Tag Archives: Clean Rooms

May 7, 2007 — /PRNewswire/ — ENGLEWOOD, CO — Baxa Corporation has signed a co-marketing agreement with CriticalPoint LLC, to promote its web-based sterile compounding curriculum. This comprehensive, ACPE-approved program consists of 32 modules that meet USP Chapter < 797 >‘s competency assessment requirements. Modules are self-paced and part of CriticalPoint’s Learning Management System (LMS), offering access from any Internet connection and providing administrative reporting for tracking employee progress and compliance.

The CriticalPoint curriculum provides step-by-step programs that build a solid foundation of best practice for pharmacists and technicians involved in sterile compounding activities. For Baxa, the modules complement the programming offered in its Skills Training, Academics, and Resources (STAR) Center on compliance and aseptic certification for USP < 797 >. Both the classroom and the online training programs were developed by industry professionals and promote skill development and making best practice better.

According to Peter Cantor, CriticalPoint development lead, “Our goal was to assemble the experts and outline the kind of comprehensive program that we felt practitioners need. We developed the content holistically and supported it with robust peer reviews.

“The real benefit to end users,” Cantor continues, “is our ability to update best practices and regulatory issues in one program to keep the curriculum current.”

CriticalPoint’s training helps facilities meet both national (USP < 797 >) and state board required training competencies. In addition, they support classroom-based training by providing a means for ongoing certification. The CriticalPoint modules are harmonized with the current USP < 797 > regulation as well as the proposed revisions, which are expected to be finalized in the summer of 2007.

Baxa Corporation will market the CriticalPoint modules as a follow-on to its classroom-based training for USP < 797 > compliance and aseptic compounding. However, the CriticalPoint modules can be used as stand-alone tools for compounding education and to ensure patient safety. Its 32 modules cover the following topics: Fundamentals of Aseptic Compounding; Environmental Monitoring and Maintenance; Documentation and Policies & Procedures; Personnel Training; Compounding Practices; Engineering Controls and Equipment Use; and Hazardous Drugs Compounding Practices.

Notes pharmacist Pete Campanella, Baxa director of professional services, “Traditionally, Baxa has developed products that promote operational excellence in pharmacy admixture and compounding. The STAR Center and CriticalPoint curricula add training and employee development to that best practice focus.”

Baxa Corporation’s STAR Center brings together professional and industry partners to provide participants with a range of experience in equipment, technology and design. The CriticalPoint modules are sold as stand-alone programs for quality assurance and competency assessment.

Source: Baxa Corporation

About Baxa Corporation
Baxa, a customer-focused medical device company, provides innovative, solution-based technologies for fluid handling and delivery. Its systems and devices promote the safe and efficient preparation, handling, packaging, and administration of fluid medications. Privately held, Baxa Corporation has subsidiaries and sales offices in Canada and the United Kingdom; direct representation in Austria, Belgium, Denmark, Finland, France, Germany, Luxembourg and The Netherlands; and distribution partners worldwide. Further information is available at www.baxa.com.

About CriticalPoint, LLC
CriticalPoint, LLC, offers interactive web-based training for compounding sterile preparations and services related to creating and enabling learning through technology in clinical settings. CriticalPoint e-Learning represents a best practices approach for interactive training for sterile compounding and is designed to assist healthcare providers in meeting quality assurance program goals and regulatory compliance. For more information visit www.criticalpoint.info.

About the STAR Center
The STAR Center is a state-of-the-art cleanroom, pharmacy and training facility located at the Baxa world headquarters in Englewood, CO. The center was purpose-built to support training in aseptic technique, pharmacy workflow and practice, cleanroom design and maintenance and USP <797> compliance among other topics. Classes are taught by industry-recognized subject matter experts. Further information is available at www.baxa.com/starcenter.

