Featured Editorial
Fault Tree Analysis: Uncovering The Root Causes Of More Complex Problems
 
By Ben Locwin, Ph.D.

A refreshed approach to fault tree analysis can be an incredibly helpful addition to your problem-solving armamentarium. Having the confidence to begin using it — or begin using it more often — is the first step toward getting more comfortable with it and mastering its effects and nuances.

Outsourcing Impact Of Focus On Innovative Treatment

In Q42017, ISR asked a follow-up question to respondents who agreed that their company’s focus on developing new innovative treatments will impact its outsourcing practices.

Industry Insights
Is Your Biologic At Risk For Protein Aggregation? Part 1
Article | By Martin Gonzalez, Ph.D., Pfizer CentreOne Contract Manufacturing

This is the first installment in a three-part series that examines what causes protein aggregation and practical steps you can take to mitigate the risk.

The Pharma Trends You Need To Know: A CDMO’s Perspective
Article | By Anil Kane, Patheon

Companies must understand how today’s new pharmaceutical landscape is causing a dramatic shift in how we plan for and execute drug development and manufacturing.

The Role Of Packaging In Supply Chain Management
Article | By Marvin Magasura, GlobalVision

In order to achieve successful supply chain management, packaging systems have to be connected with aspects of marketing, logistics, production, and the environment.

Bioburden Entry Points In Downstream Processing
Article | By Anastasia G. Lolas/M.Sc., Visionary Pharma Consulting LLC

Tips to prevent bioburden entry and proliferation and to reduce the complexity of the equipment and processes involved.

Pharmaceutical Serialization: Is Your Data Management System Ready?
Article | By Nicolas Girard, Ropack Pharma Solutions and Graham Clark, TraceLink

The FDA’s intent to not enforce the requirements of the Drug Supply Chain Security Act until November 2018 offered an additional year to meet compliance. The deadline for that grace period is now!

A Practical Approach To GMP Cleanrooms And Cleanroom HVAC
Article | By Markku Mäkinen, Elomatic

ISPE has provided a set of tools that facilitates a clearer understanding of the application of di€fferent GMP regulations, standards, and guidelines in everyday work.

Aseptic Blow-Fill-Seal: A Sustainable Process For Packaging Pharma Liquids
White Paper | By Chuck Reed, Past ISPE Chairman, Packaging COP

Aseptic blow-fill-seal systems for packaging pharmaceutical liquids incorporate materials and processes that provide critical advantages for sustainable initiatives.

Recommended Mixing Equipment For Tablet Coatings
Application Note | By Christine Banaszek, Charles Ross and Son Company

Designed for high-speed powder dispersion, the Ross Solids/Liquid Injection Manifold Mixer is well-proven in the preparation of tablet coatings. 

Cleaning Validation For Medical Device Manufacturing
White Paper | Alconox, Inc.

Cleaning validation or verification is a necessary regulatory compliance step in medical device manufacturing and reprocessing. Support from the cleaner manufacturer can save time and money.

Industrial Vacuum Cleaners: A Breath Of Fresh Air
White Paper | Nilfisk Industrial Vacuums

From research and development to packaging, contamination threatens to destroy the reputation of a product or a whole company, and even infringe on workforce safety, all of which can cost millions.

High-Volume Manufacturing: Essential Points To Consider Before You Scale Up
White Paper | B. Braun OEM Division

To successfully scale to high-volume manufacturing planning is required for streamlining the production process and minimizing the changes that could add unnecessary time and expense to the process.

Life Science Leader Magazine
 

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