Robustness Study for Hydrophilic Matrix Tablets of METOLOSE^® SR using QbD Sample Kit
Author: Sakae Obara
Sponsored By: Shin-Etsu Chemical Co., Ltd.
A sample kit of Hypromellose having different viscosity levels, hydroxypropoxy content, and particle size was applied to a robustness study of a hydrophylic matrix tablet of dipyridamole.

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.

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.

Pfizer Successfully Implements Endosafe^® Endotoxin Testing Platform
Sponsored By: Charles River Lab
Over the last 3 years, Pfizer has assessed the Endosafe^® rapid test methods on dozens of applications and gathered extensive data to support comparability to USP <85> and PharmEur. 2.6.14 Bacterial Endotoxin. This poster, which was presented by Pfizer at the 2014 PDA Annual Meeting, provides a summary of the methodology, Endosafe^® platform, collected data to support compatibility to traditional methods, examples of implementation and the operational benefits realized.

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

NEW eBook: Using GAMP to Validate Monitoring System Software
Sponsored By: Vaisala
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.

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.

Techniques for Reducing the Effects of Sample Solvent on UHPLC Analyses
Authors: Kenichiro Tanaka and William Hedgepeth
Sponsored By: Shimadzu
For HPLC, sample solvents that adequately dissolve target compounds are required; therefore, sample solvents that contain a high concentration of organic solvent are often used for reversed phase chromatography. However, these solvents sometimes cause peak broadening. This paper presents techniques to reduce the effects of sample solvents using recent widespread UHPLC analyses as examples.

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.