Improving a Pharmaceutical Water System based on a Risk Analysis Approach - Pharmaceutical Technology

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Improving a Pharmaceutical Water System based on a Risk Analysis Approach
In this study, fault tree analysis applied to a water pretreatment and purification installation exposed cause-and-effect complex interrelations in possible fault events.

Pharmaceutical Technology

Arturo Toledo Rivero, PhD,* is a chemical engineer and head of the R&D department at Liorad Laboratories, Ave. 27A No. 26402, La Lisa, Havana, Cuba, tel. +537 2717935, fax +537 2717899,
Nelson Sierra Prado is a microbiologist and head of the validation group, QA department; Anamarys González Alvarez is a chemical engineer and pharmaceutical specialist at the R&D department; and Danelys Cardoza Lobaina is a chemical engineer and quality engineering specialist in the QA department, all at Liorad Laboratories.

*To whom all correspondence should be addressed.

Submitted: Aug. 8, 2007 Accepted: Aug. 20, 2007


1. US Pharmacopoeia, Spanish Edition (US Pharmacopeial Convention, Rockville, MD, 2007), pp. 1428–1432.

2. European Pharmacopoeia 5.0 ed. (European Pharmacopoeia, 2005), pp. 2692–2698.

3. ISPE Baseline, Pharmaceutical Engineering Guides for New and Renovated Facilities, vol. 4 (Jan. 2001).

4. US Pharmacopeia, Spanish Edition (US Pharmacopeial Convention, Rockville, MD, 2007), pp. 763–764.

5. B. Dodson and D. Nolan, Reliability Engineering Handbook (1998).

6. US Food and Drug Administration, Pharmaceutical CGMPs for the Twenty-First Century, a Risk-Based Approach (Sept. 2004).

7. ICH Harmonized Tripartite Guideline, Q9: Quality Risk Management (Nov. 9, 2005).

8. R.L. Browning, "Industrial Risk Analysis," Chem. Eng. 109–114, (Oct. 20, 1969).

9. R.L. Browning, "Loss Analysis for Improving Protective Instrumentation Process," Instrument. Technol. 14 (10), 84–90 (1972).

10. P.A. Crossete, "Fault Tree Analysis for System Reliability," Instrument. Technol. 13 (8), 52–56 (1971)

11. "Análisis de Riesgo [Risk Analysis]", accessed Oct. 15, 2007.

12. NASA Lewis Research Center, "Fault Tree Analysis (FTA)," available at http://, accessed Oct. 15, 2007.

13. NASA Lewis Research Center, "Failure Mode and Effect Analysis," available at http://, accessed Oct. 15, 2007.

14. W. Monroe Keyserling, "Failure Modes and Effects Analysis (FMEA)," IOE 539 Notes, Industrial and Operations Engineering, University of Michigan, Jul. 21, 2000.

15. Kaiser Permanente, "Failure Modes and Effects Analysis (FMEA)," Team Instruction Guide, Mar. 2002.

16. Diputación Foral de Bizkaia, "AMFE: Análisis Modal de Fallos y Efectos," Librería HOR DAGO, Nov. 7, 2004.

17. Water System Revalidation Protocol, Liorad Laboratories, code P.R.S.06.06, Dec. 2006.

18. Water System Performance Qualification (PQ) Report, Liorad Laboratories, code I.P.R.S.06.06, Mar. 2007.


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