Niro at 2007 INTERPHEX

Niro will again have a substantial display at the Interphex show and will exhibit several new products. Niro will also give several technical presentations at the educational Interphex conference.

2007 INTERPHEX
April 24-26, 2007
Jacob K. Javits Convention Center
New York, US

Interphex 2007 registration: Click here.

The U.S. pharmaceutical industry has achieved its worldwide status through research and development and spends a very high percentage of its revenue on R&D compared with other industries. Each year, pharmaceutical and biopharmaceutical industry testing involves tens of thousands of new substances, yet may eventually yield fewer than 100 new drugs!

For the majority of pharmaceutical companies, the actual manufacture of drugs is the last stage in a long process that begins with scientific research to discover new products (and/or improve or modify existing ones). The research and development departments in pharmaceutical industry start this process by seeking and testing libraries of thousands to millions of new chemical and biological compounds with the potential to prevent, combat, or alleviate symptoms of diseases. Scientists use sophisticated techniques, including computer simulation, combinatorial chemistry, and high-through-put screening, to hasten and simplify the discovery of potentially useful new active pharmaceutical ingredients.

At Niro we acknowledge the importance of research and development and, therefore, all our systems are available from small R&D laboratory units through to complete integrated production systems. We enable scientists to develop the drug on a given technology and carry it through to production on the same scaled-up technology. In other words, our R&D unit and our production systems are based on the same flow, thermal, fluid dynamic and other operation principals - enabling an easier scale-up, approval, documentation and validation. Additionally, Niro Inc. has one of the best-equipped and most comprehensive process equipment test facilities in the world for testing of spray dryers, batch fluid beds (for coating, granulation, agglomeration, and drying), evaporators, tablet presses, containment interfaces, tablet coaters, powder blenders (with NIR technology), homogenizers systems (for cell disruption), and membrane filtration plants. More than 20 different pilot plants and a variety of auxiliary equipment are available for feasibility test and pilot scale testing of various processes used in the manufacture of biotechnology and pharmaceutical products. Niro provides what manufacturers need: the process knowledge, the available hardware, skilled operators, and perhaps above all, a trusted partner with access and knowledge to technology that provides unprecedented particle control that will open the door to previously unattainable delivery methods and product characteristics. In all, Niro will shorten the way from drug discovery to production.

Advances in biotechnology are transforming drug discovery and development. Scientists have learned a great deal about human genes, but the actual progress of translating that knowledge into viable pharmaceutical products has only just begun. Millions of people have benefited from medicines and vaccines developed through biotechnology, and several hundred new biotechnologically-derived medicines are currently in the pipeline.

Years ago Niro decided to be on the forefront of this development and have over the years made substantial investments in technologies and acquired companies specialized in biotechnology equipment and systems. We are now - as one of the only companies in the world - able to deliver complete bio-pharmaceutical processing lines and we look forward to deliver the systems which can produce the necessary drugs for cancer, infectious diseases, autoimmune diseases, neurologic disorders, and HIV/AIDS and related conditions.

Three of Niro Inc. operating business units will exhibit at the 2007 Interphex, namely: Courtoy, GEA Liquid Processing, and Niro Pharma Systems. Come and visit us at booth #1629!

Courtoy

Courtoy will exhibit the advanced MODUL™ S tablet press as well a self-contained Exchangeable Compression Module (ECM) which is positioned a trolley. Courtoy will demonstrate the contained cleaning of the ECM utilizing a GEA Liquid Processing CIP system.

GEA Liquid Processing

GEA Liquid Processing will exhibit the following units and systems:

• the versatile GEA BATCH FORMULA™ mixing system
• a GEA Niro Soavi laboratory homogenizer type 1001L (a.k.a. PANDA)
• and a CIP system (a.k.a. WOL - wash-off-line) specially designed to clean the self-contained Courtoy tablet press ECM (Exchangeable Compression Module)

Niro Pharma Systems

Niro Pharma Systems will display:

