Aseptic and Sterile Fill Finish Conditions

The terms – Aseptic and Sterile – are commonly used interchangeably. While they both have a similar objective, they also clearly differ in pharmaceutical and cleanroom environments. They may both be used in contamination and control approaches, but they do not have the same concept.

AbbVie Contract Manufacturing is a rooted CMO, allowing great agility in flexibility and decision-making in deal structuring. We work with your biopharmaceutical products with the same level of dedication as our own. At AbbVie, we are a leading biopharmaceutical company dealing in pharmaceutical fill finish, and our partners know the outstanding benefits of trusting us with their contract manufacturing.

Aseptic

An object, surface, environment, or product has been treated and free of contamination. As a result, viruses, bacteria, or other harmful organisms cannot reproduce or survive.  Aseptic processing maintains sterility and doesn’t necessarily create it. This is a crucial process in aseptic fill-finish.

Sterile

This is a product free from microscopic organisms. A sterilization technique focuses on keeping an environment free from all living microscopic organisms.

The Difference between Aseptic and Sterile Conditions

Sterilization is a process that can be achieved in several ways. For example, it is commonly used in medical environments to clean surgical instruments.

Asepsis is crucial for cleanrooms because people work there, and humans are transporters of microbes. Asepsis does not assure total sterility. However, it promotes a sterile environment.

The difference here can be established via related terminology. A sterilant destroys all microbial life that comes in contact with it. An antiseptic inhibits the activity of microbes on tissue. On the other hand, a disinfectant inhibits the activity of microbes on inanimate objects.

In other words, asepsis is the primary objective of any ISO-certified cleanroom facility; sterilization is the act of destroying harmful microorganisms.

How they Both Relate to Sanitization

Despite the difference in definition between Sterile and Aseptic, they both share a close relationship.
Therefore, they must both be considered during the following:

Inspection

If an item or a surface comes in contact with an unclean object, it must be sanitized immediately to prevent hazards. All personnel who work in a cleanroom must be trained to note this and ensure that the environment is free from contaminated equipment or products.

Cleaning

The surfaces of cleanrooms must be cleaned every day, and the process of cleaning must be documented in detail. This should be done to assure that the proper procedures are well followed.

Disposal

Maintaining a sterile environment is a never-ending process. An aseptic technique that is focused on achieving a sterile environment includes the following:

* Instant wipe-up of any spillage

* Proper disposal of materials

* Re-sanitization of personnel who have shuttled out and back to the sterile area.

At AbbVie, regardless of the nature of your biologic drug, you can trust us when it comes to aseptic fill finish manufacturing. We will provide safe, reliable, and ready-to-use products. To learn more about how we can assist you with aseptic fill-finish, reach out to us; we shall be more than pleased to support you.