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.

Rouge & Biofilm: Compounding Cleaning Challenges
Authors: Michael Gietl, Paul Lopolito
Sponsored By: Steris Corporation
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.

5 Rules of Sensor Placement in Validation/Mapping Applications
Sponsored By: Vaisala
New Good Distribution Practice (GDP) regulations explicitly assign responsibility for compliance to the entire distribution network. This means that a large number of previously unregulated entities must now secure their portion of the cool chain, by performing mapping studies. This has created a demand for clear and concise guidance to support mapping studies, and at the forefront of this demand are the two questions: 1) where to place sensors, and 2), how many sensors to use. To meet this demand we developed the “5 Rules of Senor Placement.” Using a heuristic approach, these rules can guide a new mapping practitioner to a reasoned rationale for sensor placement in mapping studies, and supply much needed guidance in this basic and critical validation activity.

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.

Gut Microbes and Medicines: How the GI environment impacts drug metabolism
Author: Oliver Grundmann, PhD
Sponsored By: University of Florida Pharmaceutical Chemistry
A wide range of factors determines the safety and efficacy of a drug. For example, microorganisms in the gastrointestinal tract impact how a drug gets metabolized. Topics in this discussion include: How variable is the microbial composition in the human gut? What models are being used to study the gut microbiome and its influences on drug metabolism? What role does pre-systemic drug metabolism play in the effectiveness or also in the toxicity of a drug (and impact on drug formulation)?

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.

EMC^® DOCUMENTUM ^®QUALITY AND MANUFACTURING
Sponsored By: EMC Life Sciences
Centrally control quality documentation to streamline processes and support compliance.

Ultra-high Speed HPLC Analysis of USP Methods within the New USP General Chapter 621 Allowed Limits
Authors: Kenichiro Tanaka, and William Hedgepeth
Sponsored By: Shimadzu
This paper examines the key parameters of allowed HPLC adjustments in the current and revised USP general chapter 621. It then demonstrates the successful transfer to an ultra-high-speed method, reducing analysis time and solvent consumption, and the ability to run on a UHPLC system without changing method parameters.

Tamoxifen Release from EVA Copolymers
Author: Jose Reyes
Sponsored By: Celanese
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.

Try L-HPC (Low-Substituted Hydroxypropyl Cellulose) to Formulate Solid Dosage Forms with Good Stability
Author: Sakae Obara
Sponsored By: Shin-Etsu Chemical Co., Ltd.
L-HPC (Low-Substituted Hydroxypropyl Cellulose) is a pharmaceutical excipient that has been used as a disintegrant and binder for many years.  Since it is less interactive with APIs compared to other excipients, solid dosage forms with good stability can be formulated using L-HPC.

Effect of Particle Size of HPC on Tablets Prepared by High Shear Mixer Granulation
Authors: Kenji Sugisawa, Shinichiro Tsue
Sponsored By: Nisso America Inc.
This study evaluates the effect of particle size of HPC on granule size distribution, properties, and drug release of tablets prepared by high shear mixer granulation (binder dry-mixing method) using acetaminophen as a model drug.

Extractables and Leachables Testing for Medical Applications
Author: Michael Ruberto, Ph.D.
Sponsored By: Impact Analytical
Polymer materials offer many benefits when used for packaging in medical applications.  It is important however, to thoroughly assess potential leachables by designing appropriate extractables conditions.   A materials-based approach to facilitate the identification and quantitation of all extractables and leachables is presented.