• a fully operational pharmaceutical spray dryer type PHARMASD™ type PSD-1. Niro has developed this new series of spray dryers dedicated to the pharmaceutical industry manufacturing. The dryers, named PHARMASD™ (PSD) have been designed using standard modules that incorporate all the required features necessary for cGMP production in the environment of a pharmaceutical plant.
• a newly developed HEPA (high efficiency particulate air) filters for GMP spray drying operation.
• an ASEPTICSD™ spray dryer size ASD MICRO in an Isolator Box. The ASD MICRO is the smallest Niro pharmaceutical spray dryer. The ASD MICRO is specifically designed for aseptic processing of very small volumes of active ingredients including products for injection. The drying gas capacity is 30 kg/h.
• an Aeromatic-Fielder GMP STREA™ US Advanced Laboratory Fluid Bed Processor for dry mixing, liquid spray addition, granulation and agglomeration, coating and drying
• a compact and cleanable in-process optical probe for use in powder processing - The Lighthouse Probe™. It can be used with a range of spectroscopic techniques, including NIR and UV/vis, to overcome the traditional problem of product sticking to observation windows. The probe is compact and easy to install and makes it possible to take a reliable in process measurement of quality critical product characteristics including: material and active content identification, active content uniformity during high-shear blending operations, moisture content and end-point during drying processes, coat growth during coating processes.
• The Hicoflex® Flexible Containment Interface. The Hicoflex® system provides a Low-Cost, Single Use Flexible Bag System with it's own integrated High Containment Two-Part Valve System. The Hicoflex® line of products includes:
  • Disposable, Low Cost Product Bags in 1 to 50 Liter Volumes
  • Disposable Sanitary Ferrule Interfaces (2", 4", 6" Diameter)
  • Inherent Valves performing to 1-10 μg/m3 per 15 min. Short Term Exposure
  • Sample Thiefs for product sampling.
  • Other integrated products
• A cut-away IBC incorporating a Buck® Vibroflow™ discharging system. The Vibroflow™ system creates an effective means of preventing bridging, segregation; as well as promoting mass flow even in a small volume, metering mode. Buck® Systems has developed a comprehensive and high quality range of IBCs for processing, storage, tumble blending and transport of pharmaceutical products. Buck® Systems offer an extensive selection of styles and sizes to suit all requirements ranging from 3 to 3,000 l.
• A working Pneumatic HC Valve will be on hand for demonstration. Also, detailed information about the Buck® Valve contaiment range will be available, including HC (High Containment), UHC (Ultra High Containment), TC (Total Containment) valves and docking systems.
• A new innovation from Buck® will have it's North America debut at the Interphex NYC Show. Our new MC (Modular Containment) Valve eliminates the Alpha (Active) / Beta (Passive) valve relationship Buck® invented years prior. All the containment interfaces will be the same, using low cost 'Passive' style interfaces with a secondary, concentric actuator mechanism. Performance, Design Simplicity, and Value are all improved significantly with this new technology.

Niro Pharma Systems will also feature the extensive GEA Lyophil range of LYOVAC® lyophilizers as well as the complete infrastructure around the freeze dryer including the advanced Automatic Loading and Unloading Systems (ALUS) which are protected by a worldwide patent.

Interphex conference

GEA Liquid Processing (business unit of Niro Inc.) will give two technical presentations at the Interphex conference. Mr. Tim Hoover, Business Development Manager, will present both papers.

Conference hours:
Tuesday, April 24th: 9:00am - 4:00pm
Wednesday, April 25th: 9:00am - 4:00pm
Thursday, April 26th: 9:00am - 3:00pm

Session #M22: Advances in the Integration of CIP in Solid Dosage Manufacturing Systems
Wednesday, April 25, 2007 // 3:15PM - 4:15PM
As the need for full or semi-contained solid dosage manufacturing grows, so does the need for CIP of the manufacturing equipment and systems involved, including the reliable and repeatable cleaning of Granulators, Fluid Bed Dryers, Mills, Precision Coaters, ancillary equipment and interconnecting transports. Because of the interfaces and geometries of the above mentioned manufacturing equipment, advanced CIP delivery tactics need to be considered that will ensure that the proper cleaning parameters reach the intended cleaning targets, while not altering the in-process product or endangering the operator.

Sessen#B9: Overview of Cell Rupture Operation Utilizing High Pressure Pumping Techniques
Thursday, April 26, 2007 // 9:00AM - 10:00AM
After the micobial fermentation process is complete, there are several techniques available to disrupt the cell wall and harvest the intra-celluar inclusions. Cell disruption techniques vary from chemical ersoion of the cell wall to imparting mechanical energy to the point of cell wall rupture. This session will take an overview of all available techniques, then focus on cell rupture techniques that involve high pressure pumping. A detailed examination will be done on the mechanical elements and ancillary process requirements to ensure a successful cell rupture process.

For more information, please contact: