Issue



Table of Contents

Solid State Technology

Year 2007
Issue 4

COLUMNS

Compounding Corner


Establishing a quality unit

One of the preliminary actions for USP <797> compliance is the establishment of a formal quality unit for the pharmacy, which is responsible for the quality assurance program


Unfiltered


Contamination control starts far upstream of the cleanroom

It is important to remember that a cleanroom is not a cure-all; even a cleanroom with the most stringent controls cannot correct a contaminated product.


Your Market Analysis


Ultraviolet irradiation markets and applications in cleanrooms

Cleanrooms in hospitals, food processing, pharmaceuticals, medical devices, biotechnology, and animal research are all concerned with biological contaminants and therefore are candidates for ultraviolet irradiation to treat air, water and surfaces.


Setting The Standard


IEST welcomes input on revised calibration RP

The Institute of Environmental Sciences and Technology (IEST) has released its revised IEST-RP-CC013.2, Calibration Procedures and Guidelines for Select Equipment Used in Testing Cleanroom and Other Controlled Environments.


Industry Innovators


Without the right package, your cleanroom product isn’t going anywhere

Michael Fisher, president of Fisher Container Corp. (Buffalo Grove, IL), says it’s very easy for him to describe the market of his company’s “Precision Clean Products” division.


From The Editor


Prescription for positive publicity

We’ve all become accustomed to seeing the new Direct to Consumer (DTC) product advertising from pharmaceutical companies.


NEWS

New Biolab At K State Fo


New biolab at K-State focuses on food safety

As reported in the Wichita Eagle, Pat Roberts Hall, home of the new $50 million Biosecurity Research Institute, recently opened at Kansas State University.


Particles


Particles

News snippets from the world of contamination control.


Boc Edwardsrsquos Vacuum


BOC Edwards’s vacuum and semiconductor equipment business acquired

CCMP Capital, through affiliates of international private equity firms CCMP Capital Advisors LLC and CCMP Capital Asia, Ltd., has reached an agreement with The Linde Group, the global gases company, to acquire BOC Edwards.


New Iso Draft Standard O


New ISO draft standard on filter testing available

The Institute of Environmental Sciences and Technology (IEST) has announced the publication of the first document produced by the International Organization for Standardization Technical Committee (ISO/TC) 142, Cleaning equipment for air and other gases.


Spinach Contamination In


Spinach contamination investigation results prove inconclusive

The Food and Drug Administration (FDA) and California’s Department of Health Services (CDHS) recently released a joint report on the investigation into the causes of the E. coli O157:H7 outbreak last fall


Cleanroom Expansion To H


Cleanroom expansion to help implant manufacturer increase capacity

Heritage Worldwide, Inc., a provider of pre-filled breast implants worldwide, announced that it is expanding its manufacturing capacity to accommodate the 38 percent increase in demand projected for fiscal 2007-from 105,000 units in 2006 to 145,000 units.


FEATURES

Features


Monitoring particles in process chemicals

High particle levels in process chemicals have been shown to directly affect product quality.


Features


Fire safety, corrosion resistance drive use of FCSS ductwork

The EPA’s Ruling 40 CFR1 and the National Fire Protection Association’s (NFPA) Standard 318 for Cleanrooms are affecting the way plant operators specify process ventilation systems.


Special Report


Barrier and isolation systems: Technology in transition

The life sciences industry, from manufacturers to compounders to the various regulatory and standards agencies involved, is in the midst of extraordinary changes, the end of which may never be in sight.


Interphex New York City


Interphex New York City Showguide

Now in its 28th year, INTERPHEX will host more than 1,000 global companies serving the pharmaceutical and biotechnical industries, making it one of the world’s largest and most comprehensive pharmaceutical exhibitions.


PRODUCTS

Product Spotlight


Personal protective gear

This month, we bring you a selection of personal safety gear specifically designed to ensure that worker safety is maintained at all times.


New Products


New Products

Each month, Cleanrooms brings you a collection of the latest product innovations in the contamination control industry.