Frequently, in the early stages of the development of new projects, potential customers ask us if producing in an ISO-7 cleanroom is significantly more expensive than producing in "clean" rooms that do not comply with the UNE-EN ISO 14644-1 standard.
In our response we try to restate the question and formulate it in terms that we understand help clarify the real doubt that our clients have:
What differentiates the price between the offers of different injectors is not so much that they have Clean Room facilities, according to regulations, but also that they require additional ISO-13485 Certification. It is this certification that makes it necessary to maintain a fixed structure that incorporates:
And this is where the price differences lie, in the human and technical structure capable of ensuring production stability, technical requirements and traceability necessary for the manufacture of a health product. Manufacturing, in an ISO-7 clean room, is part of Innovamed's commitment to offer the best service and the highest quality to the products manufactured in our facilities.
Please contact us. We will talk to you first about what you need, and if our services and expertise fit your requirements, the price will certainly not be a barrier.