Sterilization
Coeur, Inc. partners with leading industry experts to ensure sterility assurance and regulatory compliance. We can meet our customers’ compliance needs for AAMI\ANSI\ISO 11135 and EN550 requirements.
Coeur, Inc. guides our clients through the sterilization process:
- Identifying the cycle appropriate for specific products/materials.
- Reviewing customer products for grouping into families.
- Assisting the customer through the validation progression.
- Ensuring the product is sterilized by a process and equipment that is capable of reliably and consistently sterilizing products to a minimum sterility assurance level of 10-6.
- Defining requirements for:
- Cycle Parameters
- Test Sample Preparation
- Biological Indicator (BI) Placement
- Load Configuration
- Defining Applicable Acceptance Criteria
- Microbiological
- Residual
- Performance
- Monitoring routine sterilization processes for product release
We also maintain documentation to support regulatory compliance.
All of these services are within an ISO 9000:2000/ISO 13485:2003 certified location.