(Cited from public source) PDA TR gives information about minimum load of steam & time required for sterilization, however, without quantity of materials.
In some opinions, it define the minimum loads as the hardest to sterilize part, usually long tubing, placed in the coldest spot.
Someone defined partial loads as a portion of the established maximum validated load. Thus, minimum load studies are not required. They are often run, however, to provide additional assurance.
Provided that the load items are in the same position every time, you can then run any combination of items between the max validated load and the min validated load. This is standard accepted regulatory practice, as it would be impossible to actually validate every single combination that would be possible.
It is said any load items in daily operation must be consistently placed in the same location following the maxminum load. Any change in the loading pattern will alter the dynamics of the steam within the chamber and therefore the validated cycle/load.
A variable load configuration means that different combinations of items and/or numbers of any item(s) can be placed into the chamber. Thevalidationruns must demonstrate that the cycle is adequate for both a maximum and minimum load configuration. The minimum load tests are done with only one item in the autoclave, that item being the load item demonstrated as being the most difficult to sterilise.
From other firms materials http://www.pharmout.net/downloads/white_paper_autoclave_validation.pdf
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是指对最终灭菌类注射剂进行灭菌的湿热灭菌柜，还是用于器具、包材灭菌的干热灭菌柜？建议小赵将问题限定的细一些。方便大家讨论。
不好意思，这里再明确一下，上述问题是针对用于器具包材灭菌的湿热灭菌柜
不同的器具的装载方式都应当进行最小装载验证，如果是混在的话可以选择较难灭菌的器具作为最小装载，这需要在满载的时候去评价。