Aseptic and Sterile are a pair of synonyms in GMP guideline. In order to understand the difference between Aseptic and Sterile definition well in pharmaceutical area, here we do a further study about them.
What is Aseptic?The definition of Aseptic is as follows: 1) Free of pathogenic microorganisms ,2) Using methods to protect against infection by pathogenic microorganisms. The word is usually used in below situation.
- Aseptic Bag
- Aseptic apple juice
- aseptic technigue
- Aseptic processing
- Aseptic manufacturing
- Aseptic gowning
- Aseptic filling
In pharmaceutical area, the word Aseptic emphasize the process, so we usually say Aseptic techniques, Aseptic processing etc.
What is Sterile?The definition of “Sterile” is as follows: 1)Free from live bacteria or other microorganisms, 2) any process that effectively kills or eliminates transmissible agents (such as fungi, bacteria, viruses, spore forms, etc.) from a surface, equipment, article of food or medication, or biological culture medium. The word is usually used in below situation.
- Sterile Saline Solution
- Sterilised footwear
- Sterile Syringes
- Autoclave sterilisation
- Sterilisation of equipment by dry heat
- sterilisation of the API by radiation
- Fumigation Sterilisation
- Chemical sterilization
- Sterile Filtration
In pharmaceutical area, the word Aseptic emphasize the result, so we usually say Sterile conditions etc.
About Sterile Conditions
Aseptic is a word used to describe a procedure that is intended to avoid the unwanted transfer of microorganisms from one object or location to another. Sterile means the complete absence of life. So any medicine or surgical device, or, indeed, any object that is sterile, has no living organisms at all in it or on it.[1]Hanlon, G. and Hodges, N. (2013). Essential Microbiology for Pharmacy and Pharmaceutical Sciences. UK: John Wiley & Sons, Ltd.
About Aseptic techniques
It is easy to be confusing between sterile and aseptic techniques. The key difference between Aseptic and Sterile techniques is that aseptic technique is utilized to reduce the likelihood of contamination from harmful pathogens mainly from microorganisms while sterile is a technique used to achieve an environment that is free from all living microorganisms and their spores[2]Guidance for Industry, Sterile Drug Products Produced by Aseptic Processing -Current Good Manufacturing Practice.. Generally speaking, Aseptic kills the microorganisms only but the aseptic processing does not create a sterile condition, while a sterilization technique aims to rid an environment of all living microorganisms.
