(Download: Packaging Validation in PDF by Medistri)
As medical devices and pharmaceutical products move toward market entry, packaging is no longer assessed as a logistical element alone. For products placed on the market as sterile, packaging becomes a regulated system that must be validated to demonstrate that sterility, integrity, and product safety are maintained until the point of use.
Packaging validation provides objective evidence that the selected packaging system performs as intended under defined and reproducible conditions. Without this evidence, sterile claims, shelf-life justifications, and product release at the Go-to-Market stage cannot be sustained.
Why Packaging Validation Matters at Market Entry
At market entry, manufacturers are expected to demonstrate that packaging performance goes beyond design intent. The packaging system must be proven capable of maintaining its protective and sterile function after exposure to environmental and mechanical stresses representative of real-world distribution and handling.
Packaging validation is therefore directly linked to regulatory approval and sterile labeling. It forms a critical component of the technical documentation reviewed during conformity assessments, audits, and inspections.
Regulatory Framework: ISO 11607
Packaging validation for terminally sterilized medical devices is governed by ISO 11607. This standard defines requirements for packaging systems, including sterile barrier systems and protective packaging, and establishes expectations for validation and routine control.
ISO 11607 requires manufacturers to demonstrate that the packaging system is fit for its intended use and capable of maintaining sterility throughout the product lifecycle, from sterilization through to the point of use.
A Structured Validation Approach
Packaging validation follows a structured sequence designed to simulate real-world distribution and storage conditions. Environmental conditioning exposes the packaging system to defined temperature and humidity ranges representative of storage and transport environments. Transport simulation then applies mechanical stresses reflecting handling, shipping, and distribution scenarios.
Once these steps have been completed, sterile barrier integrity testing is performed to confirm that the packaging system has not been compromised. This final verification step is essential, as it demonstrates that sterility has been maintained despite cumulative stresses applied during validation.
This approach is typically structured around three complementary activities:
- Environmental conditioning
- Transport simulation
- Sterile barrier integrity testing
What Packaging Validation Demonstrates
A completed packaging validation provides documented and traceable evidence that the packaging system consistently maintains its protective and sterile function. At the Go-to-Market stage, this evidence supports sterile claims, shelf-life justifications, and regulatory submissions.
From a regulatory perspective, packaging validation demonstrates:
- Control over packaging-related risks
- Consistency of packaging performance under defined conditions
Medistri’s Go-to-Market Approach to Packaging Validation
At Medistri, packaging validation is treated as an integral component of the Go-to-Market pathway. Our laboratory supports manufacturers with accredited testing methods aligned with ISO 11607 and validation strategies designed to integrate packaging, sterilization, and shelf-life considerations.
By structuring validation activities and documentation in line with regulatory expectations, we support efficient market entry while reducing the risk of late-stage findings or rework.
To learn more about Medistri’s Packaging Validation Services, please visit our website here or contact us at contact@medistri.com.
– The Medistri Team
#Medistri
Medistri is Europe's leading independent contract sterilisation company, founded in 2006 and headquartered in the heart of Switzerland. We are a global player providing essential infrastructure that powers healthcare innovation worldwide.
We serve customers of all sizes, from startups, university projects, and research institutes to Fortune 500 corporations, across Medical Devices, Pharmaceutical Packaging, and Biotech.
Medistri supports products at every stage of the lifecycle: pre-clinical development, go-to-market, and full industrialization.
Our fully integrated, end-to-end in-house solution allows our customers to focus on what matters most: engineering, innovation, and development, while we manage the critical back-end processes.
Our synchronized departments work together to provide a complete stack of services:
- Contract Sterilisation & Validation Services
- Contract Laboratory Services
- Contract Manufacturing Services
- Logistics Services
- Consulting Services
We help you accelerate time-to-market, reduce barriers to scale, and deliver safer, more sustainable healthcare solutions to patients around the world.
Medistri Solutions for Products in Go-to-Market Phase
In the go-to-market phase, precision and speed are critical to demonstrate regulatory readiness, secure market access, and launch with confidence.
Medistri acts as your trusted, fully integrated infrastructure partner, providing a comprehensive suite of in-house Solutions tailored to support validation, submission, and commercial readiness.
Our solutions include packaging validation, shelf-life studies, cleaning & reprocessing validation, sterilization validation, custom cycle development, laboratory method validation, support-to-submission services, post-validation training, EO-free supply chain validation, CE Mark pathway consulting, and MDR transition consulting.
By managing the entire validation and compliance process under one roof in our Swiss facility, Medistri eliminates multi-vendor complexity, accelerates regulatory timelines, ensures consistent data quality and traceability, and allows your team to focus on strategic market entry and commercial execution.
Enabling a smooth, compliant transition from development to successful product launch.
Frequently Asked Questions
1. What is the role of regulatory consulting in medical device and pharmaceutical development?
Regulatory consulting helps manufacturers understand and apply regulatory requirements throughout product development and market entry. It ensures that validation strategies, documentation, and process controls are aligned with applicable standards and regulatory expectations.
2. Why are regulatory authorities increasing their expectations beyond testing results?
Authorities now expect manufacturers to demonstrate internal control, process understanding, and justified decision-making. This includes clear validation rationales, traceable documentation, and evidence that regulatory knowledge is embedded within the organization rather than fully outsourced.
3. How does regulatory consulting support sterilization and validation strategies?
Regulatory consulting provides guidance on selecting appropriate sterilization methods, defining worst-case configurations, and structuring validation and revalidation activities. This ensures that sterilization processes are scientifically justified, compliant, and suitable for regulatory review.
4. When should manufacturers involve regulatory consulting services?
Regulatory consulting is valuable from early development through market entry and routine production. Early involvement helps reduce late-stage findings, while ongoing support ensures compliance is maintained as products, processes, or regulations evolve.
5. How does Medistri integrate regulatory consulting with technical execution?
Medistri combines regulatory consulting with in-house sterilization, laboratory testing, and validation activities. This integrated approach aligns regulatory strategy with real industrial processes, supporting consistent compliance, audit readiness, and confident market access across the product lifecycle.