Con-trolled En-vi-ron-ment  – a surrounding that is regulated or verified

It is still spring as I write this, even though you are reading these words during our first forays into summer. Nonetheless, spring is the time for rebirth, for change, and for housecleaning. Sprucing up one’s surroundings is refreshing but takes a lot of work. In the case of a magazine, it involves more than lip service to the editorial mission; it also involves, in the caseof Controlled Environments, a change in definition and mindset.

Traditionally, we looked at the cleanroom as the controlled environment: a place to manufacture drugs, computer chips, and medical devices. But what reallyis a “controlled environment” and how can we benefit from the nameof our magazine to take us in new and exciting directions?

After attending both the PDA and INTERPHEX meetings, it was clear that the industry was in the midst of an epiphany and that our editorial mission needed to evolve.The drug package or vial is just as much a controlled environment as the spacein which it is made. The biopharmaceutical process involves numerous environmentsthat must be clean, controlled, and validated. Manufacture of the container aswell as the compound has standards and requirements that are essential to ensurea lack of contamination — else a company can suffer severe fallout fromproduct recalls and safety concerns.

Does this change mean that we are abandoning semiconductors and microelectronics?Of course not. Even companies that are involved in those industries realize thattheir greatest potential for growth is focused in the biopharm arena and arepoised to make a bigger splash with pharmaceutical clients. These vendors wantincreased identification of their products in the pharmaceutical market; whatbetter segue than to devote more editorial coverage within the pages of ControlledEnvironments to contamination control and validation of biopharmaceu-ticals?

You may have noticed in the past several issues that we have sprinkled articlesthat have not traditionally seen coverage within these pages. It’s partof our transition into this segment of the industry.

We invite you to take a fresh look at our content over the coming months as wedelve into the broader meaning of the “controlled environment.” Whobetter to take you on a tour of all the environments, both large and small, thathave standards for cleaning, validation, and monitoring? With our fingers onthe pulse of an evolving industry, we’ll continue to further define the “controlledenvironment” in ways that are meaningful to you.

Welcome to our newest Editorial Advisory Board member, Michael Rataj, Group Technical Manager at Aramark Cleanroom Services. Mike brings a wealth of industry experience and integrative thinking to our board. Welcome, Mike!