FDA Update

Consumer Inquiries: 888-INFO-FDA

April 22, 2007 — /FDA News/ — The U.S. Food and Drug Administration (FDA) is investigating an imported shipment of rice protein concentrate which has been found to contain melamine.

The rice protein concentrate may have been used as an ingredient in some pet foods. FDA’s investigation of the rice protein is being carried out by specialists in FDA headquarters and in eight FDA district offices. Thus far, the following has been established:

• The suspect shipment of rice protein concentrate was imported and offloaded during the week of April 2, 2007, by Wilbur-Ellis, an importer and distributor of agricultural products, including rice protein concentrate, with headquarters in San Francisco, CA. The source of the product is identified as Binzhou Futian Biological Technology in China.
• The shipment consisted primarily of rice protein concentrate in white bags, but also included one pink bag that was labeled, in part, with the word “melamine.”
• On April 15, Wilbur-Ellis notified FDA’s Center for Veterinary Medicine about the suspect shipment. On April 16, FDA launched a nationwide investigation tracing eight import entries identified as being shipped from the Chinese firm since July 2006. FDA testing revealed melamine in both the white and pink bags.
• Wilbur-Ellis has initiated a recall of all suspect rice protein concentrate it had imported and distributed; see http://www.fda.gov/oc/po/firmrecalls/wilburellis04_07.html.
• As a result of notification by Wilbur-Ellis, Royal Canin USA and C.J. Foods voluntarily recalled certain products; see http://www.fda.gov/oc/po/firmrecalls/royalcanin04_07.html and http://www.fda.gov/oc/po/firmrecalls/bluebuffalo04_07.html.

FDA investigators have obtained records showing distribution to five pet food manufacturers in seven locations. Investigators are currently inspecting all five manufacturers and collecting additional samples, as appropriate.

FDA has confirmed the presence of melamine in finished pet food products containing rice protein concentrate. Those products, and others within the same product line, are currently under recall by Natural Balance Pet Foods and are labeled as: Venison and Brown Rice canned and bagged dog foods; Venison and Brown Rice dog treats; and Venison and Green Pea dry cat food; see http://www.fda.gov/oc/po/firmrecalls/naturalbalance04_07.html.

If FDA’s investigation determines that additional pet food products have been manufactured from the suspect rice protein concentrate, FDA will expect manufacturers to initiate voluntary actions to remove these products from the marketplace. FDA will continue to communicate its findings promptly.

In a related development, the California Department of Food and Agriculture (CDFA) issued a press release on April 19, 2007, stating that CDFA laboratory testing had detected melamine in urine from hogs at the American Hog Farm in Ceres, CA. For further information, see
http://www.cdfa.ca.gov/exec/pa/pressreleases/PressRelease.asp?PRnum=CDFA07-038.

Due to the involvement of animal feed, FDA is working with CDFA on this development.

FDA continues to work comprehensively to protect the nation’s pet food as well as to conduct a full investigation to determine any impact on the human food supply. The agency is now sampling all rice protein concentrate from China and continues to sample all wheat gluten imported from China, and it is ready to increase its surveillance of other products, if necessary. To search for the latest list of recalled products, which will be updated when new information is received, please see http://www.accessdata.fda.gov/scripts/petfoodrecall/.

FDA News

Consumer Inquiries: 888-INFO-FDA

April 23, 2007 — /FDA News/ — U.S. Food and Drug Administration (FDA) investigators and U.S. Marshals on April 17 seized all implantable medical devices from Shelhigh, Inc., Union, NJ, after finding significant deficiencies in the company’s manufacturing processes. The deficiencies may compromise the safety and effectiveness of the products, particularly their sterility.

The products include pediatric heart valves and conduits (tube-like devices for blood flow), surgical patches, dural patches (to aid in tissue recovery after neurosurgery), annuloplasty rings (to help repair heart valves) and arterial grafts. The tissue-based devices are used in many surgical settings, including open heart surgery in adults, children and infants, and to repair soft tissue during neurosurgery and abdominal, pelvic and thoracic surgery. Critically ill patients, pediatric patients, and immuno-compromised patients may be at greatest risk from the use of these devices.

