January 5, 2007 — OAKDALE, Minn. — Dyneon LLC, a 3M company and one of the world’s leading fluoropolymer producers, recently announced that it will acquire 3M’s Bioanalytical Technologies business including the Empore™ Solid Phase Extraction family of products, effective January 1, 2007. The Bioanalytical Technologies business and Empore products will be integrated into Dyneon and will augment Dyneon’s fluoroplastics, fluoroelastomers and specialty additives lines, and provide new opportunities for growth for the Empore family of products.

“Empore customers will continue to have access to the first-rate customer service and technical support that they have come to know and expect” said Tom Martin, operations manager. “The products and manufacturing process will remain the same, as will the Empore brand promise.”

According to Bill Myers, President and General Manager of Dyneon, this strategic move builds on the synergies between Dyneon and Empore products. Both businesses manufacture high-performance materials that demand technological precision and innovation, as well as an excellent customer service and support base.

Myers added, “Integrating the Empore and Dyneon products makes good business sense. Being under one roof, we can provide an even greater range of solutions and resources for both our Empore and Dyneon customers.”

The Empore family of products, first commercialized in the 1980s, is widely used by chemists for environmental and pharmaceutical analysis.

Empore joins a diverse range of products at Dyneon. Dyneon fluoroelastomers are engineered to meet many of the most demanding sealing challenges, providing long-term protection against high temperatures and corrosive chemicals. Its fluoroplastics, including PFA, FEP, ETFE, HTE, THV and PVDF, can be processed in extrusion, injection, compression, transfer and blow molding. Dyneon’s specialty additives, including Dynamar Polymer Processing Additives, are fluoropolymer-based products that improve various processing aspects of thermoplastic resin. Dyneon is also a global leader in PTFE compounding, providing a host of standard compounds as well as expertly formulated custom compounds.

For more information about Dyneon visit www.dyneon.com . For more information about Empore products visit www.dyneon.com/empore .

About Dyneon
Dyneon, a 3M company, is one of the world’s leading fluoropolymer suppliers with operations or representation in more than 50 countries. Headquartered in Oakdale, Minn., Dyneon and its affiliates employ more than 800 people worldwide who are dedicated to customer service, technical and sales support, marketing, research, application development, and production.

About 3M — A Global, Diversified Technology Company
Every day, 3M people find new ways to make amazing things happen. Wherever they are, whatever they do, the company’s customers know they can rely on 3M to help make their lives better. 3M’s brands include Scotch, Post-it, Scotchgard, Thinsulate, Scotch-Brite, Filtrete, Command and Vikuiti. Serving customers in more than 200 countries around the world, the people of 3M use their expertise, technologies and global strength to lead in major markets including consumer and office; display and graphics; electronics and telecommunications; safety, security and protection services; health care; industrial and transportation. For more information, including the latest product and technology news, visit www.3M.com .

Dyneon, Empore, Scotch, Post-it, Scotchgard, Thinsulate, Scotch-Brite, Filtrete, Command and Vikuiti are trademarks of 3M. Used under license.

December 29, 2006 — /ISPE/ — TAMPA, FL — ISPE, a global not-for-profit Society of pharmaceutical manufacturing professionals representing more than 23,000 Members worldwide, is introducing a fresh approach to its world-class Professional Development sessions in 2007. Professional Development seminars will match up new pharmaceutical manufacturing trends with the latest ISPE technical documents at its Tampa Conference, to be held 12-15 February 2007 at the Hyatt Regency Tampa Bay in Tampa, Florida, USA.

Attendees will gain a greater understanding of specific practical applications as a result of this strategic match up. In addition, attendees will have the ability to select half-day sessions, moving from one to another to maximize their investment of time and funds during the conference.

Seminars at the Tampa event will highlight Aseptic Processing, the new ISPE Packaging, Labeling and Warehousing Operations (PACLAW 2007) Guide, Oral Solid Dosages, Sterile Manufacturing Facilities, and much more.

