Controlled for Confidence: How Hymid Ensures Medical-Grade Manufacturing
- pheobedavidson8
- 3 hours ago
- 2 min read
At Hymid Multi-Shot Limited, precision and sterility are integral to our medical plastic injection moulding processes. In order 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, featuring a fully calibrated two-shot Arburg injection moulding machine: the perfect combination to uphold the highest standards of hygiene and precision.
Hymid is certified to the ISO 13485:2016 (Medical Devices) standard, a framework that 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 have full knowledge of the stringent processes and regulatory requirements that underpin medical-grade manufacturing.
Our clean room combines advanced technology with efficiency, featuring a 60 ton two-shot Arburg injection moulding machine with micro-moulding capability, alongside ample space for secure storage and packing. Every component is produced in a meticulously controlled environment with strict particle limits, guaranteeing the highest hygiene standards for medical applications, clinical trials, and ensuring full compliance with global regulations.
Our Commitment to Quality
We combine advanced injection moulding technology with rigorous clean room protocols to guarantee every product meets the highest standards.
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.”
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.