Biological Facility Design for Compliance
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The field of biological facility design has been one of the most evolving engineering practices over the last 30 years. In the 1980s most biological facilities were modeled after generations of antibiotic production. These were large and suffered with significant bioburden problems.
By the late 1990s compliance requirements had forced the industry to adapt, and the investment dollars, complexity, and redundancies made the biotech facilities an expensive single product venture. This did not necessarily work out as many of the mega-plant’s sole product did not come to fruition in phase III trials.
In the 2000s the biological facilities became smaller by design, were more rapidly deployed and experimented with various technologies to provide regulatory compliance, and in some cases borrowing techniques from the aseptic fill/finish world to assure their success.
In more recent times, design concepts have driven the compliance into a status quo, while the construction techniques and process technology options have allowed production organizations to build quicker, at lower cost per square foot. The process technologies, specifically the disposables have been a game changer with respect to multiple product facilities, introduction of cyto toxic compounds, smaller footprint, and easier operations.
This webinar will explore the design concepts that are driving the compliance and the operability of the business. The exploration will be a “inside – out” view of a plant’s design model:
Why should you Attend:
- Process Core
- Facility Design
- Facility Operations
The pharmaceutical world is driving two contemporary themes: 1) rapid modification of existing (possibly old) biological production to accommodate new products, therapies and cell cultures, and 2) rapid design and build of a new facility on an existing site to launch a new product. All these projects have two aspects in common, rapid and risk.
Today most companies delay any decision, and when doing so making until it almost too late to act, and that leads to risk in design and deployment. In addition, early on in the process an ill defined budget is usually fixed and becomes a burden to those responsible for the effort.
This type of dilemma ultimately manifests itself with compliance risks unless the organization has the background in some of the new technologies as well as the key design features that will prevent compliance issues from the US and EU.
This webinar looks at key design features and philosophies to drive the compliance to a successful conclusion, and will explore modern technologies of facility deployment that can rein in costs and reduce schedules.
Areas Covered in the Session:
Who Will Benefit:
- Facility design direction and features (architectural and HVAC)
- Process design features and options
- Bioburden Control
- Potent / Cyto-Toxic vs. Non-Toxic Compounds
- Process Disposables / Single Use Technologies
- Project Execution Methods
- Risk Based Qualifications
- Operational Do’s and Don’ts
- Off Site Qualifications
- Modular / Podular design
- Utility Systems (water, air, gases, etc.) and options
- Enabling Good Aseptic Technique
- Environmental Monitoring
- Project Planners
- Quality Assurance
Mr. Bozenhardt has 37 years of experience in pharmaceutical, biotechnology and medical device manufacturing, engineering and compliance. Mr. Bozenhardt's expertise is in a wide spectrum of processes, engineering, compliance and computer systems and related technologies.
Mr. Bozenhardt is also a recognized expert in the area of aseptic filling facilities and systems, with service to Novo Nordisk, DSM, Catalent, Organon Teknika, Bausch and Lomb, Alcon, J&J, Bristol Myers Squibb, Janssen Pharmaceuticals, as well as operations positions within Pfizer Inc.
Mr. Bozenhardt has extensive experience in the manufacturing therapeutic biologicals and vaccines via cell culture technology, human plasma derivation and egg based technologies.
Prior to being an executive consultant, Mr. Bozenhardt was an engineering executive with Life Sciences International, Foster Wheeler, Aker Kvaerner, and KBR.
Mr. Bozenhardt has a BS Chemical Engineering and MS System Engineering from the Polytechnic Institute of Brooklyn (now Polytechnic Institute of NYU).