Leveraging Expertise In Steam Sterilization Validation for Reusable Orthopedic Devices


Leveraging Expertise In Steam Sterilization Validation for Reusable Orthopedic Devices

These days, the business of orthopedics requires some gymnastics. Balancing ever-evolving regulatory compliance needs with continuity concerns can challenge even the world’s biggest, most successful firms. As technologies and markets diverge and diversify, staying ahead of competitors and on top of lead times is hard. Missteps and hiccups can lead to delays – and break promises to patients.

Even small changes introduce complexity. Changing product design introduces risk, which can lead to test failure, increased costs, and prolonged lead times.

It’s time, in the end, that matters here. Products and businesses live and die in lead times, and many factors can dictate their length.

With so many options and potential pitfalls, deciding on the best route for sterilization validation can be daunting. Using multiple outsourcing partners can feel like a great way to tackle this complexity. However, it’s often more expensive and takes longer than relying on a single expert point of contact.

In this article, we explore the process of steam sterilization validation for reusable instruments and discuss how outsourcing to the right partner reduces risks and costs while ensuring continuity and streamlining market approval.

A Streamlined Validation Process for Reusable Instruments

Validation processes overseen by dedicated professionals are essential to reducing costs and ensuring success. Communication is key here. In sterilization validation testing, every detail matters. A single snag in the system can lead to missed deadlines and put production at risk.

Specialized management of the validation process ensures smooth coordination through every step. Here is how our team approaches a steam sterilization validation for reusable instruments.

  • Discovery. In this first step, the client communicates all relevant information about the device or system of devices contained within a package to Millstone. Our experts immediately assess the validation requirements and evaluate any challenges to the validation process.
  • Physical assessment. Millstone receives the device and meticulously evaluates its specific validation requirements related to physical components. This assessment includes examining crevices, lumens, and other target areas that pose a challenge to sterilization.
  • Protocol Development. Based on the physical assessment and information gathered in the discovery phase, Millstone prepares a device-specific protocol aligned with FDA guidance, AAMI, and ISO standards.
  • Client Review. Once the protocol is ready, it is sent to the client for review. The client can make additions and amendments to the protocol before granting approval. Client and Millstone agree on a realistic schedule for completion that achieves quality and meets product launch timelines.
  • Testing. After approval, the device is queued for testing. Biological indicators are placed on the device, particularly in target areas like recessed or textured areas. These indicators contain bacteria that are naturally resistant to the steam sterilization process. In addition to this, a thermal profile is established using strategically placed thermocouples, again, particularly within target areas. The package containing the devices is covered with a 510k certified wrap and placed in the sterilizer. This process is repeated to analyze both biological indicator sterility and the thermal profile for multiple cycles. The target area accumulated lethality will also be established from the thermal profile.Specific sterilization types like pre-vacuum and gravity steam sterilization are performed depending on client specifications. Sterilization is run according to manufacturers’ instructions and will include worst-case scenario testing by excluding drying time and reducing exposure time by half per FDA-approved AAMI TIR12 standards.
  • Report. A detailed regulatory-compliant report is delivered to the client in a timely manner.

Many sterilization validation providers will follow a similar procedure, so how can you know which provider to choose? The choice can make or break a product launch schedule, so evaluating for expertise is crucial to making an informed decision.

How To Choose An Expert Sterilization Partner

The optimal partner combines niche knowledge of medical devices with the resources and technical know-how to deliver reliable results on time. As leaders in packaging, testing and logistics for the medical device markets, we’re your single expert point of contact for sterilization validation for reusable instruments (and many other processes). Here’s how to evaluate key expertise:

Turnaround time. At Millstone, we routinely achieve 3-4 week turnaround times from protocol approval to regulator-ready reports. Our competitors typically take between 10-12 weeks to achieve the same results, meaning Millstone can protect production and give you a competitive edge.

Medical device expertise. We are fully focused on medical devices and partner with the top OEMs in the country, including the top 10 Fortune 500 med-device companies. These partnerships position Millstone as the strategic partner of choice and give us unparalleled insights into the latest developments in the industry.

Accelerated time to market. A longer regulatory process means a huge increase in costs and delays in devices that patients need. Our expertise and industry insights mean we can provide our services to products in the R&D phase of development, assisting our partners to achieve market approval. Having a single dedicated provider for the entire developmental pipeline ensures effective planning to avoid common pitfalls.

Coordination and fluidity. At Millstone, we adapt our resources to new regulatory and market requirements and strive to bring seamless testing processes to our clients. Our new facility at Bloomfield, Connecticut, with a dedicated autoclave for steam sterilization testing and a washer for automated cleaning validation, means we can serve customers with increased capacity in Q2 2024.

Lower overall cost. Our specialization means we can help our clients plan the most effective testing schedules for their devices, allowing them to allocate their resources efficiently. Our adaptability means we tailor our services to our client’s needs and can effectively provide a single expert point of contact, greatly reducing costs while ensuring success.

Knowing the risks and challenges of sterilization validations is one thing; knowing how to address them effectively and efficiently is another. Sterilization validations are required for regulatory compliance, and having a dedicated professional partner can streamline this process. At Millstone, we leverage our expertise to bring you business success through compliance which can drive faster approvals. It’s central to our mission to help you focus on lifesaving, life-changing products for patients.

Millstone’s testing services give medical device manufacturers access to the comprehensive product, packaging, and environmental testing service expertise they need with a single expert point of contact. In addition, Millstone’s end-to-end Tier 1 service, available with adjacent testing, provides a streamlined approach to expert sourcing, with contract manufacturing, quality critical inspection, in-process testing, cleaning, packaging, and sterilization handled under a single PO. Millstone’s testing services are also available as standalone contract services.

Today Millstone Medical Outsourcing is a leading provider of customized outsourcing solutions to the medical device industry. Millstone delivers expert post-manufacturing and aftermarket services for medical device manufacturers that foster quality, compliance, and business success. Millstone specializes in packaging, testing and logistics services all with an unparalleled focus on quality.

What could we help you do better? Learn more at https://millstonemedical.com.


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