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SP Industries Announces Release Of Its Latest FTS Smart Freeze-Dryer Technology
November 7, 2007 Warminster, PA
Software enhancements add functionality to breakthrough process development technology.
SP Industries announces the release of Version 2 of its breakthrough FTS SMART Freeze-Dryer Technology. This major new software release adds important user functionality for developers of lyophilization cycles. SMART Freeze-Dryer Technology is available exclusively on the FTS LyoStar II process development freeze-drying system.
According to Leslie Mather, Product Manager, R&D Lyophilizers, "Over the past few years, our pharmaceutical customers have enthusiastically embraced SMART Freeze-Dryer Technology. Through close cooperation with these users, we were able to improve key features and add new functionality that was requested. We are pleased to give the scientists even more innovative ways to use the SMART freeze-dryer system."
Adds Mather, "A select group of customers has been testing the new SMART release and their reaction has been overwhelming. This enhanced version of SMART provides a consistent, repeatable method for calculation of product temperature, cake resistance, ice thickness and heat flow on pre-existing recipes. We're now thrilled to release this to the broader marketplace."
Specific additions and enhancements included in the Version 2 release of the SMART system include:
1. Manometric Temperature Measurement (MTM) data are now available on standard (user defined) recipes. This significant new functionality allows the user to collect MTM data (resistance measurements, product temperature calculations, heat flow calculations) in the elegant SMART Freeze-Dryer format on standard automatic recipes. In this mode of operation, the operator stays in control of the cycle. While SMART data is generated, the LyoStar II runs the cycle programmed by the operator.
This new data collection ability enables the scientist to automatically collect the additional data the SMART system generates on pre-existing freeze-drying recipes. This can be of significant advantage in performing cycle robustness testing, troubleshooting problem cycles and validating changes or adjustments to legacy cycles.
2. Increased product safeties for amorphous, low collapse temperature products and for products with higher fill volumes and solids concentrations. In order to assist scientists in ensuring product safety for products that fall outside SMART's preferred boundaries (greater than 15% solids concentration and greater than 1/3 fill volume), the following adjustments to the SMART algorithm were made:
* The upper shelf temperature boundary during primary drying for amorphous products will be 5°C.
* SMART will not permit shelf temperature increases after the completion of half of primary drying.
3. Automatic Backfill and Stoppering functionality added. The operator can now choose to automatically backfill and stopper the vials as part of the recipe. This eliminates the need for personnel to be present during this step.
This improvement is in response to user requests and allows the scientist to, in effect, stop a run at precisely the desired point in drying, thus eliminating the need to visit the lab during off hours.
4. The FTS SMART system can now display vacuum units in mTorr or mBar.
5. The underlying Intellution brand software has been upgraded from Version 3.0 to the latest Version 4.0.
SMART Freeze-Dryer Technology is the result of a development partnership and an exclusive licensing agreement with the University of Connecticut (UConn) and Purdue University.
Background: Freeze-drying (also referred to as lyophilization) is an important manufacturing process step in the production of a number of pharmaceutical products. The continuing discovery and development of protein based therapeutics is increasing the need for methods that help improve freeze-drying and freeze-drying process development.
About SMART Freeze-Dryer Technology: SMART Freeze-Dryer Technology is a breakthrough development tool that enables scientists to accelerate and streamline the arduous task of developing lyophilization cycles for protein-based therapeutics.
With SMART, the scientist enters basic data such as vial size and quantity, fill volume and Tg and the system delivers an optimized freeze-drying cycle, typically after just one or two development runs. SMART eliminates the time-consuming iterative approach required by conventional cycle development. Instead, SMART's patented algorithms produce a safe, optimized cycle in just weeks, rather than several months. SMART frees up hours of valuable scientist time, and speeds the path to clinical trials, pilot and commercial production.
About SP Industries: SP Industries is a leading manufacturer of specialty glassware, environmental control chambers, glassware washers and dryers, centrifugal evaporators, and laboratory-to-production scale lyophilizers. The company, which sells its products under the following well-known brands: Wilmad-LabGlass®, Hotpack®, VirTis®, FTS, Genevac® and Hull®, is structured along two distinct business lines and two product groups. The product groups are equipment and glass. The business lines are laboratory and industrial. This approach allows SP Industries to offer its customers a fully integrated package of products and services. SP Industries has made significant investments in facilities, infrastructure, training, and people. The company has a clearly defined vision for the future that includes focusing on core competencies and developing exciting new products and services geared to meeting the demands of those markets.
The company's glass operations are located in New Jersey. The equipment line is operated from four facilities, one in Warminster, Pennsylvania and three in the New York Hudson Valley. These facilities are ISO 9001:2000 registered. Corporate headquarters and some manufacturing operations are housed in a 75,000 square foot facility in Warminster. In addition, the company continues to invest heavily in validation and commissioning competencies. With the ongoing requirements of 21 CFR Part 11 and the emergence of GAMP 4, SP Industries is uniquely positioned as the leader in compliance and GAMP 4 commitment.
SP Industries also supplies product service and is structured to be highly responsive to customers. Staffed to provide after-the-sale support for all SP products, SP Service can respond quickly to equipment service needs. Experienced personnel offer technical assistance to help customers meet new guidelines, save time, increase productivity, simplify tasks, or reduce costs.
About LyoStar II Freeze-Dryers: The LyoStar II is an R&D and process development freeze-dryer that provides unmatched process accuracy, reliability and unique ease-of-use features. The LyoStar II features RTD-controlled shelf temperature accuracy of +/- 0.5°C or better and vacuum control within 0.1% of set-point. Its robust 5.5 hp cascade refrigeration system enables shelf pull down from ambient to -40°C in less than 25 minutes, and the ultra-reliable scroll compressors feature just 3 moving parts . LyoStar II's unique integrated arm-mounted touch screen controls enable the operator to manage and monitor operations at the unit.
SP Industries, 935 Mearns Road, Warminster, PA 18974; Tel: 800-523-2327; FAX: 215-674-9829; www.SPindustries.com.