RESEARCH TRIANGLE PARK, N.C., April 23 /PRNewswire/ -- Bayer Biological Products (BP) announced today it received approval from the Food and Drug Administration (FDA) for its new sterile filling facility (SFF) at the company's Clayton, North Carolina, manufacturing plant. The FDA approval marks a significant milestone for Bayer BP and the Clayton facility, where Bayer BP manufactures life-saving, plasma-based therapeutic proteins.

The SFF will be used for final container filling, freeze-drying, and pasteurization of all products manufactured in Clayton including Prolastin, Alpha1-Proteinase Inhibitor (Human), used in the treatment of genetic emphysema, Gamimune N, Immune Globulin Intravenous (Human), indicated for patients with immune deficiencies, and Koate-DVI Antihemophilic Factor (Human), used to treat hemophilia.

"This approval will allow Bayer BP to continue its leadership in product safety, and also to continue its long-standing commitment to patient communities in the therapeutic categories it serves," said Dr. Gunnar Riemann, president, Bayer BP Division.

The application to the FDA was submitted April 30, 2002. The recent approval allows Bayer to bring the new facility into operation immediately and will ensure Bayer BP's ability to maintain the very high standard of aseptic processing required to manufacture plasma-based products. The SFF will complement other existing process measures already in place and further assure that Bayer BP products maintain the highest possible safety profile.

Brand new, state-of-the-art mechanical equipment will be utilized in tasks such as filling bulk product and adding rubber stoppers to the product vials. By design, operators will be excluded from much of the process, allowing for state-of-the-art aseptic processing with a minimum of microbial deviations.

"The SFF approval allows us to complete the final stage of product manufacturing in the most up-to-date, state-of-the-art facilities," said Mary Kuhn, senior vice president of Bayer Biological Products and Clayton site manager. "The approval is a great accomplishment for Clayton and would not have been possible without the unwavering commitment of the employees who helped drive this project forward."

About Bayer HealthCare

Bayer HealthCare combines the global activities of the divisions of Bayer AG in the fields of Biological Products, Consumer Care, Diagnostics, Animal Health, and Pharmaceuticals. More than 34,000 employees support the worldwide operations of Bayer HealthCare. Bayer Biological Products is part of the worldwide operations of Bayer HealthCare, a subgroup of Bayer AG. Bayer HealthCare is one of the world's leading innovators in the health care and medical products industries.

Information about Bayer Biological Products Division can be found at www.bayerbiologicals.com.

Noordwijkerhout, The Netherlands -- DMN-Westinghouse have upgraded their PTD plug type diverter. The new PTD is of an improved, user friendly design, pressure shock resistant up to 10 bar (size 200 excluded) and suitable for pressures up to 3 bar g. Value engineering has resulted in improved specifications and a more competitive price of the diverter, now available in 7 consecutive sizes from 50 to 200 mm pipe diameter.

The design of the PTD plug type diverter conforms to all current legislation regarding safety in the workplace. Consequently there are no moving parts on the outside. The new PTD is of an improved, user friendly design, pressure shock resistant up to 10 bar (size 200 excluded) and suitable for pressures up to 3 bar g (standard static seals). The sizes 50-150 are optionally available for pressures up to 6 bar g (inflatable seals).

The DMN-Westinghouse PTD plug type diverter has been specially designed to route powders and pellets with minimum degradation in pneumatic conveying systems. The PTD plug type diverter is applied in the chemical, pharmaceutical, plastic, food and other related industries.

Minimum degradation of product is guaranteed by precision machining, very effective sealing and a complete obstruction free passage. The user friendly fool proof design enables fast in situ internal examination, cleaning and, if necessary, replacement of seals. A quick clean version with easy slide rails is optionally available.

The PTD plug type diverter consists of an aluminum housing and end covers in which a plug with two pipes is installed. All product contact surfaces are made from stainless steel AISI 316L / DIN 1.4404. Three FDA approved silicone seals guarantee the sealing between housing and plug. The body is pressure tight, so ensuring no leakage to atmosphere. The plug type diverter can be used for product temperatures ranging from -25 °C up to +80 °C at ambient temperatures of -10 °C up to +40 °C.

For more information visit http://www.dmn-nwh.nl

Pembroke, MA -- Thayer Scale is now offering its new compact model LWF-MC-V, low feed rate, Loss Of Weight Cable Scale with Vibratory Feeder. This unique feeder has been specifically designed to fit into tight spaces such as feeding into extruder feed throats.

The Thayer LWF-MC-V Loss In Weigh Cable Scale Feeder will assure uniform, non-pulsating accurate feeding of a wide range of materials, from free flowing to friable to cohesive. The LWF-MC-V when fitted with Thayer's patented Spiralator vertical lift agitator creates a patented feeder system that assures conditioned and uniform flow of caking and cohesive powders as well as interlocking particles and delicate flakes.

The exclusive Thayer Scale "FMSS" Cable Suspension design provides extremely high sensitivity. Feeder "dead" load (feeder and weigh hopper) is mass-counterbalanced so that only material weight (live load) is measured. This feature helps assure excellent control in "noisy" environments.

All of the articulate parts of the scale mechanism are supported from "axially inextensible, but laterally yieldable" suspension elements (stainless steel pre-stressed aircraft cable), which are arranged to hang freely vertically throughout their lengths under all operating conditions, thereby avoiding any appreciable spring or hysteresis effects, variations in mechanical advantage, or binding due to imperfect leveling.

