Compressed air is used in various applications in cleanrooms for a number of manufacturers. The applications can include injection molding, operation of conveyor belts, and the aseptic cleaning process.
Compressed air can be used because of the controlled environment a component is manufactured within, but what facility managers don’t always realize is that the compressed air system itself can harbor microorganisms. This can compromise sterility or other attributes of the products. Therefore, it’s important to implement a standard procedure for routine testing of the lines.
The air lines endure contraction, oxidation, sedimentation, and condensation when stagnant for a period of time, just like other dynamic systems. This makes it important to conduct testing more frequently during:
- Seasonal changes
- Replacement of parts (e.g. hardware, filters/dryers
- An increase or reduction in production schedules
- Inactivity of the system
- Equipment modifications and changes
The simplest way to test the lines is to impact air onto a growth media. Equipment like a Slit Sampler forces Partial Flow of compressed air over a Petri plate. Whatever organisms are present become impinged onto the agar, which is incubated. The Slit Sampler method meets ISO 8573 standards.
Other microbial detection systems that may or may not meet the standards to which you’re held include these methods of capture:
- Impaction
- Centrifugal impaction
- Multi-stage impaction
Whatever method works best for you will help ensure that your product is protected from environmental contaminants. Don’t neglect to test this potential threat to your product’s sterility.
Cleanroom certification and validation are also vital parts of maintaining compliance. It’s important to use a trusted company with enough experience to understand the process and the current standards. Gerbig Engineering Company has been testing cleanrooms for thirty years. We understand your needs, and we’re equipped to provide thorough, efficient service. Contact us at 888-628-0056 or info@gerbig.com.