the regulatory requirement for demonstrating adequate efficacy. These requirements need to form part of the assessment for implementation of a disinfection program. The risk-based assessment should cover the following key areas:
•   Efficacy requirements
•   Operator exposure/ HSE considerations
•   Sterility and format of the products
•   Achievable contact times
•   Complete rotation regime and potential interactions of agents with each other
•   Conditions of use (temperature and surface)
•   Material compatibility
•   Regulations applicable to the product
•   Residues from the disinfectant and their removal
Key factors which will be covered include the risk residues present to cleanliness, their potential interaction with surfaces and other biocides or detergents, and potentially to the products being manufactured (with the biggest driver being proximity to point of fill).

Audience Take-Home Benefits:

• Learn how to use a risk-based approach when employing a disinfection program
• Understand the key areas that the risk-based assessment should cover
• Realize the risks and impact of residues
• Discover benefits of implementing a low residue program