In the Spotlight August 2009

Many industries have used automation to spare personnel from repetitive or simple labor-intensive tasks. The pharmaceutical industry has benefited from the reduced variability and consistent quality that automation helps bring to final dosage forms. This month's products automate different parts of the pharmaceutical process. The Roche Innovatis system stains and mixes samples and provides cell counts and analysis. A software suite from Virtify enables essential data to be tagged and reused in regulatory documents. Sigpack Systems offers a robot-based line that efficiently packages delicate containers such as vials, ampuls, and syringes.

Analytical system yields high-resolution images

The Cedex HiRes system from Roche Innovatis (Bielefeld, Germany) performs automated cell counts and analyses. It measures cell concentration, viability, cell diameter, compactness, specific growth rate, and aggregate ratio. The system stains and mixes cell samples automatically, and its multisampler can analyze 20 samples in sequence. The unit's liquid-management and flowcell cleaning procedures are also automated. The instrument can be controlled remotely with software that can be integrated into an automated process easily, according to the company. The software facilitates compliance with current good manufacturing practices.

The HiRes system incorporates moving microscope technology that scans the whole measurement chamber in one step. The technology has an identifiable-diameter range of 1–90 µm and provides a geometrical resolution of 0.8 µm.

In addition, the system stores measurements in a database, and measurements can be retrieved by parameters such as date, reactor number, or sample number. The product exports measurement data in various formats for use on other HiRes systems or workstations.

Cedex HiRes system

Cedex HiRes system

Roche Innovatis

www.innovatis.com

Packaging system provides flexibility

The Pharma Toploader TTP from Sigpack Systems (Beringen, Switzerland) was designed to handle fragile and sensitive pharmaceutical containers such as vials, ampuls, and syringes. The toploader is based on a concentric-running concept that allows a double-axis robot to load the front and back of the machine with trays.

A vacuum system ensures that batches of trays are transported precisely and retains their position throughout the packaging cycle. The carriers accommodate trays of various sizes and do not need to be exchanged for new formats. Cameras check the packages for completeness at each step of the packaging process. If a package is incomplete or if its barcode cannot be verified, it is discarded, thus preventing faulty packages from being filled.

Pharma Toploader TTP

Pharma Toploader TTP

Sigpack Systems

http://pa.bosch.com/sigpacksystems

Software enables regulatory compliance

Virtify's (Cambridge, MA) Virtx Enterprise Content Compliance software suite tags critical data and content for reuse. The suite is designed to ensure regulatory compliance and automate paper-based processes. It can be used to generate and store content from discovery through commercialization, says Stephen Bergson, Virtify's executive vice-president of commercial operations.

Virtx's structured content-management (SCM) solution ensures that regulatory content is accurately reused and complies with global standards. SCM can be used to develop and maintain standard operating procedures. It enables collaborative authoring and review by permitting several users to view and edit the same document in a web-based interface. This feature quickens content authoring and review cycles and reduces inconsistencies. The Virtx system also provides role-based access to prevent unauthorized document modifications.

Virtx software

Virtx software

Virtify

www.virtify.com

New Product Announcements

may be sent to New Products Editor, Pharmaceutical Technology, 485 Route One South, Building F, First Floor, Iselin, NJ 08830, fax 732.596.0005, ptpress@advanstar.com