Key Takeaways

• Packaging and sterilization must be aligned to ensure sterility, compliance, and product integrity.
• Prevalidated sterile barrier packaging reduces validation delays and accelerates time-to-market.
• Material compatibility testing is essential when transitioning to new sterilization methods.
• Sterilization disruptions can impact packaging workflows, making contingency planning critical.

The Critical Link Between Packaging and Sterilization

Sterile medical device packaging isn’t just about protection—it’s about ensuring the product remains sterile, intact, and ready for patient use throughout its lifecycle. However, many OEMs overlook how sterilization methods impact packaging material selection, leading to costly revalidations, compliance setbacks, and supply chain bottlenecks.

Sterilization capacity constraints, EO regulatory changes, and new material compatibility challenges push manufacturers to reassess their packaging strategies. If OEMs do not optimize packaging for sterilization from the start, they may face:

• Sterile barrier failures due to material degradation.
• Extended revalidation cycles when switching sterilization methods.
• Regulatory setbacks from non-compliance with ISO 11607 and FDA sterility requirements.

With increasing scrutiny on EO sterilization and growing interest in alternatives like gamma, e-beam, and chlorine dioxide, medical device manufacturers must align packaging strategy with sterilization requirements to avoid delays and regulatory risks.

The Risks of Misaligned Packaging & Sterilization

Designing packaging without considering sterilization can lead to the following:

1. Packaging Failures

Not all packaging materials are compatible with sterilization methods. EO sterilization requires porous materials like Tyvek® to allow for gas penetration, while radiation-based methods (gamma, e-beam) can degrade specific polymers.

Impact: Sterile barrier integrity may be compromised, leading to regulatory failures and product recalls.

2. Delays in Product Launch

If packaging fails validation tests after sterilization, OEMs must redesign packaging, complete new feasibility testing, and repeat the validation cycle.

Impact: Time-to-market delays may extend by months, increasing costs and affecting revenue targets.

3. Increased Costs

Packaging redesigns, additional sterility testing, and unexpected revalidations significantly increase operational expenses.

Impact: Higher costs per unit, increased testing expenses, and supply chain inefficiencies.

4. Regulatory Risks

Sterilization and packaging must comply with ISO 11607, FDA, and EU MDR standards to ensure sterility and device integrity.

Impact: Failure to meet regulatory standards can result in delayed product approvals or market rejection.

How Millstone Aligns Packaging & Sterilization Strategy

Millstone’s proactive approach to packaging and sterilization alignment helps medical device manufacturers avoid delays, compliance risks, and costly revalidations. By integrating packaging expertise with sterilization strategy, Millstone offers prevalidated packaging solutions that streamline compliance and accelerate time-to-market.

Prevalidated Packaging Solutions for Faster Compliance

Many OEMs use traditional packaging that requires complete validation cycles before sterilization approval, leading to delays.

Millstone offers prevalidated sterile barrier systems, ensuring:

• Compliance with ISO 11607 and regulatory requirements.
• Compatibility with multiple sterilization methods (EO, gamma, e-beam, chlorine dioxide).
• Reduced validation timelines by eliminating redundant packaging testing.

Manufacturers can accelerate approvals and avoid unnecessary delays by leveraging prevalidated sterile packaging.

Material Compatibility Testing for Packaging Durability

Switching from EO to radiation-based sterilization (gamma, e-beam, x-ray) requires new packaging compatibility testing to prevent material degradation.

Millstone provides sterilization feasibility testing, ensuring:

• Packaging integrity remains intact under the highest expected radiation dose.
• Sterile barrier strength is maintained across different sterilization methods.
• Device materials don’t interact negatively with sterilants (e.g., EO residuals, chlorine dioxide exposure).

By addressing material compatibility concerns upfront, OEMs avoid costly packaging failures post-sterilization.

EO Optimization to Reduce Cycle Times & Costs

Many medical devices use outdated EO sterilization cycles that consume excessive sterilant and cause supply chain bottlenecks.

Millstone helps OEMs revalidate EO cycles to:

• Reduce EO concentration for lower emissions and regulatory compliance.
• Shorten dwell times while maintaining the Sterility Assurance Level (SAL).
• Increase sterilization throughput to prevent supply chain disruptions.

Optimizing EO sterilization supports environmental goals, reduces costs, and improves production efficiency.

The Competitive Advantage of Packaging-First Sterilization Strategy

A packaging-first sterilization strategy gives OEMs a significant competitive advantage by ensuring that packaging is designed for sterility from the start, reducing the risk of revalidation delays, material compatibility issues, and regulatory setbacks. By selecting prevalidated sterile barrier systems and optimizing packaging for different sterilization methods—whether EO, gamma, or e-beam—manufacturers can streamline approvals, lower costs, and accelerate time-to-market. This proactive approach eliminates last-minute redesigns and compliance failures, allowing OEMs to maintain consistent production, regulatory confidence, and supply chain resilience.

OEMs that align packaging and sterilization from the start avoid:

• Unnecessary revalidations
• Production delays
• Regulatory compliance issues

By integrating sterilization into packaging strategy, manufacturers gain:

• Faster market entry – Prevalidated packaging reduces revalidation cycles.
• Lower costs – Optimized EO cycles reduce sterilant consumption and packaging waste.
• Regulatory confidence – Compatibility testing ensures compliance with evolving FDA & ISO standards.
• Supply chain resilience – Packaging remains stable across multiple sterilization modalities.

Why Millstone is the Leader in Sterilization-Integrated Packaging

Millstone’s holistic approach to sterilization-integrated packaging ensures that packaging solutions maintain sterile barrier integrity throughout the sterilization process. With prevalidated packaging systems and ISO 11607 compliance expertise, Millstone helps OEMs reduce time-to-market and avoid costly revalidations. By integrating testing, sterilization, and packaging, Millstone provides OEMs with a single-source partner for maintaining sterility and compliance.

• Prevalidated Packaging Expertise – Ready-to-use sterile barrier systems that meet ISO 11607 requirements.
• Material Compatibility Testing – Ensure packaging durability across EO, gamma, and e-beam sterilization.
• EO Cycle Optimization – Reduce sterilant usage while maintaining sterility assurance.
• Integrated Testing & Packaging Solutions – Seamless validation between packaging, sterilization, and compliance testing.

Unlike traditional sterilization providers, Millstone integrates packaging, testing, and sterilization strategy, ensuring OEMs don’t face unexpected challenges after designing packaging.

Future-Proofing Medical Device Packaging & Sterilization

With increasing regulatory scrutiny on EO sterilization, limited sterilization capacity, and a push for alternative methods, medical device manufacturers must take a proactive approach to sterilization strategy.

Aligning packaging with sterilization requirements from the beginning ensures:

• Sterile barrier integrity remains intact
• Material compatibility issues are identified early
• Packaging validation cycles are reduced
• Time-to-market is accelerated

With Millstone Medical’s expert sterilization strategy, prevalidated packaging solutions, and material compatibility testing, OEMs can eliminate sterilization-related delays and confidently bring safe, compliant devices to market.