All medical device companies must follow current good manufacturing practice, a set of requirements that help to ensure the safety and effectiveness of all medical products. Shelhigh’s violations include: manufacturing products in a facility with a poorly constructed and poorly maintained cleanroom where sterilized devices are further processed; failing to adequately monitor critical manufacturing environments for possible microbial contamination; failing to properly test products for sterility and fever-causing contaminants; and failing to scientifically support product expiration dates.

Physicians should consider using alternative devices. Physicians should also monitor patients with a Shelhigh implant for infections and proper device functioning over the expected lifetime of the device. Patients who think they may have received a Shelhigh device during surgery should contact their physician for more information. FDA will issue a Preliminary Public Health Notification to physicians and other health care professionals and a Preliminary Advice for Patients shortly with more information; those documents will be posted to FDA’s web site.

The seizure follows an FDA inspection of the Shelhigh manufacturing facility last fall, as well as meetings with the company at which FDA warned Shelhigh that failure to correct its violations could result in an enforcement action.

FDA also alerted the company to its manufacturing deficiencies and other violations in two warning letters. Medical devices manufactured by Shelhigh include:

• Shelhigh Pericardial Patch
• Shelhigh No-React Pericardial Patch
• Shelhigh No-React PneumoPledgets
• Shelhigh No-React VascuPatch
• Shelhigh No-React Tissue Repair Patch/UroPatch
• Shelhigh Pulmonic Valve Conduit No-React Treated
• Shelhigh No-React Dura Shield
• Shelhigh BioRing (annuloplasty ring)
• Shelhigh No-React EnCuff Patch
• Shelhigh No-React Stentless Valve Conduit
• Shelhigh Internal Mammary Artery
• Shelhigh Gold perforated patches
• Shelhigh Pre Curved Aortic Patch (Open)
• Shelhigh NR2000 SemiStented aortic tricuspid valve
• Shelhigh BioConduit stentless valve
• Shelhigh NR900A tricuspid valve
• Shelhigh MitroFast Mitral Valve Repair System
• Shelhigh BioMitral tricuspid valve
• Shelhigh Injectable Pulmonic Valve System

April 24, 2007 — CARY, NC — 3Dsolve, The Simulation Learning Company, is proud to announce the addition of Dr. Carmen M. Wagner to its advisory board. Wagner, the founder and president of Strategic Compliance International, will provide guidance to 3Dsolve as it develops multiuser, high-fidelity e-learning software for pharmaceutical companies worldwide. 3Dsolve’s aseptic training simulations are designed to run on a standard laptop, making it possible for trainees to practice cleanroom processing techniques at any time regardless of location.

3Dsolve selected Wagner to aid in the creation of learning simulations for pharmaceutical employees due to her extensive experience in the development of technical training that support regulatory compliance. The 3D simulations of real-world sterile facilities, equipment and processes will provide a safe place for pharmaceutical industry workers to practice reactions and decision-making in a variety of situations. 3Dsolve’s training applications for the aseptic environment will address topics such as basic microbiology, hygiene, gowning, handling of equipment and specific procedures covering the aseptic processing area and other operations requiring intensive practical training. The first simulation, which is designed to improve the overall process of aseptic cleanroom training, will be made globally available to pharmaceutical production personnel for a small annual subscription fee.

“In addition to saving companies the expense of maintaining dedicated cleanrooms for training, 3Dsolve’s learning simulations will give trainees a safe place to learn without taking risks with real facilities or products,” Wagner said. “The level of detail and intelligence built into the cleanroom simulations is unprecedented and represents a significant innovation in training for aseptic processing. Although, not a substitute for the ‘real’ facility exposure, it sure enhances our ability to expand the learning experience in a safe, cost-effective way.”

