White Rooms ISO-7 for medical devices

The cleanroom is a room specially designed for low levels of contamination. These rooms have environmental paràmetres strictly controlled: air particles, temperature, humidity, airflow, air pressure inside lighting.

Innovamed develops all its production processes in Cleanroom certified according to EN ISO 14644-1. We have more than 1,200 m2 of facilities with 400 m2 in Cleanroom, ISO 7 (Class 10,000) to produce medical products such as cranial fixation devices, vials for the dental sector, syringes, cartridges and filters for dialysis, single doses for ophthalmology, ...

Some of the security systems that prevent cleanroom medical products from being contaminated by microorganisms in the environment are:

Security systems

The air entering the production room is filtered as it has been filtered to remove particles treated in suspension and microorganisms. It is completely renewed between 20 and 30 times per hour to not accumulate particles.

The rooms are kept at a level slightly higher than the outside pressure, so that when the doors open, air can not get out, and outdoor contaminated air can not get in.

The walls are coated with phenolic resin and the corners are rounded and protected with stainless steel plates to avoid accumulation of dirt.

Operators must wear special suits to not emit particles or release fibers.

The rooms have locks to mantenir pressure differences.

In the cleanroom HEPA filters are used to retain particles (and annual external audits and regular internal controls are performed to ensure that they are free of particles.

Medical products manufactured in cleanroom have therefore the guarantee to get free of any particles that may contaminate. In addition, cleanroom injection is not necessarily a final production cost higher.

If you need services injection parts or plastic components, assembly or packaging for medical products in cleanroom, contact us!