In the Spotlight January 2011

Published on: 
Pharmaceutical Technology, Pharmaceutical Technology-01-02-2011, Volume 35, Issue 1

A look at manufacturing products in process control.

Editors' Picks of Pharmaceutical Science & Technology Innovations

The production lines that create small- and large-molecule dosage forms can be long and complex. Each step of the process must be monitored carefully to ensure that the resulting drug product meets its specifications and is free from contaminants. This month's products help manufacturers understand and control their production processes. Updated software from Yokogawa makes it easier than before for users to find and view process data. Mettler Toledo's workstation allows operators to ensure the safety of chemical reactions. Personnel can monitor several cell-culturing processes in real time with Stratophase's optical microchips.

Control system eases access to information

Version R4.03 of Yokogawa's (Sugar Land, TX) Centum VP production-control system incorporates an enhanced operator interface to batch software. Operators now can locate, deploy, and monitor recipes in fewer keystrokes than before. The interface also displays parameters such as elapsed time, unit status, and operation identification in one overview screen when a control recipe is running. Users thus do not have to seek information in several locations.

Centum VP software Yokogawa

In addition, the Centum VP software's operator interface uses frames and structured windows to simplify access to data and displays. Users can move between tabs with keystrokes to find information quickly, rather than calling up a new display or linking to a separate display. Yokogawa also has modified the software's trend display system. A single screen allows users to compare batches' performance with that of a reference batch.

Technology allows real-time monitoring of cell cultures

Stratophase's (Romsey, UK) SpectroSens optical microchips allow real-time, in-line monitoring of cell-culturing processes. Because the technology can monitor several parallel processes from a single control unit, it is appropriate for environments that use multiple bioreactors for development, pilot, or commercial-scale production. The technology's optical microchip sensors can be incorporated easily into multiple-use insertion probes or disposable probe formats. The output signal from SpectroSens optical microchips helps personnel identify and maintain optimal growth conditions.

SpectroSens optical microchips Stratophase

Workstation enables control of strong reactions

Mettler Toledo's (Zürich) RC1e process-safety workstation enables users to assess and control chemical reactions for creating active pharmaceutical ingredients. The workstation is based on heat-flow calorimetry, and its integrated measuring devices provide accurate and reproducible measurements of process parameters such as temperature, pressure, and pH. The unit tracks heat data in real time and allows users to optimize process parameters while a reaction is in progress.

RC1e process-safety workstation Mettler Toledo

Using information collected by the thermostat, the system calculates data such as heat transfer coefficients, specific heats, heat-flow rates, and thermal accumulation. The workstation converts basic data into crucial safety information. The safety runaway graph describes failure scenarios and helps users avoid runaway reactions, and a graph indicates the process's level of criticality.

The system is controlled by flexible software that integrates with online analytical tools. Operators can run predefined, automated procedures; directly control individual process steps with the system; or combine both approaches.