Packaging Validation — ISO 11607-1 / ISO 11607-2

What Is Packaging Validation?

Packaging validation is the systematic demonstration that a sterile medical device's packaging maintains sterility until the point of use. ISO 11607-1 defines requirements for the packaging material and sterile barrier system, and ISO 11607-2 for validation of the packaging processes (sealing, closure).

Purpose of Packaging Validation

The purpose is to show that the packaging withstands the sterilisation process, transport and storage over its shelf life, and can be opened aseptically.

Which Products Is Packaging Validation Applied To?

Sterile barrier systems (pouch, blister, Tyvek-lidded tray)
Sterile single-use device packaging
Implant packaging
Surgical set packaging

In Which Sectors Is Packaging Validation Used?

Medical DeviceHealthcarePharmaceuticals

Standards Related to Packaging Validation

ISO 11607-1end product sterile barrier packaging test
ISO 11607-2end product sterile barrier packaging test
ASTM F1980accelerated aging in packaging test
ASTM F1929
ASTM F88peeling resistance in sealing seam test
ASTM F2096
ASTM D4169
ISTApackaging transport performance test series test
ISO 11607end product sterile barrier packaging test

Packaging Validation Conditions

Scope: Material performance, sealing process, transport durability and shelf life are addressed together
Process validation: IQ/OQ/PQ studies are carried out for sealing parameters
Worst case: Assessment is performed using the most challenging product, packaging and process combination

Equipment for Packaging Validation

Seal-strength (peel) tester
Integrity test equipment (bubble, dye penetration)
Accelerated-ageing chamber
Transport-simulation equipment (vibration, drop, compression)
Sealing machine and parameter-monitoring system

Sample Requirements for Packaging Validation

Specimens representing the final packaging configuration
The number of specimens must be determined with statistical justification
A product-packaging combination representing the worst-case scenario
Specimens that have undergone sterilisation must be used

Duration of Packaging Validation

Typically several months, together with accelerated ageing; real-time ageing takes as long as the declared shelf life and is run in parallel.

Packaging Validation Procedure

1The packaging design and sterile barrier system are defined.
2Material properties and compatibility are assessed.
3IQ/OQ/PQ is carried out for the sealing process and parameter ranges are determined.
4Packaging integrity and seal strength are measured after sterilisation.
5Transport simulation is applied and integrity is rechecked afterward.
6Accelerated and real-time ageing studies are initiated.
7Aseptic openability is assessed.
8All data are combined in the validation report.

Packaging Validation Acceptance Criteria

Acceptance criteria are pre-defined by the organisation: a minimum value for seal strength, absence of defects for the integrity test, and no fibre tear for aseptic openability, among others. ISO 11607 requires the criteria to be determined and justified; it does not itself give numerical values.

Evaluation of Results

Results are evaluated separately after sterilisation, transport and ageing. Accelerated-ageing data is used initially; it must be confirmed with real-time data.

Packaging Validation Report

Packaging system description and material properties
Process validation (IQ/OQ/PQ) results
Number of specimens and statistical justification
Seal-strength and integrity results
Transport-simulation findings
Ageing data and shelf-life outcome
Aseptic-openability assessment

Accreditation

EUROLAB holds internationally recognised accreditation obtained from accreditation bodies party to the IAF and ILAC multilateral recognition arrangements, under ISO/IEC 17025 for laboratory testing, ISO/IEC 17020 for inspection and surveillance, and ISO/IEC 17021-1 and ISO/IEC 17065 for system and product certification. This chain ensures the reports and certificates issued are accepted worldwide.

Whether this test can be offered within accredited scope depends on your product and the standard applied; since accreditation is method-based, the scope is confirmed in writing at the quotation stage.

Scope and authorisations

Related Regulations

MDR (EU) 2017/745
ISO 13485 process-validation requirements

Medikal Cihaz Testleri — What Does This Testing Field Cover?

The section below describes the field that the Packaging Validation test belongs to; the conditions and acceptance criteria of this particular test are given in the sections above. The scope specific to your product is confirmed in writing at the quotation stage.

