Peer-Reviewed Research - Pharmaceutical Technology

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Peer-Reviewed Research

Ruggedness of Visible Residue Limits for Cleaning-Part III: Visible Residue Limits for Different Materials of Construction

October 2, 2013

Pharmaceutical Technology

The authors evaluated a variety of materials of construction (MOCs) and found that visible residue limits (VRLs) were higher on some MOCs than on stainless steel. The optimal viewing conditions were dependent on the MOC and the viewing background. The risk of a cleaning failure due to visual failure for different MOCs can be mitigated or eliminated using complementary cleaning validation studies.

Effective and Efficient Weighing of Potent Compounds

September 2, 2013

Pharmaceutical Technology

The advantages of using an automated powder dispensing system in a ventilated balance enclosure for efficient handling and effective containment of potent compounds are discussed.

Overcoming Limitations of Vaporized Hydrogen Peroxide

September 2, 2013

Pharmaceutical Technology

Vaporous hydrogen peroxide, used for sterilization and decontamination, is highly potent but presents implementation challenges.

Alternative Solvents for Extractables and Leachables Evaluation

August 2, 2013

Pharmaceutical Technology

The authors examine alternative solvents for extractables and leachables screening evaluation of process components that provide extraction equivalence and do not interfere chromatographically.

Evaluating Risk-Based Specifications for Pharmaceuticals

July 2, 2013

Pharmaceutical Technology

The author discusses the purpose of analysis and testing and the implications for specifications and their underlying statistical distribution.

Understanding Biological Indicator Grow-Out Times—Part II

June 2, 2013

Pharmaceutical Technology

The authors report on the range and distribution of grow-out times for biological indicators exposed to sublethal sterilization processes.

Methods for Identifying Out-of-Trend Results in Ongoing Stability Data

June 2, 2013

Pharmaceutical Technology

The authors discuss three methods for identification of out-of-trend (OOT) results and further compare the z-score method and the tolerance interval in OOT analysis for stability studies.

Understanding ICH Q11—FDA's Guidance on the Development and Manufacture of Drug Substances

May 2, 2013

Pharmaceutical Technology

The author provides a review of FDA's guidance document, Guidance for Industry: Q11 Development and Manufacture of Drug Substances, and its relation to the International Conference on Harmonization's Q11 document and its application to the industry.

Enhancing Particle-Size Measurement Using Dry Laser-Diffraction Particle-Size Analysis

May 2, 2013

Pharmaceutical Technology

The author examines dry dispersion and outlines the related analytical method development.

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