Whitepapers - Pharmaceutical Technology

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PharmTech Europe

Whitepapers

Risk-Assessment Strategy for Validating Environmental Monitoring Software

November 26, 2014

In this pre-recorded 30-minute webcast, Vaisala’s Senior Regulatory Expert Paul Daniel, explains how to use risk-assessment tools to determine the validation requirements of computerized environmental-monitoring systems. This information will help to determine what to test and how to defend decisions during an audit.

A New Developmental Grade of HPMCAS That Has a Lower Glass-Transition Temperature

November 26, 2014

A new developmental grade of HPMCAS was evaluated. This grade has a lower Tg compared to the conventional grade and can be extruded at a lower temperature in the HME process.

Pharmaceutical Development for ADCs

November 26, 2014

A new developmental grade of HPMCAS was evaluated. This grade has a lower Tg compared to the conventional grade and can be extruded at a lower temperature in the HME process.

Charles River Accugenix® MALDI-TOF Enhancements for Bacterial IDs Enable Improved Root Cause Analysis

November 26, 2014

Library coverage is often a topic of discussion for microbiologists wanting to know what the impact or relevancy of the Charles River Accugenix® library databases is on the identification of environmental, EM, or industrial microorganisms. As a contract laboratory service provider offering both sequencing (AccuGENX-ID®) and MALDI-TOF-based identifications (AccuPRO-ID® and the Axcess system), Charles River has the ability to compare reference libraries based on the microorganisms that we identify and analyze the reportable rates.

Three Steps to USP H2O Success

November 26, 2014

USP water systems are highly specific in their requirements. To get there successfully is relatively easy, BUT you are dealing with a large number of detailed requirements that MUST work in harmony to produce reliable Purified Water or Water for Injection cost effectively and with minimum maintenance. Here's how.

Extractables & Leachables Testing for Medical Applications

October 29, 2014

Polymers may be used to fabricate medical devices imparting lightweight, flexible, and durable characteristics. However, if consideration is not given to polymer stability, degradation can occur, and influence mechanical properties.

Product Manufactured for Its Intended End Use

October 29, 2014

The goal of manufacturing a product for its intended end use provides an additional level of security to the product.

HPC for Orally Dissolvable Film

October 29, 2014

We evaluated the applicability and effectiveness of HPC in Orally Disintegrating Films (ODFs) by varying the API, excipient, and molecular weight of HPC. Based on the results of the evaluation, ODFs could by prepared using HPC as the base material.

Extractables & Leachables Testing for Medical Applications

October 29, 2014

Polymers may be used to fabricate medical devices imparting lightweight, flexible, and durable characteristics. However, if consideration is not given to polymer stability, degradation can occur, and influence mechanical properties.

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Jim Miller Outsourcing Outlook Jim MillerOutside Looking In
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerAdvances in Large-Scale Heterocyclic Synthesis
Jill Wechsler Regulatory Watch Jill Wechsler New Era for Generic Drugs
Sean Milmo European Regulatory WatchSean MilmoTackling Drug Shortages
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