Tag Archives: Clean Rooms

July 16, 2007 — SAN FRANCISCO, CA — One year after shifting the objective of its lithography program to the 32 nm half-pitch node, IMEC reports progress on high-index 193 nm immersion lithography, double-patterning schemes for 193 nm water-based immersion lithography and extreme UV (EUV) lithography.

“Over the last year, we’ve made significant progress in the three litho approaches we are investigating within our advanced lithography program. Driven by the needs to quickly develop 32 nm processes for memory applications and based on the promising results, we are quite confident that double patterning will be taken up as an intermediate solution for 32 nm half-pitch before a single exposure solution is ready for production,” says Luc Van den hove, executive vice president and COO at IMEC.

High-index 193 nm immersion lithography
IMEC and ASML will extend their strategic partnership on immersion lithography with the installation of ASML’s XT:1900i (1.35 NA [numerical aperture]) at IMEC’s 300 mm cleanroom in 2008. Currently, IMEC’s immersion lithography research is carried out on ASML’s XT:1700i (1.2 NA). The ultimate target of high-index immersion lithography is to drive the NA up to 1.55 to 1.60, which will enable to extend 193 nm immersion lithography to the 32 nm half-pitch node. In the field of high-index fluids, several fluids have been investigated and at least one fluid seems to meet most criteria in terms of lithographic and interaction properties.

Double patterning schemes for 193 nm water-based immersion lithography After very early feasibility demonstration of 32 nm half-pitch patterning using double patterning, IMEC currently investigates critical challenges such as mask design split, more cost-effective processes, and critical dimension (CD) and overlay control. IMEC researches double patterning as an intermediate solution for 32 nm before a single exposure alternative is ready for production.

Using an in-house developed accurate CDU model, IMEC has demonstrated the potential capability to achieve sub-3nm CDU, which is the requirement for 32 nm half-pitch CD control. Using this model, simulations have shown that a more uniform wafer CD distribution can be obtained by minimizing the mean difference between the CD populations, by compensating for intra-field CD variation and by optimizing the etch variation across the wafer.

IMEC also researches techniques to split full chip designs in an automated way, which will be required when the double patterning technique is to be used in a production environment. To this end, design split rules need to be developed that lead to an optimum cutting and stitching strategy, where a tradeoff needs to be found between scripting complexity and design regularity. IMEC is currently running a systematic investigation of the constraints to ensure designs to be split-compliant. Work is done in collaboration with leading EDA vendors that develop the software.

IMEC also develops cost-effective process flows for double patterning. A resist freezing process in which the intermediate etch step is skipped by treating the first litho pattern such that the second resist layer can be coated and patterned on top of it, shows promising results. More and more samples developed by various resist suppliers are coming available and are then tested for feasibility and readiness at IMEC.

Extreme UV
EUV lithography is the third lithography option being explored at IMEC for the 32 nm half-pitch. This is the only lithography option with a clear extendibility toward 22 nm and possibly beyond. IMEC entered the last phase in the integration of the ASML alpha demo tool with Sn source. The optics are currently being fine-tuned for high-resolution imaging and acceptance testing. IMEC’s research program has so far been focusing on (i) interference exposures at the Paul Scherrer Institute in Switzerland for resist preparation, (ii) design and reticle tape-out as well as on (iii) EUV simulations to prepare all the projects.

Besides these three different approaches, more and more effort is also spent to identify the limitations of today’s chemically amplified resists in pushing them down to 30 nm feature sizes and below, with good line-edge roughness and high sensitivity. Alternative resist chemistries are being tested to overcome these limitations.

About IMEC
IMEC is a world-leading independent research center in nanoelectronics and nanotechnology. Its research focuses on the next generations of chips and systems, and on the enabling technologies for ambient intelligence. IMEC’s research bridges the gap between fundamental research at universities and technology development in industry. Its unique balance of processing and system know-how, intellectual property portfolio, state-of-the-art infrastructure and its strong network of companies, universities, and research institutes worldwide position IMEC as a key partner for shaping technologies for future systems.

