The ability to achieve aseptic conditions is invaluable in many medical cleanrooms and other healthcare applications. Let’s talk about what aseptic conditions are — and are not — as well and look at what you need to design an aseptic cleanroom.

What are Aseptic Conditions?

Aseptic conditions refers to the objective of a facility to limit microorganisms through design, material choices, and sterilization in order to protect sensitive work, products, or people in a space. Aseptic cleanrooms take every precaution to prevent microorganisms from entering and settling in controlled environments where they could threaten health and safety.

It’s important to note that aseptic does not mean the same thing as sterile. An aseptic environment differs from a sterile environment in that it is not just only that a space that has been sterilized, but one that has been specifically designed to maintain sterility as much as possible. 

Medical Cleanroom Applications that Require Aseptic Conditions

The purpose of aseptic cleanrooms is to prevent biological contaminants from threatening work or causing disease. Through choosing aseptic materials and specific design features, cleanrooms capable of achieving aseptic conditions can make important work safe from microorganisms such as bacteria, allergens, fungi, and pathogens. These types of cleanrooms provide a contaminant-free environment that is easier to keep clean. 

Any medical cleanroom that is threatened by the presence of microorganisms can benefit from establishing aseptic conditions, but there are many that require them in order for procedures to be safe and effective, such as:

  • Pharmaceutical cleanrooms
  • Medical device cleanrooms
  • Medical research cleanrooms
  • Hospital settings such as surgery procedure rooms

Many of these applications require additional steps to be taken for the prevention of microorganisms in their industry-specific standards. With the goal of complete asepsis, the design and construction of facilities used for the purposes listed aids in optimizing facility cleanliness and control. 

How to Achieve Aseptic Conditions in a Medical Cleanroom

Aseptic conditions are first established through the cleanroom design features, then maintained through proper training of employees to maintain sterile conditions through gowning, cleaning, and proper removal of waste.

Let’s take a look at the design features of medical cleanrooms that can work to create and maintain aseptic conditions, and how proper training and procedures can be used to optimize them.

Aseptic Cleanroom Design Features

A well-designed cleanroom that can prevent contaminants from entering the controlled environment is invaluable to achieving aseptic conditions. All components used in the cleanroom design must:

  • not contribute to contamination themselves through shedding particles or outgassing
  • be easy to clean and able withstand thorough cleaning procedures and solution

Here are the cleanroom design features that can help medical cleanrooms achieve aseptic conditions.

  • Cleanroom Walls: Medical cleanrooms design should promote coved corners wherever possible, to prevent microorganisms or contaminating particles from settling where they are difficult to be removed. All wall panels should be sealed to prevent any particles leaking into the controlled space. Positive air pressurization can help prevent entering contaminants.
  • Ceiling Grid: Sturdy, reinforced steel ceiling grids provide the necessary support for medical cleanroom systems including fan filter units, lighting, and ceiling panels, while being easy to wipe down to maintain aseptic conditions.
  • Cleanroom Filtration: Fan filter units (FFUs) are essential to achieve the required cleanliness levels proscribed by the ISO and industry-specific standards for medical cleanrooms. Room-side replaceable FFUs are ideal because they can be serviced easily, reducing effort and cost for maintenance.
  • Doors, Windows, and Pass-Throughs: Any access points, including cleanroom windows, doors, and pass-throughs, should be flush-mounted to form a complete seal when closed and prevent ledges or lips where particles could settle or be difficult to clean.
  • Special Features and Technology: Other special features, such as ultraviolet-C technology, which neutralizes bacteria and pathogens in the air, either in the ducting system or in the cleanroom itself, can be used to support filtration and establish aseptic conditions.

When choosing components for your medical cleanroom design, the best materials that will be safe to use in aseptic environments are stainless steel and plastic — either FRP or U-PVC. 

Maintaining Aseptic Cleanrooms

With every part of the cleanroom design working to establish aseptic conditions, it’s up to personnel to maintain them. This can be done through comprehensive training, adequate protective clothing, and set procedures for gowning, cleaning, and waste removal. 

Also, it’s vital to keep the cleanroom in optimal condition to ensure all systems and components are an effective defense against microorganisms and potential contaminants. Replace filters according to a regular schedule and inspect the facility regularly to check for signs of damage or deterioration. This will ensure that the cleanroom is always working hard to provide a safe environment for workers and work to continue, and that you’re always reaching your cleanroom classification.

Need help achieving aseptic conditions in your cleanroom? At Angstrom Technology we have the expertise and the tools to design the cleanroom that best fits your application and your budget. Reach out to our team today for a free custom quote.