In the Spotlight March 2008

Editors' Picks of Pharmaceutical Science & Technology Innovations

Pharmaceutical manufacturers can gain various benefits from automated equipment. Automated processes generally require minimal human intervention, which means faster completion times and a lower probability of errors. Many automated machines enable companies to incorporate process analytical technology (PAT) principles in their production procedures. Using PAT can improve manufacturing precision and help companies produce consistent high-quality dosage forms. Automation can also simplify production techniques and thus contribute to lean manufacturing and potential cost savings. The three devices in this month's column demonstrate how automation benefits different parts of the pharmaceutical manufacturing process.

Analytical system provides multiuser capability

PANalytical (Almelo, the Netherlands) introduced its fully automated "CubiX Walk-Up" system for X-ray powder diffraction (XRPD) analysis. The system complies with 21 CFR Part 11 regulations and, unlike other systems, allows multiple users to perform analysis. The instrument analyzes samples in a queue and tracks both samples and users.

In addition, the CubiX system creates reports that show instrument settings, how measurements were obtained, and the results of the analyses. Separate reports are generated for individual users and analyses.

CubiX Walk-Up XRPD-analysis system (PANalytical)

Scientists who are inexperienced with XRPD can use the instrument easily because it incorporates preprogrammed settings for measurement and analysis. The system contains setups for various types of analysis and measurement conditions.

A supervisor can set up the CubiX system and grant rights to other users. Users' rights determine which parts of the spectrum they can select for analysis. The system supports most standard operating procedures.

Encapsulator aids dosage design

The "SCI HGE 1200" hard-gelatin encapsulator from Sancilio and Co. (Riviera Beach, FL) allows users to fill capsules with tablets, powders, granules, or a combination of these materials. Fred Sancilio, the company's CEO, says the unit can fit three different tablets in a capsule. The encapsulator thus allows pharmaceutical companies to create "highly complex combinations of incompatible active ingredients ... in one dosage form," Sancilio remarks. He adds that the machine facilitates mixtures that have sophisticated release profiles.

SCI HGE 1200 encapsulator (Sancilio and Co.)

The encapsulator's design gives it a footprint of 32 in.² The machine's electronics unit is housed in a waterproof box that hangs on a bar outside the main body. The reduced footprint allows the machine to "fit in places that others can't go," according to Sancilio.

In addition, the encapsulator is primarily made of off-the-shelf components. This design facilitates maintenance, Sancilio explains.

Versatile drive offers quick setup

GE Consumer and Industrial (Plainville, CT) recently introduced its "AF-650 GP" drive to control mixers and material-handling equipment. Paul Bunnell, product manager for GE, says the drive has both heavy- and light-duty ratings and "can do a constant-torque and variable-torque load in the same drive."

AF-650 GP drive (GE Consumer and Industrial)

The unit's full display keypad facilitates setup. An "INFO" key built into the keypad is "analogous to having a manual online," Bunnell adds. The key provides parameter and setup information and status reports. In addition, the drive includes a Quick Menu of basic application parameters. The keypad also provides rotation-direction indication, custom user displays, trended data for speed, and torque.

The device's safe-stop functionality prevents it from starting unintentionally and eliminates the need for a separate unit to monitor the drive. This feature meets the EN 954-1 standard for Safety Category 3 installations.