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Freeze Drying.

BioPro International, Inc./Martin Christ

Product Line:

Martin Christ is one of the world's leading manufacturers of freeze drying equipment. With more than 50 years of experience, they offer an entire program of laboratory, pilot and product plants for most applications.

All units comply with regulations such as FDA and GMP for ease of validation. On request they can also be supplied for steam sterilization.

With many years of experience and know how, MARTIN CHRIST builds freeze drying systems with the highest standard on materials and workmanship used and offers variation on mechanical construction through to specific vacuum, refrigeration and user-friendly control systems.

Service/Technical Staff:

BioPro International Inc., has an in-house Technical Service Team and also factory trained Service Engineers strategically placed through the USA to support customers with all their needs. With over 30 years of experience in the pharmaceutical market, we are able to answer our customers questions in a professional manner. The after sales service support team is always available for technical questions.

Test Facility/Demonstration Lab:

BioPro International Inc., has the capabilities to run tests on specific applications for freeze drying to help the customer better understand their processes .and set them up with the proper system for their requirements. BioPro will perform demonstrations at the customers sites. Facilities for in-house demonstrations, are located in Farmingdale, NY and in Hayward, CA.

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Usifroid

Product Line:

As part of the Air Liquide Group, Usifroid offers a wide modular range of research, pilot, and industrial Freeze Dryers (from 5 to more than 500 sq ft) manufactured to the same state of the art quality standards and available with all the accessories to allow easy scale up.

Usifroid is also commissioning the first of a new lyophilizer's generation, newly designed for their U.S. customers.

* Fully compliant NEMA power panels, UL listing and locally fabricated

* All ASME pressure vessels

* U.S originated pumps, compressors, valves and motors meaning a reduction in local inventory

* Allen Bradley slc or plc with Fix Dynamics or InTouch HMI

Service/Technical Staff:

In house service is available with 4 technicians located in California and Maryland for the North American territories (more than 8 years of experience in the pharmaceutical market), and 12 technicians located in France for European territories (from 3 to 20 years of experience in the pharmaceutical market).

Test Facility/Demonstration Lab:

Test facilities are available in Maryland - USA (10000 sq ft) for North American territories, and near Paris - France (35,000 sq ft) for Usifroid's worldwide activities.

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Hull Company

Product Line:

Hull's family of industrial lyophilizers is the complete solution to meet all your freeze drying requirements.

* 8[ft.sup.2] through 450 [ft.sup.2] and larger systems

* Full range of standard internal polishes

* SIP and CIP

* ASME Code Section VII, Div. 1

* internal pressures from 0 to 30 psig

* cGMP compliant

* external or internal condenser designs

* standard refrigeration systems including reciprocating, rotary screw compressors, LN2 system and cascade systems

* PLC based control platforms

* automatic loading/unloading systems

Service/Technical Staff:

* Seven mechanical engineers with over 150 years combined experience

* Five electrical engineers with over 120 years combined experience

* Twenty-two service personnel with 100+ years combined experience

* Forty-five manufacturing and support staff

Hull takes great pride in maintaining a staff of individuals that are highly dedicated to the freeze drying industry.

Facilities:

Totat facility: 44,300 sq. ft.; Manufacturing And Assembly: 25,575 sq. ft.; Offices and support areas: 18,725 sq. ft.

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W. L. Gore & Associates, Inc.

Product Line:

Disposable LYOGUARD Freeze-Dry Trays provide an efficient and cost-effective method of bulk freeze-drying pharmaceuticals. The unique GORE-TEX membrane top allows high sublimation rates while containing pharmaceuticals throughout the lyophilization process resulting in higher yields, reduced cleaning cycles and reduced chance for worker exposure. The thin-film bottom closely conforms to the dryer shelf, for more uniform and efficient heat transfer. Dried product can be stored, shipped and reconstituted inside the tray at the point of use.

Service/Technical Staff:

Best known for its GORE-TEX[R] membranes, W. L. Gore & Associates is a global leader in ePTFE technology, providing advanced solutions for pharmaceutical, chemical and medical applications. With over 6,500 associates, Gore supports its Lyoguard[R] Freeze-Dry Trays through a core technical team plus a technical sales and support staff located worldwide. Introduced in 2000, LYOGUARD[R] Trays have been adopted by nearly 60 pharmaceutical companies, manufacturing blood products, peptides, oligonucleotides, other proteins, vaccines, diagnostics, and hormones.