Eight of these sessions will provide direct information related to new ISPE technical documents which will be released in 2007. These documents are reviewed by the US Food and Drug Administration and are best practices for the pharmaceutical manufacturing industry. These include:

ISPE Good Practice Guide for Commissioning and Qualification of Pharmaceutical Water Systems, which will be released February 2007;
ISPE Packaging, Labeling and Warehousing Operations (PACLAW) Baseline® Guide;
Bulk Guide Revision;
ISPE Sterile Manufacturing Facilities Baseline Guide;
GAMP® Electronic Data Archiving;
GAMP® Good Practice Guide;
Oral Solid Dosage Baseline Guide; and
Good Engineering Practice Good Practice Guide

Educational sessions include:
Risk Assessment as a Tool of Design, Implementation and Management of Critical Utilities – During this two-day seminar on pharmaceutical waters and steam, topics will include risk-based assessment for microbial testing, parametric release of pharmaceutical waters using on-line instrumentation, the new ISPE Good Practice Guide for Commissioning and Qualification of Pharmaceutical Water Systems, and case studies presented by leading pharmaceutical and biotechnology companies and industry experts.

Renovation of Pharmaceutical Facilities: API, Bio Tech, & Pilot Plants – Discuss strategies and decision-making processes for facility renovation, including the feasibility, planning, programming, design and regulatory issues impacting pharmaceutical facility renovations. Case studies on pilot plants, API, and biotechnology will illustrate the significant technical issues surrounding facility renovation, and the maintenance of compliant operations in adjacent facilities.

Aseptic Processing Technology and Guidance for Parenteral Products – Explore new sterilization, aseptic processing, and sterility assurance technologies and processes to shorten a project cycle, increase facility output, and optimize sterile areas. In four consecutive tracks, address recent developments in project execution, facility systems, process equipment, and operational considerations. Walk through design and development options for a sterile/aseptic manufacturing facility and learn the benefits and challenges of current best practices and technologies.

Design and Operation of Biotechnology — Upstream and Downstream Processing – Learn about equipment design and operation in biotechnology facilities, with details on bio-reactors and fermentors as well as harvest and purification unit operations.

GAMP® — Electronic Records: An Update on Part II with a Focus on Risk Management – Get current information on the GAMP approach to risk-based management of electronic records, and take part in workshop activities, and case study discussions that review approaches to e-record management in various domains within the health care industry, and provide insight on the FDA’s current views on the topic.

Oral Solid Dosage Manufacturing Facilities: Case Studies in the Planning, Designing, Engineering and Qualifying of Modern Day Facilities – Several real life case studies from major pharmaceutical firms cover areas of general OSD project considerations, continuous granulation/drying, advanced particle coating, and facility containment upgrade issues. Leading industry OEM’s of processing equipment and systems will present the latest in OSD process technologies and advancements in mixing/blending, granulation, drying, coating, compression, and other key unit operations.

Current Trends and Issues in Validation – This two-day program will present two sessions that focus on current trends and issues in validation. Day one will provide information on current trends in technology focusing on validation. Day two addresses issues and trends that have been implemented for validation.

ISPE Packaging, Labeling and Warehousing operations (PACLAW) Baseline Guide – This seminar will launch the ISPE Packaging, Labeling and Warehousing Operations (PACLAW) Baseline Guide. Guide task team members will present Guide chapters and outline new information; coding, reading and tracking systems in development; and current European and North American regulatory drivers that impact packaging, labeling, and warehousing. Attendees at this session will also receive a copy of the new PACLAW Guide at no charge.

Sterile Manufacturing Facilities — Latest Trends and Case Studies – Walk through design and development considerations for sterile/aseptic manufacturing facilities and learn the benefits and challenges of the latest best practices and technologies, including innovations that will shorten project processes, increase facility output, optimize sterile areas, and involve new technology for improvement of the sterile manufacturing process. Case studies provide real-world examples based on principals of ISPE’s Sterile Manufacturing Facilities Baseline Guide.

In addition to educational sessions, workshops will be held about the new Certified Pharmaceutical Industry ProfessionalTM (CPIPTM) — a new International Credential for Pharmaceutical Industry Professionals. The one hour free workshops feature a CPIP introduction, the latest on eligibility criteria, the application process, and an examination overview. For more information, visit www.ispe-pcc.org.