IMEC is headquartered in Leuven, Belgium, has a sister company in the Netherlands, IMEC Nederland, concentrating on wireless autonomous transducer solutions, and has representatives in the U.S., China, and Japan. Its staff of more than 1,500 people includes more than 500 industrial residents and guest researchers. In 2006, its revenue (P&L) was EUR 227 million. Further information on IMEC can be found at www.imec.be.

Contacts:
Katrien Marent, IMEC Corporate Communications
Tel: +32-16-28-18-80
E-mail: [email protected]

Barbara Kalkis, Maestro Marketing & PR
Tel: 408-996-9975
E-mail: [email protected]

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.

July 10, 2007 — /FDA News/ — Robert’s American Gourmet Food, Inc. of Sea Cliff, NY, is expanding its snack recall to include Super Veggie Tings Crunchy Corn Sticks Snack Food, all lots and sizes, because it has the potential to be contaminated with salmonella, an organism which 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.

Super Veggie Tings Crunchy Corn Sticks were distributed nationwide and in Canada, and sold through local distributors, Internet sales, phone orders, mail orders, and retail outlets.

Super Veggie Tings Crunchy Corn Sticks are packed in a flexible, plastic foil bag in a 6 oz. size, and has UPC 15665-10356. The brand name is Robert’s American Gourmet and all codes and expiration dates of Super Veggie Tings Crunchy Corn Sticks are being recalled.

Veggie Booty has been associated or related with approximately 54 cases of salmonella across 17 states. Roberts American Gourmet has decided to add Super Veggie Tings Crunchy Corn Sticks to the recall as a precautionary measure. The extensive investigation at the contract manufacturer and by the company is ongoing to determine the source of the contamination. The company has ceased production and distribution of both products pending results of the investigation by the FDA and the company.

Consumers who purchased Super Veggie Tings Crunchy Corn Sticks and still have product in their homes should discard the contents of the package Super Veggie Tings and contact Robert’s American Gourmet at 1-800-626-7557 for reimbursement. Anyone with any questions pertaining to the situation may also contact us at 800-626-7557.

Next-generation cryo sample prep tool offers automation and ease of use

July 12, 2007 — /PRNewswire-FirstCall/ — HILLSBORO, OR — FEI has introduced the next generation of its popular Vitrobot(TM) cryo sample preparation tool, the Vitrobot Mark IV. The Mark IV is an easy-to-use system that features a newly designed touchscreen user interface operated under a Linux operating system and robotics that ensures high-quality, reproducible freezing of samples. Automated transfer from the vitrification medium into the liquid nitrogen atmosphere offers more consistent and higher yield sample throughput.

Three-dimensional transmission electron microscopy (TEM) visualization of macromolecular structures and molecular machines in their native hydrated state has become a critical tool for structural biologists focusing on interactive biological and biochemical processes at the macromolecular level. The Vitrobot is a high-throughput tool designed to enable the physical fixation of biological structures within ultra-thin vitrified ice layers so samples can withstand the high voltages used in TEMs long enough to acquire the necessary image.

Beyond biological applications, the Vitrobot Mark IV can also be used for pharmaceutical, food, and a variety of general industrial applications where colloidal structures need to be characterized and analyzed.

FEI will feature the Vitrobot Mark IV at the 26th Annual Meeting of the American Society for Virology, July 15-17, 2007 at Oregon State University in Corvallis, OR, and at the Microscopy and Microanalysis meeting August 6-9, 2007 in Fort Lauderdale, FL (Booth 414). More about the Vitrobot can be discovered at http://www.fei.com/vitrobot.

