In pharmaceuticals, the terms aseptic and sterile are significant concerns, and sometimes it is not easy to understand the differences between the two terms. For example, just in environment classification, some people might say the sterile area, and a few use the term aseptic area. There is a difference between these two terms.
USP General information chapter no. 1116 describes The terms Aseptic and Sterile are not synonymous. It is a broad concept, and the US FDA does not include it in guidelines.
Difference between Aseptic and Sterile
Sterile means having an entire absence of viable microorganisms or organisms that have the potential to reproduce. No life at all like (bacteria, fungi, and viruses)
Sterile means any surface and product contact part which is free from microbial contamination is named sterile. The products free from all pathogens and microorganisms are called sterile products, such as surgical gloves (sterile surgical gloves), small volume parenteral, and large volume parenteral and ophthalmic products.
The technique used for the removal of all harmful microorganisms or pathogens is called the sterile technique.
Aseptic means pathogenic microorganisms-free area. The limits of Microorganisms are present there. An aseptic process forestalls contamination by the exclusion of microorganisms.
Reduce the number of life forms, in a general example, by wash hands with soap.
For practical purposes, if somebody wants an area free of microorganisms, not making it sterile but wants to keep it bacteria or pathogen-free for a long time to keep the product safe, then follow an aseptic technique to keep the product safe. For example, many food cold chains are following these aseptic conditions.
Aseptic process for handling sterile (sterilized) materials under a controlled environment. to carry out microorganisms at the minimum level.
In any environment where human operators are present, microbial contamination at some level is inevitable. Even the foremost 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 in minor locations during every aseptic processing operation is technically impossible and thus is unrealistic.
If we mention the classification of the area where sterile products are being manufactured, it is better to mention an aseptic area or controlled area, not a sterile area.