For complete seminar listings and to register for the conference, visit www.ispe.org/tampaconference , or call ISPE customer service at tel: +1-813-960-2105.

Sponsorship and table top exhibition opportunities available for the ISPE Tampa Conference. Please contact Dave Hall, ISPE Director of Sales, by tel: +1-813-960-2105, Ext. 208, or e-mail: [email protected] for details.

About ISPE
ISPE is the Society of choice for more than 23,000 pharmaceutical manufacturing professionals in 81 countries. ISPE aims to be the catalyst for “Engineering Pharmaceutical Innovation” by providing Members with opportunities to develop technical knowledge, exchange practical experience, and collaborate with global regulatory agencies. Visit www.ispe.org for Society news and more information.

January 2, 2007 — /MARKET WIRE/ — CLEVELAND, OH — Demand for cosmeceutical products is expected to increase 8.5 percent per year to over $8 billion in 2010, propelled by a stream of new and technologically advanced product introductions offering age-defying and other appearance-enhancing benefits for an aging population. Limiting opportunities will be competition from alternative treatments, such as laser resurfacing and cosmetic surgery, which often offer more dramatic results, though at a greater cost in terms of time, money and safety. Cosmeceutical products also face intense pricing competition due to the growing market penetration of private label cosmeceutical brands and the rapid commoditization of innovative ingredients and products. These and other trends including market share, market leaders, market size and company profiles are presented in “Cosmeceuticals,” a new study from The Freedonia Group, Inc., a Cleveland-based industry research firm.

The value of chemicals used in cosmeceutical products is expected to advance 8.8 percent per year to $1.2 billion in 2010, with gains spurred by the use of new, value-added active ingredients in product formulations. Chemicals used in professional products will drive gains, with strong advances expected for botulinum toxin and hyaluronic acid. Other chemicals expected to record rapid gains include amino acids, antioxidants, botanical extracts and beta hydroxy acids.

Skin care products will account for 60 percent of all cosmeceutical product demand in 2010. Anti-aging products will achieve above-average growth, with gains driven by a highly receptive, fast-expanding group of middle-aged and relatively affluent consumers who want to prevent or redress visible damage to the skin caused by aging, ultraviolet radiation and other environmental stressors. Improved formulations will further promote the use of age-defying products.

Professional products are expected to experience the fastest growth among cosmeceutical products, achieving double-digit annual gains through 2010. Strong prospects for these products are the result of growing demand and acceptance on the consumer side and the increasing availability and proficiency of practitioners. The aging of the U.S. population, an increasingly competitive work force, continued exposure to beauty “ideals” in entertainment and advertising, and favorable consumer incomes are expected to spur continued interest in professional products.

Contact:
Corinne Gangloff
[email protected]
440-684-9600

SOURCE: Freedonia Group, Inc.

In its current space mission on board the international space station (ISS), NASA is using air-sampling equipment from the Goettingen-based technology group Sartorius. The battery-operable AirPort MD8, which was brought to the ISS on a previous mission, is now being utilized in space for microbiological testing.

NASA is using air-sampling equipment on board the ISS (shown here). Photo courtesy of NASA.Click here to enlarge image

The air sampler is being used to gather information for protection of the ISS crew. The purpose of the test program is to collect and analyze microbes and allergens with which the space station crew might come in contact. Preflight, in-flight and post-flight samples are taken to determine the base contamination and to evaluate new sources of contamination. Crew members are also collecting data.

The AirPort MD8 is also being used to help prepare molecular primers, or nucleotide sequences, to further develop general microbial methods of detection at NASA and other laboratories.

The battery-operable AirPort MD8 is being utilized in space for microbiological testing. Photo courtesy of Sartorius.Click here to enlarge image

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I don’t often use this page to highlight articles running in the issue-that’s why we have a cover and table of contents. But, I’m making an exception this month because the Special Report addresses a growing and particularly important trend in contamination control, especially right now for the microelectronics industry, but one that, with the evolution of nanotechnology, will ultimately impact many other user industries as well.

