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.

Extractables & Leachables: Options for ensuring effective extractables testing Author: Eric Hill
Sponsored By: Impact Analytical
This comprehensive guide on extractables and leachables includes reporting from industry experts on these areas of expertise:

• Polymer knowledge: Using extractables and leachables studies to keep products safe—An interview with Eric Hill, President, Impact Analytical
• Extractables and leachables testing for medical applications: Managing the medical risks of using polymers
• Characterization of odor and taste components using olfactory detection and solid phase microextraction GC-MS: Ensuring products are delivered to consumers as intended
• Comparison of extraction techniques: Quantitative extraction of polymeric materials

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.

Pfizer Successfully Implements Endosafe^® Endotoxin Testing Platform
Sponsored By: Charles River Lab
Abstract: 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 Pharm.Eur. 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.

Devolatilization/Solvent Extraction via Twin Screw Extrusion
Author: Charlie Martin Lab
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.

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.

Review of Application of HPMCAS in Hot Melt Extrusion Technology
Author: Sakae Obara
Sponsored By: SE Tylose USA, Inc. (Shin-Etsu Chemical Co., Ltd.)
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.

Stability Evaluation of Amorphous Solid Dispersions (ASDs) of Felodipine (FLD) during Storage and Biphasic Dissolution
Authors: L. Sarode, S. Malekar, C. Cote, and D. R. Worthen
Sponsored By: Nisso America
The purpose: to compare HPC-SSL versus PVP-VA as pharmaceutical formulation excipients for the production of hot melt mixed ASDs of FLD.

Differentiation of Drug Particle Agglomeration in OINDPs
Authors: Oksana Olkhovyk, Diem Ngo and William H. Doub
Sponsored By: Gateway Analytical
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.

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.