Need Cleanroom Parts?

what certifications make up a cleanroom?

Our class 8 cleanroom provides manufacturers with an optimal environment to produce and package medical and/or other devices under strictly monitored and controlled conditions. A certified class 8 cleanroom is designed to eliminate external dust, volatile emissions and other contamination agents that could endanger the health of a patient.

Air filtration methods filter the air throughout the manufacturing process. Ventilation is generally achieved using unidirectional flow and turbulently vented flow to filter the air. Unidirectional flow involves using high-efficiency filters such as HEPA filters to sweep air across the room in one direction. Filters can sweep air at a speed of 80ft/min across the cleanroom thus, sweeping away airborne contaminants.

Turbulent vented flow works using filters to keep the air within the cleanroom in constant motion throughout manufacturing. The constant motion disrupts airborne microbial agents from settling onto surfaces or equipment.

Maintaining a desired air pressure according to the requirements of your medical device manufacturing process or regulations helps reduce contamination. For medical devices, a sterilized cleanroom is desired and higher pressures are ideal for reducing contaminants.

Hard wall and soft wall cleanrooms may be used depending on the manufacturing requirement. Long-term medical device manufacturing may require hard wall rooms that are permanent and short production runs may utilize soft wall rooms that may be modified if needed.

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Mold Design

Mold Design is a crucial step in the injection molding process. Once you’ve finalized your part in CAD software for fit and function, it must then be transformed into a design for molding to ensure the capture of all the specified details. In some cases, certain features of the part design may not be manufacturable via the injection molding process.

At PTI, we collaborate with you to achieve the best possible design for manufacturability. In fact, we have a FREE guide to help you with this.