Table of Contents
Solid State Technology
Year 2005
Issue 3
 | NEWS
Semi Tester Makes Move T
Semi tester makes move to Class 10,000 environment
Semi tester makes move to Class 10,000 environment
The move from Sunnyvale to San Jose has also meant a new name for InTEST's TestDesign division: InTEST Silicon Valley Corp. Corporate headquarters are in Cherry Hill, N.J.
President Nominates Acti
President nominates acting commissioner to head FDA
ROCKVILLE, Md.-Lester M. Crawford, DVM, acting commissioner of the Food and Drug Administration (www.fda.gov) since March 2004, has been nominated by President Bush to serve as the agency's next commissioner.
Contract Testing Lab Exp
Contract-testing lab expands facility and services
SALEM, N.H.-Boston Analytical, Inc., an independent, cGMP-compliant, contract-testing lab in Salem, N.H. (www.bostonanalytical.com), has built a new 2,500-square-foot facility designated specifically for microbiological testing.
Software System Seeks To
Software system seeks to help pharma manufacturers meet cGMPs
SAN JOSE, Calif.-A software platform for pharmaceutical manufacturers promises to support FDA 21st Century cGMPs by letting companies span one or multiple manufacturing sites, tightly integrate quality management procedures with manufacturing operations and IT, and reduce the cost of FDA compliance.
Hands Free Technology Ad
Hands-free technology addresses critical temperature measurements
FREMONT, Calif.-Two recently introduced, hands-free process optimization tools for semiconductor fabrication measure real-time, in situ temperature in solder reflow applications.
Company Retrofits Manufa
Company retrofits manufacturing facility for proprietary antimicrobial development
EL CAJON, Calif.-PURE Bioscience (www.pure-bioscience.com) has begun conversion of part of its manufacturing space here to a dedicated, FDA-compliant, cGMP facility for production of pharmaceutical-grade silver dihydrogen citrate (SDC).
Class 10000 Cleanroom Pr
Class 10,000 cleanroom provides more efficient, cleaner packaging suite
ATLANTA, Ga.-When Celliance Corporation, a Serologicals company headquartered in Atlanta, Ga.
Fda Proposes New Guidanc
FDA proposes new guidance for reporting drug impurities
The Food and Drug Administration (www.fda.gov) has announced a new draft, Guidance for Industry: ANDAs-Impurities in Drug Substances, that provides revised recommendations on what chemistry, manufacturing and controls (CMC) information to include regarding the reporting, identification, and qualification of impurities in drug substances produce by chemical synthesis.
Cleanzone
IEST seeking recommendations for improving ISO cleanroom standard
ROLLING MEADOWS, Ill.-Cleanroom users and administrators attending ESTECH 2005-the 51st annual meeting and exposition of the Institute of Environmental Sciences and Technology
Limits Loom For Low K Se
Limits loom for low-k semiconductor materials
New contamination control processes on the horizon?
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DEPARTMENTS
Life Sciences Personnel
Life Sciences: Personnel training
The single most critical element of the cleanroom, or any controlled environment, is the human element.
Your Market Analysis Exp
Your Market Analysis: Expanded role for life sciences cleanrooms
Cleanroom technology developed for traditional applications such as aseptic filling in pharmaceutical plants is increasingly being applied to distinctly 21st Century problems.
Setting The Standard Evo
Setting the Standard: Evolution of an IEST Recommended Practice
The Institute of Environmental Sciences and Technology (IEST) is responsible for the origination, publishing, and revision of approximately 35 Recommended Practices (RPs) in topics of interest and value to the contamination control industry.
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FEATURES
Special Report
Moving Toward Automation
During last fall’s much-publicized case of flu vaccine contamination at Chiron Corp.’s Liverpool, U.K., manufacturing facility, the Food and Drug Administration’s Center for Biologics Evaluation and Research (FDA CBER; www.fda.gov) issued a warning letter to the company that summarized numerous deviations from current good manufacturing practices (cGMP)-including several aseptic processing sterilization failures.
Features
The ABCs of disinfectant validation
Despite ambiguities inherent in the regulatory inspection process, a few absolute expectations should be met
Features
The 'quietest' lab: Achieving vibration control and balanced design at NIST
Engineers, lab planners and scientists developed unique lab layouts with groundbreaking temperature and vibration controls
Features
Relevant information for manufacturing quality control: A singular solution to a multi-industry problem
Take a tour of manufacturing in the world today and you will encounter widely varying levels of sophistication across a broad spectrum of industries.
Editorial
From the Editor: The future is now
A lot can happen in ten years. Certainly 2005 seemed a long way off when I wrote the editorial for the December 1994 special forecast issue of CleanRooms.
Features
Process Analytical Technologies (PAT) and nonviable particle counting
Pharmaceutical manufacturing environments have traditionally seen particle counting as a necessary evil to demonstrate compliance with a cleanroom standard.
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Particles.html
Particles
SCOTTSDALE, Ariz.-According to research conducted by In-Stat (www.in-stat.com), companies are increasingly developing lab-on-a-chip products despite increased competition and alternative technologies.
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PRODUCTS
New Products.html
New Products
A collection of the newest contamination-control products on the market.
Product Spotlight.html
Product Spotlight
Whatever the level and type of contamination control required by your facility, implementing and integrating the right sensors and monitors will be crucial to ensuring that it is operating at peak efficiency and maintaining adequate cleanliness levels. Here are a few of the newest sensor and critical environment monitoring products on the market.
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