Tag Archives: Clean Rooms

June 14, 2007 — /PRNewswire/ — TORONTO, ONTARIO — Dalton Pharma Services, a privately owned Canadian pharmaceutical services provider to leading pharmaceutical companies, today announced the company has entered into a long-term manufacturing services agreement with X-GEN Pharmaceuticals, Inc., a specialty pharma company based in Big Flats, NY, focused on providing quality therapeutic options in both specialized disease areas and broad range treatment choices.

Dalton Pharma Services has been contracted to fill/finish under cGMP sterile commercial products for X-GEN. The two companies, aligned in core values and business practices, are tactically poised for growth in the area of sterile injectables.

“Our establishment license from Health Canada, combined with our expert capabilities in analytical services and sterile manufacturing capacity, solidified the manufacturing agreement,” says Peter Pekos, president and CEO of Dalton. “This agreement validates Dalton’s customer oriented approach to bringing our clients’ products to the market quickly. We are extremely pleased to be working with X-GEN Pharmaceuticals, and look forward to providing further commercial manufacturing services for X-GEN, a strategic partner for Dalton,” continues Pekos.

Susan Badia, president and CEO of X-GEN, remarks, “The partnership with Dalton is an example of X-GEN’s commitment to expanding our offering of pharmaceutical products, which benefit the health care community as reliable, cost-effective treatment choices. We are excited about the opportunity to partner with a company whose client focus and commitment to quality match our own. Sharing these values with partners like Dalton is vital to our ability to provide products that fulfill the therapeutic needs of physicians and their patients.”

About Dalton Pharma Services
Dalton Chemical Laboratories Inc. o/a Dalton Pharma Services is a Health Canada approved, contract pharmaceutical manufacturer that supplies chemistry and analytical services to the biotechnology and pharmaceutical industries in the areas of medicinal chemistry, fine chemical manufacture, and custom peptides and antisense oligo production. Dalton provides cGMP manufacturing and sterile filling services to its customers at any stage of the regulatory process (Phase I, II, III or commercial). In its state of the art cGMP facilities, Dalton can produce active pharmaceutical ingredients (API), at the gram or kilogram scale. Dalton can carry out sterile fills to produce batches of finished drug product in vials or syringes, either aseptically filled or terminally sterilized, under fully validated conditions. In addition to drug testing, Dalton’s analytical chemistry laboratory offers method development, validation, ICH stability programs and HPLC-MS services to its clients.

About X-Gen Pharmaceuticals Inc.
X-GEN Pharmaceuticals, Inc. is a generic drug company specializing in the manufacturing and distribution of mature anti-infective pharmaceutical products. X-GEN’s strategic focus is on the continuous development of quality generic pharmaceuticals which enhance patient care as reliable and affordable treatment options. X-GEN’s product offering includes a broad range of dosage forms, including injectables, topical solutions, oral solutions, oral solids, powders for prescription compounding, and inhalants.

Source: Dalton Pharma Services

Contact:
Peter Pekos, Dalton Pharma Services
Tel: 416-661-2102
Fax: 416-661-2108
E-mail: [email protected]

Documents include guidelines for FPD manufacturing, SOI wafers

June 11, 2007 — SAN JOSE, CA — SEMI has published six new technical standards applicable to the semiconductor, flat-panel display (FPD), and MEMS manufacturing industries. The new standards, developed by technical experts from equipment and materials suppliers, device manufacturers, and other companies participating in the SEMI International Standards Program, are available for purchase in CD-ROM format or can be downloaded from the SEMI web site, http://www.semi.org.

SEMI Standards are published three times a year. The new standards, part of the June 2007 publication cycle, join more than 740 standards that have been published by SEMI during the past 34 years.

“These new SEMI standards, which include specifications for the flat-panel display (FPD) manufacturing industry, are the result of collaborative, consensus-driven efforts among industry experts — competitors and customers alike — to manage the ever increasing manufacturing challenges, improve yield and ensure compatibility of equipment and processes worldwide,” says Bettina Weiss, SEMI director of International Standards.

The standards released today include specifications for bar code container identification, specifications for silicon-on-insular (SOI) wafers, and a test method for surface hardness of FPD polarizing film. In addition to the six new standards, SEMI revised a previously published standard on EHS guidelines for exhaust ventilation of semiconductor manufacturing equipment. The revised SEMI S6 offers significantly more detailed guidance and provides equipment suppliers, evaluators, and users a means of validating the adequacy of exhaust ventilation.

