In pharmaceutical there is confusion between the term Sterile and Aseptic. Sometimes these two terms used interchangeably. For example in case of environment classification some people might say sterile area and some use the term aseptic area. There is difference between these two terms.
What is the difference???
Sterile- Sterile means any article, object, surface which is freed from all types of microbial contamination is called sterile. Sterile means complete absence of microorganisms ( bacteria, fungus and their spores etc.).
Aseptic- Aseptic means free from pathogenic microorganisms. It means when we call anything aseptic it means that it is free from pathogenic microorganisms but it doesn't mean that microbes are not present there. Microorganisms are present there but, they are not pathogenic means they are not disease forming.
So, this is the basic difference between both terms. If we talk about classification of area where sterile product are being manufactured it is better to say aseptic area not sterile area. Even in pharmacopoeias and guidelines the microbial limit of A class area which is the critical and most clean area for sterile product manufacturing is <1 cfu. But we can't consider it sterile. That's why there is always a threat of sterile product contamination in aseptic area if proper practices are not followed.
Hope you understand the topic well. Please leave your comment about this article and one thing I would like to share with you is that these blogs will be beneficial for pharmaceutical peoples ( microbiologists, production, quality assurance etc.) because being a microbiologist I know where is the confusion and what people want to know.
thanks and good luck
Good Sir, Now this concept is clear for me.
ReplyDeletethanks
I love your posts Sir, Your posts are very helpful and very easy to understand.
ReplyDeleteexcellent sir
ReplyDeleteThanks ramki, for your valuable comment.
Deletegot it..... thanks
ReplyDeletegot it .........thanks
ReplyDeleteMeaningful Answer for every question Thanks Dear
ReplyDeleteZafar (food TECHNOLOGIST)
Pakistan
What is the difference between sterile and no. Sterile sir
ReplyDeleteSandeep,
ReplyDeleteHats off for your clarifications. I feel very proud to be associated with this blog. I wish to pass on this blog to all fellow microbiologists in other industries as well.
Once again, you deserve a special thanks from the microbiology community.
S.Ravi
Chennai.
S.Ravi, thanks for enjoying my post.
DeleteThanks Amol Gaikwad.
ReplyDeleteThank You for Information
ReplyDeleteDear sir if grade A and B is aseptic area and meaning of aseptic is free from pathogenic microorganisms and grade C and grade D is not aseptic then in that grades is not free from pathogenic microorganisms.
ReplyDeleteIn that grade (c & d) is pathogenic microorganism present. Please clear
dear sir,
ReplyDeletelaminar air flow is aseptic area or Sterile
how to differentiate the aseptic area or Sterile
in A, B, C, D are aseptic area or Sterile
how to separate the aseptic area and Sterile
very very nice post sir I like.
ReplyDeletebut sir plz post updated Viable and Non Viable particle count limit as per usfda guideline plz sir