In the Spotlight December 2008

A pharmaceutical manufacturing line relies on more than just the equipment that produces final dosage forms. To produce high-quality drugs consistently, sterility and purity must be ensured, and dose production must be managed carefully and efficiently. This month's products bolster drug production in various ways. A software solution from Sartorius Mechatronics simplifies recipe storage, helps users track ingredient lots, and manages inventory. Kimberly-Clark Professional's new cleanroom garment helps prevent operators from contaminating active ingredients. Mettler-Toledo Safeline's metal detector helps ensure that adulterated products are not released to the market.

Cleanroom garment provides sterility and comfort

The "Kimtech Pure A5" cleanroom apparel from Kimberly-Clark Professional (Roswell, GA) is designed to enhance barrier protection. The garment is packaged inside out, thus reducing the risk that the wearer will contaminate it while gowning. A blue line along the inside shows the proper place to grasp the garment to unfold it. The product's arms and legs are gathered up by snaps that automatically release during gowning and reduce the risk that the garment will touch the floor.

Kimtech Pure A5 garment Kimberly-Clark Professional, www.kcprofessional.com

The apparel is also designed to ensure the wearer's comfort. The product is made of spunbond–meltblown–spunbond material, which is more breathable than other nonwoven fabrics, but maintains a barrier against contamination. The elastic waist and back prevent material from contacting work surfaces and billowing out, forcing air to exit the garment. The product is vacuum-sealed and gamma-irradiated to ensure sterility.

Metal detector offers sensitivity and flexibility

The "Tablex 2" metal detector from Mettler-Toledo Safeline (Tampa, FL) is designed for flexibility and convenience. The metal detector rejects irregular tablets through the device's lift-flap or side diverter. If power is lost, the metal detector defaults to the reject position so that no uninspected product passes through.

Tablex 2 metal detector Mettler-Toledo Safeline, http://us.mt.com

The Tablex 2 unit's small aperture enables it to detect pieces of metal as small as 0.2 mm. In addition, operators can adjust the head of the device on three axes to use it with any process-equipment configuration. The compact detector incorporates four casters, and users can roll it between tablet presses.

Software features phase logic and control

Sartorius Mechatronics (Edgewood, NY) introduced an updated version of its "ProBatch+" recipe-management software. Jim Rodina, tank and hopper applications support manager with Sartorius, says the new version supports the connection of controllers in accordance with standard phase logic. The software also provides the option of managing recipes through local controls.

ProBatch+ software Sartorius Mechatronics, www.sartorius-mechatronics.com

The ProBatch+ application provides a central location for recipe storage and backup on a network drive. Recipes stored on local hardware could be lost if that hardware fails, Rodina says, and the software avoids this problem. He adds that the product uses database files that are universal and can be accessed by outside systems. In addition, the application's production-control feature lets users assign lot numbers to ingredients, track their use, control inventory, and set reorder points.