ISO Standards
News
IEST paper clarifies revision to ISO Cleanroom Standards– 14-Feb-2011
Aims to help cleanroom users understand new air sampling plan in new cleanroom standards
BioMérieux gains approval for VIDAS Listeria Xpress– 27-Oct-2010
Automated test for the fast detection of Listeria species
Zeus Biomaterials facility is ISO Class 7 certified– 2-Aug-2010
Manufacture of fluoropolymer tubing, including synthesis and processing, reaches standard
Cherwell Laboratories secures ISO9001 extension– 4-Mar-2010
Cherwell Laboratories has achieved the ISO9001 assessed and registered Quality Management Standard for the calibration, service and repair of its portable microbial air samplers.
STI Electronics is certified to ISO14644-1:1999– 13-Jan-2010
STI Electronics, a US firm that provides training, electronic and industrial distribution, laboratory analysis, prototyping and PCB assembly, has received ISO14644-1:1999 certification in accordance with Nebb Procedural Standards for an ISO Class 6 (Class 1000) manufacturing cleanroom for electronic hardware.
IEST starts work on nanotechnology standard– 6-Oct-2009
A working group of the US Institute of Environmental Sciences and Technology is to embark on a new International Standard addressing nanoscale facilities as part of the ISO 14644 Series, Cleanrooms and associated controlled environments.
IEST approves revisions to cleanroom standards– 24-Apr-2009
The US Institute of Environmental Sciences and Technology (IEST) has given its unanimous approval to proposed revisions to ISO 14644 Cleanrooms and associated controlled environments—Part 1: Classification of air cleanliness and Part 2: Specifications for testing and monitoring to prove continued compliance with ISO 14644-1.
Third TT electronics site achieves medical standard– 6-Apr-2009
Three of TT electronics integrated manufacturing services five worldwide sites are now able to manufacture medical electronic systems, having qualified for ISO 13485:2003. The Rogerstone site, near Newport in South Wales, has joined the firm’s other certified sites in Suzhou, China and Perry, Ohio.
ReceptoPharm achieves ISO Class 5 cleanroom certification– 13-Mar-2009
Drug discovery firm ReceptoPharm, a subsidiary of Florida, US-based Nutra Pharma, has achieved ISO Class 5 certification for its cleanroom manufacturing and laboratory facility. The upgraded ReceptoPharm facility is used primarily for the development and production of RPI-78, RPI-78M and RPI-MN, the firm’s leading drug candidates for the treatment of Multiple Sclerosis (MS), Adrenomyeloneuropathy (AMN), HIV, pain, and rheumatoid arthritis.
Articles
Applying ISO methods to counter calibration– 21-Nov-2011
International standards for the monitoring of airborne particles apply to all cleanrooms or clean zones. The international committee, TC209 Working Group 1, has been examining potential revisions to the first two sections of the ISO 14644 document. One key change in the proposed revision is the normative reference to a calibration standard for the instrument to be used for cleanroom classification. Although calibration will probably create some additional cost, there will be noteworthy benefits in both the repeatability and the reproducibility of the measurements obtained
A prickly issue– 4-Mar-2009
John Chubb, of John Chubb Instrumentation, argues there is a fallacy in the current assessment of garment materials for control of static electricity
Six Sigma demystified– 27-Nov-2003
Dr David Johnston of Matrix Projects gives us the lowdown on the Six Sigma concept
Controlling the flow – digitally– 12-Mar-2003
Emmanuel Bernard, application engineer at Qualiflow, looks at the cost advantages of digital mass flow controllers
More ISO Standards articles ..
Events
Life Science User Group Meeting (France)– 15-Mar-2012
24 May 2012
Meeting
Lyon, France