Charting Process Improvement in Sterile Product Manufacturing - Pharmaceutical Technology

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Charting Process Improvement in Sterile Product Manufacturing
Sterile product manufacturing and related testing have evolved significantly during the last 30 years. From requirements for acceptance criteria for media-fill tests, to developing validated approaches for moist-heat sterilization, to the introduction of formalized sterility-testing practices, the pharmaceutical industry has made significant advances in testing and in key technology such as isolators, prefilled syringes, automation, and robotics. The author outlines the key regulatory and technical..

Pharmaceutical Technology

Risk analysis in aseptic processing

Late last year at the Parenteral Drug Association's Asian Symposium in Tokyo, Katayama et al. reported that they had used two risk-analysis models for aseptic processing to evaluate three different aseptic processing production lines spanning more human intervention-intensive technology to modern separative technology with a high level of line automation (5). They compared these quantitative risk analysis models (including one Jim Agalloco and I published in Pharmaceutical Technology) (6, 7) and microbiological methods and found that in the higher technology lines, risk- analysis may be a more effective way to evaluate process control than microbiological monitoring.

This finding means that less reliance on traditional microbiological monitoring and process-simulation testing and more reliance on risk analysis may be the way forward. With this in mind, I list the move toward risk- and science-based regulation and the greater emphasis on quality systems as major innovations of the last 30 years.

The pharmaceutical industry needs to be inspired enough to ask whether what it is doing makes sense, and if it does not, the industry needs to be on the lookout for better ways. Albert Einstein thought that in the case of creativity, inspiration was more important than knowledge. He just may have been right. It may also be true that if we are going to insist upon trying to measure something, we need to know how capable we are of measuring that something.

So let's hope that Pharmaceutical Technology will continue to inspire us in the future as it has it has in its first 30 years. I'll bet that it will. I also hope that as the industry moves forward, it keeps an open mind and is inspired enough not only to embrace the inevitability of change but to facilitate that change through its own creativity. The industry should demand that its standards and its harmonization efforts always be driven by evidentiary science rather than merely by someone's opinion. That is where Pharmaceutical Technology comes in, as it will continue to enhance our understanding during the next 30 years.

James E. Akers is the president of Akers Kennedy & Associates, PO Box 22562, Kansas City, MO 64113,

Where were you 30 years ago?

"In 1977, I was a post-doctoral fellow and instructor at East Carolina School of Medicine, Department of Microbiology. I took my first position in the pharmaceutical industry in 1981 at Burroughs Wellcome, Co. (now part of GlaxoSmithKline) in 1981."


1. World Health Organization, World Health Technical Report No. 28 (Geneva, Switzerland), 1973.

2. Parenteral Drug Association, "Validation of Steam Sterilization Cycles," PDA Technical Monograph No. 1, (PDA, Bethesda, MD), 1978.

3. US Food and Drug Administration, Guideline on Sterile Drug Products Produced by Aseptic Processing, (Rockville, MD), 1987, (accessed June 5, 2007).

4. R. Friedman, Presented at the 16th Annual Barrier Isolation Technology Forum, Arlington, VA, June. 5, 2007.

5. H. Katayama and A.Toda, "Risk Categorization of Aseptic Processing Facilities Based Upon Risk Assessment Scores," in Proceedings of the Parenteral Drug Association's Asian Symposium (Tokyo, Japan), 2006.

6. J. Akers and J. Agalloco, "Risk Analysis for Aseptic Processing: The Akers–Agalloco Method," Pharm. Technol. 29 (11), 74–88 (2005).

7. J.Akers and J. Agalloco, The Simplified Akers–Agalloco Method for Aseptic Processing Risk Analysis," Pharm. Technol. 30 (7), 60–72 (2005).


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