About FEI
FEI is a global leader in providing innovative instruments for nanoscale imaging, analysis, and prototyping. FEI focuses on delivering solutions that provide groundbreaking results and accelerate research, development, and manufacturing cycles for its customers in semiconductor and data storage, academic and industrial R&D, and life sciences markets. With R&D centers in North America and Europe, and sales and service operations in more than 50 countries around the world, FEI’s Tools for Nanotech(TM) are bringing the nanoscale within the grasp of leading researchers and manufacturers. More information can be found online at http://www.fei.com/.

Source: FEI

Contact:
Dan Zenka, APR, Global Public Relations of the FEI Company
Tel: 503-726-2695
E-mail: [email protected]

July 10, 2007 — /FDA News/ — The European Food Safety Authority (EFSA) and the U.S. Food and Drug Administration (FDA) signed the first U.S./European agreement in the area of assessing food safety risk on July 2. This is the first formal international cooperation agreement EFSA has signed and the first formal step in cooperation between the two bodies.

“I am delighted to be signing this agreement today with the FDA. Food safety knows no national boundaries and the food chain is today truly a global one,” said Catherine Geslain-Laneelle, EFSA’s executive director. “We need to work with the best scientific minds from across the world and extend scientific cooperation to assess food safety risks and protect consumers even more. Sharing data and knowledge across our two organizations is an important first step in achieving this goal.”

“As a science-based and science-led agency, FDA recognizes that scientific cooperation is vital for the success of its mission, which is to provide the best possible health protection for the public,” said Andrew C. von Eschenbach, MD, commissioner, Food and Drugs. “I welcome this opportunity for scientific exchanges with our European colleagues — exchanges that will be focused on ensuring the safety and wholesomeness of food, a major area of responsibility of our agency.”

The agreement is designed to facilitate the sharing of confidential scientific and other information between EFSA and the FDA, such as methodologies to ensure that food is safe. A formal agreement ensures appropriate protection of such confidential information under the applicable legal frameworks in both the United States and the European Union. Informal cooperation and dialog have already been established between the two bodies; this agreement will enable these to be formalized and extended.

For more information on the U.S. Food and Drug Administration, please see:
http://www.fda.gov/.

For more background information about the European Food Safety Authority, please
visit: http://www.efsa.europa.eu.

July 9, 2007 — /PRNewswire/ — AGAWAM, MA — A new, free white paper, detailing critical industrial sterilization and contamination control programs and compliance challenges in the pharmaceutical and medical device manufacturing industries, is now available for download at http://www.microtestlabs.com/environmentpaper.

One of the biggest challenges faced by medical device manufacturers is determining exactly what is required for compliance. For parenteral manufacturers, the environmental control parameters are highly stringent and pose significant compliance challenges.

In the white paper, titled “Environmental Testing & Monitoring: Deciphering Compliance Requirements for Pharmaceutical and Medical Device Manufacturers,” Microtest project manager Scott Mackin reviews key elements of a best practice environmental testing program, including sterilization standards, FDA compliance requirements, and vital factors in maintaining controlled environments.

At Microtest, Mackin has assisted a number of medical device manufacturers in designing, implementing, and maintaining both sterilization and environmental monitoring programs.

Microtest, a full service testing services and contract manufacturer, offers a complete range of onsite and remote monitoring programs for specialized environmental testing services. Microtest experts utilize cutting edge technology and processes to determine viable microbial and nonviable particulate levels of any area used for medical device and pharmaceutical cleanroom or manufacturing purposes.

Download the free white paper, “Environmental Testing & Monitoring: Deciphering Compliance Requirements for Pharmaceutical and Medical Device Manufacturers,” at: http://www.microtestlabs.com/environmentpaper. Or, for more information, visit Microtest on the Web at http://www.microtestlabs.com or call toll-free 1-800-631-1680.

About Microtest
Microtest is a leader in testing services and contract manufacturing for the medical device, pharmaceutical, and biotechnology industries. Based in Agawam, MA, the company’s expertise and flexible processes enhance product safety and security, accelerate time-to-market, and minimize supply chain disruption.

