Contacts: Jacky Jiang
FAX: 0086 371 55951125
ADD: 51 Xiasha 22nd Street, Hangzhou, China
Physical PQ of sterilizer
Physical PQ (PPQ) shall prove PPQ
- Meet the specified acceptance criteria throughout the loading process during the proposed routine process specification.
- The reproducibility of the process.
If the failure can be attributed to factors unrelated to the effectiveness of the validated process, it can be recorded as unrelated to process performance without the need for three consecutive successful runs. Examples of such failures may include, but are not limited to, power failures, other service interruptions, or external monitoring equipment failures.
PPQ shall confirm the following process: PPQ
PPQ shall be carried out in accordance with the loading pattern and pallet separation specified in the documented procedure. For larger pretreated regions, small loads do not have a significant effect on the regional dynamics, so it is not necessary (and may not be practical) to study the pretreated regions under various load states.
The PPQ guidelines for pretreatment also apply to performance qualification of conditioning (i.e. during sterilization).
- a) The minimum temperature for the product to enter the sterilization process and / or the specified conditions required for the sterilization process shall be determined;
- b) At the end of the prescribed pretreatment time (if used), the sterilization load temperature and humidity have been determined;
- c) The specified maximum running time between the completion of pretreatment (if used) and the start of the sterilization cycle is appropriate;
- d) At the end of the specified treatment time, if used, the sterilization load temperature and humidity have been determined;
- e) If the parameters are released, record the chamber humidity;
- f) The gas EO has entered the sterilization room;
g)pressure rise and the quantity of EO used or concentration of EO in the sterilizer chamber have been established . If parametric release is to be used;
h)during the sterilization cycle, the temperature and humidity (if recorded) of the chamber and, where applicable, other process parameters have been established;
i)the temperature of the product load during exposure has been established;
The temperature sensors within the sterilization load should be placed in the locations that are most likely to experience the greatest temperature variation. These locations should take into account hot or cold spots located during OQ. The locations of hot and cold spots within a load can be significantly different than the locations in an empty chamber.
- During PQ, it is important to take into account the relationship between the load temperature and the chamber temperature in order to ensure adequate load temperature in the routine process. If sensors are used in the sterilization chamber and 100 % EO or potentially flammable sterilant mixtures are used, the temperature and humidity sensors should be intrinsically safe, or should be of an explosion proof design. These sensors should also be functionally compatible with EO and with any diluent gases.
- j)during aeration (if used), the temperature of the sterilization load has been established.
- NOTE This can be established during additional studies after completion of MPQ/PPQ.
01-01dry heat sterilization