Test Facility/Demonstration Lab:

LYOGUARD[R] Freeze-Dry Trays were developed in consultation with the pharmaceutical lyophilization industry. Ongoing product testing and development is conducted at our fully equipped facility in Elkton, MD. A Validation Guide, with current test data, is available from Gore, and a Device Master File has been filed with the FDA.

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Kinetics Thermal Systems

Product Line:

Kinetics Thermal Systems offers a range of freeze-drying products and services. Products cover the following range of sizes and applications:

* Custom-designed steam sterilizable freeze-dryers for full-scale production of lyophilized products.

* Pilot production systems used in the manufacture of clinical trial materials

* Laboratory freeze-dryers used for research and process development

* Laboratory systems used for sample preparation and preservation.

Products are engineered to provide ease of training, operation, and maintenance and to reduce cycle development and production cycle times.

Service/Technical Staff:

The professionals at Kinetics understand the importance of a highly trained and efficient service department. A staff of expert service technicians qualified to maintain and repair any refrigeration, control, fluid, and vacuum systems that kinetics manufactures and sells is available 24 hours a day, 7 days a week, on a worldwide basis. We have service division offices strategically located across the United States, as well as a global network of affiliated service firms for quick response throughout the world.

Test Facility/Demonstration Lab:

Kinetics provides tours of its factory on request, Equipment can be demonstrates at the factory or at a customer's facility.

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The VirTis Company

Product Line:

VirTis supplies research, pilot scale and production freeze dryers to the pharmaceutical industry that offer unparalleled levels of control, flexibility and reproducibility. From the smallest benchtop to a large production system, our configure to order systems are engineered and designed for the way you work with the right capacity, efficiency and price to match our product with your applications. With the ability to manufacture a freeze dryer with up to 416 square feet of shelf space VirTis has been applying its engineering expertise to thousands of scientific, commercial and industrial specialized processes for many years.

Service/Technical Staff:

Our search for technical excellence includes an unwavering commitment to quality, value and service - before, during and after installation. We provide validation and critical support through an in-house staff of engineers, technicians and product managers with half of them having over 20 years experience with the pharmaceutical industry. VirTis has a 24-hour response team and a worldwide presence of independent representatives that ensures prompt attention to your needs around the globe.

Test Facility/Demonstration Lab:

The VirTis Company designs, manufactures and tests all products according to rigorous guidelines imposed by ISO 9001 quality standards. VirTis has been in business for over 48 years and has a 45,000 square foot manufacturing and testing facility in Gardiner, New York. The facility has a research and development laboratory for product trials, customer training and the continuous search for innovation and new technology.

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STERIS Corporation

Product Line:

STERIS is the world leader in the manufacture of FDA, cGMP and GAMP-compliant LYOVAC[R] freeze-drying systems, which are built to customers' User Requirement Specifications (URS). Their space-saving design allows for flexible integration into a pharmaceutical processing system. LYOVAC freeze dryers can be fully automated using the Automatic Loading and Unloading System (ALUS) and the new Thermodynamic Lyophilization Control (TLC). These high quality systems have detailed documentation packages available to minimize validation timelines.

STERIS LYOVAC pharmaceutical freeze-drying models include:

* LYOVAC[R] FCM 10 and FCM 30, for pilot lyophilization and small-scale production plants

* LYOVAC[R] FCM 40 to FCM 600, for large-scale Flexible Compact Modular production plants

* LYOVAC[R] GT Series (GT 50- GT 500), for large-scale production plants

* Additional models in development

Service/Technical Staff:

STERIS has a field-based technical service force available to customers worldwide. Factory experts in freeze dryer (lyophilization) technologies are available to provide Systems Planning, application, Factory Acceptance Testing (FAT), validation and other support functions. The company has over 47 years of experience in the industry, and sold their first system for pharmaceutical production in 1960. More than twenty automatic-load systems (ALUS) have been built, tested, installed and validated by STERIS GmbH to date.

Test Facility/Lab:

The STERIS GmbH cycle development laboratory is located within our facility in Hurth, Germany. STERIS's equipment and technical expertise enable customers to develop the optimal freeze-drying cycle parameters to meet their User Requirement Specifications.

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Title Annotation:list of companies, products, and services
Publication:Pharmaceutical Processing
Geographic Code:1USA
Date:Jun 1, 2001
Words:1503
Previous Article:Bioprocessing.
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