Contact:
Maggie Chamberlin Holben, APR
Absolutely Public Relations: 303-984-9801 or 303-669-3558
Email: [email protected]

Peter Cantor
CriticalPoint, LLC: 240-238-4352
Email: [email protected]

FDA News
Consumer Inquiries: 888-INFO-FDA

Glycerin contaminated with diethylene glycol (DEG) remains a potential health hazard to consumers

May 7, 2007 — /FDA News/ — The U.S. Food and Drug Administration (FDA) is warning pharmaceutical manufacturers, suppliers, drug repackers, and health professionals who compound medications to be especially vigilant in assuring that glycerin, a sweetener commonly used worldwide in liquid over-the-counter and prescription drug products, is not contaminated with diethylene glycol (DEG). DEG is a known poison used in antifreeze and as a solvent. Today, the agency is issuing guidance to industry recommending methods of testing glycerin and other controls to identify any contamination with DEG before use in the manufacture or preparation of pharmaceutical products.

At the present time, FDA has no reason to believe that the U.S. supply of glycerin is contaminated with DEG, though the agency is cognizant of reports from other countries over the past several years in which DEG-contaminated glycerin has caused human deaths. FDA is emphasizing the importance of testing glycerin for DEG due to the serious nature of this potentially fatal problem in combination with the global nature of the pharmaceutical supply chain and problems that continue to occur with this kind of contamination in some parts of the global supply of glycerin.

DEG poisoning is an important public safety issue and FDA is exploring how supplies of glycerin become contaminated. In addition, FDA is working with a variety of manufacturing and pharmacist organizations to raise awareness of this risk and to put into place controls to ensure that this problem does not happen in the U.S. or elsewhere.

The most recent incident occurred in Panama in September 2006 and involved DEG-contaminated glycerin used in cough syrup, which resulted in dozens of hospitalizations for serious injury and more than 40 deaths. In late 1995 and early 1996, at least 80 children died in Haiti due to DEG-contaminated glycerin in acetaminophen syrup. Between 1990 and 1998, similar incidents of DEG poisoning reportedly occurred in Argentina, Bangladesh, India, and Nigeria and resulted in hundreds of deaths. In 1937, more than 100 people died in the United States after ingesting DEG-contaminated Elixir Sulfanilamide, a drug used to treat infections. This incident led to the enactment of the Federal Food, Drug, and Cosmetic Act, which is the nation’s primary statute on the regulation of drugs.

FDA reminds pharmaceutical manufacturers, compounders, repackers, and suppliers, as well as brokers and distributors, that all pharmaceutical manufacturing operations, including the re-packaging and re-labeling of ingredients like glycerin, must conform to current good manufacturing practice (CGMP). The guidance provides recommendations for complying with CGMP and is intended to help manufacturers, compounders, repackers, and suppliers avoid the use of glycerin that is contaminated with DEG and prevent incidents of DEG poisoning. For a copy of the guidance, go to http://www.fda.gov/cder/guidance/7654fnl.htm.

May 4, 2007 — /PRNewswire/ — OXFORD, UNITED KINGDOM — Midatech Group Ltd., a world leader in the production and application of nanoparticles for therapeutic and diagnostic applications, has announced the opening of its specialist design and manufacturing facility for cGMP grade nanoparticles in Bilbao, Spain. Midatech Biogune S.L. is the world’s first cGMP grade manufacturing plant for the production of nanoparticles at a scale commensurate with pharmaceutical applications.

Staffed by an experienced, multi-disciplined team, the plant will initially focus on the design and manufacture of nanoparticles to supply Midatech Group’s series of projects applying nanotechnology for therapeutic purposes. These include using nanoparticles as scaffolds for synthetic vaccines and antibiotics, as drug delivery vehicles for RNAi drugs and drugs able to cross the blood brain barrier, as well as targeted cancer treatments and imaging agents. Midatech’s nanoparticles will allow drug companies to deliver new and existing medicines at significantly lower doses and with greater specificity, thereby reducing toxicity.

Speaking on the opening, managing director of Biogune Justin Barry stated, “We are delighted to launch the new facility in the dynamic environment of the Zamudio Science Park. We are very proud of the capabilities and future potential of the site which represent a real step forward in realizing the potential of nanoparticles for medical advancement. We would like to thank both the Basque regional government and the Zamudio Science Park whose support and dedication has been invaluable in helping us to realise our objective.”

Midatech Biogune will be exhibiting at the upcoming BIO Boston conference, May 6-9 in Boston, MA, at booth number 1087 in the Spain pavilion.

