Whitepapers - Pharmaceutical Technology

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PharmTech

Latest Issue
PharmTech Europe

Whitepapers

Complying with Combustible Dust Standards

August 27, 2014

Dust collector explosions are a danger in many industries, but the pharmaceutical industry is particularly at risk. Does your dust collection system comply with combustible dust standards? This white paper reviews the OSHA National Emphasis Program for combustible dust, the NFPA standards that address explosion hazards, and the types of equipment used for explosion protection.

Review of Application of HPMCAS in Hot Melt Extrusion Technology

August 27, 2014

HPMCAS (Hypromellose Acetate Sucinate) has been used for enteric coating and solubility enhancement for over 30 years. This white paper shows basic data of this polymer for solubility enhancement using melt-extrusion process.

Differentiation of Drug Particle Agglomeration in OINDPs

August 27, 2014

This whitepaper presents the results of a collaborative study with the FDA that reviewed the effects that can occur in aqueous nasal spray suspensions during long-term shipping or storage conditions. Having the knowledge of the environmental conditions and their effects on OINDPs may benefit developers of formulations containing multiple APIs and/or excipients such as nasal suspensions, dry powder inhalers, and metered dose inhalers.

Strategies for Successful Scale- Up Using Quality by Design

July 30, 2014

This executive summary will outline best practices for ensuring successful scale-up for manufacturing finished drug products by offering a systematic approach and technical case studies for implementing QbD through development to scale-up to commercial manufacture.

Improving Product Quality with Risk Assessment Tools

June 25, 2014

With the product lifecycle moving so fast, many organizations may ask the question, "How can we effectively measure quality?" The answer is risk management. Learn the elements of risk management and how they help to identify, prevent, and mitigate risk throughout an organization.

NEW eBook: Using GAMP to Validate Monitoring System Software

May 27, 2014

Learn how to use the GAMP methodology to validate monitoring system software. This ebook describes a 10-step process to help ensure your environmental monitoring systems align with both your QMS and good practice as described by the ISPE. Also, learn about the category of system that best suits your qualification capabilities and how to manage costs and risks.

Tamoxifen Release from EVA Copolymers

July 30, 2014

As a unique and important controlled-release excipient, EVA was evaluated in the study with selected active pharmaceutical ingredients (API). The API solubility and release profiles were studied using Hansen Solubility Parameter calculations and experimental in-vitro elution. The paper demonstrates a method that can be used for initial formulation design for controlled drug delivery from EVA copolymers.

Rouge & Biofilm: Compounding Cleaning Challenges

July 30, 2014

Rouge and biofilm are commonly found in pharmaceutical manufacturing vessels and process piping. The presence of rouge on stainless steel surfaces may promote the development of biofilm and make it more difficult to remove. A robust cleaning and derouging procedure followed by process disinfection can be effective in controlling microbial contamination associated with biofilm.

NEW eBook: Strategic Cold Chain Management

July 30, 2014

Get this eBook on USP and EU GDP guidance, including the latest revisions from the U.S. Pharmacopeial Convention and Good Distribution Practices according to the European Commission. This PDF outlines simple, applicable recommendations on following the guidance, and forthcoming changes.

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Survey
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
70%
Breakthrough designations
4%
Protecting the supply chain
17%
Expedited reviews of drug submissions
2%
More stakeholder involvement
7%
View Results
Eric Langerr Outsourcing Outlook Eric LangerRelationship-building at Top of Mind for Clients
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerRisk Reduction Top Driver for Biopharmaceutical Raw Material Development
Jill Wechsler Regulatory Watch Jill Wechsler Changes and Challenges for Generic Drugs
Faiz Kermaini Industry Insider Faiz KermainiNo Signs of a Slowdown in Mergers
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