A Risk-Based Approach to Variable Load Configuration Validation in Steam Sterilization: Application of PDA Technical Report 1 Load Equivalence Topic

References

1. 1.↵
   PDA Technical Report 1: Industrial Moist Heat Sterilization in Autoclaves; 2007.
2. 2.↵
   PDA Technical Report 1: Industrial Moist Heat Sterilization in Autoclaves, Section 4.4.1.1; 2007; p 28.
3. 3.↵
   HTM 2010, Part 3: Validation and Verification, Section 13.15; Her Majesty's Stationary Office: London, 1994; p 87.
4. 4.↵
   HTM 2010, Part 3: Validation and Verification, Section 13.14; Her Majesty's Stationary Office: London, 1994; p 87.
5. 5.↵
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   Revisiting the moist heat sterilization myths, Myth #15. PDA J. Pharm. Sci. Technol. 2009, 63 (2), p. 89–102.

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6. 6.↵
   1. Agalloco J. A.,
   2. Akers J. E.,
   3. Madsen R. E.

   Moist heat sterilization—myths and realities, Myth #10. PDA J. Pharm. Sci. Technol. 1998, 52 (6), p.346–350.

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7. 7.↵
   1. Block S. S.

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   Principles of Thermal Destruction of Microorganisms. In Disinfection, Sterilization and Preservation, 3rd ed.; Block S. S. Ed.; Lea & Febiger: Philadelphia, 1983; pp 759–783.
8. 8.↵
   1. Agalloco J. A.,
   2. Akers J. E.,
   3. Madsen R. E.

   Moist Heat Sterilization—Myths and Realities, Myth #8. PDA J. Pharm. Sci. Technol. 1998, 52, (6), p. 346–350 (1998).

   OpenUrlFREE Full Text
9. 9.↵
   HTM 2010, Part 3: Validation and Verification, Section 8.10; Her Majesty's Stationary Office: London, 1994; p 57.
10. 10.↵
    PDA Technical Monograph 1: Industrial Moist Heat Sterilization in Autoclaves, Section 4.4.1.5; 2007; p 30.
11. 11.↵
    ICH Q9 Quality Risk Management, Section 4.6; 2005; p 5.
12. 12.↵
    PDA Technical Report 44: Risk Management, Section 3.3.2; 2008; p 10.