
Need Cleanroom Parts?

ISO 13485, ISO 9001:2015, AC8160, ISO 14001:2015
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.

MEDICAL PART MANUFACTURING STANDARDS
CLEANROOM CERTIFICATIONS
PTI adheres to strict protocols that meet the demands of industries requiring ISO 14644 Cleanroom specifications. We also follow ISO 13485, which includes using quality management systems to ensure proper cleanliness during the manufacturing process. And ultimately, PTI provides A to Z documentation for proof of standard under audit.
- ISO 14644
Specifies the classification of air cleanliness in terms of concentration of airborne particles in cleanrooms and clean zones; and separative devices as defined in ISO 14644-7. - ISO 13485
Specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Such organizations can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e.g. technical support).
OVER 10,000 SQUARE FEET OF CERTIFIED CLEANROOM MANUFACTURING

HOW WE’RE EQUIPPED TO HANDLE your cleanroom manufacturing:
Our cleanroom molding and cleanroom manufacturing department are operated within a hard-wall area measuring over 10,000 square feet, with an additional 5,000 square feet of white room assembly space. It is certified to ISO Class 8 standards and follow good manufacturing practices (GMP). Within our cleanroom facility, we have 24 state of the art presses dedicated to cleanroom operations, capable of 22 to 245 tons.
We have a dedicated management team to handle the critical elements of monitoring and maintaining these areas. Through a disciplined system of policies, procedures, guidelines and training, our employees are fully equipped and ready to meet all regulatory compliance requirements.



Reduce CONTAMINATION RISK BY HAVING ALL OF YOUR CLEANROOM PART MANUFACTURING COMPLETED UNDER ONE ROOF
Secondary operations:
• Pad printing
• Laser marking
• Appliqué and badging
• Product and part assembly
• Welding and staking applications
• Packaging services
about cleanroom manufacturing
VENTILATION METHODS
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.
AIR PRESSURE
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.
Construction Type
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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Design For Manufacturing Guide
Made in the USA

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.

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