蒸汽灭菌柜验证的10大注意事项(中英文).pdf

White Paper Top 10 considerations when validating an autoclave Validating an autoclave is a daunting and time-consuming task. This white paper details the tricks, tips and traps to such a validation project from how to choose your Control to which load configuration to use for your validation runs. ©2013 PharmOut. This document has been prepared solely for the use of PharmOut and its clients. Copying is prohibited. Page 1 of 13 Version -01 White Paper Top 10 considerations when validating an autoclave Consideration 1 Choosing the right sterilisation cycle to implement There are three basic types of sterilisation cycles. Choose the right one according to the type of goods to be sterilised: Hard Goods (Vacuum) Suitable for items that are easy to sterilise, because air removal and steam penetration are highly effective on these items. e.g., open glassware and large diameter piping A typical hard goods cycle may draw one vacuum prior to introducing steam to reach the desired sterilisation temperature. Wrapped Goods (Vacuum) Utilized for items that are difficult to sterilise, because air removal and steam penetration are harder to achieve on these items than on hard goods. e.g., empty bottles (glass or plastic) with lids, gowns, long hoses/tubes, vent filters, portable vessels with small inlet/outlet ports A typical wrapped goods cycle may draw three or more vacuums prior to reaching sterilisation. A post-sterilisation vacuum draws the steam from the load items. Liquids (Non-vacuum) Items that contain liquids generally cannot have a deep vacuum pulled or the liquid will be drawn out of them. Autoclave cycles for liquids generally heat up and cool down without a vacuum. Steam, introduced into the top of the chamber, displaces the air. The air is pushed to the bottom of the chamber and is removed. ©2013 PharmOut. This document has been prepared solely for the use