Navigating Cleanroom Classifications and Wipe Selection
Selecting the appropriate cleanroom wipe requires a deep understanding of the ISO 14644-1 standards, which classify cleanrooms based on the concentration of airborne particles. A Class 1 environment is the most stringent, while a Class 9 environment is the least. For manufacturers, matching the wipe to the cleanroom class is vital for maintaining compliance and ensuring product integrity. In ultra-clean environments like ISO Class 3 or 4, only the highest grade of laundered, sealed-edge polyester wipes should be used. These wipes are processed in a cleanroom laundry to remove any residual particles or ions that might have been introduced during the knitting process. Using an unapproved wipe in these areas can lead to immediate contamination and the potential loss of sensitive components.
As we move to ISO Class 5 and 6 environments, the requirements remain high but allow for a broader range of products. Here, pre-wetted wipes become a popular choice. Pre-wetted wipes are saturated with a specific ratio of isopropyl alcohol and deionized water, which reduces the risk of chemical spills and ensures a consistent application of the cleaning agent. This also eliminates the need for spray bottles, which can themselves be a source of contamination. In these settings, the focus is on balance between cleaning efficiency and operational speed. Our range of pre-wetted wipes is designed to provide the perfect moisture level for effective surface decontamination without leaving behind excessive residue or streaks.
For ISO Class 7 and 8 environments, which are common in many medical device packaging areas and secondary pharmaceutical manufacturing, poly-cellulose non-woven wipes are often the standard. These wipes offer a great balance of performance and economy. They are highly absorbent, making them ideal for cleaning up liquids or applying disinfectants over large surface areas. While they shed more particles than 100% polyester wipes, they are perfectly acceptable for these less sensitive zones. It is important for facility managers to establish clear protocols on which wipes are allowed in which zones to prevent accidental cross-contamination. Color-coded packaging or clear labeling can help operators distinguish between different grades of wipes.
Beyond particle counts, other factors like chemical compatibility and extractable levels must be considered. In the aerospace industry, for example, wipes must be low in silicone and other lubricants that could interfere with paint adhesion or the bonding of composite materials. In the pharmaceutical sector, the focus may be more on endotoxin levels and sterility. Sterilized wipes, often treated with Gamma irradiation, are necessary for aseptic processing areas where microbial control is paramount. These wipes come with certificates of irradiation to verify their sterility. Our manufacturing process includes rigorous testing for all these parameters, ensuring that our wipes meet the specific regulatory requirements of various high-stakes industries.
As a manufacturer with years of experience, we provide more than just products; we provide guidance. We help our clients audit their cleaning processes and select the most cost-effective wipe for each specific zone of their facility. This consultative approach helps companies reduce waste by not over-specifying in less critical areas, while ensuring that the most sensitive zones are never compromised. Our commitment to quality and transparency means that you can rely on our technical data to support your validation efforts. By choosing our cleanroom wipes, you are choosing a partner dedicated to the success of your contamination control strategy and the long-term health of your production environment.
