Pharmaceutical Technology, Nov 1, 2008 - Pharmaceutical Technology

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PharmTech Europe

Pharmaceutical Technology, Nov 1, 2008
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USP <1117> "Microbial Best Laboratory Practices": An Interview with Scott Sutton
By Maribel Rios
Scott Sutton discusses the current state of USP ‹1117› and USP's plans for future revisions.
Guidelines for Selecting Normal Flow Filters
By Jonathan Royce , Jeffrey Carter, PhD , Jakob Liderfelt
Proper selection of normal flow filters leads to increased process efficiency from early phase product development through to full-scale biopharmaceutical production.
Comparison of Conventional Cleanrooms, Restricted Access Barrier Systems, and Isolators
By Maurizio Battistini
A comparison of conventional cleanrooms, restricted access barrier systems, and isolators, shows the benefits of using isolators in high-potency drug manufacturing.
Considerations on Re-Use of Sterilizing-Grade Filters
By Jerold M. Martin
The author examines re-use of hydrophilic- or hydrophobic-membrane sterilizing-grade filters in liquid sterilizing applications.
Improving the Integrity Test Assurance of Multiround Housings Assessments
By Pascal Martin , Magnus Stering , Maik W. Jornitz , Jens Meyer
The authors describe a novel approach for the integrity testing of large sterile filter systems such as multiround housings and describe a multipoint diffusion test capable of detecting minor failures.
Establishing Material Compatibility, Process Conditions, and Bubble Points of Filters
By Brian K. Meyer , Diego Vargas
The authors explain the factors that can cause a failure in a bubble-point integrity test and what to consider when a product-specific bubble point must be defined.
Manufacturing High-Potency Drugs Using Isolators
By Maurizio Battistini
The author discusses the key issues to consider when using isolators such as containment, protection of personnel, the efficiency of biodecontamination cycles, sterility assurance levels, barriers and their integrity, and environmental impact.
Freeze-Drying with Closed Vials
By Jacques Thilly , Yves Mayeresse
The authors present an aseptic-filling process for freeze-dried liquids using the closed-vial technology.


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FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
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Jill Wechsler Regulatory Watch Jill Wechsler Data Integrity Key to GMP Compliance
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