Controlled for Confidence: How Hymid Ensures Medical-Grade injection moulding Manufacturing

At Hymid Multi-Shot Limited, precision and sterility are integral to our medical plastic injection moulding processes. To meet the stringent requirements of the medical industry, our manufacturing facility houses a Class 7/8 Clean Room, commissioned from Connect 2 Clean Rooms. This features a fully calibrated two-shot Arburg injection moulding machine, creating the perfect combination to uphold the highest standards of hygiene and precision.

Our Compliance Standards for medical injection moulding manufacturing

Hymid is certified to the ISO 13485:2016 (Medical Devices) standard. This framework governs every stage of the product lifecycle, from design and development through manufacturing, storage, and distribution. As a result, you can be sure that our staff possess a thorough understanding of the stringent processes and regulatory requirements that underpin medical-grade injection moulding manufacturing.

Our clean room combines advanced technology with efficiency. It features a 60-ton two-shot Arburg injection moulding machine with micro-moulding capability. Additionally, we have ample space for secure storage and packing. Every component is produced in a meticulously controlled environment with strict particle limits. This guarantees the highest hygiene standards for medical applications and clinical trials, ensuring full compliance with global regulations.

Our Commitment to medical-grade Quality

We combine advanced injection moulding technology with rigorous clean room protocols to guarantee that every product meets the highest standards of medical injection moulding manufacturing.

Our Clean Room protocols include:

• Regular particle counter registration

• HVAC systems with HEPA filtration

• Strict gowning and hygiene procedures for all personnel

  
  

This meticulous approach ensures your products are manufactured in an environment that prioritises safety, conformity, and reliability. For you, this means reduced risk of contamination, fewer quality concerns, stronger brand reputation, and complete confidence that every component meets the strict requirements of the industry.

Managing Director, Tom McMurtrie says, “Our Class 7/8 Clean Room isn’t just a feature; it is a testament to quality and compliance, reflecting Hymid’s dedication to delivering high-quality components that meet the most demanding industry standards.”

The Importance of Clean Room Technology

Clean room technology plays a vital role in the production of medical devices. It helps maintain the integrity of the products we manufacture. By controlling environmental factors such as temperature, humidity, and particulate contamination, we ensure that our components are produced under optimal conditions. This is especially critical in the medical field, where even the smallest particle can compromise the safety and effectiveness of a device.

Advanced Manufacturing Techniques

At Hymid, we employ advanced manufacturing techniques that enhance our production capabilities. Our two-shot injection moulding process allows for the creation of complex geometries and multi-material components. This innovation not only improves the functionality of the products but also reduces assembly time and costs.

Why Choose Hymid?

Choosing Hymid as your manufacturing partner means opting for quality, reliability, and expertise. We understand the unique challenges faced by the medical industry. Our commitment to excellence ensures that we deliver solutions that meet your specific needs.

If you are looking for a manufacturing partner to assist with your medical device development, don't hesitate to give us a call or send us an email.

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