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Clean-Room Production

Strict hygiene standards regulated under DIN EN ISO 13485 (for non-implantable medical devices) must be observed when manufacturing medical technology components. We specialize in plastic injection molding within ISO class 8 and 7 clean-room environments (ISO class 7 equivalent to GMP class C), and have been clean-room qualified since 2005 per ISO 14644-1 standards. What began with simple injection-molded parts for lancing devices has evolved at RKT to include complex microfluidic test carrier systems requiring an analyte-free environment.

Injection Molding in or next to the Clean Room

We injection mold inside cleanrooms, but also at times locate the injection molding machine just outside the clean room utilizing a containment and protection system for transfer of the parts into the cleanroom environment. This provides protection for the parts while reducing the potential for contamination from auxiliary activities such as injection mold machine maintenance.

Trained Cleanroom Staff

Human beings are a significant source of contamination in clean rooms. To mitigate this, we design our processes to minimize human interaction, utilizing robotics for part handling whenever feasible. Any manual tasks in semi-automated assembly are performed by our trained clean-room staff, who strictly adhere to stringent clothing and conduct standards. Our team’s commitment to cleanliness is reflected in consistently excellent monitoring results, validated through regular air particle measurements and germ swab samples.

Each cleanroom process is tailored to each product. Maximizing the number of production processes in the room minimizes the time, effort, and contamination involved in personnel entering and exiting the room. Storage in the room is minimized to limit contamination to minimize associated cost.

Analyte-Free

We also plan and prioritize sensitive process steps to ensure analyte-free results. To prevent germ contamination in the cleanroom, we utilize biosafety cabinets equipped with UV light. Production in biosafety cabinets provides for a clean room classification of up to ISO 6.

Whatever the case, we collaborate closely with you to design custom clean room solutions tailored to your product’s requirements.

Humidity and Temperature Control

Clean-room production involves more than maintaining particle-free environments; humidity and temperature must also be precisely controlled. In some cases when handling delicate and hygroscopic lyophilizates (freeze-dried substances), conditions must not exceed a relative humidity of 50% and a temperature of 25 degrees Celsius.

Numerous factors can significantly impact the success of clean-room production. Comprehensive monitoring and documentation ensure we adhere to numerous requirements, our processes being closely tracked through CAQ systems. Using this system, we are able to provide a detailed certificate with all relevant measurement and production conditions data under which a production lot was produced.

If your goal is to transform your product idea into an efficient production process in a professional cleanroom environment, we are your experienced partner ready to develop and manage every step of the process.