Process validations for newly manufactured devices- Is your new device clean?
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This document discusses validating that medical devices are clean after manufacturing. It notes that being sterile does not necessarily mean being clean. It recommends establishing acceptance criteria for residue levels on devices through testing methods like gravimetric analysis, total organic carbon measurement, and particulate counting. Test results should be monitored over time according to a routine schedule and sampling plan to ensure manufacturing processes control residue levels and meet regulatory standards for patient safety and compliance. Process validations can reduce risk by limiting unnecessary contamination sources and making contaminants easy to remove from devices.
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Process validations for newly manufactured devices- Is your new device clean?
- 1. © Nelson Laboratories 2014 Process Validations for Newly Manufactured Devices Is Your New Device Clean? BIOMED Boston 26 March 2014 1:40pm Tech Theater #921 Alexa Tatarian Chemistry Study Director Nelson Laboratories
- 2. MedTech Clinical Significance © Nelson Laboratories 2014 Clean Biocompatible Sterile Just because something is sterile, it does not mean that it is necessarily clean WHAT?: Device Cleanliness
- 3. Standard Information • 21 CFR Part 820: Production and Process Controls (manufacturing material)GMP Requirement • Standard Practice for Reporting and Assessment of Residues on Single Use ImplantsASTM F2847 • New Guide for Validating Clean Lines for Medical DevicesASTM WK33660 • New Practice for Establishing Limit Values for Residues on Single Use ImplantsASTM WK32535 © Nelson Laboratories 2014
- 4. Regulatory Concern Recalls Liability from manufacturing material being introduced to the patient Increased awareness in GMP audits for manufacturers © Nelson Laboratories 2014 WHY?: Patient Safety and Regulatory Compliance
- 5. Mock Manufacturing and Cleaning Process © Nelson Laboratories 2014 Machining De- Burring Grit Blast Rough Clean Polish Rough Clean Laser Mark Passivation Final Clean with Detergent Oil Particulates Detergent Water Contamination Polishing Compound Nitric/Citric Acid
- 6. Reduce Risk in the Process Choose biocompatible agents Easy to remove Streamline processes © Nelson Laboratories 2014 Limit introduction of unnecessary sources of contamination
- 7. How to Validate Test Options Benefit Types of Residuals Result Gravimetric Extractable Residue (ASTM F2459) Quantify Residue Oils, lubricants, detergents, coatings, particulates, etc. Weight of residue (mg, mg/device, or mg/cm²) Total Organic Carbon (TOC) Quantify Residue Detergents, alcohols, organics, etc. TOC readout (ppb, µg/device, µg/cm²) Detergent Residuals (UV/VIS) Quantify Residue Detergents mg/device, mg/cm² Particulates (USP 788) Quantify Residue Particulates Count ≥10µm and ≥25µm Cytotoxicity (ISO10993-5) Show if residue is cytotoxic Anything cytotoxic Pass/Fail Bioburden Microbiological examination Aerobic bacteria and fungi Quantitative CFUs Bacterial Endotoxin Microbiological examination Gram-negative bacteria Pass/Fail Quantitative EUs © Nelson Laboratories 2014 HOW?
- 8. Acceptance Criteria Positive Controls Unclean devices compared to clean devices Historical Data Trend data Alert and Action Levels Additional Tests Cytotoxicity Microbiological Tests Compare to Toxicological Data NOAEL, LOAEL, LD50, etc. © Nelson Laboratories 2014
- 9. Routine Monitoring Schedule Routine Monitoring Weekly Monthly Quarterly Semi- annually Control process Alert Levels Action Levels Change Evaluate Accept Reject © Nelson Laboratories 2014 Once acceptance criteria has been established:
- 10. Sampling Plan Group together when possible Material types • (SS, Ti, PEEK, etc.) Processes • Similar contaminants Worst Case Most difficult to clean Most concerning residuals © Nelson Laboratories 2014
- 11. Thank you! © Nelson Laboratories 2014 Alexa Tatarian Study Director Nelson Laboratories 801-290-7910 atatarian@nelsonlabs.com