The Cleanroom Construction Associates (CCA) staff has combined for over twenty different white papers and published articles in all avenues of cleanroom, design, construction, and operation. These articles are referenced below for review and use by our current or potential clients. Feel free to read through them and utilize any that you feel can assist your efforts. If you'd like more information, please contact the author directly.
whitepapers
February 16, 2015
Summary of USP* 797 – Pharmaceutical Compounding – Sterile Preparations
Source of base information: Pharmacopeial Form – Volume 29 (4) July – August 2003 Effective Date: January 1, 2004 FDA enforceable: yes Scope – “The content of this chapter applies to health care institutions, pharmacies, physicians practice facilities and other […]
whitepapers
February 16, 2015
Retrofitting and Upgrading Operational Cleanrooms
Tim Loughran A2C2 magazine As contamination becomes of greater concern in the semiconductor, storage, and peripheral industries, existing facilities need to be upgraded to tighter cleanliness levels wile maintaining operations. One of the toughest construction jobs is retrofitting, upgrading, or […]
whitepapers
February 16, 2015
Point of View: Facilities Cleanliness Requirements
When the solution is simple, God is answering. – Albert Einstein The relationship between facility cleanliness and product cleanliness, between design criteria and operational conditions is one that even today oftentimes remains a mystery. Particle fallout is the source of […]
whitepapers
February 16, 2015
Lithium Battery Manufacturing for Automotive use and the Associated Manufacturing Facility Requirements.
In 2009 the Department of Energy provided over $2 billion in grants and $25 billion in funding for low interest loan guarantees for the proliferation of the manufacture of alternate energy vehicles. The lion’s share of that funding went to […]
whitepapers
February 16, 2015
Environmental Monitoring: Particle Counts are Easy
Scott Mackler February 2004 Manufacturing pharmaceutical and biotechnology products requires that the appropriate level of quality be designed and constructed into the facility — and systems — that support the production process. As a result of recent 483 observations and […]
whitepapers
February 16, 2015
Enhanced Biosafety BSL3+ Facility Design and Performance Qualification
Conor Murray, Contamination Control & Biosafety Expert Chairman, Irish Cleanroom Society, Chairman International Cleanroom Education Board Abstract This paper deals with biosafety change drivers, biosafety risk assessments, high containment biosafety design, secondary containment barrier design, commissioning & qualification as well […]
whitepapers
February 16, 2015
Case Study: Cambrex Biosciences Process Development Lab Expansion
In the Summer of 2002, Cambrex Bio Science Baltimore, Inc. commissioned a 3rd Party engineering firm to develop a Basis of Design (BOD) document for the 30,000 ft2 expansion of their process development laboratories at their Baltimore facility. The expansion […]
whitepapers
February 16, 2015
Basis of Design for Life Science Cleanroom Facilities
Basis Of Design For Life Science Cleanroom Facilities by Scott E. Mackler April 1, 2010 The successful design and realization of a validatable life sciences cleanroom won’t happen by chance. Early and continuous coordination and communication among all parties involved […]
whitepapers
February 16, 2015
Basis of Design for Life Science Cleanroom Facilities – Part 2
Scott Mackler
A2C2
June 1998
It was Louis Sullivan, designer of so many of Chicago’s fames high-rise buildings, who wrote, in 1960, “Form ever follows function.”Years before, Winston Churchill had written, “We shape our buildings, and afterwards our buildings shape us.”
A2C2
June 1998
It was Louis Sullivan, designer of so many of Chicago’s fames high-rise buildings, who wrote, in 1960, “Form ever follows function.”Years before, Winston Churchill had written, “We shape our buildings, and afterwards our buildings shape us.”