Research ArticleRESEARCH
A Risk-Based Approach to Variable Load Configuration Validation in Steam Sterilization: Application of PDA Technical Report 1 Load Equivalence Topic
Anthony Pavell and Keith A. Hughes
PDA Journal of Pharmaceutical Science and Technology March 2010, 64 (2) 124-136;

References
- 1.↵
PDA Technical Report 1: Industrial Moist Heat Sterilization in Autoclaves; 2007.
- 2.↵
PDA Technical Report 1: Industrial Moist Heat Sterilization in Autoclaves, Section 4.4.1.1; 2007; p 28.
- 3.↵
HTM 2010, Part 3: Validation and Verification, Section 13.15; Her Majesty's Stationary Office: London, 1994; p 87.
- 4.↵
HTM 2010, Part 3: Validation and Verification, Section 13.14; Her Majesty's Stationary Office: London, 1994; p 87.
- 5.↵
- Agalloco J. A.,
- Akers J. E.,
- Madsen R. E.
- 6.↵
- Agalloco J. A.,
- Akers J. E.,
- Madsen R. E.
- 7.↵
- Block S. S.
- Pflug I.,
- Holcomb R.
- 8.↵
- Agalloco J. A.,
- Akers J. E.,
- Madsen R. E.
- 9.↵
HTM 2010, Part 3: Validation and Verification, Section 8.10; Her Majesty's Stationary Office: London, 1994; p 57.
- 10.↵
PDA Technical Monograph 1: Industrial Moist Heat Sterilization in Autoclaves, Section 4.4.1.5; 2007; p 30.
- 11.↵
ICH Q9 Quality Risk Management, Section 4.6; 2005; p 5.
- 12.↵
PDA Technical Report 44: Risk Management, Section 3.3.2; 2008; p 10.
In This Issue
PDA Journal of Pharmaceutical Science and Technology
Vol. 64, Issue 2
March/April 2010
A Risk-Based Approach to Variable Load Configuration Validation in Steam Sterilization: Application of PDA Technical Report 1 Load Equivalence Topic
Anthony Pavell, Keith A. Hughes
PDA Journal of Pharmaceutical Science and Technology Mar 2010, 64 (2) 124-136;
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