The new standards released today include:
– SEMI C61 — Specification for Bar-Code Container Identification
– SEMI D49 — Specification of Single Substrate Orientation for Loading/Unloading Into/From Equipment to Specify ID Reader Position
– SEMI D50 — Test Method for Surface Hardness of FPD Polarizing Film
– SEMI E148 — Specification for the Definition of Time Synchronization Method and Format
– SEMI E149 — Guide for Documentation Provided to the Equipment User for Use with Semiconductor Manufacturing Equipment
– SEMI M71 — Specification for Silicon-On-Insulator (SOI) Wafers for CMOS LSI 130 nm Technology Generation and Beyond

The SEMI Standards Program, established in 1973, covers all aspects of semiconductor process equipment and materials, from wafer manufacturing to test, assembly, and packaging, in addition to the manufacture of flat-panel displays and microelectromechanical systems (MEMS). About 1,100 volunteers worldwide participate in the program, which is made up of 17 global technical committees. Visit http://www.semi.org/standards for further details about SEMI Standards.

SEMI is a global industry association serving companies that provide equipment, materials and services used to manufacture semiconductors, displays, nanoscaled structures, microelectromechanical systems (MEMS), and related technologies. SEMI maintains offices in Austin, Beijing, Brussels, Hsinchu, Moscow, San Jose (CA), Seoul, Shanghai, Singapore, Tokyo, and Washington, DC. For more information, visit http://www.semi.org.

Contacts:
Bettina Weiss/SEMI Scott Smith/SEMI
Tel: 408.943.6998 Tel: 1.408.943.7957
E-mail: [email protected] E-mail: [email protected]

June 5, 2007 — /PRNewswire-FirstCall/ HARLEYSVILLE, PA — Raymond J. De Hont, chairman and CEO of Met-Pro Corporation, announced today that the company’s Flex-Kleen Division, in Itasca, IL, has received two orders from a large company serving the building supply industry for a total of seventeen (17) dust collectors for use in manufacturing plants in the southwestern and midwestern United States. The total value of these orders is in excess of $670,000. The equipment is expected to ship in the third and fourth quarters of the company’s current fiscal year.

“This is the latest in a series of orders from the same customer. It validates Flex-Kleen’s solid market position as a key supplier of high quality, reliable dust collection equipment to the building supply industry and reinforces Flex-Kleen’s reputation as a leader in this field,” states De Hont. “Together with a steady stream of customer interest and quotation activity, it allows us to remain optimistic about Flex-Kleen’s prospects for the current fiscal year.”

About Met-Pro
Met-Pro Corporation, with headquarters at 160 Cassell Road, Harleysville, PA, was recently recognized as one of America’s “200 Best Small Companies” by Forbes magazine. Through its divisions and subsidiaries, in four states, Canada, Europe, and The People’s Republic of China, a wide range of products and services are offered for industrial, commercial, and residential markets. These include product recovery and pollution control technologies for purification of air and liquids; fluid handling technologies for corrosive, abrasive, and high temperature liquids; and filtration and purification technologies including proprietary water treatment chemicals and filter products. For more information, please visit http://www.met-pro.com.

Source: Met-Pro Corporation

June 5, 2007 — PEABODY, MA — Continued customer demand for Technical Manufacturing Corporation’s (TMC) precision floor vibration isolation systems has fueled the company’s fourth building expansion in the last 15 years.

The additional 9,000 sq. feet of manufacturing space includes large clean assembly areas to assemble, clean, and package systems bound for semiconductor factories and semiconductor equipment makers, pharmaceuticals, medical research labs, and advanced photonics facilities. The addition also includes a state-of-the-art welding facility and increased manufacturing space.

“With few exceptions, TMC products are conceived, developed, and manufactured at our Peabody, MA, factory,” says Steve Ryan, vice president of marketing. “Our world-class R&D and state-of-the-art manufacturing processes stimulate constant innovation and new product introductions that solve our customers’ most difficult building floor vibration problems.”

TMC purchased the present site in Peabody, MA, and constructed the original 35,000-sq.-foot building in 1984. The current expansion brings the building to 80,000 sq. feet on an 11-acre site. Dedicated to manufacturing TMC’s precision vibration isolation systems, the facility was specifically designed and built to include many custom features that enable the efficient manufacturing, handling, assembly, testing, and packaging of TMC’s growing product line.

TMC designs and manufactures precision vibration isolation systems for sensitive research and manufacturing processes worldwide. The ISO 9001-certified company’s products are standards in the semiconductor manufacturing, life sciences, and photonics industries and are also used in academic, industrial, and military research projects.

