In accordance with its original plan, QuantumClean accomplishes goal of earning ISO certification for all six of its U.S. sites

April 26, 2007 — /PRWEB/ — DUBLIN, PA — QuantumClean(R), the leading provider of outsourced parts cleaning and refurbishment for the semiconductor industry, recently announced the ISO certification of all six of its U.S. Advanced Technology Cleaning Centers(R), an accomplishment that sets the company apart from other outsourced parts cleaning service providers.

QuantumClean achieved its goal of having all U.S. sites certified by April 2007, consistent with its strategy to be the only outsourced parts cleaning provider with service centers in every major semiconductor market in the U.S.

“With the standardized operating protocols, methods, and procedures required for ISO 9001:2000 certification, our customers are assured that they are receiving an unwavering level of excellence and performance,” said Michael Brakefield, corporate quality director for QuantumClean. “With ISO-certified service centers in each major semiconductor market in the country, we are able to provide unparalleled excellence to our customers.”

The Maine, Arizona, Washington, and California sites were the final QuantumClean locations to receive ISO 9001:2000 certification. The Maine and Arizona ATCCs(R) received ISO 9001:2000 certification in February, and the Washington and California ATCCs(R) earned certification in March. The ATCCs(R) in Irving, TX, and Colorado Springs, CO, received recertification in February.

QuantumClean’s ISO certification provides assurance that business is operating as planned and that problems are being addressed effectively. The standard and prescribed processes required for ISO certification provide better consistency in performance and keep the company focused on the established business objectives to drive increased customer satisfaction. The certification also offers an independent ongoing compliance review of business operations, bolstering QuantumClean’s own continual improvement procedures.

ISO 9001:2000, an international quality management system standard, aids in the operation of QuantumClean’s business by meeting internal and customer requirements, requiring continual improvement, increasing top management involvement and maintaining enhanced customer satisfaction as the company’s top goal.

About QuantumClean
QuantumClean (Quantum Global Technologies, LLC) is the leading provider of outsourced parts cleaning, process tool part restoration and surface treatment for semiconductor fabricators. The company operates technologically innovative cleaning centers in every major semiconductor market across the U.S. and Asia, providing process improvement through consistently cleaner parts(R) that exceeds industry standards, dramatically reducing its customers’ Total Cost of Ownership. Founded in 2000, QuantumClean is headquartered in Dublin, PA, with Advanced Technology Cleaning Centers(R) in the Silicon Valley, Pacific Northwest, Arizona, Colorado, Texas, and New England regions.

For more about QuantumClean, visit their web site at http://www.quantumclean.com.

Partnership will reduce microbial growth on coated cheese products

April 25, 2007 — /BUSINESS WIRE/ — WAKEFIELD, MA — Although some types of cheese feature mold as part of their appeal, for the most part people don’t want cheese covered with mold. When microbes compromise dairy products, your nose is the first to know. Opening a refrigerator that contains moldy cheese products can be a traumatic experience. This is precisely why Agion Technologies, Inc., a leading provider of silver-based antimicrobial solutions, today announced that it has partnered with AgPOLYMER to incorporate its natural, antimicrobial technology into cheese coatings to inhibit the growth of mold and bacteria in the waxy case. Agion offers the only naturally safe antimicrobial approved for food processing and food service on the market today. Cheese lovers can now rejoice as Agion’s antimicrobial technology has effectively created self-cleaning surfaces for cheese coatings to make sure microbes are controlled, thus avoiding any traumatic smell experiences your nose could encounter.

“Our partnership with Agion is allowing us to transform the way in which dairy products can be better protected utilizing antimicrobial technology,” said Vittorio Capra, President of AgPOLYMER. “Our experience in creating cheese coating polymers coupled with Agion’s unique technology gives us the platform we need to introduce the first antimicrobial cheese coating to the market.”