About Midatech Biogune S.L.
Midatech Biogune S.L. is a state-of-the-art facility for the design and manufacture of glyconanoparticles to cGMP standards. The facility, which opened in March 2007, is situated in Bilbao, Spain, and is part of Midatech Group Ltd, a company dedicated to developing its glyconanoparticles for a wide range of therapeutic applications.

About Midatech Group
Midatech Group Ltd. is a world leader in the design, synthesis, and manufacture of biocompatible nanoparticles. These nanoparticles can be used to create a wide variety of products with novel characteristics, functions and applications that have the potential for multiple diagnostic and therapeutic applications. The creation of the Midatech Biogune plant is a key part of the business strategy.

Created in 2000, Midatech has IP covering design, manufacture, and application/use of nanoparticles in both diagnostic and therapeutic pharmaceutical areas. As well as in-house product development, it is prepared to license this IP to third-party pharmaceutical and diagnostic development partners while retaining manufacturing rights. Midatech has exclusive world-wide rights for technology relating to the synthesis and applications of self-assembling nanoparticles.

The Technology
Midatech’s biocompatible nanoparticles possess a number of unique properties that make them ideal for therapeutics, diagnostics and other enabling applications.

  • Nanoparticles are water soluble.
  • Nanoparticles can present multiple ligands, allowing for multivalent drug or multi-drug delivery on a single particle.
  • Their size enables drug delivery via different routes of administration, such as parental or intranasal. Their stability to enzymatic digestion may also permit oral therapy.
  • Their outer shell (or corona) can be designed to be “stealth” (invisible to the host immune system), and are thus expected to present no immunological liability.
  • Nanoparticles self-assemble in a single step chemical process. Manufacture is therefore simple, safe, scaleable and low cost.
  • Nanoparticles are superparamagnetic, enabling them to be used as both non-invasive imaging agents (MRI), and as vehicles for inducing cell suicide by hysteresis heating (apoptosis caused by heating of an intracellular or cell-surface bound nanoparticle with an alternating magnetic field).

For further company information, see www.midatechgroup.com.

Source: Midatech Group Ltd

May 4, 2007 — VALENCIA, CA — UltraViolet Devices, Inc. (UVDI), a leading manufacturer of products for air and water treatment, is pleased to announce being awarded a multi-million dollar contract from a Fortune 500 worldwide leader in innovative operating room products.

The Sparks Technology division of UVDI provides a unique combination of molecular and HEPA grade filtration solutions that are used in a surgical waste management application. This solution not only increases the performance of the device but also protects the patient and surgical team from odors and airborne contaminants. The turn-key solution utilizes Sparks Technology’s patented bonded activated carbon technology (BPS£) and overall value added design expertise in particulate and odor removal for air and fluid waste streams.

About UltraViolet Devices, Inc.
UVDI is a leading high volume manufacturer and supplier of UV and molecular filtration products for both air and water purification. Under the ALTRU-V® brand, UVDI markets a full line-up of UV-C products for the commercial HVACR market providing the key benefits of reduced energy consumption, and lower maintenance costs, while delivering cleaner, healthier air. UVDI’s Sparks Technology Division is one of a few companies in the world that manufactures bonded activated carbon and is the exclusive manufacturer using BPSTM – Bonded Particulate Structure technology to produce high quality molecular filtration products. UVDI also provides product design, development and manufacturing for OEM customers that are sold under market leading brand names.

Contact:
Larry Randall – Sr. Product Marketing Manager
+1-661-257-4672
[email protected]
UltraViolet Devices, Inc.
26145 Technology Drive
Valencia, CA 91354
+1-877-787-3882
+1-661-295-8140
www.uvdi.com

COMPANY RELEASE

According to the company, the FDA restates its prior claims but offers no evidence of its various allegations

May 3, 2007 — /PRWEB/ — Union, NJ — The FDA has again gone public with a press release, this time regarding a formal request to Shelhigh, Inc. to voluntarily recall all of its medical devices remaining in the marketplace, including hospital inventories, ostensibly due to sterility concerns.

For the FDA to allege that these procedures are now in violation of regulations is inaccurate and misleading.

“This is the first formal request by the FDA for Shelhigh to recall its products, and since the FDA allegations are unfounded, Shelhigh has no intention to initiate a product recall,” said Shelhigh founder Shlomo Gabbay, MD. “The FDA should understand that it must prove its allegations before it can make a request and their newest statements do not provide any further factual support for their claims.”

