Education Sessions
E-IN3a & b
Environmental Control and HVAC Issues: Challenges, Requirements and Solutions
(Two Successive Sessions)
| 6 November 08.15-11.30; 14.15-17.30 | Track: Innovation |
ISPE CEUs: 0.5
Correctly designed and optimally operating HVAC (heating, ventilating, and air conditioning) systems are fundamental to the pharmaceutical industry's capability of developing and manufacturing safe and efficacious products; protecting the environment; and creating a safe workplace for personnel.
This ISPE session will provide cutting-edge information and case studies relevant to OSD, sterile and potent product manufacture that illustrate the best current practice in our industry. The latest guidance concerning air filtration, clean room standards and good engineering practice will be explained in depth. A platform will also be provided to create a forum to debate two important high profile subjects:
- HEPA filter specification & testing practice.
- Guidance on specification, testing and monitoring unidirectional airflow systems.
These subjects are expected to be taken up within ISPE's HVAC Community of Practice (CoP)
The programme includes a HEPA filtration forum.
Take Back to Your Job
- Current information on air filtration standards and practice in the US and EU
- Really understand the HEPA filter bleed-through problem
- Consider alternative filter leak test methods
- Gain an understanding of the principles, issues and control techniques for achieving effective unidirectional airflow systems
- Knowledge of conservation technologies and options for HVAC, and the conflicts with safety and quality criticality
- Understand what constitutes Good Engineering Practice for HVAC: GEP, the foundation for all qualified systems
Who Should Attend
Building operations engineers and technicians, facility designers, facility QC and QA, facility inspectors, and facility maintenance management.
Communities of Practice: Active Pharmaceutical Ingredients (API), Commissioning and Qualification (C&Q), Heating, Ventilating, and Air Conditions (HVAC), and Sterile Products Processing (SPP)
Session Leaders
- Gordon Farquharson, Principal Consultant, Bovis Lend Lease-Technology Division
- Donald Moore, Engineering Consultant, Eli Lilly & Co
Session Speakers
- Norman Goldschmidt, Sr Director - Global Eng, Bristol-Myers Squibb
- Dean Hale, Engineering Consultant, Eli Lilly and Co
- Dan Milholland, Principal, Milholland & Associates
- Dustin Schafer, Mechanical Engineer, CRB Consulting Engineers Inc
- Ulla Thomsen, MSC Mechanical Engineering, Novo Nordisk A/S
