September / October 2013 Cover

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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.

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.

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.

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.

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).

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.

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.

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.

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.

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.

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.

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