Bandages (which will be sterilized after production) Manufacturing Specifications

N

normhowe

#1
Hello,

What are the general environmental and manufacturing requirements for bandages which will be sterilized after production? Eg, what kinds of specifications for bioburden need to be in place? What would the classification of the cleanroom need to be typically?
 
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Stijloor

Staff member
Super Moderator
#2
Hello,

What are the general environmental and manufacturing requirements for bandages which will be sterilized after production? Eg, what kinds of specifications for bioburden need to be in place? What would the classification of the cleanroom need to be typically?
Can someone help?

Thank you!

Stijloor.
 
D

Denis

#3
Hi normhowe

You'll need to provide a bit more information - below are some guidelines to make an asseessment etc.

What are your current bioburden level measurements?

What type of sterilisation method will (would) you be using?

What is your current clean room classification?

What do your environmental monitoring results indicate?
 
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