In order for cleanrooms to yield optimal results, it’s important to have a clear understanding of how they are maintained. There are two methods that are used to control microbial contamination in cleanrooms: sterilisation 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, sterilization processes and aseptic process are two separate methods.
Sterilisation Processes
The Center for Disease Control (CDC) defines sterilisation as the use of a physical or chemical procedure to destroy all microorganisms including large numbers of resistant bacterial spores 1. Sterilisation kills all viruses, bacteria, fungus and spores whether they are harmful or helpful. The goal is to create an environment free of all living microorganisms.
The CDC recommends many disinfectants to be used alone or in combinations to sterilise 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
Aseptic processes are more complex than sterilisation 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, this method acts as a barrier to prevent contamination.
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 instruments and gloves 3.
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 and keep up with cleanroom maintenance and certifications.
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 sterilisation 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 pressurisation, 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 practices and aseptic technique.
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
