ASEPTIC PROCESSING: TWO - Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing - page 265

and aseptic processing will remain an integral part of the product and process
life cycle. Risk assessment through the life cycle demands the diligent
administration and management of “living” documents in the contemporary
context and necessarily employing multiple tools. This chapter has provided
some direction for prudent choice of the most pertinent tools for expedient,
economical, and efficient execution of aseptic risk assessments.

REFERENCES

1. PDA. Technical Report No. 1, Validation of Moist Heat Sterilization Processes: Cycle
Design, Development, Qualification and Ongoing Control. PDA; J Pharm Sci Technol
61(supplement S-1).
2. Agalloco JP, Akers JE. A critical look at sterility assurance. Eur J Pharm Sci

2002;7(4):97-103.
3. Agalloco JP, Akers JE. The myth called sterility. Pharm Technol 2010;34 Available
at http://pharmtech.findpharma.com/pharmtech/Analytics/The-Myth-Called-Sterility/
ArticleStandard/Article/detail/660544.
4. Tidswell. Risk assessment in parenteral manufacture. In: Williams KL, editor. Endo-
toxins, Pyrogens, LAL Testing and Depyrogenation. 3rd ed. New York, USA: Informa
Healthcare; 2007.
5. Whyte W. A cleanroom contamination control system. Eur J Parenter Sci

2002;7(2):55-61.
6. McCormick D. Poor OOS review leads causes FDA citations. Pharm Tech-
nol 2006;30Available at http://pharmtech.findpharma.com/pharmtech/In+the+Field/
December-2006/ArticleStandard/Article/detail/390980.
7. Jimenez L. Microbial diversity in pharmaceutical product recalls and environments.
PDA J Pharm Sci Technol 2007;61(5):383-399.
8. Tellez S, Casimiro R, Vela AI, Fernandez-Garayzabal JF, Ezquerra R, Latre MV,
Briones V, Goyache J, Bullido R, Arboix M, Dominguez L. Unexpected inefficiency
of the European pharmacopoeia sterility test for detecting contamination in clostridial
vaccines. Vaccine 2006;24:1710-1715.
9. Pittet D. Nosocomial bloodstream infections. In: Wenzel RP, editor. Prevention and
Control of Nosocomial Infections. 3rd ed. Baltimore (MD): Lippincott Williams and
Wilkins; 1997. p. 711.
10. Soufir L, Timsit JF, Mahe C, Carlet J, Regnier B, Chevret S. Attributable morbidity
and mortality of catheter-related septicemia in critically ill patients: a matched, risk-
adjusted, cohort study. Infect Control Hosp Epidemiol 1999;20(6):396-401.
11. Oncu S, Sakarya S. Central venous catheter-related infections: an overview with
special emphasis on diagnosis, prevention and management. Internet J Anes-
thesiol 2003;7(1) Available at http://www.ispub.com/ostia/index.php?xmlFilePath
=journals/ija/vol7n1/cvc.xml.
12. Safdar N, Maki DG. The pathogenesis of catheter-related bloodstream infection with
noncuffed short-term central venous catheters. Intensive Care Med 2004;30(1):62-67.
13. Tidswell EC, Rockwell J, Wright M-O. Reducing hospital acquired infection by quan-
titative risk modeling of intravenous (IV) bag preparation. PDA J Pharm Sci Technol
2010;64:82-91.