The very nature of cleanrooms and pharmaceutical manufacturing makes training difficult. Given the potential cost resulting from an interruption of operations due to a simple mistake, training in aseptic procedures within the cleanroom itself, with an actual operation running, is very difficult. Students are often expected to train as observers and then imitate the aseptic techniques they have seen when approved to perform the tasks. In practical terms, this is equivalent to having a student pilot observe a seasoned aviator and then go solo without ever having taken the controls.

3Dsolve’s aseptic cleanroom training simulations will apply best-of-class instructional design and state of the art simulation technologies to solve the mission-critical problem of training pharmaceutical industry workers in proper aseptic techniques for cleanroom operations. Using standard personal computers, operators will be able to complete several hours in the simulated environment, honing and internalizing critical skills, either prior to interacting with the actual processing line, or in parallel with the “real life” experience, which may make them more comfortable to experiment and learn, helping eliminate the risks of human error posed by new employees. By using this simulation learning technology, trainees can gain hands-on experience regardless of where they choose to access the program. This allows for training to be executed in the field or in the comfort of one’s home.

About Carmen Wagner
Dr. Carmen M. Wagner has over 25 years of experience in the health industry and is founder and president of Strategic Compliance International, Inc (SCI). Wagner is broadly experienced in research, technical operations, quality assurance, and regulatory affairs having held positions of increasing responsibility in numerous Fortune 100 companies. Her corporate management experience includes tenure at E.I. DuPont; Johnson & Johnson; American Cyanamid/Lederle-Praxis (now Wyeth Vaccines); Serentec, Inc.; and MERIX Bioscience (now Argos Pharmaceuticals), where she held the position of vice president of quality and technical affairs. Visit SCI on the web at http://www.sci-nc.com.

About 3Dsolve
3Dsolve, The Simulation Learning Company, creates collaborative simulation learning solutions for government, military, and corporate applications, a market estimated to reach $37 billion by 2011. 3Dsolve’s simulation learning products use realistic, interactive 3D graphics, based upon industry standards, enabling users to learn by doing. In each of the last four years, 3Dsolve has been named as one of Military Training Technology magazine’s Top 100, the “companies that have made a significant impact in the military training industry,” with special awards for innovation in 2004, innovation and rising status in 2005 and innovation once again in 2006. 3Dsolve’s headquarters are in Cary, North Carolina, near world-renowned Research Triangle Park. Visit 3Dsolve on the web at http://www.3dsolve.com.

Contact:
Dana Cowley
ClearImage (for 3Dsolve)
[email protected]
919-863-2393 x217

‘The risk to Hoss’s customers is low,’ says PA Dept of Health

April 20, 2007 — /PRNewswire/ — CLAYSBURG, PA — HFX Corp. announced today that the company has issued a voluntary recall for 259,230 pounds of beef products due to a possible contamination with E. coli 0157 bacteria. The United States Department of Agriculture announced the recall late Friday.

“Late Thursday, we learned that there had been a positive test for the bacteria in Eastern Pennsylvania,” said John H. Brown, president of HFX Corp., a meat processing plant located in Claysburg, PA. “As soon as we learned of the positive test, we immediately began recalling the affected products and are well on our way to seeing that all of it is removed from the consumer pipeline. For example, all beef being recalled has already been removed from our Hoss’s Steak and Sea House restaurants.”

HFX began aggressively recalling the beef products immediately after learning of the single positive test because, according to Brown, “the well being of our customers is our number one priority. Although the recall was voluntary, the USDA facilitated the recall’s speed by sharing their expertise and working in close cooperation with us. We also worked closely and productively with the Pennsylvania Department of Health.”

According to the Pennsylvania State Department of Health, five cases of E. coli 0157:H7 were diagnosed in York, Dauphin, Centre, and Venango counties in late March. None of the patients are hospitalized and all have recovered.

“Because the number of cases is small and the exposure period was several weeks ago, the health department believes the risk to Hoss’s customers is low,” said an official Pennsylvania Department of Health press release issued late today. Although HFX is affiliated with the Hoss’s restaurant chain, the facility also processes beef for a large variety of wholesale and restaurant customers.