Source: Microtest

Contact:
Don Goncalves
Tel: 781-793-9380
E-mail: [email protected]

Brandie Gerrish
Tel: 781-793-9380
E-mail: [email protected], both of Tiziani Whitmyre, Inc. for Microtest

Media is manufactured in cleanroom conditions under GMP guidelines

July 9, 2007 — Biotest has announced the launch of heipha(TM) ready-prepared culture media in the North American market; for over 30 years heipha culture media has been distributed in Europe. The heipha line includes prepared media in petri dishes and contact plates, as well as liquid media in tubes, bottles and bags for fills. Furthermore, all agar media is manufactured under cleanroom conditions in accordance to GMP guidelines. Ken Troia, director of sales and marketing, states, “Biotest is excited to offer superior quality heipha media manufactured under quality systems similar or identical to those found in the pharmaceutical industry. Our manufacturing standards have allowed us to establish the reputation of delivering the highest quality products and we look forward to continuing that reputation across our North American market.”

Included within the heipha portfolio is the ICR line of culture media designed for monitoring within isolator and cleanroom environments. The ICR line is gamma-irradiated culture media which can be stored at room temperature. Additional features include individual identification labels as well as colored SDA media to allow differentiation from TSA media. Shari States, Microbiology Group product manager, notes, “The ICR line was designed to meet the needs of those who understand the criticality of maintaining a sterile environment. We take pride in the products that we produce, ensuring that every aspect is designed with quality in mind.”

About heipha
The heipha Dr. Muller GmbH company is a member of the Biotest Group. For over 30 years heipha Dr. Muller GmbH has been a leading manufacturer of high quality culture media for microbial diagnostics, environmental monitoring and sterility testing. It offers more than 600 different products used in the medical and industrial field. heipha Dr. Muller GmbH is based in Heidelberg, Germany.

About Biotest
In the United States, Biotest manufactures/distributes products in three distinct segments: environmental monitoring, transplant diagnostics, and blood transfusion diagnostics. Biotest is based in Denville, NJ, and is a subsidiary of German based Biotest AG.

www.BiotestUSA.com

July 10, 2007 — WESTBROOK, ME — To help laboratories improve pipetting technique and reduce laboratory error, ARTEL held a Pipetting Proficiency Training and Certification Seminar, including the industry’s first certification for multichannel pipetting technique. All participants succeeded in measurably improving the repeatability of their pipetting. Twenty-seven technicians from biopharmaceutical, clinical, and university laboratories attended.

Operator technique is a major source of pipetting error and inaccurate data, especially during use of multichannel pipettes. Compared to single-channel pipettes, multichannel devices are more prone to mechanical and operator error. Technique problems common to multichannel pipettes include incorrect rocking motions or excessive force when mounting tips, and the hand-warming that results when fingers are used to tighten tips. These and other critical issues were addressed during the training.

Participant Melissa Emberger, associate compound archivist at pharmaceutical company Eisai, remarked, “There are so many variables in pipetting that I was unaware of before I took this training.”

Attendees were trained using the ARTEL Method(TM), which includes a pre-skills assessment of pipetting technique, education about the impact of poor pipetting skills on laboratory results, hands-on technique coaching with immediate feedback, and a post-training skills assessment. The ARTEL Method also includes instruction on how pipettes fail, ergonomics, and best practices for determining calibration frequencies and setting tolerances.

“Our pipetting training programs are not just simple tutorials. We employ our proven, consistent training method to educate attendees on the science behind pipettes and to teach a standardized pipetting technique,” said George Rodrigues, PhD, senior scientific manager, ARTEL, and speaker at the seminar. “We also provide certification using an objective measurement tool so that laboratory technicians can demonstrate proficiency to meet regulatory and internal quality requirements. At any laboratory worldwide, ARTEL certification indicates an objective, quantified and identical standard of excellence.”

