A Case Study for an Improved Approach to Cleanroom Disinfection, Minimizing the Impact and Reducing Downtime

A Case Study for an Improved Approach to Cleanroom Disinfection, Minimizing the Impact and Reducing Downtime

04/17/2018, 3:30 PM - 4:15 PM

Technical Conference Stage 3, Booth 1376, Exhibit Hall

Language:
English

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 disinfection. When selecting a cleanroom disinfection program there are many considerations in addition to the regulatory requirements. 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 including format of the product • Contact time • Complete regime of products and the compromise these have vs one another • Conditions of use (temperature and surface) • Material compatibility with surface of use • Regulations applicable to the product • Residues from the disinfectant and their removal Even when the above are addressed there is always a compromise between these different characteristics. We will examine a case study for a global generics manufacturer where by the implementation through a proactive risk based approach to cleanroom disinfection has improved efficiencies and reduced total cost of ownership. The benefits realized through the implementation of a low residue program will be explored as this is often overlooked by high impact characteristic of large surface disinfection. When "visually clean" is the standard, the impact can be far greater in terms of remedial action and management. Key factors which will be covered include the risk residues present to cleanliness, their potential interaction with surfaces, other biocides or detergents and potentially to the products being manufactured (with the biggest driver being proximity to point of fill).

Contributors

  • Emily Russell

    Speaker

    Marketing Communications

    Ecolab Life Sciences

    Life Sciences - Senior Marketing Communications

  • James Tucker, Msc

    Speaker

    Global Scientific Affairs Manager – Ecolab Life Sciences

    Ecolab Life Sciences

    James’ background is in microbiology and molecular biology. He holds an MSc in bioinformatics and first degree in applied biology; he also holds a...

Type of Session

  1. Type of Session
    Session

Learning Objectives

  1. Learning Objectives 1. 1. Understanding the trade-offs for disinfection selection 2. 2. Utilizing a risk based approach for selection of disinfectants 3. 3. Understanding the latent benefits of residue management disinfection programs

Categories

  1. Track
    Manufacturing Efficiencies & Improvements

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