The terms “aseptic” and “sterile” are often used interchangeably. They both refer to a similar objective—eliminating/reducing potentially harmful microorganisms, but the differences are crucial in cleanroom and pharmaceutical environments. While both are commonly used contamination-control techniques, they are, in fact, different concepts.
Aseptic vs. Sterile
Any cleanroom staff must understand the key distinctions between the two. The industry recognized definitions of each are as follows:
- Aseptic: A surface, object, product, or environment has been treated such that it is free of contamination. Bacteria, viruses, or other harmful living organisms cannot survive or reproduce. Aseptic processing doesn’t create a sterile condition; it only maintains sterility.
- Sterile: A product that is completely free of microscopic organisms. While sterile means the complete absence of bacteria, viruses, and fungi along with spores, it doesn’t distinguish between specific pathogens. A sterilization technique aims to rid an environment of all living microorganisms.
How Does Each Process Differ?
Sterilization is a radical process that can be achieved in various ways. It is often used in medical environments, for example, to clean surgical instruments.
Isopropyl alcohol is a common localized disinfectant. For sterilizing large areas, hydrogen peroxide or peracetic acid droplet foggers may be used. Devices are often sterilized with autoclaves or gamma radiation.
Asepsis is important for cleanrooms where people work because humans are effective transporters of microbes. It does not guarantee full sterility. Nonetheless, it promotes a sterile environment by incorporating measures such as established cleanroom practices, training, and wearing gowns and other protective gear.
The key differences can be explored through related terminology. A sterilant, whether a liquid or vapor, destroys all microbial life it comes in contact with. An antiseptic destroys or inhibits the activity of microbes on living tissue, while a disinfectant does so on inanimate objects, although spores may survive.
In short, sterilization is the process of eliminating harmful microorganisms; asepsis is the key objective of any ISO-certified cleanroom facility.
Under Which Context Would Each Condition Be Necessary?
Aseptic is used in context with cleanroom operating procedures. In addition to wearing gowns, it is also applied to the requirements of having personal protective clothing. Gloves, masks, hoods, goggles, aprons, and lab coats fall under this category.
The standard operating procedures of a cleanroom essentially dictate the facility’s aseptic approach. These often include guidelines such as:
- When to change protective clothing
- In what order to don and remove such items
- Test tools and equipment used on cleanroom staff after wearing protective items
- Hand washing
- Removal of watches and jewelry
- Visual inspection of work areas
- Frequency of sanitization
- Use of solutions with at least 70% alcohol
In addition, aseptic conditions are also maintained in areas where achieving complete sterilization is unlikely, such as a hospital or physician’s waiting room.
Where Sterile Conditions Are a Must
Cleanrooms are generally not completely free of microbes. The greater concern is with controlling airborne particles. Nonetheless, HEPA filters are capable of capturing a variety of microbes.
Sterility, under the definition described above, is even more important in operating rooms where any level of microbes can infect an open wound. A range of pharmaceutical products must be sterile as well. These range from syringes to ophthalmic formulations, to hemodialysis solutions and sterile medicines.
How Both Pertain to Sanitization
The relationship between aseptic vs. sterile is a close one despite the differences in definitions. In regard to sanitization, both must be considered during the following steps:
- Inspection: If a surface or item comes in contact with a contaminated object, it must be immediately sanitized to eliminate hazards. All personnel hired to work in a cleanroom must be trained to identify these and ensure the space is free of trash, debris, or contaminated products or equipment.
- Cleaning: Cleanroom surfaces must be cleaned daily, and the cleaning process should be documented in clear detail to assure proper procedures are followed. To ensure your team is following all applicable standards, maintain logs of when it was sterilized and how and what was used to disinfect the cleanroom.
- Disposal: Maintaining a sterile environment is an ongoing process. Aseptic processes aimed at achieving a sterile environment include proper disposal of materials, immediate wipe-up of any spillage, and re-sanitization of personnel who have left the sterile area and return to it.
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