Partnership to produce first patient transfer products With Microban(R) antimicrobial technology

June 5, 2007 — /PRNewswire/ — HUNTERSVILLE, NC — Microban International, Ltd. has entered into a strategic partnership with Medcare Products, Inc., an American manufacturer of top-quality mobile and ceiling-mounted patient lifts, standard and disposable slings, transfer aids, and repositioning equipment. Because of this partnership, Medcare’s patient slings and belts will be the only slings and belts available with built-in Microban(R) antimicrobial product protection, and will join a growing list of products used in health care facilities with this innovative technology.

As the fabrics are infused with Microban(R) protection during the manufacturing process, Medcare’s patient slings will provide an added level of protection from microbes, such as bacteria, mold, and mildew that can cause stains, odors, and product deterioration. And as bacteria can multiply quickly on the slings after repeated uses, Microban(R) protection works 24/7 to keep the slings cleaner for longer between cleanings, and will last for the useful lifetime of the sling.

“In response to a strong desire for antimicrobial protection in health care facilities, we are extremely pleased to announce this new partnership with Medcare Products,” comments David Meyers, CEO of Microban International. “I’m confident that the health care industry will embrace this new product containing Microban(R) technology because of the extra product protection it provides against microbes.”

“This innovative technology, combined with our existing patient transfer products, provides us with a unique advantage in the healthcare products market,” says Medcare’s CEO Brooks Smith. “We are proud to be the first supplier of patient slings and belts with Microban(R) antimicrobial product protection — this technology can not be found in any other patient lift equipment in the U.S. and provides an additional level of product protection we know health care facilities are looking for.”

About Medcare Products, Inc.
Medcare Products, Inc. is a premier manufacturer of top-quality mobile and ceiling mounted patient lifts, standard and disposable slings, transfer aids, and repositioning equipment. The Medcare line of standard and bariatric equipment delivers solutions to both the acute care and long term care markets. With a primary focus on injury prevention systems, Medcare specializes in providing proper accredited patient lifting seminars accompanied by superior service. For more information on Medcare Products, please contact Stacy Lemmer at (952) 894-7076 ext. 122, or visit http://www.medcarelifts.com.

About Microban International, Ltd.
Microban International, Ltd. is a global technology and marketing company dedicated to enhancing high quality consumer, industrial and medical products with branded built-in protection from microbes. Microban International licenses the Microban(R) global brand name, sells custom-engineered compounds, and provides a range of services, including regulatory and marketing support. The Microban(R) brand promises continuous and durable antimicrobial product protection, built-in during manufacture to not wear out for the useful life of the product. Microban International is headquartered in North Carolina with operations in North America, Europe, and Asia. For more information on Microban please contact (704) 875-0806 or visit http://www.microban.com.

Contact:
Sarah Hoxie for Microban
Tel: 704-875-0806

Source: Microban International, Ltd.

Recall — Firm Press Release

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

June 6, 2007 — /FDA Digest/ — Springfield, OR — Toby’s Family Foods is recalling Toby’s Lite Sour Creme and Toby’s Toasted Sesame Dressing because the products may be contaminated with salmonella, an organism that can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting, and abdominal pain. In rare circumstances, infection with salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis.

Toby’s Lite Sour Creme and Toby’s Toasted Sesame Dressing were distributed primarily in Oregon, as well as Washington and California, through natural food and specialty retailers. The products include:
– 8 oz. plastic containers of Toby’s Lite Sour Cr

May 31, 2007 — /PRNewswire-FirstCall/ — HARLEYSVILLE, PA — Raymond J. De Hont, chairman and chief executive officer of Met-Pro Corporation, announced today that the company’s Strobic Air subsidiary in Harleysville, PA, has received orders to supply laboratory fume hood exhaust systems, utilizing a total of 34 Tri-Stack(TM) fans, to two premier biomedical research facilities in the midwestern and southern United States. The total combined value of these orders is in excess of $1.2 million. All of the equipment is expected to ship in the third and fourth quarters of the company’s current fiscal year.

Strobic Air was awarded these contracts based on its best-in-class reputation for supplying low-profile exhaust systems that are specifically designed to handle the complex issues of laboratory exhaust. All of the fans included in these orders will be provided on highly customized systems to meet the specific space constraints and height limitations required by each facility.

“These orders are further examples of Strobic Air being recognized as the supplier of choice for technologically advanced fume hood exhaust systems at institutional, industrial and government laboratories,” says De Hont. “Together with a steady level of customer interest and quotation activity for similar type projects, they allow us to remain optimistic about our prospects for future orders of this type at Strobic Air.”

