Conclusion

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, jagalloco@aol.com
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, akainckc@aol.com

Key words: aseptic processing, cleanrooms, isolators, operators, RABS, sterile.

References

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2. ISPE, "Restricted Access Barrier Systems (RABS) for Aseptic Processing Definition," Aug. 16, 2005.

3. PDA, "Process Simulation Testing for Sterile Bulk Pharmaceutical Chemicals," Technical Report 28, PDA J. Pharm. Sci. Technol. 60 (s-2) suppl. (2006).

4. PDA, "Design and Validation of Isolator Systems for the Manufacturing and Testing of Health Care Products," Technical Report 34, PDA J. Pharm. Sci. Technol. 55 (5) suppl. (2001).

5. H. Avallone, "Current Regulatory Issues Regarding Parenteral Inspections," J. Parenteral Sci. Technol. 43 (1), 3–7 (1989).

6. V. Sigwarth, A. Gessler, and A. Stark, "Relevance of Physical Glove Integrity Testing to Microbial Contamination of Isolator Systems," presented at ISPE meeting, Prague, Czech Republic, 2005.

7. J. Agalloco and J. Akers, "Simplified Risk Analysis for Aseptic Processing: The Akers-Agalloco Method," Pharm. Technol. 30 (7), 60–76 (2006).