Hi All,

We are a precision plastics injection molding manufacturer. I was asked by upper management to do a gap analysis on our current process and set up to get ISO 13485 cerified (currently we are ISO:9000,14k certified) as our company has a plan to manufacture plastic medical parts. The details of the types of parts so far are still unknown. I need your expertise to help me answer the following;
1. Are there any information as far as the general types of medical parts corresponding to their respective Cleanroom requirements? Currently, we are running in I shall say a controlled cleanroom environment (which to my observation is 100k cleanroom or worse).

2. As far as validation of the design or part, do we need to perform simulation according specific usage of the part as a validation method to minimize risk? If so at which stage this should be performed? design or every batch after production?

Thank you all

Regards,

Ed

Hi All,

We are a precision plastics injection molding manufacturer. I was asked by upper management to do a gap analysis on our current process and set up to get ISO 13485 cerified (currently we are ISO:9000,14k certified) as our company has a plan to manufacture plastic medical parts. The details of the types of parts so far are still unknown. I need your expertise to help me answer the following;
1. Are there any information as far as the general types of medical parts corresponding to their respective Cleanroom requirements? Currently, we are running in I shall say a controlled cleanroom environment (which to my observation is 100k cleanroom or worse).

2. As far as validation of the design or part, do we need to perform simulation according specific usage of the part as a validation method to minimize risk? If so at which stage this should be performed? design or every batch after production?

Thank you all

Regards,

Ed
From the MDDI article, CLEANROOMS (http://www.devicelink.com/mddi/archive/00/02/008.html) Injection Molding under Cleanroom Conditions (http://www.devicelink.com/mddi/archive/00/02/008.html) In Europe, cleanrooms of Class 6 (100,000 particles/cu ft) and those of Classes 5 to 3 (10,000 to 100 particles/cu ft) are generally specified for injection molding.
The mfr of the medical device is responsible for design validation. You should validate your process and develop a means to verify that the parts meet specifications for each batch or lot.

Thank you Al.

Regards,
Ed