About Met-Pro
Met-Pro Corporation, with headquarters at 160 Cassell Road, Harleysville, PA, was recently recognized as one of America’s “200 Best Small Companies” by Forbes magazine. The company, which manufactures and sells product recovery and pollution control equipment for purification of air and liquids and fluid handling equipment for corrosive, abrasive, and high temperature liquids, was established in 1966. It provides products to residential, commercial, industrial, and municipal markets that include, but are not limited to, pharmaceuticals, chemicals, petrochemicals, water, and aquariums. For more information, please visit http://www.met-pro.com/.

Source: Met-Pro Corporation

June 1, 2007 — CALABASAS, CA — National Technical Systems, Inc. (NTS), a leading provider of engineering services, announced today the acquisition of TRA Certification, located in Elkhart, IN, by its joint venture company, National Quality Assurance, USA (NQA). Terms of the acquisition were not disclosed.

NQA is one of the world’s largest ISO certification bodies, providing services for thousands of industry leaders. This is NQA’s second acquisition in just over 12 months. Combined with the acquisition of California-based AIR in 2006, NQA has added more than 400 new customers in just over a year. NQA has also benefited from an increase of new business from organic growth, outside of these acquisitions, further adding to the significant boost in the total number of new customers added over the past year. This expansion of the NQA customer base creates new opportunities for additional growth for NQA, as many of these organizations are in need of the complementary services offered by NQA.

TRA is an established player in the registration industry, in business for over 15 years; it is one of the longest running ISO certification bodies in North America. The TRA location allows NQA to establish a strategic presence for the support of its current and new customers in the region.

“I am delighted to be joining NQA. I have confidence that this established and respected organization will continue to service our customers at the highest level,” comments Tom Arnold, president of TRA Certification.

Kevin Beard, president of NQA, states, “We at NQA are thrilled to have TRA join us. Our two organizations have worked closely together in the past, and I am confident that our history of cooperation will enable us to make this a smooth and seamless transition, for both our organizations and our customers.”

“Adding 400 new customers is significant for both NQA and NTS; allowing us to offer the full breadth of services provided by both to a broader audience, increasing opportunities for revenue growth all around,” states Bill McGinnis, CEO and president of NTS. McGinnis says, “NQA has been steadily growing its base business over the past year and continues to show strong growth for the future.”

About NQA, USA
NQA, USA, headquartered in Acton, MA, was established in 1992 as a joint venture between National Quality Assurance, Limited (headquartered in London, England) and National Technical Systems, Inc. (located in Calabasas, CA). NQA, USA is a world-renowned ISO 9001, ISO 14001, TS 16949, and AS9100 registrar. NQA, USA’s single point of contact saves clients time, while its well-trained, efficient staff located nationwide, provides local attention. NQA’s worldwide operations are accredited to perform management systems registrations by ANSI – ANAB (American National Standards Institute/Registrar Accreditation Board) and UKAS (United Kingdom Accreditation Service). NQA, USA has expertise in many diverse industries including aerospace, transportation and distribution, printing, professional services, automotive, foods, electronics, computers, and software.

About NTS
National Technical Systems, Inc. is a leading provider of engineering services to the defense, aerospace, telecommunications, automotive, and high technology markets. Through a world-wide network of resources, NTS provides full product life-cycle support, offering world class design engineering, compliance, testing, certification, quality registration, and program management. For additional information about NTS, visit www.ntscorp.com or call 800-270-2516.

June 4, 2007 — /PRWEB/ — AGAWAM, MA — Med-Conduit, an innovative developer and marketer of central venus catheters (CVCs) has teamed with Microtest Laboratories of Agawam, MA, a leading provider of testing services to the medical device industry.

CVCs are found in use at intensive care and long term units in hospitals. When inserted into a patient, it enables that patient’s skin to grow into the device and form a biological seal that has a significant impact on preventing infection at the site of insertion, explains Dr. Gerald Bousquet, M.D., president of Med-Conduit.

Microtest is conducting bacteria testing on a new cap that Med-Conduit is implementing for its CVCs, says Bousquet.

Bousquet turned to Microtest for its current testing needs after working with the company and its founder, Steve Richter, PhD, on a previous project.

Richter had assisted Bousquet to navigate the stringent U.S. Food and Drug Administration (FDA) application process and successfully obtain the critical FDA approvals he required to manufacture and sell a product at his previous company, Microwave Medical Systems. The product, the Microwave Sanitizer, is a microwave designed to sanitize the catheter connection area to decrease the risk of infection for patients in peritoneal dialysis.

“Dr. Richter’s prior experience working at the FDA, combined with his deep expertise and background in medical device development, and his personal passion to succeed, made all the difference in securing the approvals we required,” Bousquet says. “Dr. Richter even traveled with our company principles to meet with the FDA in Washington, DC.”

