INDUSTRY INFORMATION
In a constantly shifting regulatory environment, B & V Testing offers this space to help clients stay abreast of important industry developments. Check out the links below to industry technical organizations, or, for more information, contact us at 800.851.9081 or at Info@BandVTesting.com.
March 2007
B & V Testing presents "Decon 2.0: Emerging Decontamination Technologies: VHP and Chlorine Dioxide Gas Decontamination Field Studies" to the Massachusetts Biotechnology Council Safety, Environmental & Facility Operations Committee, Cambridge, Massachusetts.
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Emerging Decontamination Technologies Presentation
October 2006
B & V Testing presents "Vaporized Hydrogen Peroxide (VHP) Decontamination Field Studies: Conventional and Unconventional Applications" at the 49th annual Biological Safety Conference of the American Biological Safety Association, Boston, Massachusetts. Download presentation here:
Decontamination Field Studies Presentation
Summer 2006
Proposed changes to USP 797 introduced for comment. See www.usp.org. B & V Testing introduces USP797 controlled environment gap analysis. For more information, contact us
April 2006
B & V Testing presents "Chemical Fume Hood Field Performance Testing: Past, Present and Future" Êat the Controlled Environment Testing Association 2006 Annual Meeting, Las Vegas, Nevada.
Download the presentation:
Chemical Fume Hood Field Performance Testing: Past, Present and Future
September 2005
B & V Testing participates in NSF 49 task force to consider alternative decontamination technologies.
For more information, contact us at 800.851.9081 or Info@BandVTesting.com.
June 2005
IEST-RP-CC034.2: HEPA AND ULPA FILTER LEAK TESTS released
This expanded Recommended Practice covers definitions, equipment, and procedures for leak testing HEPA and ULPA filters in the factory, at the job site before installation, and as-installed in cleanrooms and in unidirectional-flow, clean-air devices.
For more information go to www.iest.org.
September 2004
FDA releases Guidance for Industry—Sterile Drug Products Produced by Aseptic Processing—Current Good Manufacturing Practice U.S. Food and Drug Administration, Center for Drug Evaluation and Research
For more information go to www.fda.gov.
For a free consultation on whether your cleanroom testing program complies with the current FDA guidelines contact us at 800.851.9081 or Info@BandVTesting.com.
September 2004
NIOSH issues Alert: Preventing Occupational Exposures to Antineoplastic and other Hazardous Drugs in Healthcare Settings. Provides health care workers and employers with measures for minimizing exposure to hazardous drugs.
For more information, go to www.cdc.gov/niosh/topics/hazdrug/
September 2004
CETA issues Applications Guide for the use of Barrier Isolators in Compounding Sterile Preparations in Healthcare facilities
For more information, go to www.cetainternational.org.
For isolator testing and certification services contact us at 800.851.9081 or Info@BandVTesting.com
January 2004
On January 1, 2004, United States Pharmacopeia issued Chapter 797, Pharmaceutical Compounding – Sterile Preparations. CETA issues FAQs related to USP797. Go to www.cetainternational.org
For more information on testing and certification services related to USP797 contact us at 800.851.9081 or Info@BandVTesting.com.
INDUSTRY LINKS
Through our active participation in industry technical organizations, B & V Testing stays abreast of—and also has the opportunity to shape--a constantly changing regulatory environment. The valuable and unique insights evolving from these activities help our customers to anticipate and act on important industry trends and developments.
ABSA - American Biological Safety Association www.absa.org
ASHRAE - American Society of Heating, Refrigeration and Air Conditioning Engineers, Inc. www.ashrae.org
CETA - Controlled Environment Testing Association www.cetainternational.org
FDA - Food and Drug Administration www.fda.gov
IEST - Institute of Environmental Sciences and Technology www.iest.org
ISPE - International Society for Pharmaceutical Engineering www.ispe.org
NEBB - National Environmental Balancing Bureau www.nebb.org
NSF - National Sanitation Foundation www.nsf.com
PDA - International Association for Pharmaceutical Science & Technology - Parenteral Drug Association www.pda.org