$75

Disinfectant Residues and their Implication to End Users

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Mia Francesca

4100 Main at North Hills St #114

Raleigh, NC 27609

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Join PDASE and ECOLAB for this Dinner and Dialogue

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Presentation Objectives:When “visually clean” is the standard in cleanrooms, the impact of residues can be far greater in terms of remedial action and management. The benefits realized through the implementation of a low residue program will be explored for large surface disinfection. 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 removalKey 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

Biography: Madison is a pharmaceutical microbiologist who has experience in the manufacture of a range of pharmaceutical formats including non-sterile liquids, topicals, and parenteral drug products. Madison’s experience includes working with a team to design and qualify a clinical drug product manufacturing facility. She has experience developing an environmental monitoring program for an ISO classified aseptic manufacturing facility and established an on-site microbiology laboratory. She has also been responsible for site-wide aseptic operations, training, and gowning programs. Madison has led numerous investigations into environmental monitoring non-conformities, utilizing risk management to identify and mitigate contamination risks. She has implemented necessary changes to facility design, procedures, and personnel training to optimize the process and minimize contamination risks. She holds a BSc in Microbiology, is a IRCA accredited GMP provisional auditor, and is a member of the PDA and American Society for Microbiology.

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Mia Francesca

4100 Main at North Hills St #114

Raleigh, NC 27609

View Map

Refund Policy

Refunds up to 7 days before event

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