Medical device testing shows that a device is safe for the patient and the user and maintains its intended performance. In this family safety is not only about avoiding harm; a device failing to perform its expected function is also treated as a risk. A monitor missing an alarm or a pump delivering the wrong dose is directly a patient safety event.

At the centre of the field is RISK MANAGEMENT, and this is what sets medical apart from other sectors. The risk management process run under ISO 14971 also determines which tests are required. The test list is not copied from a table of standards; it is derived and justified from the device's intended use, the nature and duration of patient contact, the use environment and foreseeable misuse.

Assessment consists of several separate bodies of work, each with its own set of standards. Biocompatibility runs through the ISO 10993 series, electrical device safety through the IEC 60601 series, sterilisation through ISO 11135/11137/17665, packaging through ISO 11607, software through IEC 62304 and usability through IEC 62366. The quality system (ISO 13485) is the framework that binds these together.

Which tests are required is determined by the device's CLASS and its MODE OF CONTACT WITH THE BODY. A product in brief contact with skin and an implant entering the bloodstream do not go through the same test set; the scope is set by a biological evaluation plan prepared under ISO 10993-1. That plan justifies in writing which endpoints are required and why the others are not.

Packaging and sterilisation are taken as seriously as the device itself in this field. For a sterile device the packaging is not a transport container but the barrier that maintains sterility; if the barrier is breached, the device is no longer sterile. Packaging processes are therefore validated and shelf life is supported by real-time ageing data.

For devices containing software, assessment shifts from testing towards PROCESS assurance. IEC 62304 defines which development and verification steps must be followed according to the safety class of the software; the evidence is the traceability of the development process. Testing software does not make it safe — the process record does.

The clinical side is a separate column of the technical file. Test reports show that the device is technically safe; clinical evaluation establishes that the device delivers the intended clinical benefit and that the benefit-risk balance is acceptable. Neither replaces the other.

Method groups in this field

Biocompatibility
Cytotoxicity, irritation, skin sensitisation, systemic toxicity, haemocompatibility, genotoxicity and local effects after implantation. The required endpoints are set by the ISO 10993-1 plan.
Electrical device safety
IEC 60601-1 basic safety and essential performance; EMC, alarm, usability and environmental requirements through the collateral standards.
Sterilisation validation
Validation of sterilisation processes by ethylene oxide, radiation or moist heat; bioburden and sterility assurance level studies.
Packaging
Integrity of the sterile barrier system, seal strength, distribution simulation and shelf-life studies.
Microbiological tests
Bioburden determination, sterility testing, bacterial endotoxin and, where required, carrier validation studies.
Software and usability
IEC 62304 life cycle evidence and use-error focused evaluation under IEC 62366.

Commonly confused in this field

Cytotoxicity alone is not evidence of biocompatibility; the required set of endpoints is determined and justified according to ISO 10993-1.
An ISO 13485 certificate does not confer CE marking; classification under the MDR, the technical file and the notified body process run separately.
Accelerated ageing does not replace real-time ageing; a shelf life claim is supported by real-time data.
A change of material (supplier, pigment, sterilisation method) may require the biological evaluation to be repeated; it is not a silent change.
An assessment made without the collateral and particular standards for IEC 60601-1 is incomplete; which -1-x and -2-x standards were applied must appear in the report.
In vitro diagnostic devices fall under the IVDR rather than the MDR, and laboratory equipment is often on the IEC 61010-1 side.

Which decisions these results support

MDR/IVDR technical file and notified body assessment
Completing the biological evaluation plan
Sterilisation and packaging validation
Determining shelf life and storage conditions
Determining the scope of reassessment after a design change

Related Tests

Frequently Asked Questions About Packaging Validation

Is accelerated ageing sufficient on its own?

It can be used initially for a shelf-life declaration, but ISO 11607 requires it to be confirmed with real-time ageing data. In practice, two studies are started in parallel: the product goes to market with accelerated data, and the declaration is confirmed as real-time data becomes available.

Does a packaging change invalidate the validation?

Changes in material, sealing parameter, packaging geometry, or sterilisation method require an impact assessment. Depending on the result of the impact analysis, partial or full revalidation may be required.