Commercialization Support
To accelerate the product development process, SurModics offers a comprehensive array of integral project services throughout the product development cycle. These services include in-house surface characterization, analytical chemistry, clinical study coating or manufacturing support, manufacturing equipment, and worldwide regulatory support.
Our technology and value-added services help our customers to bring high performance products to market successfully and more quickly. We have dedicated technical groups that provide ongoing support for customers who use SurModics' technologies on their product. Our experienced teams can help with technical questions or problem diagnosis, and can also connect the manufacturer directly with the appropriate SurModics expert if needed. Your customer support contact can routinely travel to your facility to assist in evaluating any process changes or new equipment, help you increase throughput, troubleshoot any potential problems, or train coating personnel.
SurModics offers clients state-of-the art processing, clean room production, and manufacturing facilities. Clients support the process with specific production equipment and staff.
- Three clean-room suites that can be operated independently for drug and drug delivery products
- An additional clean-room suite (3 rooms) dedicated to biomaterial production
- Facilities for terminally-sterilized parenteral formulations (Low bioburden/particulates)
- Class 100 to Class 100,000 (ISO 5- to ISO 8)
- Supporting utilities and Quality Systems
- ~ 650 sq. ft. of classified area within each suite
- ISO Class 5 to 8, temperature and RH controlled
- Quarantine and storage areas for each suite
- Qualified utilities
- Qualified environmental monitoring
- Qualified refrigerators and freezers