To receive certification, participants must achieve superior precision (CV or coefficient of variation of less than one percent) and pass a written test covering class material. After this training session, attendees using single-channel pipettes improved their precision by nearly a factor of five, with the average CV falling from 1.9 percent to just 0.4 percent. Multichannel pipette users improved more than two-fold, with the average CV falling from 1.3 percent to 0.5 percent.

Pipetting performance is verified using the ARTEL MVS(R) (Multichannel Verification System) and PCS(R) (Pipette Calibration System). Providing immediate, traceable measurement of dispensed volume accuracy and precision, these systems facilitate hands-on training and supply documentation of competence. In addition, the MVS is the only system that can instantly provide an assessment of each individual channel of multichannel instruments, facilitating its use for multichannel pipetting technique training.

As a guest speaker at ARTEL’s seminar, Hans Ulrich, director of product technology at Eppendorf North America, provided an overview of the mechanical function of pipettes and proper instrument repair and maintenance. “For data accuracy, it is crucial that laboratories standardize all critical tasks and minimize sources of error, and this most certainly includes pipetting technique,” said Ulrich.

ARTEL also offers training for Pipette Quality Management Certification. These two-day seminars assist laboratorians with establishing or improving their internal quality assurance programs for liquid handling devices to meet regulatory requirements. Visit www.artel-usa.com/seminars for a list of upcoming seminars.

ARTEL will hold Pipetting Olympics at the 2007 AACC Annual Meeting & Clinical Lab Expo (Booth #4143), July 17-19 in San Diego, CA. This competition awards technicians for superior pipetting skills and, for the first time, will include a multichannel pipetting event. For more information, visit www.artel-usa.com or call 207-854-0860.

About ARTEL
ARTEL is the worldwide leader in liquid handling quality assurance. ARTEL manufactures the most accurate, precise, and easy-to-use systems for ensuring data integrity in liquid volume measurement. ARTEL systems, based on proprietary Ratiometric Photometry, conform to ISO 8655-7 and provide NIST-traceable results. In addition, ARTEL provides liquid handling quality assurance support and consultation services including on-site pipetting technique training and certification for pipette users and laboratory managers, as well as Liquid Handler Performance Verification services for automated laboratories. Since 1982, ARTEL technology has been proven in daily use in thousands of laboratories including pharmaceutical, clinical, forensic, public health and environmental. Leading institutions such as Amgen, ARUP, Bristol-Myers Squibb, Celgene, Centers for Disease Control, DuPont, Eli Lilly, FBI, Genentech, Genomic Health, Mayo Clinic, Memorial Sloan-Kettering Cancer Center, Merck, Pfizer, Procter & Gamble, and U.S. FDA depend on ARTEL technology to help them meet their objectives for quality and productivity.

July 9, 2007 — /PRNewswire-FirstCall/ — MENTOR, OH — STERIS Corporation today announced that Tetra Pak, a world leader in food processing and packaging solutions, has selected the company as a strategic global supplier for the provision of sterilization systems on a Tetra Pak beverage filling platform currently in the final stage of development.

The selection follows several years of joint development between the companies resulting in the creation of a unique aseptic beverage filling platform that uses a proprietary STERIS vapor sterilization system and represents an advancement over traditional packaging sterilization methods. The new sterilization system provides a technology that permits continuous optimization of this core process and contributes to improved capacity and flexibility on Tetra Pak’s next filling platform.

Commenting on the selection, Les C. Vinney, president and chief executive officer of STERIS, said, “Tetra Pak’s selection of STERIS as a strategic global supplier is expected to represent the first commercial success of scale for our Defense and Industrial business unit under the leadership of our life sciences group president Gerry Reis, and is validation of the potential for our technology in entirely new industries. It is very rewarding to see many years of development and investment place us in a position to create a significant new revenue stream for the company in an industry similar in scale to those we currently serve. The full benefit of this collaboration, while not materially impacting the current fiscal year, is expected to be realized in the coming years as we build upon our strategic supply relationship with Tetra Pak.”

