September/October 2013
Volume 33, Number 5

NOTE: Pharmaceutical Engineering article PDF documents are not to be posted on any Web site, blog site or page, or any other internet site without prior permission from ISPE. (Copyright © 2013 ISPE. All rights reserved.)


 

Supply Chain Management

Labeling Pharma “Green” and Compliant in a Track and Trace World
by Dana Buker, David Loy, and Harini Pillalamarri
This update presents a discussion of the current regulatory landscape and how compliance and a “green” approach can merge for the benefit of suppliers, regulatory bodies, and the general public as well. The original article introduced arguments for the implementation of an electronic labeling system in the life science industries with a focus on the sustainable “green” benefits of electronic label management.
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Facilities and Equipment

Sustainability and its Relevance to the Pharmaceutical Industry
by Rob Bowen
This article demonstrates the relevance of sustainability to the pharmaceutical industry and presents a viable path to achieving sustainability in the industry.
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Energy Benchmarking in the Pharmaceutical Industry
by Josh Capparella
This article describes the role of energy performance benchmarking in the pharmaceutical industry, explains why large variations in building performance exist and how to use benchmarking data to drive meaningful results into a successful energy management program.
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Construction Waste Reduction
by Jessica Cochran and Alicia Pandimos Maurer
This case study presents the strategies and outcomes of implementing a plan to divert waste from the landfill and back into the supply chain during construction for building demolition waste reduction.
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Best Practices in Total Particulate Monitoring in Cleanrooms, RABs, and Isolators
by Members of the Heating, Ventilation, and Air Conditioning (HVAC) and Sustainable Facilities Communities of Practice
This article presents best practices when designing, qualifying, and routinely monitoring for total particulate (viable and non viable) in cleanrooms, Restricted Area Barrier systems (RABs), and manufacturing isolator systems, (excluding sterility testing isolators).
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Quantifying Green Manufacturing: An Environmental Assessment Primer from LEED to Benchmarking
by Kacy Wander
This article presents an introduction to corporate sustainability policy and compares several international building assessment systems and emissions reporting practices.
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Production Systems

Alternative Dechlorination Methods in Reverse Osmosis (RO) Applications
by Mark Wilf, PhD
This article examines the effects of different methods of water dechlorination on prolonging the lifespan of RO membranes used for industrial water treatment.
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Regulatory Compliance

A Review of Regulations and Developments in GMP and Supply Chain Integrity of Active Pharmaceutical Ingredients
by Sia Chong Hock, Katherine Loh Kai Xin, Vimal Sachdeva, and Chan Lai Wah
This article presents an overview of the current regulations and developments in good manufacturing practices and supply chain integrity of active pharmaceutical ingredients, and analyzes the challenges faced by regulatory authorities and industry.
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Are You Controlling Your Boundary?
by Stephanie Wilkins, PE
This article clarifies what constitutes a segregated and dedicated facility and discusses the risk of cross contamination if the boundary is not managed properly.
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Research and Development

Realizing Process Analytical Technology (PAT) in Process Development by Implementation of Near Infrared (NIR) Spectroscopy
by Michael Fowler, Janssen Vanderhooft, and Venkatesh Subramanyan
This case study demonstrates how using NIR spectroscopy in mix process development can shorten process development and scale-up timelines, accelerate time to market, enable generic products to include DoE, enhance the process knowledge, and optimize manufacturing processes for transdermal products.
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Product Development

Choosing the Optimal Hygienic Seal for Enhanced Process Performance
by Robert Dubiel and James D. Vogel, PE
This article presents how seals used in hygienic clamp fittings, diaphragm valves, and O-rings are integral to process performance, preventing leaks and contamination.
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Industry Interview

Pharmaceutical Engineering Interviews
by Julie Kim, Global Franchise Head of BioTherapeutics, Baxter International, Inc.

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Also Inside

From the Editor

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ISPE Update
- 2013 ISPE Annual Meeting – Your Competitive Advantage
- Getting FDA Approval for Breakthrough Therapies
- ISPE Releases Data from Drug Shortage Survey


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New Product Highlights and Classified Advertising with Advertiser’s Index

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President's Message

Industry Relies On ISPE and We Are Delivering
ISPE President and CEO highlights the technical programs and leadership initiatives underway as ISPE continues its focus on important manufacturing, technical, quality and regulatory issues to help members become more knowledgeable.
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Online Exclusives

ISPE Quality Metrics Project
by Christopher J. Potter on behalf of ISPE’s Quality Metrics Project Team
This article describes a groundbreaking ISPE initiative that will help move the pharmaceutical industry toward the “desired state” and address the problem of drug shortages by defining objective quality metrics to support a risk based inspection program.
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Packing Line Power Use and Heat Gain
by Martin Wheeler
This article discusses three approaches used to reduce energy usage in pharmaceutical processes.
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Global Regulatory News
This article describes a groundbreaking ISPE initiative that will help move the pharmaceutical industry toward the “desired state” and address the problem of drug shortages by defining objective quality metrics to support a risk based inspection program.
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NOTE: Pharmaceutical Engineering article PDF documents are not to be posted on any Web site, blog site or page, or any other internet site without prior permission from ISPE. (Copyright © 2013 ISPE. All rights reserved.)