Is it really more expensive to produce under ISO-7 cleanroom conditions?

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: 

• Quality Department (qualified personnel and laboratory equipment) 
• Operating systems with the capacity to ensure product traceability  
• Preparation and development of external and internal audits 
• Qualification of the facilities (IQ) and development of the know-how to perform the process validations (OQ /PQ), post injection equipment and sterile barrier packaging, if requested by the customer 
• Issuance of Quality Certificates for each production, according to the required Product Specifications. 

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. 

In the Faqs section you will find answers to more frequently asked questions. You can also contact with  Eusebio Riola through eriola@innovamed.es