Microtest offers a host of single-source solutions that assist medical device manufacturers facing a rising volume and complexity of challenges in product development and validation, including:
– Medical device sterilization validations
– Package validations
– Microbiology and cleanroom services
– Analytical services

A new free white paper written for medical device manufacturers discusses sterility testing as well as reviews different testing methodologies. Titled “Sterility Testing: Essential Things You Must Know,” it’s authored by Steve Richter, and is available for download at: http://www.microtestlabs.com/sterilitypaper.

About Microtest
Microtest is a leader in testing services and contract manufacturing for the medical device, pharmaceutical, biotechnology industries. Based in Agawam, MA, USA, the company’s expertise and flexible processes enhance product safety and security, accelerate time to market, and minimize supply chain disruption. For more information, visit www.microtestlabs.com or call 1-413-786-1680 or toll-free 1-800-631-1680.

June 4, 2007 — LONDON, U.K. — BOC Edwards, a leading supplier of vacuum, abatement, chemical management equipment and services to the world’s semiconductor OEMs and fabs, announced today that CCMP Capital has completed its acquisition of the company. This marks BOC Edwards’ return to independent status almost 40 years after it was acquired by BOC.

CCMP Capital, through funds managed by CCMP Capital Advisors, LLC and CCMP Capital Asia Limited, completed the deal with The Linde Group, the global gases company, within three months of its signing on March 12, which was subject to regulatory review and other closing conditions. Linde had previously announced the divestment following its acquisition of The BOC Group in September 2006.

BOC Edwards is a leading global supplier of equipment and services to the world’s most advanced industries, including semiconductor, flat panel display, chemical, metallurgical, analytical instrumentation, and R&D. It supplies major customers in Asia, Europe, and the Americas through a worldwide manufacturing and sales network. Its turnover in 2006 was over $1 billion.

Commenting on the announcement, Nigel Hunton, chief executive of BOC Edwards, says, “In the last 40 years our business has grown out of all recognition. We feel that our return to independent status, with a strong partner in CCMP, makes us well placed for success as we transition to our next phase of development.”

Stephen Welton from CCMP Capital Advisors adds, “We believe that as an independent company BOC Edwards is ideally positioned to drive further growth in core existing markets such as semiconductors with an exciting range of new products coming through, whilst actively developing in new emerging markets such as solar where we will focus considerable additional resources.”

John Lewis from CCMP Capital Asia, comments, “BOC Edwards has been present in Asia for a large proportion of the last 40 years and as global electronics and technology production resources become more concentrated in Asia, we expect BOC Edwards to prosper. CCMP’s presence and experience in these markets brings extra impetus to this opportunity.”

About BOC Edwards
BOC Edwards is a leading supplier of integrated solutions for the manufacture of microelectronics devices, including semiconductors and flat panel displays. It is also a world leader in vacuum technology for industrial, scientific, process, and R&D applications. BOC Edwards employs around 4,000 people globally, in the design, manufacture and support of high technology vacuum equipment. BOC Edwards invented the concept of the commercial oil-free “dry” vacuum pump and now supplements this with a wide range of other pumping technologies as well as related products and services.

About CCMP Capital
CCMP Capital Advisors, LLC investment team has invested over $12 billion in over 380 buyout and growth equity transactions since 1984. The foundation of CCMP Capital’s investment approach is to leverage the combined strengths of its deep industry expertise and proprietary global network of relationships by focusing on five targeted industries: Consumer, Retail and Services; Energy; Healthcare Infrastructure; Industrials; and Media and Telecom. Through active management and its powerful value creation model, CCMP Capital’s team has established a reputation as a world-class investment partner.

About CCMP Capital Asia
CCMP Capital Asia is one of the largest and most experienced buyout firms in Asia, with US$2.7 billion in capital commitments under management. Since its launch in May 1999, CCMP Capital Asia has advised on total investment commitments of approximately US$2.25 billion in 26 companies with total transaction value of over US$10 billion. The commitments are spread across Asia in CCMP Capital Asia’s focus markets of Australia and New Zealand, Greater China (including China, Hong Kong, and Taiwan), Japan, Singapore, and South Korea. CCMP Capital Asia’s core strategy is to target control investments in market leading companies with strong cash generative business models, high barriers to
entry and differentiating capabilities or products. In particular, the firm focuses on companies where it is able to utilize its operationally driven business model to create value and drive returns.

Contact:
Andrew Davis
Tel: +44 (0) 1293 603507
E-mail: [email protected]