The FDA in its current press release misleadingly states that Shelhigh’s own records indicate a number of sterility test failures and that its testing and retesting procedures were not properly performed.

“At no time during the inspection or through the documentation of their observations did the FDA inspectors indicate that the sterilization method employed by Shelhigh was improper or would fail to produce the desired result. The sterilization method employed by Shelhigh has been validated on numerous occasions and has been included as part of required submissions to the FDA,” Dr. Gabbay said.

“Sterility testing of Shelhigh products is performed by an independent International Standards Organization (ISO) certified contract laboratory. Our firm has implemented sterility testing procedures that have been in effect since prior to 2000 and have been reviewed through numerous FDA inspections of the Shelhigh facility,” said Dr. Gabbay. “For the FDA to allege that these procedures are now in violation of regulations is inaccurate and misleading.”

The FDA also provided a separate questions and answers document that was apparently designed to counter statements made by Shelhigh in its earlier news releases.

“Our customers and the public may go to the Shelhigh web site to view our responses to the answers that the FDA provided and I trust that they will be enlightened by the explanation that we provide,” said Dr. Gabbay. “I just hope that the FDA halts its public posturing and returns to discussions with Shelhigh. I prefer that we close out any remaining issues that the FDA may have through constructive dialog so that Shelhigh can return to the business of saving lives.”

About Shelhigh
Shelhigh is known for its proprietary No-React(R) tissue products that utilize the widely accepted glutaraldehyde fixation process while avoiding the acknowledged problems that accompany glutaraldehyde. No-React tissue products have over 10 years proven performance of resisting infection and calcification, even in cases of active infective endocarditis. Today Shelhigh offers a wide variety of cardiothoracic surgical solutions, all incorporating No-React tissue for superior performance.

Contact:
Douglas Goldman
Shelhigh, Inc.
908-206-8706

*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.

May 3, 2007 — /FDA News/ — PLYMOUTH, MA — On 5/02/07, SmartPak Canine executed a voluntary nationwide recall on all lots of LiveSmart Adult Lamb and Brown Rice food. This product tested positive for presence of melamine in a test received earlier in the day.

The LiveSmart Lamb formula is only sold in portion-paks shipped straight to the consumer’s home each month, so there are no bags of potentially affected product on store shelves anywhere in the country. The focus of the recall has been informing affected customers via telephone, email, and letter. Ninety-nine percent of the roughly 220 pet owners feeding LiveSmart Adult Lamb via its portion pak pet food subscription service were contacted by live phone contact or message, and/or email. The company has had live contact with the majority of affected pet owners, and is continuing an aggressive outreach program to ensure that the notification has been received. To reduce likelihood of pet owners continuing to feed the food, replacement product is being shipped to affected customers free of charge.

At the time the recall was initiated, there had not been any ill effects reported in dogs. Through the efforts to reach out to all customers, the company has become aware of two instances of vomiting and learned that a 10 year old rottweiler had passed away two weeks previous to the recall. These reports have been forwarded to FDA and are being investigated by the company’s medical director to determine if they are connected with the LiveSmart Adult Lamb formula. The company has asked that any dogs showing signs of kidney illness (loss of appetite, weakness, vomiting, diarrhea, excessive thirst) be seen by their veterinarian.

The company is presently investigating the source of the contamination in conjunction with its contract manufacturer, Chenango Valley Pet Food. The LiveSmart Adult Lamb formula does not contain rice protein concentrate nor wheat gluten. All the meat and vegetable matter, with the exception of New Zealand lamb, is of U.S. origin. It appears that the product may have been cross-contaminated at the Chenango plant by a prior batch of food unassociated with SmartPak that contained an ingredient that had been contaminated with melamine.

SmartPak has also tested each of its other four brands for melamine contamination, and there was no melamine detected in the samples of these foods.

Those brands are LiveSmart Adult Chicken and Brown Rice, LiveSmart Senior Chicken and Brown Rice, and LiveSmart Puppy Chicken and Brown Rice.

