Selecting a sterilization modality and approach is an important aspect of delivering sterile medical devices. Further, third-party sterilizers are most commonly selected to deliver this final, critical-to-quality service. So, how should a medical device manufacturer select a sterilization provider?
We assembled the following key question areas to help inform your decision.
Capabilities: Assure the provider has the capabilities that you need
- What modalities do you offer (e.g. E-Beam, Gamma, EO?)
- What is your available capacity for product like mine?
- What is your standard turnaround time for shipments? Are expedite options available?
- What in-house lab capabilities do you have, if any?
- Where are your facilities located?
- Do you offer specialty capabilities (e.g. refrigerated / frozen storage, arranging shipping, etc.)
Pricing Model: Assure that you understand how pricing is determined and could change over the lifetime of your product
- What is your pricing structure for validation activities (e.g. dose mapping, specific dosing, dose audits, etc.)
- Please explain how you set pricing for production processing.
- What is your pricing surcharge for expedited processing?
- Once my product is validated, what fees would be charged for a standard production run?
Quality: Understand the provider’s quality system and history
- Are you audited to the ISO 13485 quality standard for the manufacturing of medical devices for the standard of the modality that you are using (e.g. 11135, 11137)?
- Are you registered with the FDA or any other regulatory bodies (e.g. Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) or the European Commission’s MDR (Medical Device Regulation)
- What is your availability to host an audit?
- What is your scrap rate?
- Please outline your business continuity plan.
- Is your quality system paper or digital? How are certificates of processing delivered?
Service: Understand how the provider assures an excellent customer experience
- Please summarize your customer feedback over the past year.
- How do you support your customers day-to-day? Is there a dedicated point of contact for ongoing support?
- Do you offer consultation services during the design and material selection stages to ensure sterilization compatibility and help us understand / optimize the process?
- Have you been subject to any litigation around the sustainability of the facility we would use?
Selecting the right sterilization provider can be a complex decision. Explore our sterilization facility map to find a partner near you, or contact our team for precise, efficient, and reliable E-Beam irradiation services.
Good luck and happy hunting!
The NextBeam Team
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