Alternate Approach for Defining Worst Case in Steam Sterilization Validation of Porous/Hard Goods Loads

References

1. 1.↵
   Parenteral Drug Association Inc. Technical Report No. 1: Validation of Moist Heat Sterilization Processes: Cycle Design, Development, Qualification and Ongoing Control; Bethesda, MD, 2007.
2. 2.↵
   1. Agalloco J.

   Maximum and Minimum Loads in Steam Sterilization: Establishing a Cycle Development Strategy That Fulfills Regulatory Requirements. Pharmaceutical Manufacturing [Online] 2018, https://www.pharmamanufacturing.com/articles/2018/maximum-and-minimum-loads-in-steam-sterilization/ (accessed November 5, 2019).
3. 3.↵
   BS EN 285:2015: Sterilization—Steam Sterilizers—Large Sterilizers. BSI Standards Limited, 2015. 
4. 4.↵
   International Organization for Standardization, ISO 17665-1: Sterilization of Health Care Products—Moist Heat—Part 1: Requirements for the Development, Validation and Routine Control of a Sterilization Process for Medical Devices. ISO: Geneva, 2006.
5. 5.↵
   International Organization for Standardization, ISO 17665-2. Sterilization of Health Care Products—Moist Heat—Part 2: Guidance on the Application of ISO 17665-1. ISO: Geneva, 2009.