We have an autoclave on site which runs both porous and fluid loads. In our initial validation of the loads, HTM 2010 was used as a reference document to establish criteria. We recently were made aware that HTM 2010 has been ‘archived’ and replaced by CFPP 01-01 which refers to BS EN 285 for laboratory sterilisers.
We are about to validate some new loads for our previously validated autoclave. Are the above two documents (CFPP and BS EN 285) the best reference documents to establish criteria for our new fluid loads from?
Has anyone any other reference documents for fluid load validation?
Usually lab autoclaves are used for porous and liquid loads. I refers usually to PDA Technical Report No.1 and EN 285, but there are more references that you can use. But be aware that porous and liquid loads have two different approaches:
Porous load - Sterilization program for porous load should have from three to ten pre-vacuum cycles (depend of the load) and control probe is in the drain. Here is very important next: steam quality testing, equilibration time and holding time at 3oC temperature band. If the cycle is overkill use B stearothermophilus. All of this means that air is removed from all parts of the load and replaced with steam (eq. time) and temp. and time are 1210C - 124oC for at least 15 minutes. If some required Fbyo and if D value is less then 2minutes then you must reduce cycle to calculate Fbyo. Fo values are not usefull for porous load.
Liquid load - Control probe is in the load (worst case location). You sholud have one vacuum cycle or no vacuum cycle (gravity displacement). No need for steam testing, no eq. time. Fo must be greater 15 if your cycle is overkill,or have 15 minutes above 121oC, calculate Fo for entyre cycle cause liquid load can be temperature labile. Use B. stearothermophilus in ampoules and reduce cycle to calculate Fbyo if D value is less than 2 minutes.