Cross Over from Class III BCS to High Containment Isolators
Sponsored by: Powder Systems Limited
- Class I I I
- High Containment Isolaters
Date: 10 September
Time: 3PM London/10AM New York
What are the benefits of using high containment gloveboxes for Class III BSC applications?
Handling bio hazardous materials today poses more adverse complications to operators than in years past. In this age of infectious diseases such as Ebola virus and blood borne pathogens such as HIV, or Hepatitis, containment and decontamination is essential in handling these materials. Being able to handle these infectious materials is critical in the development for cures. By using the same methodologies as used in the pharmaceutical industry for handling potent compounds, a cross over in equipment has occurred with bio hazardous materials that provides more stringent operator protection and meets decontamination requirements.
This presentation will educate the attendee on the crossover from standard Class III Bio Safety Cabinets (BSC) to High Containment Gloveboxes that addresses the use of volatile toxic chemicals, radionuclides or infectious bio hazardous materials, some of which require specific controlled environmental conditions. After an overview of pathogen process applications and the issues of handling them under safe and regulatory requirements, Michelle Frisch will review the characteristics and classifications of BSC and the cross over to high containment gloveboxes. The main process benefits of the utilization of high containment gloveboxes for Class III BSC applications will then be identified with a supporting Case Study of Blood Borne Pathogens handling in a controlled environment with automated decontamination. Finally the necessary testing and regulatory requirements will be presented and how they can be achieved.
Join us for this webinar after which you will understand the complications and complexities of working with bio hazardous materials and learn how to implement high containment glovebox use over typical BSC. The webinar will illustrate why high containment glovebox achieve the optimum in operator protection while providing better processing and decontamination, thus better satisfying regulatory bodies.
Michelle Frisch MBA,
Sr. Manager, Global Technical Systems
Michelle Frisch holds two Bachelor of Science degrees, and also maintains a Technical Education Teaching Certificate. She also has completed her Masters in Business Administration. She is a member of the prestigious "Golden Key National Honor Society".
Michelle worked for Boise State University as a program manager, in conjunction with OHSA, establishing/developing OSHA compliance and writing operational/training manuals for external corporations. Along with this she developed risk assessment training for blood born pathogens and high risk environmental exposure.
Michelle has been working with the pharmaceutical industry for over 18 years, specializing in high containment technologies with Powder Systems Limited (PSL), establishing PSL USA in 1997. She is a member of the American Institute of Chemical Engineers, American Industrial Hygiene Association, AAPS, SBE, ISPE, and is on the Standards Committee for the American Glovebox Society. Michelle has also served on the subcommittee for COP for ISPE.
Key Learning Objectives
- Overview of pathogen processes and handling issues under safe and regulatory requirements.
- Identification of process benefits when using high containment isolators over Class III BSC.
- Learning how to implement high containment gloveboxes over typical Class III BSCs.
- Identification of the testing and regulatory requirements and how to achieve them.
- Operation Manager
- Facility Manager
- Engineering Manager
- Procurement Manager
- Project management
- Lab Managers
- R & D Managers or Directors
- QA managers
- Chemical Development managers