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CMC Forum Press Releases
Useful Terms for Integrating Modular Design-Build Execution Strategies into Biotech Projects: Meeting Schedule, Cost, and Compliance Goals
Kevin L. Koffke, and R. Grant Merrill

Here are definitions of some less-familiar terms from the January 2008 facilities-focused article,

"Integrating Modular Design-Build Execution Strategies into Biotech Projects: Meeting Schedule, Cost, and Compliance Goals" by Kevin L. Koffke and R. Grant Merrill. Thanks to the authors for providing them!

ACPH (air change per hour): The number of times within a hour that the entire volume of a room is circulated by its HVAC system

basis-of-design document: a design document that describes the purpose of a given system and how that system will accomplish its required task

clean-build protocol: a protocol that stipulates performing construction in a way that minimizes airborne particulate and surface contamination; in some extreme cases, this can require that work be performed using cleanroom gowning procedures.

conceptual design: a document created before a system is qualified as the basis of design due diligence: in facility design/construction, the legal care and attention undertaken to establish that design and construction activities meet or exceed industry standards and guidelines

ETOP (engineering turn-over package): design documents turned over to a client to establish a design/constructed base line; these are often used for supporting installation qualification (IQ) procedures.

order-of-magnitude budget: preliminary budget created from estimated cost that are established early in a project

URS (user-requirements specifications): specification stating all end-user requirements

walkable ceiling: a ceiling system that is structurally sound to support personnel walking directly on its surface for access throughout the life of a facility for activities such as maintenance, calibration, and troubleshooting

 
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Biopharmaceutical Production
Facility Design Strategies for Single-Use Technologies

Please join us for a free webinar addressing strategies for facility design in biopharmaceutical manufacturing:

Wednesday, 29 February 2012
8:00 AM and 1:00 PM EST

Presented by:

Ingrid Long, MSc
Research Engineer
GE Healthcare Life Sciences

Register today!

During the webinar, Ms. Long will discuss the impact of different strategies for facility design, with a focus on the following topics:

* Replacement of traditional equipment with the single-use equivalent
* Biopharmaceutical manufacturing in a single room
* Benefits of facility design with respect to cost, risk, and flexibility

Register today!


Nine Conferences — One Location: Hilton Bayfront (San Diego, CA)
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