Whether it’s for medical applications, electronics, optics, cosmetics, or more, partnering with an ISO Class 8 Clean Room certified manufacturer can make all the difference on a highly sensitive project.
Custom Profile details the importance of this partnership and what it means to hold this specific ISO certification.
What Does ISO Class 8 Clean Room Certified Mean?
An ISO Class 8 Clean Room certification is technically an ISO 14644-1 certification, which is an overarching set of guidelines for cleanrooms and controlled environments. There are nine levels to ISO clean room certification, with one (1) being the cleanest room and nine (9) being the most lenient of clean room standards.
Class 8 Clean Rooms must have fewer than 29,300 particles/meter3 that are greater than or equal to 5 microns in the designated room. This results in at least 20 air changes per hour with routine cleaning of all equipment in the room. An ISO Class 8 Clean Room is roughly 10 times cleaner than the traditional air-conditioned office space.
Expected Operational Practices from Manufacturers
One can imagine that maintaining any level of clean room status requires exhaustive procedures and dedicated team members to uphold the level of cleanliness that’s not only required, but demanded.
Manufacturers like Custom Profile start off with the basics, which means evaluating environmental control procedures such as constant monitoring and control of particle levels. This requires controlling elements such as temperature, humidity, pressure differentials, and in some cases, even static levels.
Of course, there are going to be team members entering and exiting the clean room that will impact the environment. In many facilities, there are separate areas where employees will change into proper equipment, such as head covers, specialized lab coats, eye coverings, gloves, and booties.
Lastly, documentation on everything related to the clean room includes all cleaning procedures, production runs, materials used, number of team members in and out of the room, and total time spent in the room.
Key Benefits
There are specific benefits that stem from having a partnership with an ISO Class 8 Clean Room certified manufacturer.
- Drastically lower contamination levels become the reality for not only your extrusion projects, but anything they come into contact with during and after manufacturing.
- Consistent quality is achieved as there is more control over the manufacturing room that impacts part quality.
- Fewer product failures and overall defects happen as a result of clean rooms because harmful, airborne contaminants are removed.
- Easier market-readiness is introduced as customers and OEMs know what goes into manufacturing in a clean room.
- Faster to meet regulatory requirements depending on industry.
- Improved customer perception and brand identity.
- Long-term cost effectiveness.
Partner With Custom Profile, an ISO Class 8 Clean Room Certified Manufacturer
Custom Profile has created the custom extrusion products your team, customers, and industry rely on. Whether it’s window trim, components for consumer products and appliances, or parts for medical equipment, we’re the manufacturer that can handle it all.
We hold an ISO Class 8 Clean Room certification, which allows us to handle the most sensitive projects where there is no room for contamination and harmful agents impacting the production and quality of your order.
Need ISO Class 8 Clean Room manufacturing services with an experienced and trusted partner? Contact us today, and we’ll set up an initial consultation to discuss the parameters of your project.