Weight loss is measured by an highly accurate, very sensitive, high output electronic force measurement sensor. The Thayer Series LC-137 weight resolver is a force measuring device designed specifically for use with Thayer Scale weighing systems. It is a precision-built, heavy duty device designed for long term stability and accuracy under the most demanding applications. It is initially calibrated and installed by the factory and normally requires no routine maintenance. So rugged is the "FMSS" Scale system that the LC-137 Weight Resolver is guaranteed for 15-years.

Thayer Scale is a pioneer-developer of continuous weighing and feeding equipment for the dry solids conveying and processing industries. Their Weigh Belt and Loss Of Weight Feeders cover an extremely wide range of applications covering virtually all industries that involve dry solids conveying and processing.

For further information contact:
Mr. Thomas Picone
Thayer Scale
91 Schoosett St
Pembroke, MA 02359
Telephone: 781-826-8101
Fax: 781-826-7944
Email: sales@thayerscale.com
Web site:  http://www.thayerscale.com

Batch Control : Market Adjusts to Enable Supply Chain Synchronization

Dedham, Massachusetts -- The market for batch control systems in 2002 reached $2.4 billion, and will grow at an average annual rate of 3.4 percent through 2007, according to "Batch Control System Worldwide Outlook", a recently released study from ARC Advisory Group.

In the industrially developed world, there are many aging control systems. Though functioning, many of these systems do not meet today’s need for sophisticated control, historical recording for traceability, human operator interface, and supply chain synchronization. These older systems need to be replaced by modern batch control systems on open platforms to achieve current regulatory requirements and current business performance needs.

“Manufacturing efficiency and flexibility will be the key to meeting the needs of powerful mass merchandisers. Consumers are demanding increased variety and quality,” says Asish Ghosh, ARC Vice President and principal author of the study. To maximize business performance, a manufacturing company will optimize its production plants along with its enterprise and supply chain domains. The need to optimize the supply chain is increasing the need for real-time plant and production information, which is fueling the growth of manufacturing automation and its integration to business system.

It is no longer sufficient for an enterprise to have islands of automation along with isolated supply chains. To maximize the potential of batch production, manufacturing plants and supply chains need to work together in an optimized fashion. In this new environment, manufacturing will continue to maintain its central role, but enterprise-wide optimization of production facilities and supply chains are going to be increasingly important for maintaining the bottom line. Manufacturing companies will be optimizing not only their production plants but also their enterprise and supply chain domains. Manufacturers used to be satisfied when control loops were properly tuned, recipes, phases ran in proper order, and products were produced to their required quality specifications. With today’s global environment, increased competition, and the need for custom products, enterprise, and supply chain optimization are becoming increasingly important.

Already one of the most highly regulated industries in the world, US FDA ruling 21 CFR Part 11 has placed additional burden on the pharmaceutical industry in terms of electronic records requirements for currently installed systems and all future systems. This ruling and similar rulings are affecting other regulated industries such as food, beverage, and fine chemicals.

The ARC "Batch Control System Worldwide Outlook" market study is an in-depth analysis of the worldwide batch control systems marketplace. It serves as an effective planning guide for companies providing batch control systems, as well as companies contemplating the procurement of one. The report is specifically prepared to provide strategic information to industry executives involved with their company's batch control systems. Included in the study are detailed descriptions of market size and segmentation, market forecasts, industry structure, and supplier profiles. In addition to the quantitative assessment of the marketplace, this report explores the important issues that will affect this marketplace in the future.

ARC Advisory Group provides strategic planning and technology assessment services to leading manufacturing companies, utilities, and global logistics providers, as well as to software and solution suppliers worldwide. From Global 1000 companies to small start-up firms, ARC has the strategic knowledge needed to succeed in today’s technology driven economy. Further information can be obtained from ARC, Three Allied Drive, Dedham, MA 02026, 781-471-1000, Fax 781-471-1100, E-mail info@arcweb.com , Web http://wwwARCweb.com 

People post their requests for help and offer their suggestions to others in our open forum.

Mr. Dinniss needs a temperature-measuring powder:

I am looking for a powder that can indicate what temperature it has been subjected to?  It is for use in seeing what temperature a small dose (~15mg) of powder gets up to when it is heat sealed into a blister.
(Click here to post a reply)

Cheers,
James Dinniss
GlaxoSmithKline
jwd25805@gsk.com

Mr. Robinson needs dispose of rocket propellant:

I am a retired aerospace environmental engineer who worked out processes for disposal of waste rocket propellant. I have worked out a process (Carbon Black data sheet is available upon request) for carbon black production by reformation of biomass with carbon dioxide to create carbon monoxide which is catalytically decomposed to carbon.

Since the carbon would be in an air dispersion after formation, I would like to know how to use it as a controlled dust explosion. Does anyone have any information?  (Click here to post a reply)

Thanks,
R.J.Robinson
robsacrob@cs.com

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FOR SALE: Gottwald Ship Loader/Unloader

Gottwald Mobiload ML101, Year of manufacture: 1983, s/n 156003. For loading and unloading of ships up to a sizes up to 25,000 tdm. On 4 axles, self-propelled. Capacity 2,900 bags/hour.  Price $150,000 ($Euro) Click photo for details

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This weeks photo is of an Atlantic Coast Crushers' Flow Smasher Crusher, processing 15,000 pounds per hour of magnesium sulfate, reducing the particle size to less than 1/4" output size at a major chemical processing plant. Flow-Smasher is a heavy-duty, high torque, high capacity crushing machine capable of reducing large chunks of friable bulk materials to a consistent, free-flowing size.

Photo courtesy of Jim Herdman of Atlantic Coast Crushers.

Send us your photos:  We would love to have your photo of a bulk materials process, packaging, conveying or handling "action shot" for our home page.  Send your photograph and description to: news@powderandbulk.com