Michael Grosse, executive vice president, development and engineering, Tetra Pak, said, “This joint development between STERIS, world leader in vapor sterilization technology, and Tetra Pak, world leader in aseptic technology, will enable us to provide our beverage customers with a unique, highly robust, cost-effective packaging solution.”

Tetra Pak is the world leader in aseptic carton packaging solutions for ambient liquid dairy, juices, nectars and still drink products, a market which is expected to grow at an annual average rate of 5% in the coming years. Tetra Pak has approximately 9,000 packaging machines in operation worldwide. In 2006, Tetra Pak reported revenues of 8.5 billion euros (U.S. $11.4 billion), sold approximately 700 packaging machines, and produced more than 129 billion packages from its installed base of equipment.

About STERIS
The mission of STERIS Corporation is to provide a healthier today and safer tomorrow through knowledgeable people and innovative infection prevention, decontamination and health science technologies, products, and services. The company’s more than 5,000 dedicated employees around the world work together to supply a broad array of solutions by offering a combination of equipment, consumables, and services to healthcare, pharmaceutical, industrial, and government customers. The company is listed on the New York Stock Exchange under the symbol STE. For more information, visit http://www.steris.com/.

About Tetra Pak
As a world leading company in food processing and packaging, Tetra Pak’s motto “protects what’s good” (TM) reflects the philosophy upon which the company conducts business in order to make food safe and available, everywhere. Operating in more than 165 markets with over 20,000 employees, Tetra Pak believes in responsible industry leadership, creating profitable growth in harmony with good corporate citizenship, and a sustainable approach to business.

Tetra Pak works closely with its suppliers and customers on preferred processing and packaging solutions to provide convenient, innovative and environmentally sound products to millions of people worldwide. More information about Tetra Pak is available at http://www.tetrapak.com/

Source: STERIS Corporation

Contact:
Aidan Gormley, senior director,
corporate communications and investor relations, STERIS Corporation
Tel: 440-392-7607

Linda Bernier, director,
corporate public relations, Tetra Pak
Tel: +39-348-145-4229

July 9, 2007 — /ENS/ — AMES, IA — Agriculture Secretary Mike Johanns and members of Iowa’s Congressional delegation helped dedicate a new USDA high-containment large animal facility on July 3 that will host several research facilities in one location. Construction lasted more than three years and cost some $85 million. The new building encompasses more than 155,000 sq. feet and will house cattle, bison, elk, deer, reindeer, sheep, and hogs.

Employees in the new facility will contribute to the $100 billion U.S. livestock industry by conducting research, diagnostics, and training, as well as testing vaccines and evaluating veterinary biological products.

“Construction of this state-of-the-art animal health center is an important milestone in USDA’s efforts to provide first-class animal health services,” says Johanns. “The work here has generated tremendous benefits for livestock, agricultural workers, and consumers.”

The high-containment designation means the building is designed for optimal safety and security because the scientists will work with a variety of endemic, zoonotic, and foreign animal diseases in what is called Biological Safety Level 3, BSL3, space. This includes features such as airtight walls, filtered air, and liquid waste treatment technology.

Research will be conducted on the dreaded transmissible spongiform encephalopathies, such as mad cow disease and chronic wasting disease.

The center consolidates three units within two agencies of the U.S. Department of Agriculture (USDA).

It will be used by the USDA’s National Animal Disease Center, which conducts research concerning animal health and diseases with an agricultural impact. This center is part of the USDA’s Agriculture Research Service.

The National Veterinary Services Laboratories, which are part of the USDA’s Animal and Plant Health Inspection Service (APHIS) will utilize the new building. This lab serves as a national and international reference laboratory and provides diagnostic services, reagents and training.

And APHIS’ Center for Veterinary Biologics, which regulates vaccines, bacterins, antisera, diagnostic kits, and other biological products for the diagnosis, prevention, and treatment of animal diseases, will also be housed in the new building.

The new facility is the second component of the multi-phase, $460 million project. A consolidated lab and a low-containment animal facility are still under construction.

