Manufacturing

Pharmaceutical Science & Technology Innovations

This month's column highlights some of the latest innovations in packaging seen at this year's Interphex conference.

The authors examine the VHP resistance of microbial isolates recovered from controlled environments and compared them with commercially available biological indicators under various test conditions.

Rapid structural elucidation of compounds in complex mixtures is a powerful technique in metabolite, degradation and process control applications. The ability to follow the fragmentation pathway through sequential MSn transitions provides added confirmation and increases the selectivity for monitoring compounds of interest in a complex mixture. Previously, the limiting factors in applying this technique were sensitivity at MS4 and higher transitions, and the cycle time required to acquire multiple MSn spectra across a narrow LC peak. Recent developments in trapping, detection efficiencies and scan rates have reduced these limitations and enabled rapid characterization of multiple compounds from single chromatographic runs.

Resolving the asset headache - the author explains how effective asset management can enable pharmaceutical companies to boost operational profit, increase production uptime and adhere to regulatory standards.

Tosoh has developed a new product - Toyopearl Toyoscreen that allows fast identification of the optimal resin for your sample. You can develop the optimal conditions for the separation in addition to the determination of the dynamic binding capacity. All the resins prepacked in these columns are real process resins concerning particle size. Results on the small columns can be scaled up to production.

If an inspection reveals any shortcomings ... a manufacturer may be warned, fined, or its facility closed down until full control can be demonstrated to the satisfaction of the authorities ....

Automated actuation of nasal sprays removes operator bias during measurement of particle size, spray-plume geometry, and delivered dose.

The electronic tongue technology provides a technically suitable and cost-effective method for screening and directing taste formulation, while eliminating both safety concerns and subjective bias.

Pharmaceutical Science & Technology News

In part two of a series of three articles, mixing rates and mechanisms are examined using rectangular bin blenders and two free-flowing mixtures.

As FDA prepares for the Critical Path initiative, offices across the agency are expanding the use of the risk-based approach to regulation and applying a quality systems approach to internal operations.

Pharmaceutical Science & Technology Innovations

The limitation-of-risks (LR) method can be used as an engineering tool in risk assessment work for the identification, minimization, and evaluation of potential airborne risks, and for the identification of adequate monitoring points.

The authors outline stability studies designed to evaluate the effect of temperature excursions on product quality that may occur during distribution.

The role of microbial testing to ensure the sterility of aseptically filled sterile products is explained, from the product development phase to in-process monitoring to finished product testing.

The American society of Mechanical Engineers's Council on Codes and Standards has formed 10 subcommittees to update and broaden the scope of the BPE standards.

Comprehensive Web sites, journals, and other sources help pharmaceutical makers find packaging-related data quickly and easily.

Technologies ranging from new expression systems to PAT-inspired analyzers are driving biotech manufacturing forward to keep up with demand.

pharmaceutical science and technology innovations

Pharmaceutical Science & Technology Innovations

pharmaceutical science and technology news

Added functionality excipients facilitate the development of novel drug delivery methods and improve processing techniques.

Currently, high-production rates and continuous production processes favor existing tableting technologies. However, if tablet development becomes rate-limiting in the future, alternative technologies may prove attractive.

Some of the common problems faced by formulators and how using ion exchange resins may be able to solve them are discussed.