Troubleshooting - Pharmaceutical Technology

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PharmTech Europe

Troubleshooting

Determining Facility Mold Infection

October 2, 2014

Pharmaceutical Technology

The recovery of an occasional mold does not merit any particular concern. On the other hand, evidence of mold proliferation indicative of infection of facilities or equipment must be taken seriously and requires the prompt implementation of corrective and preventive actions.

Solving Tablet-Sticking Problems with I Holland's Predictive Model

September 23, 2014

I Holland, in collaboration with the University of Nottingham and experts from the Laboratory of Biophysics and Surface Analysis, United Kingdom, recently completed a two-year tableting science anti-stick research (TSAR) project, which sought to understand why certain formulations stick to tablet tooling.

Complying with Revised Weighing Guidelines

August 2, 2014

Pharmaceutical Technology

The latest revisions to the USP General Chapters <41> Balances and <1251> Weighing on an Analytical Balance aim to ensure weighing accuracy and eliminate unnecessary overtesting by simplifying previous descriptions and reflecting current state-of-the-art weighing practices.

Multifactor Non-linear Modeling for Accelerated Stability Analysis and Prediction

July 2, 2014

Pharmaceutical Technology

The right approach can provide a clear, statistically defendable method for determining dissolution and accelerated stability.

Understanding the Cleaning Validation Lifecycle

April 16, 2014

Equipment and Processing Report

The cleaning validation lifecycle includes assessment, development, validation, and monitoring.

Defining the Sterile Barrier of Complex Drug Delivery Systems

March 17, 2014

Equipment and Processing Report

New injection-delivery systems with multiple closure points pose challenges for container closure integrity testing.

Separation of Compliance and Performance Under FDASIA

March 2, 2014

Pharmaceutical Technology

The root cause of drug shortages is mismanagement of variation.

Checklist for Computer Software Validation

February 2, 2014

Pharmaceutical Technology

Non-compliance issues show that users find dealing with computer systems challenging.

Battling Off-Weight Tablets

January 2, 2014

Pharmaceutical Technology

Training, calibration, and preventive maintenance help prevent over-and under-weight tablets. The author discusses causes of off-weight tablets and best practices for tableting.

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Jill Wechsler Regulatory Watch Jill Wechsler Biopharma Manufacturers Respond to Ebola Crisis
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