Ensuring the safety and efficacy of medical devices is challenging for original equipment manufacturers (OEMs), particularly within the complex value chain of manufacturing, where reliable validation data from suppliers is essential to meet industry standards.
Porex
Between 2018 and 2022, the FDA recalled over 13,000 devices, underscoring the need for selecting the right materials as well as robust supplier collaboration. As a leader in porous membranes, Porex Membrane Technologies works closely with OEMs, providing innovative venting and filtering solutions for the medical sector. In combination with Oxyphen, Porex has further solidified its position as a leader in porous membranes, offering comprehensive technical and commercial support from concept to full production.
The importance of validating material compatibility for medical devices
Porex
Bringing a medical device to market is a lengthy process, taking three to seven years from concept to FDA approval according to a report in the journal, JACC: Basic to Translational Science.
One of the biggest challenges is obtaining convincing safety data, as proving materials are safe for their intended use requires substantial time and investment. This crucial step can delay other parts of the regulatory process. However, once cleared, manufacturers can move forward with validation, verification, and shelf-life studies with increased confidence and reduced risk, streamlining the path to approval.
When suppliers understand the users’ requirements and provide solid proof of performance based on material engineering principles, the pathway to approval becomes simpler. Porex embraces this fully, meaning every product developed with its membranes is built with the needs of medical device design, patient safety and regulatory compliance in mind.
While the material supplier provides preliminary validation proof to demonstrate compliance with key regulatory and quality standards, the OEM ensures this validation is acquired in its final device design. With this approach, the safety and effectiveness of a device is reviewed with its specific intended use and function. This collaborative approach streamlines the path to regulatory approval and ensures material safety and reliability.
When it comes to meeting safety and compatibility standards for injectable drug delivery devices, Porex provides robust material data and testing depending on the material range or solutions, including:
Cytotoxicity testing (ISO 10993): Porex collects cytotoxicity information to demonstrate that its porous materials are non-toxic and safe for use in medical devices, helping OEMs meet biocompatibility requirements.
Compliance with regulatory standards: Porex’s materials comply with USP Class VI, proving they are suitable for use in medical applications, and FDA 21 CFR 177.1550, confirming their safety when in contact with drugs. This ensures materials meet regulatory expectations for drug delivery devices.
No harmful substances: Porex ensures that materials are free from heavy metals, APFO, PFOA, BPA, latex, and phthalates – critical in ensuring chemical compatibility and patient safety.
By offering rigorous testing, Porex helps OEMs confidently meet regulatory validation requirements, streamlining their path to FDA and other global approvals for drug delivery devices.
Validating other challenges in device design: A case study
Validating correct dosage
Porex
As the self-administration of injectable devices becomes more common, concerns about significant health risks linked to over/under-dosing have emerged. Porex Virtek Sintered PTFE membranes address this, playing a critical role in ensuring the effectiveness of wearable drug delivery devices.
To mitigate the risks of dosing inaccuracies in drug delivery systems, it is crucial to ensure pressure equalisation through high airflow and leak-proof designs. Porex conducts internal validation tests to confirm airflow and pressure equalisation rates – a standard but essential process that helps remove unexpected issues during final device validation.
Engineered with super-hydrophobic materials, Porex’s membranes maintain proper airflow and pressure balance, as well as preventing clogging – one of the primary causes of inaccurate dosing linked with vented components.
Validating clogging for continuous airflow
Porex membranes are engineered for high-precision dosing in drug delivery systems. Airflow testing helps to validate in advance consistent drug delivery where high airflow can support fluid flow in drug reservoirs to help significantly reduce dosing errors of high-viscosity drug formulations. Contact angle tests confirm a material’s super-hydrophobic properties, preventing water absorption and clogging, even with drug liquids.
Comprehensive water-entry pressure tests validate the membranes’ leak-proof integrity and establish critical IP ratings necessary for maintaining drug stability and sterility.
Validating filtration efficiency
Additionally, Porex considers how to prevent contamination within device design – developing a new standard for the industry. For years, bacterial filtration efficiency (BFE) testing was relied upon as a standard to validate risk of medical device contamination. Yet with viral interference also a major concern – and with a smaller particle size of capture – a higher level of protection and test was required.
Porex pioneered a new standard of protection, designing viral filtration efficiency (VFE) tests, improving on BFE standard by capturing virus-containing aerosol particles at a rate of 99.99% filtration efficiency.
As the initiator of VFE testing, Porex became the first in the industry to run the new analysis method on filtration media for medical devices.
By utilising advanced materials and thorough testing methods, Porex membranes mitigate dosing inaccuracies, contributing to safer patient outcomes. This commitment to quality empowers healthcare providers to deliver accurate treatments, enhancing the efficacy of self-administered injectable devices. Choose Porex for a dependable solution in drug delivery.
Empowering healthcare innovation
As part of Filtration Group, Porex Membrane Solutions’ industry-leading portfolio of expert-selected membrane materials empower innovation by navigating venting and filtration challenges. With over 60 years’ experience and partnerships with over 1,500 manufacturers in 65 countries, Porex provides solutions to complex product development challenges in the medical sector.
Committed to supporting medical device manufacturers, Porex delivers high-quality materials and innovative solutions that streamline FDA approvals, providing the safety, efficacy, and reliability essential for next-generation medical devices.
For more information, visit www.porex.com.