Manufacturing

US District Court Rejects FDA Suit to Block Device Manufacturer

Novartis Purchases Chiron in a Total Buyout

The authors present a new approach to risk assessment for aseptic processing that emphasizes the contributions of personnel.

The authors focus on the effects of cellulosic materials during the performance qualification validation of a transfer barrier isolator used for the purpose of sterility testing.

Making active pharmaceutical ingredients (APIs) requires long chains of chemical reactions and large quantities of solvents. Ask API manufacturers how they'd like to improve this process, and the responses are likely to be "make the reactions faster," "make the reactions cheaper," or "make the reactions more efficient." Then after all these economically driven answers, you might here, "make the reactions more environmentally friendly."

The common crystal form of ibuprofen was changed to optimize processing and manufacturing properties. Six modified crystal forms were prepared and assessed for dissolution, morphology, particle size, density, thermal characteristics, powder x-ray diffractometry, flow properties, and tabletability.

To implement process analytical technology systems into the current information technology landscape, manufacturers will need to adopt continuously available systems and infrastructures.

The EU ATEX Directive 1999/92/EC (ATEX 137) regarding the minimum requirements to protect the health and safety of workers potentially at risk from explosive atmospheres came into European law in January 2000. In the UK, the ATEX 137 Directive has been implemented as part of the Dangerous Substances and Explosive Atmospheres Regulations (DSEARs), which were issued in December 2002.

Process industries are faced with increasing demands for product safety, improved quality, efficiency and profitability. The chemical, pharma and cosmetic industries are no exception.

Virtual labels eliminate the need for troublesome transfer ribbons or inkjet fluids, which are inherent with traditional labelling technologies.

Performing studies to mathematically 'correlate' swab and rinse sampling values does not add any value. What's more, do not expect them to mathematically correlate.

A range of insect exterminator equipment has been developed to improve the level of hygiene offered to the pharmaceutical and chemical manufacturing sectors. Berson's Insectron range uses ultraviolet (UV-A) and green light to attract flying insects, which are sensitive to these light sources.

Sigma-Aldrich Fine Chemicals (SAFC) has set up a new business division called SAFC Biosciences to encompass its biopharmaceutical development and cell culture-related manufacturing services.

Biomanufacturing managers believe the current lack of adequately trained personnel is one of the most serious problems facing the biomanufacturing industry.

Roche Plans New US Manufacturing Facility for Tamiflu while Cipla Prepares to Market Generic

Patheon, CEPH Begin Corrective Action Program for Omnicef OP

New 620 series pumps provide exceptional levels of performance, accuracy and output for biopharm manufacturers requiring low shear, hygienic fluid handling, with minimal downtime and long term cost savings. Flow rates are up to 18 litre/min and range features a choice of drives, two levels of PIN process protection and minimal downtime.

New Legislation To Ensure Stable Flu Supply

Design Exhibition, ?From Master?s Thesis to Medicine Cabinet?

Collaboration Targets Single-Shot Japanese Encephalitis Vaccine

Formulation residue, observer viewing distance, light intensity, viewing angle, observer viewing position, and observer-to-observer variability affect the ability to confirm the cleanliness of manufacturing equipment.

Formulation residue, observer viewing distance, light intensity, viewing angle, observer viewing position, and observer-to-observer variability affect the ability to confirm the cleanliness of manufacturing equipment.

A radiotracer technique is a simple, fast, and sensitive technique for analyzing the integrity of clinical supply packages to water.

Although patient compliance problems have been receiving attention for at least a decade, many medications are still dispensed in bottles that contain a supply intended to last days or weeks and require considerable effort on the part of the patient or caregiver to keep track of the dosing schedule. As a result, when it comes to consistently taking the right dose at the right time for the duration of a prescription, many consumers don't do a very good job.

Two scenarios demonstrate the need to use the percent of parent drug loss rather than the percent of degradation products formed when reconciling mass balance calculations.