In this troubled economy biopharmaceutical companies are struggling to keep prices down, get new products to market faster, all while maintaining superior quality control, sterility, and safety.

This increased pressure means companies must design and build new facilities and cleanrooms faster while keeping contamination control a priority. Modular cleanroom systems may be a means to keeping costs down along with being a time effective answer to immediate enclosure needs. In “Modular Cleanrooms for Business Startups and New Product Development,” Kevin Weist discusses the considerations and options of using modular cleanrooms.

Along this same vein, Kimberly Kirkland, B.Sc., M.P.H. focuses on the quality and control aspects of USP 797 as they relate to the immediate environment in which compounded sterile preparations (CSPs) are prepared. USP 797 contains specific requirements for ongoing air and surface evaluations to ensure product sterility and safety. Increasingly, affected organizations are realizing the importance of USP 797 compliance.

And summing up more thoughts on this topic in his Regulatory Forum, Bikash Chatterjee, writes about “Meeting the Global Compliance Challenge.” He states that there can be no doubt that the last decade for the pharmaceutical and biotech industry has been full of extraordinary change. Regulatory changes underscore the reality that our industry needs to evolve.

INTERPHEX 2010
Later this month we will be attending INTERPHEX 2010 April 20 – 22 at the Jacob K. Javits Center in New York.

For more than 30 years, INTERPHEX has served as the world’s largest and most trusted meeting place for leading-edge technology, education, products, services, capabilities, and networking that drive scientific and process innovation in FDA regulated drug manufacturing—from development to market.

Within the pages of this issue we feature an INTERPHEX Product Showcase which includes some new and/or improved products that will be highlighted by vendors. This is just a small sampling and no doubt there is much more to see when you are on the exhibit floor.

Please come visit us at INTERPHEX! Controlled Environments Magazine® strives to provide the most current information to contamination control professionals. We want to meet with our colleagues and talk with industry experts who can bring new perspectives to controlled environment issues.

See you there!