AIHA 2011 Northeast Regional Industrial Hygiene Conferance & Exposition -New Jersey
December 2, 2011
Fast Track Implementation of Containment Engineering Controls for Band 4 Material OSD Clinical Manufacturing Using Innovative Technologies & Design.
Mr. Hari Floura (Floura LLC) & Mr. Ken Pirozzi (Novartis) will share their experience in the execution of a project to allow clinical manufacturing of Band 4 Materials (OEL = 1 µg/m3, 8 Hour TWA), at the Novartis East Hanover site. The requirements of the project were as follows:
- Complete project in 4 months
- Allow handling of batch sizes ranging from 1kg to 35kg
- Address the following processes and associated equipment:
▫ Dispensing of API
▫ Bin Blending
▫ Extrusion
▫ Milling (Fitzmill)
▫ Encapsulation
▫ Capsule Polishing - Solutions must ensure minimal to no impact with regard to existing equipment and process requirements.
The designs generated were based around the creative use of hard-wall containment, flexible film containment and a novel new contained transfer technology device, in order to meet the challenging budget and schedule needs.Pharmaceutical Technology Magazine
Are Disposable Components Powerful Enough to Manufacture Highly Potent Drugs? By Erik Greb , Hari Floura contributed his thoughts to this article
Pharmed Resources Disposable & Single Use Biopharmaceutical Manufacturing Systems Conferance - Philadelphia
September 27-28 2010:Hari Floura will present:
Strategies to Implement Containment Solutions under Time & Budget Constraints Using Disposable Technologies Pharmaceutical and Biotech companies of all sizes are increasingly required to handle high risk and potent compounds in the laboratory during drug discovery, through final product packaging and quality testing. In addition the Biopharma industry is additionally faced with the challenge of increasingly tight budgets and schedules during execution of capital projects. This session will discuss practical measures for safely handling, containing and minimizing exposure risk. Mr Floura will demonstrate, via case studies and practical examples, how single and multiple use disposable containment solutions can be applied where traditional containment methods may not be practical or economically feasible. During his session Hari will discuss and describe:
- The use of disposable systems to provide operator protection and maintain cGMP conditions
- The implementation of disposable engineering controls to contain new and old process equipment
- Disposable single and multi-use contained transfer systems
- Advantages and disadvantages as related to the technologies discussed
Link: http://www.pharmaedresources.com/brochures/Disposables_Sep10.pdf
TEVA The Americas Environmental Health & Safety Conference
Containment 101 & Strategies to Implement Containment Solutions under Time & Budget Constraints - 2010AIHA Pharmaforum - Denver
May 22-27 2010Hari Floura presented: Strategies to Implement Containment Solutions under Time & Budget Constraints
AIHA - PDC
December 3 2009
Hari Floura presented: Practical Solutions for Handling & Containing Potent Compounds and Other Dust Generating Operations (Extended Session)
Philadelphia Section AIHA Pharmaceutical Forum - Practical Approaches to Dust Control
March 24th, 2011
All manufacturing industries, at some point, will deal with dust generating processes that can be potentially hazardous to worker health. This presentation will discuss:
- Assessing and understanding the potential risk
- The effectiveness of Personnel Protective Equipment (PPE) and pairing PPE with engineering controls
- The technologies available to control risk
- Practical cost effective examples for safely handling, containing and minimizing exposure.