Glazpart are proud of our clean room / area facility which was heavily utilised during the covid outbreak period. This room operates at a Class 7000 (7) level with fully trained operators moulding medice device closures. Which are taken off robotically with a 6 axis arm and packed.

Cleanrooms are an integral part especially of the medical device moulding process. In situations where hygiene is critical an ISO class 7 clean room / area ensures that contaminants and particles are managed and monitored to ensure your products meet strict requirements. But what is an ISO class 7 cleanroom, what does it mean, and why is it essential to work with an experienced manufacturer that offers a clean room / area facility?

What is a Cleanroom?

A Cleanroom or area is usually required in the production of medical, consumable s and other hygiene-sensitive products. Cleanrooms and areas are designed so that contaminants and particle flow can be managed and monitored closely to maintain requirements. ISO classifications run from one to nine, with nine being the least strict along the lines of the allowed concentration of particles per m³ of air. As well as air changes, facilities like gowning rooms and sticky mats on entry and exit points can be required to maintain manufacturing standards and to reduce the chances of possible contamination.

Other industries that need an ISO Class 7 cleanroom include, ISO Class 7 rooms provide air cleanliness of a maximum of 352,000 particles per m³ at 0.5μm and 60 to 90 air changes per hour. Many industries utilise the ISO class 7 certification for a range of processes. Such as,

• Medical device manufacturing
• Electronics manufacturing
• Pharmaceutical compounding
• Laboratories
• Aerospace product development

And cleanroom / area processes that may need a class 7 room or area include. Manual, semi-automatic and fully automatic medical device assembly, Ultrasonic welding, Hot-plate welding, Hot-wire welding, Blister packaging, Pouch sealing

Minimum requirements for ISO Class 7 cleanrooms

For Cleanrooms to adhere to the ISO Class 7 cleanroom classification, there are a number of stringent measures that manufacturers have to abide by to manufacture medical devices, these include;

• 30 to 70 air changes per hour.
• 352,000 PPC (particles per cubic meter) at 0.5μm, 83,200 PPC at 1μm and 2,930 PPC at 5μ
• Required testing (ISO 14644-2) every six months.
• A separate room for gowning.

Cleanroom classification – How do Glazpart assure high standards and quality?

The ISO classification directly relates to air quality with a scale of one through nine (one being the most stringent) determining what level of cleanroom protection is required for a specific product. These classes are incredibly strict with each determining the cleanliness of the air as well as the air particles present and grading the room accordingly. This is based on measurements of microns per M³ of air and factors into the various ISO cleaning standards ratings.

As an injection moulder with an ISO class 7 cleanroom, we offer spaces specifically designed for processing Class I and Class II medical devices. These requirements include safety measures such as separate changing rooms, regular air testing, and highly efficient HEPA filters which work around the clock with 99.997% efficiency at 0.3 microns.

This accuracy ensures a controlled environment where products can be produced to exacting ISO cleaning standards to ensure the same conditions for every device.

Benefits of an ISO Class 7 Cleanroom?

An ISO class 7 cleanroom offer a level of control that regular manufacturing doesn’t. As explained above, the use of specialised air filters, safety practices, and regular testing means we offer spaces for medical device manufacture that are clean, controlled, ands safe.

A certified ISO class 7 cleanroom also means that we are able to produce class I and class II medical devices. This opens our capabilities to include a wide range of devices that fit under umbrella definitions for medical devices with low risk, and medical devices with low to medium risk which runs the gamut from single-use tests to inhalers, and other specialised medical devices.

What products can be produced in an ISO Class 7 Cleanroom?

ISO Class 7 cleanrooms allow us to produce products such as Class I and Class II medical devices but additionally open the door to a range of processing methods commonly used in medicine. These include blister packaging and pouch sealing for medication, devices, and other medical equipment, manual and automatic medical device assembly, and welding. These services cover a variety of products and medical devices and show how important production with the assistance of ISO class 7 cleanrooms is to the medical manufacturing community.