Questions regarding this recall may be directed to Paal Gisholt, the company’s president and CEO, who may be reached at 800-461-8898. Affected customers are asked to call the company’s toll free customer service number at 800-461-8898, which is available 24/7. Additional information will be reported on the company’s web site as it becomes available.

Consumers with questions about the pet food they use should visit the FDA web site at www.fda.gov.

Contact:
Paal Gisholt
774-773-1100
Consumers:
800-461-8898

May 3, 2007 — /MARKET WIRE/ — SAN DIEGO, CA — Althea Technologies, Inc., a leading provider of innovative technologies and services for pharmaceutical development and manufacturing, announced today it has completed the initial phase of construction on its new 30,000 sq. ft. cGMP manufacturing facility. Althea also announced that it has begun contract discussions with potential clients for future use of the increased manufacturing capacity. The active pharmaceutical ingredient (API) and aseptic fill/finish wings are currently under construction. The warehouse and materials management section of the facility has been completed. Initial construction of the facility began in early January 2007, immediately following a successful financing of $23 million with Telegraph Hill Partners, located in San Francisco, CA.

The continuing facility expansion of Althea’s San Diego campus is focused on meeting current and future client demands for larger batch sizes as products move into Phase III and commercial manufacture. The new building is the third Althea facility located on the company’s San Diego campus and upon completion Althea will occupy a total of 80,000 sq. ft. The API facility features a fermentation train leading to 1,000 L scale batch production with appropriate downstream processing facilities. The aseptic fill/finish wing will include automated vial and syringe filling, inspection, and labeling equipment capable of producing batch sizes of 100,000 plus units.

Rick Hancock, Althea’s chief operations officer, stated, “The continuing growth of our facilities allows us to support our clients from pre-clinical through commercial-scale production. We are also supplementing our organizational infrastructure to support the increased program and systems requirements though an aggressive hiring program focused on recruiting additional seasoned quality and manufacturing staff for several positions.”

About Althea Technologies, Inc.
Althea Technologies, a leading San Diego-based pharmaceutical services firm, provides critical manufacturing and development services that support researchers worldwide in their advancement of novel therapies and efforts to apply new genomic information. Althea’s services include cGMP contract manufacturing of recombinant proteins, DNA-based therapeutics and vaccines, aseptic filling, and gene quantification using real-time PCR and gene expression analysis under GLP conditions. Additionally, Althea has introduced new services and technologies for the identification and development of genetic biomarkers with innovative programs such as the company’s proprietary eXpress PathwaySM. For more information, visit www.altheatech.com.

Source: Althea Technologies, Inc.

Contact:
Althea Technologies, Inc.
Alan Moore
Executive Vice President and CBO
(858) 882-0205

New curriculum part of PerkinElmer’s comprehensive solutions to meet customers’ educational needs with high-quality, convenient, consistent training

May 3, 2007 — WALTHAM, MA — PerkinElmer, Inc., a global leader in Health Sciences and Photonics, has announced new online curriculum to support customers in the pharmaceutical, clinical and other heavily regulated industries with training on regulatory compliance topics.

The curriculum is part of PerkinElmer’s ongoing commitment to provide comprehensive service and support to enable laboratories to advance the pace and precision of their product development and testing. The training offerings complement PerkinElmer’s OneSource(R) compliance and validation services, which specialize in robust solutions that maximize laboratory productivity.

“PerkinElmer’s online curriculum offers professionals the convenience and flexibility they need to access training on demand while offering employers the assurance that their personnel are trained in a consistent manner with proven effective techniques and mission-critical content,” said Ralph Dioguardi, global training leader, PerkinElmer Life and Analytical Sciences. “The compliance modules complement PerkinElmer’s other training resources and aid customers in their efforts to secure and maintain certifications.”

