Drug Development

Bruno C. Hancock is a scientist in the solids development group at Pfizer.

Articles

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.

X-ray Microtomography of Solid Dosage Forms

James P. Agalloco is the president of Agalloco & Associates, P.O. Box 899, Belle Mead, NJ 08502, tel. 908.874.7558, jagalloco@aol.com. He is also a member of Pharmaceutical Technology’s editorial advisory board.

The sterility testing of samples from an aseptic process may be considered an entirely separate aseptic process that is subject to the same types of adventitious contamination as the aseptic process itself.

Importance of Background Microbial Levels in the Manufacture and Testing of Sterile Products

An increasing number of new compounds are being introduced into pharmaceutical pilot plants.The knowledge base for these compounds regarding their toxicities,physical handling, and cleaning is limited.The authors examine various approaches for addressing the cleaning validation of new compounds and discuss the role of determining appropriate visible residue limits.

Using Visible Residue Limits for Introducing New Compounds into a Pharmaceutical Research Facility

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

Comparative Evaluation of Three Active Air Samplers for the Monitoring of Airborne Microorganisms

What the industry needs most is not reduced oversight. What we need is, competent, constructive, informed, consistent, fair, and predictable inspection.

Famine in Field Inspection

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.

Establishing Target Fills for Semisolid and Liquid Dosage Forms

The authors argue that chlorine dioxide (CD) is a safe and effective decontaminating agent that can be used for challenging applications.The effectiveness of CD gas for sterilizing complex isolator systems is studied.

Isolator Decontamination Using Chlorine Dioxide Gas

Managers of FDA-regulated firms must be proactive in how they manage their company's compliance with good manufacturing practices regulations.

Management Controls for GMP Compliance

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.

Process and Scaling