Inspection System removes defectives from product stream.

Press Release Summary:




Optyx®SG/P is designed for manufacturers of OTC and regulated solid dose pharmaceuticals, with special focus on softgel applications. At production speeds of up to 1,000,000 softgel capsules/hr, FDA 21 CFR part 11-compliant unit automatically inspects each capsule - based on color, size, and shape - to identify and remove defects and foreign capsules. Parallel processor enables operators to monitor images of every object of interest acquired by OptyxSG/P.



Original Press Release:



Symetix Introduces Optyx®SG/P Automated Inspection System for Solid Dose Pharmaceuticals



May 29, 2007 - Symetix introduces Optyx®SG/P, a new optical inspection system designed specifically for manufacturers of OTC and regulated solid dose pharmaceuticals, with a special focus on softgel applications. The FDA 21 CFR part 11 compliant OptyxSG/P automatically inspects each softgel capsule at high production speeds and identifies and removes defects and foreign capsules from the product stream. Automating inspection with OptyxSG/P enhances product quality and improves production line efficiency while significantly reducing labor costs.

Like the Optyx/SG introduced in 2005 for nutraceutical manufacturers, the new OptyxSG/P for pharmaceutical manufacturers verifies product color, size, and shape to assure every softgel capsule confirms to product specifications. With ultra-high resolution, OptyxSG/P reliably detects and removes foreign capsules as well as the smallest color and shape defects, including air bubbles, stained capsules, and misshapen product. The system can inspect up to 1,000,000 softgel capsules per hour.

OptyxSG/P features a new parallel processor that enables operators to monitor images of every object of interest acquired by OptyxSG/P, such as objects failing inspection. When a rogue object is encountered, the inspection system stops product flow, and all the objects that are classified as rogues are presented to the operator and stored in the batch log file. This functionality assures rogues are eliminated from the product stream.

Software enhancements for FDA 21 CFR part 11 compliance include: secure and encrypted logs, secure passcode management, a Freeze on Reject (FOR) feature, parameter histograms, and guided changeover. A number of new self-aware features include Eject Function Confirmation (EFC) and intelligent sensing for belt speed, belt tracking, proper change parts, and failure of any system lamp or ejector valve.

OptyxSG/P uses proprietary color cameras to view product - four primary inspection cameras are located both above and below the product stream. Symetix image processing technology quickly analyzes the product images, comparing each object to previously defined accept/reject standards. When defective product or foreign capsules (rogue capsules) are identified, the system activates the close-coupled high-speed ejector system to remove it from the acceptable product stream.

Unlike manual inspection, OptyxSG/P is objective and consistent, which improves final product quality. Automating inspection with OptyxSG/P increases product yield by minimizing the removal of acceptable product, which is common with manual inspection. OptyxSG/P reduces the risk of contamination by minimizing human contact with product. Based on labor savings alone, OptyxSG/P offers payback as rapid as one year. Improvements in production efficiency further speed payback.

As softgel manufacturers race to automate their production lines, continuous processes are replacing batch processes. Symetix is enabling this paradigm shift with Optyx/SG for nutraceutical manufacturers and OptyxSG/P for pharmaceutical manufacturers. If needed, manufacturers can batch-feed the bulk-to-bulk OptyxSG/P today and later integrate the OptyxSG/P with the other Symetix CONTINUOUS SOFTGEL FINISHING LINE(TM) components to achieve fully-automated, high-throughput softgel finishing line operation. To assure final product quality, Optyx is located immediately prior to packaging.

Designed to meet FDA requirements and comply with GAMP 4 guidelines, OptyxSG/P benefits from the company's 10-year history of supplying FDA-validated inspection systems to the pharmaceutical industry. Symetix offers complete engineering services and validation packages.

About Symetix
Symetix is the pharmaceutical business unit of Key Technology. With 60 years of experience in the food, tobacco, and pharmaceutical industries, Key is a leading manufacturer of best-in-class process automation systems. Symetix offers worldwide sales representation and maintains demonstration and testing facilities at Key's headquarters and manufacturing divisions in Walla Walla, Washington, USA, and at Key Technology BV in Beusichem, the Netherlands. Key's common stock trades on the Global Market tier of The NASDAQ Stock MarketSM under the symbol: KTEC.

Reader Inquiries:
Brenda Murphy
Symetix
150 Avery Street
Walla Walla, WA 99362 USA
Tel: 800.941.3701 or 509.522.3524
Fax: 509.522.3361
Email: bmurphy@symetix.com
URL: www.symetix.com

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