I am trying to gather information on what guidelines are available overseas for proving or disproving sterility quality and surgical usage of instruments which are sterilised in manufactured Rigid containers and have retained a small amount of moisture/comdensation during the steam sterilisation process. If anyone has any info on this or can point me in the right direction I would appreciate it. Thanks

Dear

If you can't find the source of your wet containers among the listed possible sources posted in Q00681 and also the extended drying time doesn't help - then pre-conditioning the container load might help.
Place the containers with the instruments inside the sterilizer, close the door but don't start the programm immediately. Allow the load first to gradually heat-up in the chamber for about 10 minutes. Then start the program.
To avoid "wet " and other problems" with containers; aks your container manufacturer the following or similar question:

• Is your rigid container systems classified as a Class II medical device?
• Did your company perform sterilization validation studies?
  Would you provide a report detailling these studies?
• Did your validation studies include speciality devices e.g. power equipment, endoscopes, long lumend instruments etc.
• Did your company perform validation sterilization validation studies for your organizing case?
• Did your company validate the decontamination processes for your organizing case with full contents?

I have addapted the above question, which are recommended by the Food ands Drug Administration (FDA) USA.
I hope this is of some help!

Kind regards
Josy

Dear Rose.

You have at home the right answer. Look at Standard AS/NZS 4815:2001, Sec. 3 and App. D.
Now look at ISO/DIS 17665:2004. This is, to my opinion the current approach to assure a reliable process, meaning: SAL is depended equally (more or less) on the interface of: Goods to be sterilized, packaging, Autoclave and user.
This is the theory. Now the Practice:

1. The goods (instruments) must be autoclaveable. (Manufacturer Declaration)
2. The Packaging (Container) must be valid (Manufacturer Declaration to which Standard it complies).
3. The Autoclave must be valid (Manufacturer Declaration to which Standard it complies).
4. The responsible (educated, trained etc.) person must study this combination.
5. Develop the appropriate process to assure a successful cycle.
6. Prove it! Validate the effectiveness of the process.

Wishing you success, happy New year.
miki