Manufacturing

A comparative study of three air samplers used for bioaerosol collection was performed to evaluate the average recovery of colony-forming units and to assess the precision of each device.

X-ray microtomography has great potential for improving the understanding of the structural features of solid dosage forms and the changes in those features during manufacturing, handling, and storage. This article describes the basic principles of the technique and provides examples of its potential applications.

The validation of alternative microbiological testing is an opportunity for a manufacturer to decrease the amount of time required for laboratory results. To properly validate these alternatives, a practitioner must first identify what is being studied. The regulatory effect on established product and process specifications and levels must be completely evaluated, as changing the method of analysis may well change the apparent number in the sample.

To meet the requirements of the USP ?755? Minimum Fill and ?698? Deliverable Volume tests, target fill levels greater than 100% must be established. This article proposes a criterion for establishing an appropriate target fill level such that a sample will have a 95% probability of passing these USP tests at 95% confidence.

How important will anticounterfeiting measures become to protect the European pharma industry?

This article examines the importance of core design and formulation on the quality of a film coated tablet...

Warning Letter: Germiphene

Warning Letter: Germiphene

Emissions control has long been a primary concern for the pharmaceutical processing industry in Europe, which relies on the use of a number of organic solvents for the manufacture of pharmaceutical products...

The limited effectiveness of some existing drugs and demand for new therapeutic candidated for complex diseases has spurred the development of the biopharmaceutical market...

This article describes the approach to maintenance management that delivers enhanced compliance for direct impact GMP systems...

Shortages of Key Drugs

"Stable Liquid" Technology Permits Heptavalent Vaccine Against Botulism

Novel Microbial Expression System Yields Dowpharma-Pfizer Agreement

Nanoparticle Synthesis Process Facilitates Chiral Separations

UK MHRA Okays Chiron Flu Vaccine Plant; FDA Approval Still to Come

FDA Approves Treatment for Smallpox Vaccination Side Effects

Nanoparticle Synthesis Process Facilitates Chiral Separations

Big Pharma Companies Team Up to Develop Once-Daily, Triple-Combination HIV Drug

Pharmaceutical packaging can no longer be an afterthought in pharmaceutical product development.

Some published articles purport to demonstrate the difficulties and problems of the laser diffraction technique without mentioning that these apparent problems are inherent in all particle-sizing techniques. This article discusses some of the advantages of using laser diffraction for particle sizing-including repeatability, ease of verification, and speed of measurement-and why it has become the preferred technique in a range of industries.

After a five-year downturn, cautious optimism is taking hold among API manufacturers.

pharmaceutical science and technology innovations

IPEC-Americas has just completed a major update to its significant change guideline to address current issues in the manufacture of excipient ingredients and to assist manufacturers in developing an impurity profile.

This article outlines a comprehensive approach for organizing a firm's aseptic operations, including planning for routine and nonroutine interventions, establishing effective process simulations, and determining which vials to incubate.

The authors evaluate the implications of product photosensitivity and how it influences various aspects of product development. They discuss a product photosensitivity classification system and present a photosensitive pharmaceutical product case study.

New fixed-dose combination drugs aim to enhance safety and efficacy, while regulators clear a path for more drug–device combination products.

The author reviews dimensional analysis as a straight-forward approach to scale up.

The author describes strategies for analytical method development that are helpful in achieving quality by design and efficiency.

The author points out some major obstacles to effective scale-up and describes methods available to pharmaceutical scientists for addressing scalability issues.