The Misconception About Sterile and Aseptic Processes and Why it Matters to Your Cleanroom

understanding of how they are maintained. There are two methods that are used to
control microbial contamination in cleanrooms: sterilization processes and aseptic
process. There is a misconception that these two processes are one in the same. While
they are often used in tandem to maintain the stable environment of the cleanroom,
The Center for Disease Control (CDC) defines sterilization as the use of a physical or
chemical procedure to destroy all microorganisms including large numbers of resistant
bacterial spores (1). Sterilization kills all viruses, bacteria, fungus and spores whether
they are harmful or helpful. The goal is to create an environment free of all living
The CDC recommends many disinfectants to be used alone or in combinations to
sterilize cleanroom equipment and surfaces. These include hydrogen peroxide,
peracetic acid, alcohols and chlorine compounds. Formulations of these chemicals are
designed for specific purposes. It is important that cleanroom disinfectants are
registered with the Environmental Protection Agency or cleared by the Food and Drug
Administration and applied for their intended use (2).
Aseptic processes are more complex than sterilization processes. While a sterile
environment is completely free of microorganisms, aseptic describes something that
has been made contamination-free. Whenever a human operator enters a cleanroom,
some level of microbial contamination can be expected. Rather than eliminating all
Microorganisms may be present in the cleanroom, but they are not pathogenic. This is a
standard that won’t duplicate bacteria or create more viruses. Aseptic processes require
an understanding of the existing microorganisms, and knowing which will compromise
the product. Microorganisms that will contaminate the product are excluded.
Aseptic processing facilities include easily cleanable floors, walls and ceilings of smooth
hard surfaces, temperature and humidity controls, and HEPA filters to filter the air
supply into the cleanroom. Aseptic processes also include procedures for using sterile
Aseptic and sterile processes work hand in hand to create a stable cleanroom
environment, prevent contamination and protect the integrity of your product.
Regulations for cleanroom design are intended to make these processes sustainable.
When a cleanroom is compromised due to contamination, the result is a
time-consuming and expensive shutdown, cleaning and re-certification. Contamination
can also hurt your brand’s reputation and financial bottom line. To avoid these harmful
ramifications, it is important execute a comprehensive training program for personnel
As a cleanroom performance testing contractor, Sure-BioChem Laboratories has
experience and expertise in a variety of cleanroom processes and applications. Our
breadth of knowledge on sterilization and aseptic processes make us a preferred source
for cleanroom certification in accordance with ISO specifications. Our team provides
testing and monitoring for HEPA air filter integrity, room pressurization, temperature and
humidity monitoring and environmental monitoring of air and surface microbes. In
addition, we can provide your personnel with competency training for cleanroom best
Resources:
1. https://www.cdc.gov/oralhealth/infectioncontrol/glossary.htm#S
2. https://www.cdc.gov/infectioncontrol/pdf/guidelines/disinfection-guidelines-H.pdf
3. https://www.fda.gov/media/92841/download