The subject is tool-level contamination control. While cleanroom and minienvironment designers are already facing the challenges of molecular-level contamination, this level of control alone will clearly not suffice to effectively deal with the problem. The reason: the process tools themselves are not protected from collecting, generating and containing product-deadly contaminants.

It’s a complex problem that will ultimately require more than one single solution. Basically though, to keep molecular contaminants from entering a tool’s process environment, the ambient cleanroom or minienvironment must either be kept totally free of contaminants, or filtration systems must be put in place at the tool. In either case, this begs the question of how process materials and product are to be brought into the tool and removed from it without compromising one or both environments. Perhaps it raises the more challenging question of who is going be responsible for the solution. Should it be the cleanroom or minienvironment designer, the cleanroom user, or the tool vendor?

There will no doubt be a lot of debate, finger-pointing, and hard negotiation before the final answer is reached, but nevertheless, that final answer will inevitably be that the problem must be solved at the source of the problem, the tool vendor. It will not be acceptable for a process tool vendor to require that the user provide a specified cleanliness level in order to guarantee the proper operation of their equipment-not when the tool itself is a principle contributor to contamination levels.

The sooner that tool vendors accept this inevitability, the sooner affordable, working solutions can be brought to the market. These solutions will require process tools to incorporate tightly integrated contamination control and cleaning systems, rigid operational protocols, and highly sensitive and accurate monitoring instruments. Tool vendors should begin working immediately and intensively with the contamination control industry toward developing and implementing these capabilities in their systems. Better to bite the bullet now than be taken out by it later.

John Haystead,
Editor-in-Chief

W. L. Gore & Associates, Inc. (Newark, DE) recently donated a supply of cleanroom garments to be used in the semiconductor research space of the Birck Nanotechnology Center’s Scifres Nanofabrication Laboratory, an ISO Class 3 (Class 1) facility at Purdue University.

At a recent reception, Purdue University honored W.L. Gore & Associates for its donation of cleanroom garments to the Birck Nonotechnology Center’s Scifres Nanofabrication Laboratory. Shown here: Sean Doyle and bill Hanna of W.L. Gore & Associates; a Purdue student; Alan rebar, executive director of Discovery Park; and John Weaver, BNC facility manager. Photo courtesy of W.L. Gore & Associates.Click here to enlarge image

John Weaver, facility manager of the center, said in a recent press release, “I have used GORE Cleanroom Garments since they were first de­signed. When I heard about this donation, I was thrilled because these are state-of-the-art garments that will help us to achieve the maximum level of cleanliness in the cleanroom.”

GORE™ Cleanroom Garments are made with a proprietary expanded polytetrafluoroethylene (ePTFE) membrane laminated to a 100 percent polyester knit. The ePTFE membrane does not allow particulates to pass through, making it an ideal protective barrier in a cleanroom garment. This membrane provides filtration efficiency of 99.9999 percent or better for particles measuring 0.12 μm or greater. However, the microporous structure of the membrane allows air to flow freely through the garment so that the wearer does not retain so much heat. The garments are non-shedding, and flame- and chemical-resistant. During testing, the garments dissipated static in less than 0.1 second at 500 to 5,000 volts when the wearer was making contact with grounded or antistatic flooring.

W. L. Gore has nearly 50 years of research experience in the field of fluoropolymers, enabling the company to engineer the types of products needed in a cleanroom environment. “During the 20 years I have worked with Gore engineers,” Weaver said, “I have found them to be very strong technically and extremely responsive to ideas about their products. They have worked closely with me in every cleanroom project I have managed to make sure that we had the best production or research facility possible.”

The leadership role of IEST in shaping future research and practices

By Tengfang Xu, PhD, PE, Technical Vice President, IEST; Jan Eudy, Past President, IEST; Chuck Berndt, Communications Vice President, IEST

A leading industrial standards-writing organization since 1953, IEST has established seven tracks of Recommended Practices (RP) in the Standards and Practices (S&P) portion of the Contamination Control (CC) program, including the most recent program in Nanoscience and Nanotechnology. In addition, there are other parallel activities in IEST’s Design, Test, and Evaluation and Product Reliability divisions. Within each of these programs, scientists, engineers and contamination control professionals from all over the world interact closely in working group meetings, seminars and tutorials. Together they have developed, published and disseminated technical information and industrial standards, including RPs, reference documents (RDs), and ISO standards to address ever-evolving challenges in contamination control and sustainable development of the industries served by IEST.

