As a result of EPA mandates medical device manufacturing require new and innovative sterilization methods. These novel sterilization methods require a quality and regulatory framework of documentation in order to facilitate the adoption these new modalities.
Chlorine Dioxide validation process.
Ethylene Oxide is most common form of sterilization for medical devices. Chlorine dioxide is a cost effective validated approach that does not compromise plastic or batteries and repeatedly and reliably achieves sterility assurance levels.
Chlorine Dioxide Benefits:
- Battery, electronics, PTFE, and broad polymer compatibility
- Short Cycle times, Fast acting sterilant
- Existing packaging can often be used (Oliver Packaging link)
- Non-carcinogenic sterilizing agent
- Minimal environmentally friendly residuals
- Ambient Temperature Process
- Reduced cost
- Entire process occurs in single chamber, reduced product handling
Implementation for medical device companies can be streamlined if the quality and regulatory documentation follows comprehensive quality planning and supported by deliberate risk management compliant to ISO14971 and ISO24971 requirements and recommendations.
We authored and customized the following document suite to facilitate development, validation, and implementation of new technology.
| Process Challenge Device (PCD) Validation (Fractional) | The purpose of this qualification is to establish the hierarchy of chlorine dioxide resistance between the natural bioburden occurring as a result of the manufacturing process, internal product challenge devices IPCD’s, and external product challenge devices. EPCD’s.. |
| Microbiological Performance Qualification (MPQ) | This purpose of this microbiological performance qualification is to demonstrate that the sterilization process and equipment are capable of reliably and consistently sterilizing the products; to a Sterility Assurance Level (SAL) of 10 -6 or less. The validation will be following the overkill half cycle approach as described in ISO11437 annex D and also ISO 11135 annex B as appropriate. |
| Regulatory Plan | Document providing change description, standard assessments, and summarized view of technical documentation and DMR changes required to replace EO sterilization with Chlorine Sterilization |
| Sterile Load Process Controls | Load configuration diagram and a cycle specifications will be developed through the validation process. |
| Quality Plan | Sterilization Adoption is a substantial change to the quality system and impacts several quality system processes. The plan evaluates the change, identifies risk controls, and dispositions residual risks associated with the transition of sterilization methods across production, sterile release, and process validation. |
| Validation Plan | The document outlines the plans and sequence of events for validation/qualification of various product configurations. The plan should include identification of Quality System deliverables, rationale for worst case, product family definition, and process controls to ensure risks are reduced as far as possible. |
| Sterilization Form | Summarized information required to fully describe the sterilization process. |
Project management, customization for medical device and cost optimization, and effective stakeholder communication were additional services provided throughout the implementation of the project plan we developed.
Operational Velocity not only accelerates existing processes, we help build pathways for innovative markets for medical device companies to adopt and drive continuous improvement across our industry.
Please let us know if you would like more information about this innovative technology.
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