In addition to the recall efforts, HFX is conducting a review of its food safety programs and has eliminated the use of three meat industry tenderizing processes: blade tenderization, vacuum marination, and marinade injection. “Although these processes are widely used in the meat processing industry, we felt that they contain some level of risk, so we are discontinuing use of the processes,” said Brown. “The health of our customers and consumer confidence in our products is too important to take any chances, even if the risk is small.”

United States Department of Agriculture release and recall lot numbers:
http://www.fsis.usda.gov/PDF/Recall_019_2007_Release.pdf

Source: HFX Corp.

Contact:
Bridget Bingham for HFX Corp., 814-693-3421
[email protected]

FDA News

Consumer Inquiries: 888-INFO-FDA

April 20, 2007 — /FDA News/ — The U.S. Food and Drug Administration (FDA) today announced that Worldwide Fish & Seafood, Inc., Minneapolis, MN, (doing business as Coastal Seafood) a seafood processor and three of its officers have entered into a consent decree of permanent injunction due to violations of the Federal Food, Drug and Cosmetic Act.

The consent decree requires the company to come into compliance with the act by developing and implementing adequate Hazard Analysis and Critical Control Point (HACCP) plans.

The seafood HACCP regulations require that all seafood processors develop and implement adequate HACCP plans that identify all food safety hazards that are likely to occur for each kind of seafood product, and contain preventative measures that the processor can implement to control those hazards.

Over six years, seven FDA inspections revealed that the defendants’ HACCP plans were not adequate to prevent conditions that could pose a potential public health risk. In particular, the defendants’ HACCP violations related to their failure to ensure that their seafood products were transported and continuously stored at adequate refrigeration temperatures to prevent bacteria growth and pathogen development.

The defendants agreed to come into compliance with the act and its implementing regulations by, among other requirements: obtaining an expert consultant to evaluate the HACCP plans for all of the defendants’ products and the defendants’ implementation of the plans; and submitting to FDA inspection to ensure that the HACCP plans are being adequately implemented.

The defendants have already received FDA approval of the HACCP plans prepared by their expert and currently in use.

The decree allows FDA to order a shutdown, recall, or other corrective action in the event of future violations, and requires the defendants to pay the costs of inspections performed pursuant to the decree. The decree was entered by Judge Joan Erickson of the U.S. District Court for the District of Minnesota on April 18, 2007.

Rice protein concentrate from China tainted with melamine derivative prompts recall announcement

**COMPANY RELEASE**

April 20, 2007 — /PRNewswire/ — ST CHARLES, MO — Royal Canin USA is announcing today that the company has determined there is a melamine derivative in the rice protein concentrate in some of its dry pet food products.

Although Royal Canin USA has no confirmed cases of illness in pets, we have decided to voluntarily remove all of our dry pet food products containing rice protein concentrate. We are taking this proactive stance to avoid any confusion for our customers about which Royal Canin USA products are safe and which products may be affected.

“We are as passionate about the health and happiness of our customers’ pets as we are of our own, so we are committed to taking the steps necessary to ensure this never happens again,” said Olivier Amice, President and CEO of Royal Canin USA.

As a precaution, Royal Canin USA is voluntarily recalling the following dry pet food products:
ROYAL CANIN VETERINARY DIET^TM (available only in veterinary clinics)
Dry Dog Food

• Canine Early Cardiac EC 22^TM
• Canine Skin Support SS21^TM

Dry Cat Food

• Feline Hypoallergenic HP23^TM

ROYAL CANIN SENSIBLE CHOICE^® (available in pet specialty stores nationwide)
Dry Dog Food

• Chicken Meal & Rice Formula Senior
• Lamb Meal & Rice Formula Puppy
• Lamb Meal & Rice Formula Adult
• Lamb Meal & Rice Formula Senior
• Rice & Catfish Meal Formula Adult

Based on today’s announcement, pet owners should immediately stop feeding their pets the Royal Canin USA dry pet food products listed. Pet owners should consult with a veterinarian if they are concerned about the health of their pet. No other Royal Canin diets are affected by this recall and CONTINUE TO BE safe for pets to eat.

