Medical Devices

To assist customers in bringing medical devices to market in the fastest, most efficient fashion, as well as to assure the development of cost-effective long-term sterilization solutions, SteriPro Consulting is pleased to provide the following services to help clients navigate Stages 1-4 in the life of a medical device:

Stage One: Material characterization services

Prior to selecting materials for a healthcare device and its packaging, it is essential to establish the effect sterilization will have on those materials. The material characterization process utilizes a series of tests to ascertain the properties of a proposed material both before and after sterilization. These procedures include:

• Assessment of the overall biological safety of a device
• Leachate analysis of extractable components for health-based risk assessment
• Equivalence to clinically established materials
• Equivalence of finished device to prototype device
• Screening of potential new materials for use in medical devices

Stage Two: Biocompatibility services

This phase of medical device testing evaluates biocompatibility appropriate to the component material or finished product. The scope of biocompatibility testing includes:

• Genotoxicity, carcinogenicity and reproductive toxicity testing
• Blood interaction testing
• Cytotoxicity (in vitro) testing
• Post implantation effects testing
• EO residual testing
• Reference materials—biological
• Degradation of materials related to biological testing
• Sensitization and irritation testing
• Systemic toxicity testing
• Identification and qualification of degradation products from polymers, ceramics, metals and alloys
• Toxicokinetic study design for leachables

Stage Three: Manufacturing and environmental process control

The third phase of testing includes qualification tests to demonstrate that manufacturing process controls are sufficient to meet both pre-production quality assurance requirements and post-production product specifications. These procedures include:

Environmental control

• Environmental monitoring program
• Microorganism identification
• Viable and nonviable particulate analysis

Manufacturing process control

• Raw material characterization (e.g., infrared analysis, cytotoxicity, physiochemical tests to establish the effects of sterilization on characteristics determined in Stage One material characterization testing)
• Bioburden analysis
• Process water system validation
• Bacterial endotoxin (LAL) testing
• Device cleaning processes qualification
• Package qualification

Sterility

• Biological indicator studies (spore count and d-value)
• Sterilization cycle development and validation
• Dose determination and validation
• Sterility tests (AAMI, USP)
• Package validation

Finished product qualification

• Functional and performance stability testing
• EO dissipation curve studies and assessment of user exposure levels
• Other chemical residue testing
• Bacterial endotoxin testing–in vitro (LAL)
• Biocompatibility analysis
• Nonviable particulate analysis
• Label claims and instructions for reusable devices
• Shelf life qualification

Stage Four: Release and audit testing

This final stage of testing is designed to assure that finished products satisfy regulatory requirements (ISO, QSR) related to product consistency and compliance with label claims, as well as Sterigenics' internal Quality System regulations. These procedures include:

• Audit and release testing
• Bacterial endotoxins (LAL) testing
• Rabbit pyrogen test
• Safety evaluation
• EO residuals testing
• Sterility testing
• Bioburden analysis
• Microbial limits test
• Cytotoxicity testing
• Materials characterization testing