There is a growing demand from consumers for manufacturers to introduce new ways to protect food product packages that are highly susceptible to the growth of microbes. AgPOLYMER is striving to offer the latest in antimicrobial technology in its products to prevent the growth of bacteria and mold, by protecting the cheese coating surface. The silver-ion zeolite is directly incorporated into the polymer and then the coating is applied to the cheese.

“Agion continues to deliver advanced antimicrobial solutions for industries where the introduction of antimicrobial technology can be used to enhance product quality,” stated Ginger Merritt, vice president of sales and marketing for Agion Technologies. “We were able to partner with AgPOLYMER to address specific needs that will allow them to market a unique product to the European dairy industry.”

Agion antimicrobials are registered with the EPA for use in food processing facilities and approved by the EPA and FDA for food contact surfaces. The antimicrobials are also EFSA-registered and approved under the European Biocidal Products Directive (BPD). Agion’s antimicrobial is included on the USDA list of non-food compounds for food processing plants, as maintained by NSF. The Agion products have NSF 51 Certification for food processing and food service equipment as well as NSF Standard 42 approval for the incorporation of the technology into carbon block water filter systems.

About AgPOLYMER
AgPOLYMER has a technological heritage of over 40 years of experience in the cheese coating dairy industry. AgPOLYMER is a modern company intended to base its own growth on innovation, with care for the environment, improving the existing products and developing new products to meet the market requirements. AgPOLYMER is strategically placed to serve North European as well as South Mediterranean markets, strengthening more and more its position as a reliable and responsible partner for the international dairy industry. Additional information can be found at http://www.AgPOLYMER.com/.

About Agion Technologies, Inc.
Agion Technologies, located in Wakefield, MA, is a leader in providing customized, natural, antimicrobial solutions based on silver that continuously inhibit the growth of bacteria, mold, and fungus. Agion’s antimicrobial technology is used in consumer, industrial, and healthcare industries and has been incorporated into a variety of products including cell phones, shoes, keyboards, pens, water filters, air conditioning and heating units, medical catheters, ice machines, and faucet handles. Agion’s customers include many leading brands such as Motorola, Sherwin Williams, AK Steel, Carrier, DuPont, Honeywell, Adidas, Sanford/Paper Mate, Ice-O-Matic, Scotsman, Stanley Bostitch, and Oster. Since the company’s founding in 1997, Agion Technologies has led the market for naturally safe antimicrobial solutions with support from private equity funds and strategic partners including BASF Venture Capital, H.B. Fuller Ventures, SAM Private Equity, Motorola Ventures and Paladin Capital Group. For more information about Agion Technologies, visit www.agion-tech.com.

Contact:
Kel and Partners
Michelle DeLuties, 508-366-2099 ext. 122
[email protected]

April 26, 2007 — ST. LOUIS, MO — SAFC, a member of the Sigma-Aldrich Group, has announced the construction completion of two major new protein API facilities at its St. Louis, MO, manufacturing campus.

A new biologics manufacturing facility consists of a 25,000 sq. ft. cGMP purification and manufacturing suite for transgenic plant and other non-animal derived protein APIs and a 6,000 sq. ft. facility for purification of animal-derived protein APIs. Validation for commercial operation of this $16 million expansion at the 400,000 sq. ft. St Louis manufacturing campus is expected by mid-year 2007.

“This expansion for SAFC Pharma further reflects our recognized market leadership in cGMP purification of therapeutic proteins from natural sourced material,” said SAFC president Frank Wicks. “The expanded capacity responds to the increased demand for large-scale supply and will meet late-stage clinical trial and commercial manufacturing needs for both transgenic and naturally-sourced APIs.”

The biologics facility features some of the largest extraction and purification suites of their kind in the industry. The Class 100,000 (ISO 8) and Class 10,000 (ISO 7) cleanrooms will accommodate multiple one-meter chromatography columns and ultrafiltration operations, with API target quantities in the five-kilogram range. Also featured is a Class 10,000 (ISO 7) lyophilization suite.

