· In pharmaceutical there is confusion between
the term Sterile and Aseptic. Sometimes these two terms used interchangeably or
synonymous. 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..
·
USP General chapter 1116 mentioned The terms Aseptic and Sterile are
not synonymous.
Sterile:
·
Sterile means having a complete
absence of viable microorganisms or organisms that have the potential to
reproduce.
· Sterile means any article, object, surface which is free
from microbial contamination is called sterile.
· Sterile means complete absence of microorganisms.
Aseptic:
· Aseptic means free from pathogenic microorganisms..
· 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.
·
An aseptic process is one that
prevents contamination by the exclusion of microorganisms.
·
Aseptic process for handling sterile
(sterilized) materials in a controlled environment designed to maintain
microbial contamination at levels known to present minimal
·
risk.
·
In any environment where human
operators are present, microbial contamination at some level is inevitable.
·
Even the most cautious clean-room
environment design and operation will not eliminate the shedding of
microorganisms if human operators are present.
·
Thus, an expectation of zero
contamination at all locations during every aseptic processing operation is
technically not possible and thus is unrealistic.
· If we talk
about classification of area where sterile product are being manufactured it is
better to say aseptic area or controlled 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 is sterile. That's why there is always a threat of
sterile product contamination in aseptic area if proper practices are not
followed..