The series of standards, RPs, and RDs are developed through years of discussion, deliberation and review, thus providing peer-reviewed best practices, standardized procedures and test methods to furnish guidance and address problems in contamination control. In general, IEST’s procedures for the development of standards, RPs, or RDs are in accordance with its status as an ANSI-accredited Standards Developer Organization (SDO). Specifically, RPs and RDs are formulated by IEST Working Groups (WGs) through a cooperative exchange of knowledge, experience and ideas that culminates in useful and timely information invaluable to all that avail themselves of this knowledge. These documents are reviewed every three years so that new knowledge, information and methods may be integrated into them in a timely manner.

All WG member contributions are provided by professionals on a volunteer basis. There are increasing challenges associated with keeping up with new knowledge requirements. However, IEST has successfully relied on ever-evolving leadership and concerted efforts by numerous volunteers to develop, revise and publish new documents at a faster pace than had been seen in recent decades. For example, eight updated revisions of existing or brand new RPs have been published since 2005, and approximately seven more RPs and RDs are well positioned in the pipeline for official publication by early 2007.

Due to their quality and timeliness, many IEST RPs are primary references and sources of information for compliance with the ISO 14644 series of international standards developed by ISO Technical Committee (ISO/TC) 209, Cleanrooms and associated controlled environments. Additionally, IEST conducts technical seminars, workshops and tutorials at its annual technical meeting (ESTECH), its Fall Conference, and online to assist related industries to better understand the “state-of-the-art” philosophies and effectively utilize IEST Recommended Practices and ISO standards.

Being the leading organization and a voting member of the ANSI-accredited U.S. Technical Advisory Group (TAG) to ISO/TC 229, Nanotechnologies, IEST is in a unique position to contribute its expertise in developing international standards for controlled environments to anticipate the unique needs of the emerging nanoscience/nanotechnology industry. For example, the IEST has formulated a new program to address the complex issues relevant to all industries working in this area. It includes nanoparticles, other relevant contamination control issues, and building facilities to conduct research and produce products related to nanotechnology. Leading industry experts in this area have been gathering at IEST conferences since the Fall Conference in 2005 and are working diligently on a first-ever industry road map and subsequent RPs in the IEST Recommended Practices NANO200 series. The first document, titled “Planning, Design, Construction & Operations Considerations for Facilities Engaged in Research or Production at the Nanometer Scale,” is, as mentioned earlier, the “road map document” for all industries building facilities to perform research and manufacturing at nanoscale levels. The document is scheduled for publication in the latter part of 2007.

IEST leaders are continually embracing new challenges and taking advantage of new opportunities to lead the way in the development of groundbreaking documents. We invite you to join in and participate in the relevant WGs, whether you are from the industrial sector or from academia. To increase your knowledge of the constantly evolving issues of the contamination control industry, you will want to obtain the most recent versions of these documents and become an active part of the organization. For further information, please visit www.iest.org.

The following is an overview of the IEST Working Groups and Recommended Practices.

WG-CC001: HEPA and ULPA Filters

This RP covers basic provisions for HEPA (high-efficiency particulate air) and ULPA (ultra-low penetration air) filter units as a basis for agreement between buyers and sellers. Filters that meet the requirements of this RP are suitable for use in clean air devices and cleanrooms that come within the scope of ISO 14644-1 and -2 (formerly Federal Standard 209) and for use in supply air and contaminated exhaust systems for which extremely high filter efficiency (99.97 percent or higher) for submicrometer particles is required. Six levels of performance and six grades of construction are included in this discussion. IEST-RP-CC001.4 was published in November 2005 and is due for review in November 2008.