The new e-learning curriculum includes:

  • Good Clinical Practice (GCP) Level 1 — This course covers the ethical and scientific quality standards for designing, conducting, recording and reporting human clinical trials. GCP compliance ensures the protection of the rights, safety and well-being of trial participants and the credibility and integrity of clinical trial data. Content includes a review of clinical trials, GCP guidelines and informed consent.
  • Good Clinical Practice (GCP) Level 2 — Level 2 includes a review of the standards used in clinical studies from start-up to post-study audits. The function of independent review boards, recording and reporting of adverse events and the de-qualification process are among the topics covered.
  • Good Manufacturing Practice (GMP) — Participants receive an introduction to the concepts and requirements necessary for compliance with GMP for pharmaceutical and biopharmaceutical research and development. Students will review how to establish and document a system of GMP controls required to manufacture drug products in the United States, the European Union, Japan, and many other parts of the world.
  • Good Laboratory Practice (GLP) — This is an introductory course focusing on the concepts and requirements necessary for compliance with GLP research and development. It will address how to establish and document a system of GLP controls required to test medical products where data is intended for inclusion into a regulatory filing in the United States, the European Union, Japan and in many other parts of the world.
  • 21 Code of Federal Regulations (CFR) Part 11 — The curriculum covers the FDA’s “21 CFR Part 11,” which provides the set of rules for electronic signatures and electronic records. The course discusses why Title 21 was developed, the role it plays in adhering to other sections of 21 CFR and explores the general concepts of security in a Part 11-compliant system.

Once registered, a participant may access the media-rich, computer-animated training modules for up to 30 days from the convenience of their office or home. Each module takes approximately 60 to 90 minutes to complete and offers the chance to self-check understanding of the content. For details regarding curriculum and registration, visit www.perkinelmer.com/training.

About PerkinElmer
PerkinElmer, Inc. is a global technology leader focused in the following businesses — life and analytical sciences, optoelectronics, and fluid sciences. Combining operational excellence and technology expertise with an intimate understanding of its customers’ needs, PerkinElmer creates innovative solutions — backed by unparalleled service and support — for customers in health sciences, semiconductor, aerospace, and other markets whose applications demand absolute precision and speed. The company markets in more than 125 countries, and is a component of the S&P 500 Index. Additional information is available through www.perkinelmer.com or 1-877-PKI-NYSE.

FDA News
Consumer Inquiries: 888-INFO-FDA

May 2, 2007 — /FDA News/ — The U.S. Food and Drug Administration (FDA) today issued a formal written request to Shelhigh, Inc. to recall all of its medical devices remaining in the marketplace, including hospital inventories, because of sterility concerns.

On April 17, 2007, U.S. Marshals, at FDA’s request, seized all medical devices including components at Shelhigh’s Union, N.J., facility after finding significant deficiencies in the company’s manufacturing processes. During the seizure, Shelhigh was asked to perform a voluntary recall of its products, but the company declined.

FDA recommends that doctors and hospitals consider using alternative products. Physicians and patients concerned about Shelhigh devices can visit www.fda.gov/cdrh/safety/041907-shelhigh.html and www.fda.gov/cdrh/medicaldevicesafety/atp/041907-shelhigh.html for more information, including a list of the company’s products.

“Since these are critical devices implanted into seriously-ill patients, ensuring their sterility is absolutely essential to prevent infection,” said Daniel Schultz, M.D., director, FDA’s Center for Devices and Radiological Health. “FDA will continue to provide up-to-date information to patients and physicians about this ongoing public health matter.”

The company’s deficiencies, described in a complaint filed with the U.S. District Court of New Jersey, may compromise the safety and effectiveness of the devices. Shelhigh’s own records indicate a number of sterility test failures and that its testing and retesting procedures were not properly performed.

Shelhigh devices are used in infants, children and adults. The products include pediatric heart valves, tube-like devices for blood flow (conduits), surgical patches, dural patches to aid in tissue recovery after neurosurgery, annuloplasty rings to help repair heart valves, and arterial grafts.

Adverse reactions or quality problems experienced with the use of these products may be reported to FDA’s MedWatch Adverse Event Reporting program either online (www.fda.gov/medwatch/report.htm), fax (800-332-0178), or regular mail (use postage-paid FDA form 3500 available at www.fda.gov/MedWatch/getforms.htm and mail to MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787).

May 2, 2007 — /PRNewswire/ — WEST CHESTER, PA — VWR International, Inc., a portfolio company of Clayton, Dubilier & Rice, Inc. (CD&R) and a leader in the global laboratory supply industry, today announced that CDRV Investors, Inc., its parent company, has entered into a definitive agreement that will result in VWR being acquired by Madison Dearborn Partners (MDP). The transaction is expected to be completed during the third quarter of 2007, subject to customary closing conditions. Terms of the transaction were not disclosed.

