The situation where all viable microorganisms and organisms are not able to reproduce, this is called sterile. Sterile means complete isolation of microorganisms whether they are pathogenic or not.
It means the absence of pathogenic organisms and microorganisms, there may be microorganisms but they are not pathogenic.
When a tool, or surface has been made contamination-free, and that tool or surface does not regenerate pathogenic microorganisms is called aseptic in nature.
Sources of contamination in the aseptic area:
Where human presence is available there are chances of developing contamination remains every time viable.
In the presence of humans, technically clean areas do not remain clean any more, It requires regular aseptic processing to keep it aseptic.
Difference between aseptic and sterile
There are always chances of misinterpretation between sterile and aseptic areas. Most people are confused that these two similar looking terms are the same definitions. Aseptic and sterile are two different things in broad terms.
On the other side, sterile represents a condition where all microorganisms, germs, bacterias are completely destroyed. In a sterile process nothing left alive to contaminate or reproduce again. Every microorganism, bacteria, protozoa, fungi, and spore destroyed absolutely.
A room or a tool which have human presence can not be made sterile, it just can be made aseptic or controlled conditioned. It can prepare to that aseptic level where chances of reproduction of contamination are near to zero.
In the sterilization process every live bacteria or germs are completely destroyed, availability of bacteria or germs may lead to harmful situations. Generally Injectable medicines are administered IV route then any contaminating microorganism can harm the health after reaching in human blood.
Benefits of sterilization:
The surgery tools are sterilized in an autoclave for recommended time 15 minutes at 121oC – 124oC. After sterilization it ensures the zero bacteria on the surfaces of surgery tools so that they can not transfer the contamination to the open wounds of the body during the surgery.
Human operators in sterile areas are only contaminating factors to the sterile products or surfaces, if they are directly exposed to the products or surfaces. But if proper sterile dress, hand gloves, masks, and shoes covers(sterile) are worn, it can be minimized to the zero contamination levels.
However, regular sterilization processes are most necessary before performing every production shift.
What is the definition of sterile?
A condition can be termed as sterile if it is complete unavailability of microorganism, fungi, bacteria, and spores. Formaldehyde and Potassium dichromate fumigation and application of IPA 70% solution on the surfaces and tools can make an area sterile.
Method of sterilization:-
For the complete destruction of bacteria, fungi, viruses, protozoa, and microorganism a sterilization process is required. There is not any absolute state of sterility possible; it can only achieve a level of sterility where chances of contamination can be minimized and observed.
The heating process is an autoclave (Steam sterilization) In this process tools or products are exposed to saturated steam under pressure in an autoclave that achieves the destruction of microorganisms of enzymes and proteins (structural).
In sterilization process proper control of time, temperature, and pressure is very important,
The air present in the autoclave before steam formation should be ejected out.
The best results are obtained at 121 to 124 0c. For 15 minutes, and at 200kPa pressure.
Where 1atm= 101 325 pa
|Temp(oC)||Approximately Pressure (kPa)||Minimum Sterilization time(min)|
|134-138||300 (~3.0 atm)||5|
Often people consider sterile and aseptic to be the same process. They have no fault in this, both the processes are used in the similar-looking work. In fact, there is a fundamental difference between the two that is their spectrum of work. Aseptic is the soft process of asepsis, while sterile is a hard attack on microorganisms, fungi, and bacterias.
In the aseptic process where the disease-spreading bacteria, microorganisms, fungi are prevented from growing again, and to ensure that all those bacteria do not reproduce.
The author has 20 years of experience in the Pharmaceutical Manufacturing Companies. Have exposure to all audit documents for WHO-GMP, PIC/S, USFDA, Export documents, US-FDA documents, Validation of Pharma machinery, and Quality Control Instruments. Expert in Pharma Plant Setup and sale and acquisition of running pharma company.