WG-CC002: Unidirectional Flow Clean-Air Devices

This RP covers definitions, procedures for evaluating performance, and major requirements of unidirectional-flow clean-air devices. It may be used to define a basis of agreement between customer and supplier in the specification, procurement, and certification testing of unidirectional flow clean-air devices with self-contained motor-blowers and nonpowered terminal units with replaceable filter. It also presents recommendations for recertification under direction of the customer on devices owned by the customer. IEST-RP-CC002.2 was reviewed and validated in June 2004 and is due for review in June 2007.

WG-CC003: Garment System Considerations for Cleanrooms and Other Controlled Environments

This RP addresses the gowning of personnel as an important aspect of cleanroom contamination control. It provides non-mandatory guidance for the selection, specification, maintenance, and testing of apparel and accessories appropriate for use in non-aseptic and aseptic cleanrooms and other controlled environments. IEST-RP-CC003.3 was published in August 2003 and the Working Group is currently planning version 3.4.

WG-CC004: Evaluating Wiping Materials Used in Cleanrooms and Other Controlled Environments

This RP describes methods for evaluating, selecting and testing wipers used in cleanrooms and other controlled environments for characteristics related to both cleanliness and function based on intended usage. IEST-RP-CC004.3 was published in August 2004 and is due for review in August 2007.

WG-CC005: Gloves and Finger Cots Used in Cleanrooms and Other Controlled Environments

This RP describes procedures for testing, selecting and evaluating gloves and finger cots used in cleanrooms and other controlled environments. Tests are provided for determining cleanliness, physical and chemical integrity, and other relevant properties. Guidelines are also provided to assist users in the proper selection of gloves or finger cots. IEST-RP-CC005.3 was reviewed and validated in September 2006 and is due for review in September 2009.

WG-CC006: Testing Cleanrooms

This RP covers testing methods for characterizing the performance of cleanrooms. It is intended to assist planners, designers, manufacturers and buyers in preparing detailed specifications for cleanroom procurement and for assuring cleanroom operational compliance. Performance tests are recommended for three types of cleanrooms at three operational phases. Where the test method is affected by the type of cleanroom, alternative procedures are defined. For some of the tests, several different methods and instruments are allowed so that different end-use considerations can be accommodated. The test methods also may be used or adapted for periodic monitoring of cleanroom or clean zone performance capability. IEST-RP-CC006.3 was published in August 2004 and is due for review in August 2007.

WG-CC007: Testing ULPA Filters

This RP covers production testing of filters for particle penetration and pressure drop of ultra-low penetration air filters (ULPA). The penetration range of the procedure is 0.001 percent to 0.0001 percent, using particle counters. This procedure describes the equipment, aerosol properties, processes, and calculations for determining the efficiency of ultra-low penetration air filters, using particle counters. The procedure may be applied to production applications. Guidelines are provided for constructing a suitable test duct and sampling system. Also provided are test criteria for quantifying penetration in the range of 0.001 percent to 0.0001 percent, using test aerosol particles in the size range of 0.1

This year’s ESTECH event, which will be held April 29-May 2 at the Indian Lakes Resort in Bloomingdale, IL, will feature a number of new seminars.

Chemical and Biological Defense will focus on test design, analysis, and evaluation of equipment or processes including: chemical and biological defense systems; chemical demilitarization equipment and facilities; and hazardous chemical transportation.

A new seminar and panel discussion, presented by members of the 797 committee and CleanRooms magazine, will be providing the latest information on areas of contamination control implementation through US Pharmacopeia (USP) Chapter 797, Pharmaceutical Compounding: Sterile Preparations. This is the first set of such standards issued by the USP.

The Vacuum Testing seminar will explore two case histories: the Automated Transfer Vehicle and the Mars Rover. Leak rate testing and the selection and use of data acquisition and control systems for vacuum chambers will also be discussed.

Risk Assessment, Disaster Recovery will focus on the risks, both foreseen and unforeseen, that may impact cleanroom operations, as well as disaster recovery plans upon exposure of these risks.

The Vibration/Shock Test Equipment Technology seminar will focus on test equipment technology advances and control systems, which have dramatically improved laboratory testing capabilities for electrodynamic, servo-hydraulic, and pneumatic test systems since the inception of dynamic testing.

For more information on the seminars or to register for the event, visit www.iest.org.