This announcement follows a period of significant growth and profitability for VWR, driven by strategic initiatives designed to make VWR the supplier of choice in the $27 billion global laboratory supply industry. With 2006 revenue of over $3.2 billion, VWR is the second largest distributor in the industry and has a global base of customers in pharmaceuticals, biotechnology, education, and industry.

“This transaction is clear recognition of our achievements over the past three years,” said VWR president and chief executive officer, John Ballbach. “Together with the team from CD&R, we have put together a very talented management team, restructured our operations to more efficiently serve customers, made significant debt repayments and launched our business in Asia. We are very appreciative of our employees’ efforts, as well as the loyalty of our customers, which have together made VWR the market leader it is today. We look forward to continuing to execute our strategy together with Madison Dearborn Partners and to maintaining our position as a market leader.”

Madison Dearborn Partners is one of the most successful private equity investors in the U.S. Since its formation in 1993, MDP funds have closed over 100 transactions in the U.S. and Europe. Tim Sullivan, a managing director for MDP, said, “We believe VWR is the premier distributor to the global laboratory supply industry. The company’s outstanding management team, superior distribution capabilities and excellent vendor and customer relationships are keys to its success. We are excited about the company’s leadership and opportunity for continued growth.”

Richard J. Schnall, a VWR director and partner at Clayton, Dubilier & Rice, which acquired VWR from Merck KGaA in April of 2004, said, “We are extremely proud of the management team and of the performance gains achieved by the business over the period of our ownership. VWR is a great company and is positioned to continue to grow and prosper in the future.”

VWR announced on March 12, 2007, that it was exploring strategic options for the Company.

About VWR International, Inc.
VWR International is a leader in the global research laboratory industry with worldwide sales in excess of $3 billion US dollars. VWR’s business is highly diversified across products and services, geographic regions and customer segments. The company offers products from a wide range of manufacturers, to a large number of customers primarily in North America, Europe, and other locations. VWR’s principal customers are major pharmaceutical, biotechnology, chemical, technology, clinical, food processing and consumer product companies, universities and research institutes, governmental agencies, environmental testing organizations, and primary and secondary schools. VWR distributes a diversified product mix, including chemicals, glassware and plasticware, equipment and instruments, furniture, protective apparel, production and safety products, and other life science and laboratory products and supplies. VWR supports its customers by providing storeroom management, product procurement, supply chain systems integration, technical services and laboratory bench top delivery. VWR maintains operations in over 20 countries and employs over 6,000 people worldwide. VWR International is headquartered in West Chester, PA.

VWR and design are registered trademarks of VWR International, Inc.

About Madison Dearborn Partners, LLC
Madison Dearborn Partners, based in Chicago, is one of the most experienced and successful private equity investment firms in the United States. MDP has more than $14 billion of equity capital under management and makes new investments through its most recent fund, Madison Dearborn Capital Partners V, a $6.5 billion investment fund raised in 2006. MDP focuses on management buyout transactions and other private equity investments across a broad spectrum of industries, including basic industries, communications, consumer, financial services, and health care. For more information, please visit the MDP web site at www.mdcp.com.

About Clayton, Dubilier & Rice, Inc.
Clayton, Dubilier & Rice, Inc. (CD&R) is a leading private equity investment firm that has earned consistent, superior investment returns using an integrated operational and financial approach to building and growing portfolio businesses. Since its founding in 1978, CD&R has managed investments of over $8 billion in 39 U.S. and European subsidiaries or divisions of large multi-business corporations with revenues exceeding $40 billion, representing an aggregate transaction value of over $40 billion. CD&R led a group of investors in the purchase of The Hertz Corporation from Ford Motor Company in December 2005. The firm’s investments have also included Kinko’s, which was sold to FedEx in February 2004; Culligan International, leading global provider of water treatment product and services; and Scotts, a leader in do- it-yourself lawn and garden consumer products. CD&R is based in New York and London. For more information about CD&R, visit www.cdr-inc.com.

Source: VWR International, Inc.

Contact:
Alan Oshiki of Broadgate Consultants, LLC
+1-212-232-2354
[email protected], for VWR International, Inc.