Completely separated to prevent potential cross-contamination, the facility for animal-derived API purification also features Class 100,000 (ISO 8) and Class 10,000 (ISO 7) cleanrooms. These will also include multiple one-meter chromatography columns and ultrafiltration operations to give API quantities in the five-kilogram range.

Both facilities are supported by SAFC Pharma’s extensive process development, quality control, and quality assurance capabilities and teams in St. Louis.

About SAFC
SAFC is the custom manufacturing group within Sigma-Aldrich that focuses on both biochemical production and the manufacturing of complex, multi-step organic synthesis of APIs and key intermediates. SAFC has manufacturing facilities around the world dedicated to providing manufacturing services for companies requiring a reliable partner to produce their custom manufactured materials. SAFC has four operating segments — SAFC Pharma, SAFC Supply Solutions, SAFC Biosciences, and SAFC Hitech — and had annual sales of $500 million in 2006. SAFC is one of the world’s 10 largest fine chemical businesses.

About Sigma-Aldrich
Sigma-Aldrich is a leading life science and high technology company. Our biochemical and organic chemical products and kits are used in scientific and genomic research, biotechnology, pharmaceutical development, the diagnosis of disease and as key components in pharmaceutical and other high technology manufacturing. We have customers in life science companies, university and government institutions, hospitals, and in industry. Over one million scientists and technologists use our products. Sigma-Aldrich operates in 36 countries and has 7,500 employees providing excellent service worldwide. Sigma-Aldrich is committed to accelerating customer success through leadership in life science, high technology and service. For more information about Sigma-Aldrich, please visit our web site at http://sigma-aldrich.com.

April 25, 2007 — BIOTECHNICA, Europe’s biggest biotechnology show, is partnering with the INTERPHEX, the largest pharmaceutical trade event in North America, in 2008. The new partnership creates a global meeting-place for companies engaged in the core pharmaceutical and biotech sectors, including process development and R&D through services, manufacturing and packaging.

The agreement made between Deutsche Messe (Hannover, Germany), and Reed Exhibitions, the US organizers of INTERPHEX, further integrates the pharmaceutical and biotech industries by offering a single venue that serves as a platform for the entire marketplace.

The co-located event will be the biggest gathering of the life sciences industry on the North American continent. BIOTECHNICA and INTERPHEX will provide an entire spectrum of R&D and upstream and downstream processing technologies.

BIOTECHNICA and INTERPHEX debut at The Pennsylvania Convention Center, Philadelphia, PA, from March 26-28, 2008. More than 1,000 exhibitors will converge to showcase a range of state-of-the-art solutions. At the same time, a Congress program boasting more than 100 lectures will help life sciences professionals acquire valuable knowledge that can help their organizations gain a competitive edge.

“By virtue of this cooperation agreement the BIOTECHNICA product family will now be represented on three important continents: Europe, North America and Asia,” says Jürgen Fürstenberg-Brock, director of Deutsche Messe. “Over the past 15 years, Europe’s leading biotechnology show has developed into a global platform for the entire sector. Every year, in early July, Shanghai will host BIOTECH CHINA. With the advent of BIOTECHNICA AMERICA, the BIOTECHNICA family will span the entire globe.”

“The partnership advances our goal of providing the life sciences industry with the leading event in the world,” says Kevin Richards, group vice president, Reed Life Sciences. “The new relationship continues the expansion of the INTERPHEX brand and positions the event for further growth worldwide.”

BIOTECHNICA — which once again takes place this year in Hannover, Germany from October 9-11, 2007 — is the European summit of the biotech industry and bundles the know-how and expertise of the European biotech sector. The new spirit shown by BIOTECHNICA is demonstrated not only by its stand at this year’s INTERPHEX, but also by the fact that each party to this new German-US trade show alliance will be taking part in the other party’s event. BIOTECHNICA has for many years been more than a trade show — it has long served as a meeting-place for all the diverse fields of biotechnology. In addition to the exhibits, it features a high-calibre program of talks and conferences — now more comprehensive than ever — and the attractive EUROPEAN BIOTECHNICA AWARD. This year, for the first time, there will also be a BIOTECHNICA PARTNERING event with the keynote Drug Device Combination Therapy.

