Across
- 2. Test units that are actual product samples representative of routine production, including packaging materials and processes. Test units will be of the microbiological quality of the product routinely processed by the sterilization process being validated.
- 6. Group or subgroup of product characterized by similar attributes determined to be equivalent for evaluation and processing purposes.
- 11. Test cycle in which the extent of treatment is reduced by 50 % as compared with an operating cycle.
- 14. Removal of the sterilizing agent from the chamber and the load at the end of the exposure phase.
- 15. Validated process used to render product free from viable microorganisms.
- 17. Declaration that product is sterile based on records demonstrating that the sterilization process variables were delivered within specified tolerances.
- 19. Value of a cycle variable including its tolerance used for control, monitoring, indication and recording of an operating cycle.
- 20. Confirmation process, through the provision of objective evidence, that the requirements for a specific intended use or application have been fulfilled.
Down
- 1. Treatment of product, prior to the operating cycle, to attain specified values for temperature, relative humidity, and/or other process variables.
- 3. Item providing a defined resistance to a cleaning, disinfection, or sterilization process and used to assess performance of the process.
- 4. Probability of a single viable microorganism occurring on an item after sterilization.
- 5. Test system containing viable microorganisms providing a specified resistance to a specified sterilization process.
- 7. Technical operation performed as part of development, validation or requalification to determine the presence or absence of viable microorganisms on product or portions thereof.
- 8. Population of viable microorganisms on or in product and/or sterile barrier system.
- 9. Method of defining a sterilization process that achieves a maximal sterility assurance level (SAL) for product substantially less than 10-6.
- 10. Treatment of product prior to the exposure phase to attain a specified temperature, relative humidity, or other process variable throughout the load.
- 12. Health care product or procedure set used to represent the most difficult to sterilize item in a product family or processing category.
- 13. Product, equipment or materials to be processed together within an operating cycle.
- 16. Operating cycle in which the exposure phase is reduced compared with that specified for the sterilization cycle.
- 18. Part of the sterilization cycle during which the sterilizing agent and/or its reaction products desorb from the health care product until predetermined levels are reached.