Along with this announcement, Royal Canin USA will no longer use any Chinese suppliers for any of our vegetable proteins.

“On behalf of the entire Royal Canin family, our hearts go out to the pet owners and everyone in the pet community who have been affected by all of the recent recalls,” said Dr. Denise Elliott, Director of Scientific Affairs for Royal Canin USA. “We are working very closely with the FDA to assist in its efforts to determine the cause of this most recent and disturbing development.”

The safety and nutritional quality of our pet food is Royal Canin USA’s top priority as we understand that the health of pets comes first. Pet owners who have questions about this recall and other Royal Canin USA products should call 1-800-592-6687 or visit our web site at www.royalcanin.us.

All Royal Canin USA products have a satisfaction guarantee and we will refund or replace the diets that have been recalled.

Source: Royal Canin USA

Contact:
Erik Mueller for Royal Canin USA
636-926-1089
Web site: http://www.royalcanin.us/

Discussion will cover a real world example of a PAT Solution Using Proficy^TM RX

April 20, 2007 — CHARLOTTESVILLE, VA — GE Fanuc Automation, a unit of GE Industrial, today announced that Bart Reitter, GE Fanuc global industry manager, life sciences, would be speaking at INTERPHEX 2007, being held at the Jacob Javits Convention Center in New York City, April 24-26, 2007. Reitter’s presentation will discuss “PAT: A Real World Successful Drying Application.” The session will take place on Wednesday, April 25 from 9:00 to 10:00 a.m.

This session will be a discussion of a successful deployment of GE Fanuc’s PAT Solution deployed to deliver measurable results to a contract manufacturer of bulk active pharmaceuticals and advanced intermediates. Outcome of the project includes enhanced visibility into the drying process and a dramatic reduction in product drying time.

Reitter will be sharing the podium with GE Fanuc customer John Iapichino, instrument and controls engineer for AMRI/Organichem Corporation, who is using GE Fanuc’s Proficy^TM RX, PAT software solution.

“As PAT deployments grow,” said Reitter, “so do the number of instruments and software applications. The quantity and type of data also grows significantly. It is imperative that organizations have a robust data infrastructure to support those deployments. Consideration needs to be given not only to spectral data acquired from the instrument, but also to process, batch, alarm and event data as well. With the goal of PAT being a comprehensive understanding of the process, it is important to build out a data infrastructure that can acquire, store and analyze all of that disparate data.”

GE Fanuc is a leader in providing manufacturing solutions to the life sciences industry. The company’s PAT offering, comprised of Proficy^TM RX, Proficy^TM Historian, Proficy^TM HMI/SCADA iFIX and Proficy^TM Real Time Information Portal is a unique software solution that provides standardized control and networking of multiple instruments, preprocessing of analytical data ensuring similar data formats and protocols, robust storage of process, spectral, batch, alarm and event data, operator interface capability and reporting and analysis tools.

GE Fanuc will be exhibiting at INTERPHEX 2007 in Booth 2300.

About INTERPHEX 2007
INTERPHEX 2007 is the world’s largest and most comprehensive pharmaceutical conference and exhibition. It is presented by Reed Exhibitions and sponsored by ISPE, the international society for pharmaceutical engineering, and Pharmaceutical Processing magazine. The application-oriented INTERPHEX 2007 conference program will offer more than 100 separate educational sessions to help
pharmaceutical and biotech professionals develop critical skills to increase on-the-job performance. Approximately 1000 leading global companies serving pharmaceutical and biotechnical industries will showcase the latest lines of equipment, technologies and services.

About GE Fanuc Automation
GE Fanuc Automation Corporation, a joint venture between GE and FANUC LTD of Japan, delivers automation hardware and software designed to help users reduce costs, increase efficiency and enhance profitability. With solutions and services for virtually every industrial segment, GE Fanuc Automation provides a diverse array of capabilities and products, including controllers, embedded systems, advanced software, motion control, CNCs, operator interfaces, industrial computers, and lasers. Headquartered in Charlottesville, VA, GE Fanuc Automation is a part of GE Industrial and combines the diverse global strengths of the GE family with the local presence customers need to design, develop and maintain their automation investments.