Contacts:
For BIOTECHNICA
Detlev Rossa
+49-511-89-31010
[email protected]

For INTERPHEX
Lisa Helfer
+1-212-529-4500
[email protected]

Intensive training in all aspects of environmental monitoring, disinfectant qualification, and cleanroom contamination control

April 24, 2007 — /MEDICAL INDUSTRY E-MAIL NEWS SERVICE(TM)/ — SAN JOSE, CA — Microrite announced details today of its popular training course on all aspects of environmental monitoring, disinfectant qualification, and cleanroom contamination control, set for June 7-8, 2007, at the Doubletree Suites in Boston MA.

SCHEDULE:

DAY 1
Environmental Monitoring – A Complex System Simplified

Correct use of EM data will help you maintain control of your facility. This data will provide critical manufacturing facility condition information at a glance. This seminar will provide the tools to establish compliant and practical environmental monitoring programs and the keys to using the data to control contamination

This seminar will include:

• Discussion on the various cleanroom classification schemes, EM regulations, and guidances
• Guidance on setting up a meaningful EM plan, including number and location of sites
• Microbial identification, when it is necessary and why
• Discussion on choice and evaluation of equipment for EM
• How to create a plan to track and trend EM data, and when and why to identify EM isolates
• Discussion on evaluation of microbial identification systems
• Guidance on trending EM data, in order to retrieve important information on the condition of the manufacturing facility
• Overview of the key components of EM summary reports that will provide rapid review of EM controls and precisely relate this to the manufacturing facility condition
• EM-related investigations, what to look for and where
• How to evaluate automated systems for EM
• Discussion on FDA 483 observations on EM and data trending

DAY 2
Understanding the Qualification of Disinfectants and Key Elements of Cleaning Procedures

Contamination prevention in manufacturing facility begins with the choice, qualification, and proper application of disinfectants during cleaning. Cleaning and disinfecting a manufacturing suite is a science, not an exercise. Understanding disinfectant qualification methods and the translation of this qualification to cleaning procedures is the key to avoiding contamination and its pitfalls, such as failed media fills or sterility tests. Use your EM trending data to develop effective disinfectant efficacy studies and implement robust cleaning procedures to prevent contamination in your manufacturing facility, to ensure your product’s integrity

This seminar will include:

• Detailed discussion of bacterial and fungal contamination in cleanrooms, their source and quantities
• Disinfectants commonly used, their modes of action, efficacy, and toxicity
• Create your own plan; use your EM data to choose the disinfectants and cleaning frequencies
• Discussion on current methods used in the industry to qualify disinfectants
• Tools to develop an effective disinfectant qualification program
• Commonly observed deficiencies in disinfectant qualification studies that may lead to observations
• Translation of disinfectant qualification results to cleaning procedures to prevent contamination
• Discussion on FDA 483 observations related disinfectant qualification and cleaning procedures
• Case studies where errors in choice of disinfectants or disinfectant qualification have lead to major contamination issues

For the complete course brochure:
http://sacserv.com/tracking.jsp?linkid=88517

Contact:
Ziva Abraham
Microrite, Inc.
5019 New Trier Ave
San Jose CA USA 95136
408-445-0507 phone
408-445-1236 fax
[email protected]

compiled by Carrie Meadows

Basan to acquire Metron’s cleanroom consumables assets
The basan Group, a distributor of cleanroom products and services in Europe and Asia, has agreed to acquire certain assets from Metron Technology, Inc., constituting Metron’s Europe and Southeast Asia cleanroom consumables and garment manufacturing business. This acquisition will significantly expand basan’s capabilities to provide high-value cleanroom equipment and consumables as well as cleanroom supply management and personnel training capabilities worldwide.

