Feedback    Advertise    Reprints    About    Help    Contact   
Upstream Processing Downstream Processing Manufacturing Analytical Facilities
Archive by Issue Archive by Article Type Supplements
CMC Forum
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

 
| | Share
The Best of GE Healthcare: Tools for vaccine processes

In vaccine development and manufacturing, GE Healthcare provides a suite of scalable solutions from cell culture through purification to analysis, which offer flexibility and economy, improve purity and secure quality.

Register to download these two NEW application notes:

Microcarriers and disposable bioreactors for MDCK and Vero cell culture
Secure cell propagation with adherent cells at reduced cost and with increased flexibility

DNA removal from influenza virus culture
HTPD and DoE for development and optimization of a chromatography step for the removal of host cell derived genomic DNA


BPI’s Senior Technical Editor’s at the CRS Annual Meeting in Portland, OR This Week (7/12/10–7/14/10)
Webinars   
Subscribe   
Reprints   
Contact   
About   
Informa plc
©2002 - 2009 BioProcess International
Ph: 508-616-5550