An obvious but simple truth and perhaps the most critical truth of all is that the absence of microorganisms in any aseptic
environment can never be proven. In isolators, we rarely detect microorganisms, but in cleanrooms, we rarely go more than
a few days without recovering organisms despite sampling methods that have a rather poor limit of detection. The most painful
truth of all, therefore, is that manned cleanrooms were never sterile, are not sterile now, and never will be sterile. We
suspect it is rather obvious what that means about sterile products made in these facilities. Make no mistake; we think that
by and large products made in the best manned cleanrooms are safe, maybe even safe enough. Cleanrooms that are less than the
best, however, are a very different matter altogether. One last truth: There are better technologies available for aseptic
processing than conventional manned cleanrooms, and we should be using those technologies. Unless we do, the truth is we will
never reach the goal of having operators playing a diminishing role in aseptic operations.
James P. Agalloco* is the president of Agalloco & Associates, PO Box 899, Belle Mead, NJ 08502, tel. 908.874.7558, firstname.lastname@example.org
He also is a member of Pharmaceutical Technology's Editorial Advisory Board. James E. Akers is the president of Akers Kennedy & Associates, PO Box 22562, Kansas City, MO 64113, email@example.com
*To whom all correspondence should be addressed.
Key words: aseptic processing, cleanrooms, isolators, operators, RABS, sterile.
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Systems," presented at ISPE meeting, Prague, Czech Republic, 2005.
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