SAFC completes construction of protein API facilities

SAFC, a member of the Sigma-Aldrich Group, has completed the construction of two new protein active pharmaceutical ingredient (API) facilities at its St. Louis, MO, manufacturing campus. A new biologics manufacturing facility consists of a 25,000 sq. ft. cGMP purification and manufacturing suite for transgenic plant and other non-animal derived protein APIs, and a 6,000 sq. ft. facility for purification of animal-derived protein APIs. Validation for commercial operation of this $16 million expansion at the campus is expected by mid-year.

BIOTECHNICA, INTERPHEX partner for 2008

BIOTECHNICA, Europe’s biggest biotechnology show, is partnering with INTERPHEX, the largest pharmaceutical trade event in North America, in 2008. The co-located event is expected to be the biggest gathering of the life sciences industry on the North American continent. BIOTECHNICA and INTERPHEX will provide an entire spectrum of R&D and upstream and downstream processing technologies. BIOTECHNICA and INTERPHEX debut at The Pennsylvania Convention Center in Philadelphia from March 26-28, 2008.

In the universe of contamination control technology, there are various products and solutions ranging from “high-tech” to “low-tech” offerings. But when it comes to meeting real-world user desires and requirements, this distinction may be irrelevant; some of the most ingenious and beneficial innovations may not appear all that significant at first.

At INTERPHEX, held last month in New York, contamination control companies introduced a plethora of new products that certainly spanned this wide realm, all with one thing in common: They were created in direct response to user feedback and industry needs.

To give just a representative sampling, DuPont, for example, introduced its new “engineered elastic nonwoven” technology, a stretchable, latex-free fabric with varying degrees of elastic recovery power that can be specifically matched to different user requirements. Potential applications include stretchable gown sleeves and cuffs for cleanroom apparel as well as elastic protective covers and interlinings.

Similarly, Kimberly-Clark Professional, which also announced that it will consolidate all of its cleanroom products, including the “Safeskin” glove line, under the “Kimtech Pure” brand name, demonstrated a new pre-saturated wiper dispenser that allows individual one-handed dispensing and incorporates a self-closing/self-sealing lid. The dispenser is part of KC’s complete new line of dry, pre-saturated, and sterile wipers for cleanroom environments.

Also responding to customer feedback, Contec’s new “EasyCurve” mop uses a flat, fabric-laminated head attached to a curved, stainless steel frame with a pivoting connector for easier and more effective cleaning of curved surfaces such as those frequently found in ceilings, walls, and floors of critical environments. The mop uses a separate “sling” style wringer that installs over an autoclavable 6.5 gallon (25 L) polypropylene bucket.

Moving along the line, Pall Corporation rolled out a new collection of fluid management and contamination control technologies specifically targeting the biopharmaceutical industry. The “Allegro” line includes single-use biocontainers for collection and transport of process materials, intermediates, and cell culture media as well as disposable filters, tubing, and aseptic connections. Also introduced were the “KleenPak” self-enclosed, tangential flow (TFF) microfiltration capsule and the “Omega” T-Series membrane cassettes for ultrafiltration of high-purity biological products.

In the electronics technology arena, Johnson Controls announced the expansion of its “Metasys” facility management system for validated environments (MVE). The new version operates on an IT-standard, web services platform and provides secure remote monitoring and data acquisition from a greater number of disparate collection points and systems.

Last but not least, Hach Ultra’s new “Anatel PAT700” TOC water-analysis system incorporates an On-board Automated Standards Introduction System (OASIS), which reduces operator intervention and ensures the instrument is always operating in a validated state. If the analyzer detects a TOC or conductivity value exceeding preset limits during operation, it will automatically save a sample for further analysis.

As you can see, while some of these new products and innovations may seem more glamorous than others, they all provide substantial practical benefit to real-world users. And, in that sense, they are all equally of value to the contamination control community.

John Haystead,
Editor-in-Chief