For more information, visit www.gefanuc.com or contact: GE Fanuc Information Center
P.O. Box 8106
Charlottesville, VA 22906
800-GE-FANUC (800-433-2682)
Fax: 434-978-5205
e-mail: [email protected].

April 18, 2007 — HOUSTON and DALLAS, TX — Air Liquide Electronics U.S. LP was presented with the Texas Instruments (TI) 2006 Supplier Excellence Award in recognition of Air Liquide Electronics’ bulk gas operations services for TI over the past calendar year. Air Liquide Electronics U.S. LP president Rich Jahr accepted the award, presented by TI executives Kevin Ritchie, Shaunna Black, and Rob Simpson, at an April 17 ceremony held at Air Liquide’s bulk gas plant on TI’s Dallas campus.

Addressing Air Liquide and Texas Instruments employees present at the event, Jahr said, “We have been a proud supplier of Texas Instruments for more than 40 years. To be recognized for our continued advancements and innovations in the products, services and expertise that we provide to a remarkable company like TI is a tremendous honor and pleasure. I’m extremely proud of and thankful to the people at both of our companies who have set such high marks for talent and productivity.”

Air Liquide has been a supplier to TI since the 1960s and, today, Air Liquide Electronics provides the company with a wide array of value-driven services and expertise, including industrial and specialty gases and Total Gas and Chemical Management (TGCM) as well as state-of-the-industry laboratory and analytical services. The success of Air Liquide Electronics’ relationship with TI has been a cornerstone for developing highly beneficial working partnerships with semiconductor customers throughout the U.S. and around the world.

In recognition of Air Liquide Electronics’ contribution to TI’s business, senior vice president Kevin Ritchie commented, “TI depends on the innovation and expertise of our suppliers to help us achieve and maintain high levels of technology and productivity. We have come to rely on Air Liquide to deliver valuable products and management services, and we appreciate their outstanding support and efforts.” TI vice president Rob Simpson added, “When we work with Air Liquide, we know we’ll get quality performance, competitive pricing, and a partner that is mutually interested in our success.”

TI’s Supplier Excellence Awards were established in 1984 and are presented annually to suppliers who exemplify the highest level of excellence and emphasize continuous improvement efforts to set higher goals and achieve greater customer results. It is TI’s highest honor for its suppliers.

Air Liquide Electronics U.S. LP is the Dallas, Texas based subsidiary of American Air Liquide Holdings, Inc. responsible for serving the semiconductor industry in the U.S. It serves the semiconductor industry in the U.S. by providing ultra pure gases, liquids, and advanced molecules used in the fabrication of silicon chips, as well as providing specialized equipment and related gas and chemical management services. Through its Balazs Analytical Services division, Air Liquide Electronics also provides state-of-the art analytical and laboratory services. American Air Liquide Holdings, Inc. is the U.S. subsidiary of Air Liquide Group responsible for its U.S. operations.

Present in 72 countries, Air Liquide is a world leader in industrial and medical gases and related services. The Group offers innovative solutions based on constantly enhanced technologies. These solutions, which are consistent with Air Liquide’s commitment to sustainable development, help to protect life and enable our customers to manufacture many indispensable everyday products. Founded in 1902, Air Liquide has more than 36,000 employees. The Group has successfully developed a long-term relationship with its shareholders built on trust and transparency and guided by the principles of corporate governance. Since the publication of its first consolidated financial statements in 1971, Air Liquide has posted strong and steady earnings growth. Revenues in 2006 totalled 10,949 million euros, with sales outside France accounting for almost 80%. Air Liquide is listed on the Paris stock exchange and is a component of the CAC 40 and Eurostoxx 50 indices (ISIN code FR 0000120073).

