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To ensure safe market access, you must guarantee that your medical devices reach the end user intact and sterile. This requires demonstrating the performance of your packaging, particularly its ability to maintain sterility in accordance with ISO 11607-1.
By relying on LNE’s expertise, you secure every step of the market launch process: from protecting your products to ensuring regulatory compliance and delivery. This reduces the risks of non-compliance, product returns, or logistical failures.
Why validate my packaging?
With a comprehensive range of testing and validation services, LNE enables you to :
- Ensure the reliability of your sterile barrier systems (e.g., pouches, blisters, vials, etc.) for medical devices and guarantee the maintenance of sterility
- Optimize your non-sterile packaging (e.g., secondary packaging, transit packaging, etc.) for better overall protection
- Ensure the safety of your general transport packaging (boxes, cartons, consolidated shipping crates, etc.) against logistical constraints
Result : You gain confidence and credibility with regulatory authorities and your customers, while accelerating your time-to-market.
NEW - Thanks to the expansion of its Cofrac accreditation (Testing No. 1-0606), LNE has further strengthened its reputation and now offers you a testing framework that complies with the requirements of ISO 11607-1.
* Locations and scopes available on Cofrac.fr.
How to validate medical device packaging?
To ensure the compliance and reliability of your packaging, validation involves a series of tests designed to replicate the real-world conditions of your medical devices.
These tests allow you to:
- Anticipate the aging of your packaging
Through accelerated aging tests (temperature, humidity), you validate the lifespan of your sterile barrier systems and ensure the long-term stability of your packaging, in compliance with ASTM F1980. - Protect your products against environmental stresses
Pre-packaging tests simulate the extreme climatic conditions (temperature, humidity, pressure) encountered throughout the distribution cycle. This allows you to manage the risks associated with your supply chain, in accordance with ISO 14971 and ASTM D4332 standards. - Ensure the durability of your packaging during transport
Transport simulations (shocks, drops, vibrations, compression) accurately replicate real-world logistics stresses. You ensure that your products arrive intact at your customers’ locations, in accordance with ASTM standards. - Demonstrating the performance of your sterile barrier systems
A series of tests verifies the integrity and quality of your sterile packaging in accordance with ISO 11607-1:- visual inspection of seals to detect defects (ASTM F1886)
- leak tests to identify any leaks (ASTM F1929)
- Measurement of seal strength and quality (ASTM F88 and NF EN 868-5 Annex D)
- Evaluation of ease of opening (peelability) (NF EN 868-5 Annex E)
- Internal pressure tests to detect major defects (ASTM F2096)
Discover our webinars
Sterile packaging for medical devices: validation strategies and best practices
Key topics covered:
- Validation strategy for the sterile barrier system in accordance with ISO 11607-1 & -2
- Aging and transport validation
- Sterile barrier system integrity testing
- A session and conclusion
Watch the webinar (in french)
How to improve the performance of your packaging ?
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Key topics covered:
- Regulations
- Eco-design of packaging
- Optimization of the packaging functionality
Watch the webinar (in french)
FAQ
Yes.
ISO 11607-1 and ISO 11607-2 standards (see §4.4.3) require validation of test methods.
- If testing is outsourced, the laboratory may provide Cofrac accreditation to demonstrate compliance.
- If testing is performed internally, the methods must be validated by the manufacturer.
Yes.
Sterile barrier integrity tests must be performed:
- after accelerated aging,
- and then confirmed after real-time aging.
Accelerated aging tests provide preliminary results, but these must be confirmed under real conditions.
The verification plan must justify:
- the choice of tests performed under accelerated aging,
- and those performed under natural aging conditions.
Note: accelerated aging is not mandatory if complete real-time data are available (see §8.3.2 and §8.3.3 of ISO 11607-1).
No.
Visual inspection according to ASTM F1886 is not sufficient on its own due to limitations in accuracy and potential bias (see §10 and related tables).
It must be supplemented with other appropriate tests, including:
- seal integrity testing,
- and testing of the materials composing the sterile barrier system.
Applicable methods are detailed in Annex B of ISO 11607-1.
Requirements are defined in:
- ISO 11607-1 (§8.2.3 and §8.3.6),
- ISO/TS 16775 (§5.25.2.2).
For aging and transport testing:
- Products may be grouped into families.
- « Worst case » configurations may be selected for testing.
- The manufacturer must justify:
- the grouping into families,
- the choice of worst-case scenarios.
Regarding batches:
- process validation tests (PQ) must demonstrate repeatability, reproducibility, and capability,
- however, aging and transport tests (verification tests) do not necessarily need to be performed on three different batches.
Why choose LNE
- One location, one point of contact: Centralized testing to simplify your processes, save time, reduce costs, and speed up your time to market.
- Rare multidisciplinary expertise : Conformity testing, calibration, regulatory assistance, and packaging qualification… all expertise under one roof.
- Clear and actionable test reports : a structured document, ready for use to facilitate submission to a notified body.
- An internationally recognized reference body : ISO 17025-accredited laboratories (Cofrac*) and strong synergies with its subsidiary GMED, a major notified body in the medical secto
Our Accreditations and Regulations
- Tests conducted under Cofrac* accreditation No. 1-0606 (in French)
- LNE, an organization certified by the International Safe Transit Association (ISTA)
* Locations and scopes available on cofrac.fr.
- ISO 11607-1
- ISO 14971 “Risk Management for Medical Devices”
- NF EN 868-5: Annex D: Method for determining the seal strength of pouches and tubular materials, and Annex E: Method for determining the peel characteristics of laminated paper/plastic film
- ASTM F1886
- ASTM F1929
- ASTM F88
- ASTM F2096
- ASTM F1980
- ASTM D4332
- ASTM D4169, ISTA...
Facilities and Equipment
To conduct these tests, LNE has a wide range of facilities at its disposal
- Climate chambers
- Equipment for transport simulation,
- Equipment for performance testing of sterile barriers:
- Tensile/Compression Machine
- Buble Test Machine
- Dye test
Additional services
- Training:
Packaging materials and systems for terminally sterilized medical devices (Ref. SA54)
*List of accreditations, locations, and scopes available on cofrac.fr.
