Strategies for Successful Scale-Up Using Quality by Design
Sponsored By: DPT Laboratories
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.

Comparative Dissolution Profile – A Quality Control Tool
Authors: Sethu Ragupathy and Sunil Potdar
Sponsored By: SGS Life Science Services
In vitro methods to measure the dissolution rate of the API from the solid oral form are officially recognized by regulatory agencies as an important consideration when formulating solid-oral-dosage forms.

A Proactive Approach To Asset Management: Millions can be made by using a web-based asset management solution to keep track of idle pharmaceutical equipment and redeploy it elsewhere in the company
Sponsored By: EquipNet
A proactive approach to asset management is empowering life science companies to get control of their manufacturing and laboratory environments. By identifying idle and surplus equipment, and subsequently selling that equipment, these organizations are able to fund new capital purchases, recoup money from capital that they already own, and uncover value from equipment that would otherwise continue to take up precious space in their facility. An asset management program that incorporates equipment redeployment, secondary market sales, online auctions, and even recycling can garner millions of dollars.

Devolatilization/Solvent Extraction via Twin Screw Extrusion
Author: Charlie Martin
Sponsored By: Leistritz
Devolatilization (DV) is the process by which various amounts of unreacted monomer, solvent, water or other undesirable volatile contaminants are removed from a polymer melt. A twin-screw extruder (TSE) is a device that is commonly utilized to compound polymer formulations to facilitate specific end-product performance. Oftentimes, there are chase impurities in the polymeric system that needs to be cleansed, sometimes as a result of tighter governmental or commercial standards, or due to the deleterious effects the residuals may have on final product properties.

Improving Product Quality with Risk Assessment Tools
Author: Brenda Percy
Sponsored By: EtQ Inc.
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.

Evaluating Coder Technologies for Pharmaceutical Applications
Sponsored By: Videojet Technologies Inc.
Now that the deadlines for compliance are clear, pharmaceutical companies are fast transitioning from planning to implementation. And while serialization is a complex topic, working with a qualified coding provider can help you take one challenge off the agenda. Serialization success starts with a high-quality code on your packaging.

Complying with Combustible Dust Standards
Authors: David Steil, Tony Supine, and Mike Walters
Sponsored By: Camfil Air Pollution Control
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.

Evaluation of a New Co-Processed Excipient “SmartEx” for Orally-Disintegration Tablets
Author: Sakae Obara
Sponsored By: Shin-Etsu Chemical Co., Ltd.
A new co-processed excipient “SmartEx” has been developed for orally disintegrating tablets. The white paper contains results of studies on its physical properties, tablet performance, and stability.

HPC for Orally Dissolvable Film
Authors: Kenji Sugisawa, Shinichiro Tsue, Yoshiko Takeuchi, and Hirofumi Takeuchi
Sponsored By: Nippon Soda Co., Ltd.
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
Author: Michael Ruberto, PhD
Sponsored By: Impact Analytical
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.

Charles River Accugenix MALDI-TOF Enhancements for Bacterial Identifications
Authors: C.E. Farrance, N. Patel, and A. Russell
Sponsored By: Charles River
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.

Product Manufactured for Its Intended End Use
Author: Dora Meissner
Sponsored By: BioSpectra
The goal of manufacturing a product for its intended end use provides an additional level of security to the product.

Three Steps to USP H₂O Success
Author: Geoff Sheffrin
Sponsored By: OBK Technology Ltd.
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.

One Machine, Three Container Types
Author: Felix Henning
Sponsored By: Optima Packaging Group GmbH
Great progress continues to be made in the flexibility of packaging processes. With state-of-the-art equipment from Optima Pharma, it is now possible to process three different container types, nested syringes, nested vials, and nested cartridges, on a single machine.