The simple, beautiful details
01/01/2001
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As we race to adapt and integrate new technologies and processes into our clean manufacturing environments, we often forget to take a close look at the fundamentals along the way. By asking a few simple questions, we may be able to fold new processes into our standard operating procedures (SOPs) or quickly eliminate the thought of them altogether.
How do we actually define a certain technology? Will it, in fact, increase production and make our lives easier? And most importantly, especially for pharmaceutical and biotech manufacturers, two of the most heavily regulated industries in the world, how is a certain technology cleaned and maintained? Without the "beautiful details," we're only making more work for ourselves.
It seems that this is when we inevitably turn to the clean manufacturing stars who are setting the course for maintaining standards, developing guidelines and laying down the rule sets that will assist in the safe production of the world's cures or the microelectronic breakthrough of the future.
Take a moment to think of one or two of these stars in your particular industry. You've read their names in the pages of CleanRooms and association publications that cross your desk—these are the few who have somehow carved out the time and have taken a rare, selfless approach to doing business.
I couldn't get this thought out of my mind as I watched a couple rise over the Parenteral Drug Association's (PDA) annual meeting in Philadelphia. PDA is currently wrestling with the proper adaptation of isolators—technology that is almost perfectly suited for the manufacturer of sterile products and the containment of especially potent materials. Yet very little, if any, validation guidance has been penned, and the industry still needs a solid definition of what an isolator actually is and how it differs from a traditional barrier system.
James Agalloco, chair of this year's PDA conference committee and one the market segment's stars, shared the principle areas of discussion and debate to a room full of design, manufacturing and quality-control engineers. The ensuing discussion was based on pure fundamentals: What is an isolator? In what class room should an isolator reside? What are the types and principal design requirements? What environmental monitoring technique is appropriate?
These are the simplest of questions; however, when answered and agreed upon, they will give the PDA, and Agalloco, a successful finish to one of the association's most aggressive and pertinent contamination control papers to date. Put in your two cents at pda.org.
Mike Levans
Chief Editor