By 2009, when the project is expected to conclude, the Ames complex will be one of the largest animal health centers in the world with 1 million sq. feet of laboratory and research facilities.

July 9, 2007 — TUCSON, AZ — BioVigilant announced on July 5 that it has hosted the first consortium meeting for Instantaneous Microbial Detection earlier last month at Amgen corporate headquarters in Thousand Oaks, CA. The meeting was initiated following strong interest from the pharmaceutical manufacturing sector to implement the Instantaneous Microbial Detection (IMD) technology into its environmental air monitoring systems. The
meeting was attended by representatives from 12 pharmaceutical and biotech companies including Alcon, Amgen, Bayer, DSM Pharmaceuticals, Eli Lilly and Company, Genentech, GlaxoSmithKline, Johnson and Johnson, and four others. Members presented results of testing of IMD instruments and discussed strategies to implement this exciting technology.

Dr. Michael J. Miller, Senior Research Fellow for Eli Lilly and Company and a globally recognized leader in rapid microbiological methods, states, “The technology platform being developed by BioVigilant has the potential for significantly enhancing the manner in which
the pharmaceutical industry will monitor and control our manufacturing environments. Furthermore, the ability to provide results continuously and in real time is aligned with the industry’s desire to adopt new technological advances and risk-based approaches that focus on process control strategies and scientific methods in order to meet patient requirements. These concepts are at the core of Quality by Design.”

Doug Rufino, senior director of lab services and analytical development for DSM Pharmaceuticals, notes, “The ability of IMD to provide real-time microbial detection will drastically change the landscape for aseptic training as well. It can be adapted to provide
immediate use for gown qualification and fill-line training on water-based fill-line trials in efforts to pin-point where viables are detected to immediately correct behavior. This of itself can make an enormous improvement in quality of aseptic operations as well as
significant cost-avoidance savings.”

Rainer Newman, executive director of technology of Johnson and Johnson, describes one of the key benefits of the technology: “Using the IMD apparatus as a PAT application will fundamentally change the way investigations into environmental excursions are conducted.”

Miriam Rozo, manager of microbiology from Johnson and Johnson, adds, “The IMD has the potential to provide for a significant cost reduction and quicker detection of shifts in the environment where sterile products are aseptically produced.”

“The gathering of so many thought leaders in the industry is wonderful testament to the interest that the IMD technology has generated within such a short period of time, and we are honored to have this opportunity to continue to strive to provide solutions to pharmaceutical manufacturers’ needs,” says Deward Manzer, BioVigilant’s CEO. “We have collaborated with our pharmaceutical manufacturer customers over the past two years and understand the demands they face internally as well as externally. For example, our technology fits extremely well in meeting the FDA’s PAT (Process Analytical Technology) initiative and will enable our customers to provide continuous, real-time results for their environmental quality assurance testing requirements.” Manzer briefly compares BioVigilant’s Instantaneous Microbial Detection capabilities with the current, conventional plate culturing method: “Our instrument can determine simultaneously for each particle the size of the particle and whether it is biologic or inert, indicating immediately to the user if there has been contamination. This is in contrast with the current method using culturing, which generally takes from two to seven days from test to results. During the waiting time for the current method, production can occur in a contaminated environment, which is detrimental and very costly to pharmaceutical manufacturers. BioVigilant’s instruments can help to reduce significantly, or, in some cases, even eliminate these problems.”

About BioVigilant
BioVigilant develops, builds, and maintains a family of environmental monitoring instruments for use in pharmaceutical manufacturing, military, homeland security, food processing, health care, and other applications. Through the novel use of Instantaneous Microbial Detection technology, BioVigilant’s scientists have created instruments with entirely new classes of functionality and unparalleled sensitivity and accuracy than had been possible using existing methodology.
http://www.biovigilant.com/

Contact:
Chuck Bolotin
BioVigilant vice president of marketing and sales
Tel: 520-498-0427
E-mail: [email protected]