Steps to Contract Coating Services:

Identify needs:

Working closely with an AST technical representative, our customers define the properties needed in a coating or surface treatment.

Feasibility study:

For a nominal fee, AST will treat a small lot to demonstrate the applicability of the coating.

Development work:

Generally, some fine-tuning of the coating or process is needed in order to optimize results. Our staff works with the customers in this stage to ensure the changes are cost effective and practical for future production. ISO 13485:2016 practices are followed.

Validation:

A validation protocol will be developed and the study run. A formal report will be prepared and customer specific SOP’s will be written.

Approval:

Upon customer approval, the process is formally transferred to manufacturing for routine contract services.

Facilities:

AST Products maintains three Class 100,000 cleanrooms and one Class 10,000 cleanroom. General laboratory and office space is at AST’s disposal as well. Housed in a 23,000 square foot building, AST’s contract services can not only coat your medical devices, but also handle procurement and storage requirements.

Commitment to Quality:

In 2018, AST upgraded its quality system to meet the requirements of ISO 13485:2016. Not only does AST carefully control its process and documentation, it also commits significant resources to continuous improvement and customer satisfaction.

Availability:

AST is committed to fast turnaround of quality coated parts. Its technical staff is available to answer any questions and to provide continual support to all of our customers.