Contacts:
Air Liquide USA LLC Corporate Communications
Diane Labelle, 713-624-8082
Michael Rosen, 713-624-8023
www.airliquide.com

Mobius^TM MIX200 Disposable Mixing System reduces risk and speeds time-to-market for biopharmaceutical manufacturers

April 19, 2007 — BILLERICA, MA — Millipore Corporation, a leading provider of products and services that improve productivity and results in biopharmaceutical manufacturing and in clinical, analytical and research laboratories, today announced it is launching a new disposable mixer designed to help companies mix pharmaceutical ingredients and prepare cell culture media. The Mobius^TM MIX200 Disposable Mixing System will be introduced at the upcoming INTERPHEX 2007 Conference, which is being held April 24-26, 2007, at the Jacob K. Javits Convention Center in New York.

The Mobius^TM MIX200 Disposable Mixing System is a modular mixing solution that enables companies to improve their flexibility and reduce their downtime and contamination risk by using disposable rather than stainless steel components. It combines Millipore’s substantial engineering knowledge and biopharmaceutical expertise with products from the company’s recent acquisitions of NovAseptic and Newport Bio Systems.

“Over the past two years, we have significantly expanded our portfolio of disposable products and the Mobius MIX200 Disposable Mixing System is a great example of how we have expanded our capabilities to bring new innovations and increased value to our customers,” said Jean-Paul Mangeolle, President of Millipore’s Bioprocess Division. “Our ability to provide integrated disposable solutions makes us a critical partner as biopharmaceutical companies seek to implement their disposable manufacturing strategies. With our expanded footprint, we can help our customers reduce their risk, increase their speed, and gain an edge in the marketplace.”

Biopharmaceutical companies are increasingly seeking to replace stainless steel hardware with disposable plastic products. These disposable products eliminate the need for cleaning validation and shorten cycle times between processing runs. Millipore’s Mobius^TM suite of disposable technologies includes filtration products, process containers, mixers, connectors, and valves. In addition to these products, Millipore offers design, validation, and support services required to integrate and deliver a complete disposable solution.

Unlike some disposable mixers that can take as long as 45 minutes to warm up, the Mobius^TM MIX200 disposable mixing system requires no warm up time and significantly increases the speed that biopharmaceutical customers mix their products and prepare cell culture media. It provides mixing efficiency in a contained system, saving valuable process and validation time. The Mobius MIX200 system includes a 200 liter carrier, a single-use magnetically driven impeller inside a disposable Mobius process container made of PureFlex^TM film, and an electronic drive unit. The MIX200 mixer is the first in a series of mixers Millipore will be introducing. It will be followed by 100L and 500L versions.

Additional benefits of the MIX200 mixing system include:

• Reduced downtime for cleaning validation and process engineering
• Validation, quality, and regulatory compliance support
• Disposable technology for increased production capacity in multi-product facilities
• Easy set up and use
• Small footprint and mobile carrier construction for enhanced flexibility

Millipore’s Bioprocess Division delivers integrated solutions and services for every application, every step and every scale of the drug development and manufacturing process. With more than 50 years of experience, Millipore provides the world’s leading biotechnology and pharmaceutical companies with resources designed to improve yields, process economics and speed to market. For more information, visit www.millipore.com/bioprocess.

About Millipore
Millipore is a leading provider of products and services that improve productivity and results in biopharmaceutical manufacturing and in clinical, analytical and research laboratories. The Company is organized in two operating divisions. Its Bioprocess Division helps pharmaceutical and biotechnology companies to optimize their manufacturing productivity, ensure the quality of drugs, and scale up the production of difficult-to-manufacture biologics. Its Bioscience Division helps optimize laboratory productivity and workflows by providing reagents, kits and other enabling technologies and products for life science research and development. Millipore has a deep understanding of its customers’ research and manufacturing process needs, and offers reliable and innovative tools, technologies and services. The Company is part of the S&P 500 Index and employs approximately 5,800 employees worldwide. For additional information on Millipore Corporation, please visit its website at: www.millipore.com.

Contacts:
Joshua Young
Director, Investor Relations
Millipore Corporation
978-715-1527
800-225-3384
[email protected]
Lynn Garvin
Vice President, Corporate Communications
Millipore Corporation
978-715-1043
[email protected]