Medical Packaging testing

Packaging testing for Medical Devices

As an accredited testing laboratory, INNOPROOF provides cutting-edge mechanical validation for medical device packaging to ensure strict regulatory compliance and absolute product safety. Backed by extensive biomechanical expertise, we empower manufacturers worldwide to navigate the market launch of their innovations swiftly and confidently.

Because maintaining a sterile barrier is paramount for single-use devices and implants, even the slightest defect requires rigorous quality assurance. Our specialized testing services guarantee that your packaging systems withstand all logistical stresses, preserving sterile integrity from production to the point of care.

Examples for Medical Packaging we test

  • Tyvek®/film pouches for catheters
  • Sterilization pouches for surgical instruments
  • Peel pouches for disposable products such as needles and syringes
  • Blister packs for wound dressings
  • Blister packs for surgical implants
  • Blister packs for diagnostic components or test kits
  • Thermoformed plastic trays for implants
  • Trays for surgical instrument sets
  • Trays for catheter or endoscopy accessories
  • Tyvek®/PET packaging systems for pacemakers
  • Packaging for orthopedic implants (e.g., hip or knee implants)
  • Packaging for stents
  • Syringe packaging
  • Infusion set packaging
  • Packaging for needles and lancets
  • Packaging for surgical gloves
  • Packaging for rapid diagnostic tests
  • Packaging for specimen collection kits
  • Packaging for reagent kits
  • Folding cartons for sterile medical devices
  • Shipping cartons for medical products
  • Transport packaging containing sterile barrier systems
  • Insulin syringes
  • Intravenous catheters
  • Surgical instruments
  • Wound dressings
  • Pacemakers
  • Hip implants
  • Stents
  • Diagnostic test kits

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Key Medical Packaging Testings

Defines requirements for materials, sterile barrier systems, and packaging systems ensuring sterility until point of use.

Defines validation requirements (IQ/OQ/PQ) for packaging and sealing processes.

Measures the resistance of packaging to compressive loads during stacking and transport.

Measures the force required to peel apart sealed packaging materials.

Packaging burst testing is a destructive quality control method used to measure the maximum pressure a package or its seals can withstand before rupturing. It ensures that products remain safely contained during transit, storage, and handling. This test is critical across multiple industries, including medical devices, pharmaceuticals, food, and consumer goods.

First, the package is securely connected to a test nozzle. Next, air is pumped inside at a controlled, constant rate. The internal pressure rises until the package ruptures. The system records the peak pressure in units like psi, kPa, bar, or kg/cm².

The test identifies if heat seals or adhesive bonds are strong enough to prevent leaks. It ensures the packaging can handle high-altitude air transit or physical compression.

There are two different methods to choose from:

  1. Open/Free Burst Test: The package expands freely like a balloon until it pops. This measures the overall weakest point.
  2. Restrained Burst Test: Two rigid plates limit the expansion of the package body. This isolates and tests only the perimeter seals.

Identifies visible defects such as channels, wrinkles, or incomplete seals.

Measures linear dimensions such as length, width, and seal geometry.

Detects channel leaks in porous sterile barrier seals using dye solution.

Detects package leaks by pressurizing and observing bubbles in water.

Customized Medical Packaging Testing Solutions

Next standard test methods, we also build special test setups when a product needs something more specific. Our team works directly with manufacturers to figure out what could go wrong in real life and then designs tests that can realistically check for those risks. This helps make sure the packaging is safe, reliable, and suitable for medical use.

We combine practical testing equipment with scientific and regulatory know-how to produce clear and trustworthy results. These results help companies improve their products, manage risks better, and get approval for different international markets more smoothly.

Importance of Standards in Medical Packaging Testing

By using standardized methods such as ISO 11607-1 and ISO 11607-2, manufacturers can demonstrate that their packaging meets regulatory expectations. At the same time, test methods like ASTM F88/F88M, ASTM F1929, and ASTM F2096 provide consistent and repeatable ways to evaluate seal integrity and package tightness.

For manufacturers, these standards help to:

  • Demonstrate the safety, quality, and performance of medical packaging and products
  • Reduce regulatory risks by ensuring compliance with international requirements
  • Support approval and access to global markets more efficiently
  • Improve product and packaging design through structured testing and feedback
  • Identify potential risks and failure modes early in the development process
Medical Packaging Testing Laboratory

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Our Medical Packaging Testing Workflow at INNOPROOF

At INNOPROOF, we follow a clear and structured process to test medical packaging systems in a reliable and easy-to-understand way. The goal is to make sure that packaging is safe, compliant, and works in real-life conditions.

Understanding the request & defining requirements

At the very beginning, we focus on understanding the medical packaging, its function, and the customer’s expectations. We clarify how the packaging must perform in real use, especially regarding sterility protection and transport safety. Based on this, we select the relevant international standards such as ISO 11607-1 to define a solid testing basis.

Creating the test concept & quotation

Next, we develop a customized test concept that fits the specific packaging system. This includes selecting suitable test methods (e.g. seal, leak, or mechanical tests), defining sample quantities, and estimating the project timeline. The customer receives a clear and structured quotation that explains all planned steps in simple terms.

Receiving samples & performing the tests

After approval, the packaging samples are sent to our laboratory, usually as finished products or prototypes. We then carry out the tests according to the agreed standards and procedures. This often includes mechanical stress tests such as compression testing according to ASTM D642 as well as seal integrity and leak detection tests. The goal is to reproduce realistic conditions such as transport, storage, and handling.

Evaluation & reporting of results

In the final step, all test data is carefully analyzed and documented in a clear and structured report. The report is prepared according to accredited standards and can be used for regulatory submissions and product optimization. It provides manufacturers with reliable results to improve packaging design and ensure compliance and safety.

Why Choose INNOPROOF for Medical Packaging Testing

Advanced testing technology

Our laboratory uses modern and high-precision testing systems, including equipment like the Instron ElectroPuls E3000. This allows us to perform dynamic and highly accurate mechanical tests on medical packaging. In this way, we can realistically simulate stresses that occur during transport, storage, and handling.

Direct communication & flexible collaboration

As an owner-managed company, we work with short decision paths and very direct communication. Clients always have clear contact persons and can quickly clarify questions or project details. This makes the whole testing process faster, more personal, and easier to manage.

Clear and useful test reports

We prepare test reports that are structured, easy to understand, and technically reliable. The results are presented in a clear format with tables, figures, and explanations. This helps customers use the data directly for product improvement, quality control, and regulatory submissions.