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Rapid Microbial Methods & Developing a Risk-Based Cleaning and Disinfection Programme
Wednesday 23rd January 2019

The workshop will begin with a survey of rapid microbial methods, including spectrometric and optical methods that are used for sensing contaminants. Operating principles will be discussed and related to microbial attributes being interrogated. The Pros and Cons of the methods will be analyzed with respect to traditional microbial quality control methods. Finally, the practical aspects of implementation, validation, and regulatory considerations will be discussed. The workshop will also cover a risk-based cleaning and disinfection program and the current best practices in the industry to control bioburden in cleanroom operations. Participants will gain insight into the latest cleaning methods and frequencies. Disinfectant rotation and rinsing and residue removal in cleanrooms will also be covered from a risk -based approach. Finally, the current industry best practices on disinfectant validation will be covered along with the best methods to overcome disinfectant validation challenges.

Workshop Leaders:

Andrew Bartko, Research Leader, Battelle Memorial Institute
Jim Polarine, Senior Technical Service Manager, Steris Corporation

Dr. Andrew P. Bartko received a B.S. from the University of Pittsburgh in 1997 and a Ph.D. in physical chemistry in 2002. His graduate work consisted of deciphering spatially heterogeneous relaxation dynamics of glass forming systems using novel rotational single molecule microscopy techniques. In 2002, Dr. Bartko joined the Softmatter Nanotechnology and Advanced Spectroscopy Team at Los Alamos National Laboratory where he studied the ultrafast photophysics of semiconducting quantum dots. Dr. Bartko is a senior scientist in Battelle’s Technology Development Group where he contributes to several applied spectroscopy efforts that focus on biological and chemical sensing. He now leads Battelle’s Rapid, Enumerated, Bioidentification System development program.

Jim Polarine is a senior technical service manager at STERIS Corporation. He has been with STERIS Corporation for seventeen years. His current technical focus is microbial control in cleanrooms and other critical environments. He has lectured in North America, Europe, Middle East, Asia, and Latin America on issues related to cleaning and disinfection in cleanrooms. Mr. Polarine is a frequent industry speaker and published several PDA book chapters and articles related to cleaning and disinfection and contamination control. He is active as co-chair on the PDA’s microbial investigations task force. Mr. Polarine graduated from the University of Illinois with a Master of Arts in Biology. He previously worked as a clinical research coordinator with the Department of Veterans Affairs in St. Louis, MO and as a biology and microbiology instructor at the University of Illinois. His main hobby is storm chasing and is very active in tornado research and tornado safety.

The workshop will include a synopsis of Rapid Microbial Methods options to the industry as well as a technical description of sensing of contaminants in production. Participants will also gain a deeper understanding of the advantages and limitations of contamination sensing and barriers to implementation. They will also gain insight into how Rapid Microbial Methods compares with traditional methods. The second half of the workshop will provide current industry insight and case studies on developing a risk-based cleaning and disinfection program. This workshop should be attended by quality managers, validation managers, production managers, operations managers, regulatory managers, and consultants in the pharmaceutical, biotech, hospital compounding, and medical device industries.

Workshop programme

13:30 Registration and Coffee

14:00 Chairman's Opening Remarks

14:10 Commercially off-the-shelf options and technical aspects of sensing

Andrew Bartko

Andrew Bartko, Research Leader, Battelle Memorial Institute

  • Microbial contamination detection and identification
  • Fidelity of results
  • Actionable limits
  • Time to result / action
  • 14:40 Implementation of strategies

    Andrew Bartko

    Andrew Bartko, Research Leader, Battelle Memorial Institute

  • Comparability to standard methods
  • Return on investment
  • Risk reduction advantages
  • 15:10 Afternoon Tea

    15:40 Validation pitfalls to avoid

    Andrew Bartko

    Andrew Bartko, Research Leader, Battelle Memorial Institute

  • Viable but not culturable
  • Approaches to regulatory approval
  • Case studies
  • 16:20 A risk based cleaning and disinfection program

    Jim Polarine

    Jim Polarine, Senior Technical Service Manager, STERIS Corporation

    16:50 Validating disinfectants used in cleanroom operations

    Jim Polarine

    Jim Polarine, Senior Technical Service Manager, STERIS Corporation

    17:20 Closing Remarks and End of Workshop

    +

    FEATURED SPEAKERS

    Andrew Bartko

    Andrew Bartko

    Research Leader, Battelle Memorial Institute
    Jim Polarine

    Jim Polarine

    Senior Technical Service Manager, STERIS Corporation

    Andrew Bartko

    Research Leader, Battelle Memorial Institute
    Andrew Bartko

    Jim Polarine

    Senior Technical Service Manager, STERIS Corporation
    Jim Polarine

    VENUE

    Copthorne Tara Hotel

    Scarsdale Place, Kensington, London, United Kingdom

    The Copthorne Tara Hotel London Kensington is an elegant contemporary four-star hotel in prestigious Kensington, located just a two minutes walk from High Street Kensington underground station, making exploring easy. The hotel offers well-appointed and comfortable guest rooms combining Standard, Superior and Club accommodation. Club rooms offer iconic views over the city and include Club Lounge access for complimentary breakfast and refreshments. Guests can sample the authentic Singaporean, Malaysian and Chinese cuisine at Bugis Street, traditional pub fare at the Brasserie Restaurant & Bar or relax with a delicious drink at West8 Cocktail Lounge & Bar.

    The Copthorne Tara Hotel boasts 745 square meters of flexible meeting space, consisting of the Shannon Suite and the Liffey Suite, ideal for hosting conferences, weddings and social events. Facilities include access to the business centre 24 hours a day, fully equipped fitness room, gift shop, theatre desk and Bureau de Change. With ample onsite parking outside the London congestion charge zone and excellent transport links via Heathrow Airport, the hotel is the perfect location for business or leisure stays. The hotel is within close proximity to the shops of High Street Kensington, Knightsbridge and Westfield London, Olympia Conference Centre, Royal Albert Hall, Kensington Palace and Hyde Park.

     

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    Copthorne Tara Hotel

    Scarsdale Place
    Kensington
    London W8 5SR
    United Kingdom

    Copthorne Tara Hotel

    The Copthorne Tara Hotel London Kensington is an elegant contemporary four-star hotel in prestigious Kensington, located just a two minutes walk from High Street Kensington underground station, making exploring easy. The hotel offers well-appointed and comfortable guest rooms combining Standard, Superior and Club accommodation. Club rooms offer iconic views over the city and include Club Lounge access for complimentary breakfast and refreshments. Guests can sample the authentic Singaporean, Malaysian and Chinese cuisine at Bugis Street, traditional pub fare at the Brasserie Restaurant & Bar or relax with a delicious drink at West8 Cocktail Lounge & Bar.

    The Copthorne Tara Hotel boasts 745 square meters of flexible meeting space, consisting of the Shannon Suite and the Liffey Suite, ideal for hosting conferences, weddings and social events. Facilities include access to the business centre 24 hours a day, fully equipped fitness room, gift shop, theatre desk and Bureau de Change. With ample onsite parking outside the London congestion charge zone and excellent transport links via Heathrow Airport, the hotel is the perfect location for business or leisure stays. The hotel is within close proximity to the shops of High Street Kensington, Knightsbridge and Westfield London, Olympia Conference Centre, Royal Albert Hall, Kensington Palace and Hyde Park.

     

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    WHAT IS CPD?

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