Accelerated aging

Accelerated aging can be carried out in accordance with ASTM F1980 to receive data on the approval of your products at an early stage. With storage at elevated temperatures, an accelerated aging time can be calculated using the Arrhenius equation. We carry this out as recommended in the standard at 55 ° C in our qualified temperature chambers, other temperatures according to customer specifications are also possible. . All data from accelerated aging must be verified with data from real-time aging. Here we can offer aging at a controlled 23 ° C and 50% RH or, if sufficient, at a monitored room temperature.


Standards: ASTM F1980

Sealing force test

We carry out the tests to measure the sealing force and peelability in our climate laboratory at 23 ° C and 50% RH in accordance with ASTM E171 / E171 M and DIN EN ISO 11607-1.

Our method for the sealing force test meets the requirements of ASTM F88 / F88 M as well as DIN EN 868-5.

The force required to open the packaging is measured. The peelability should be assessed according to the requirements of ASTM F88 / F88 M and EN 868-5 Appendix E in order to ensure the aseptic provision of the product.

The seal seam width is also determined and assessed in accordance with EN 868-5.


Standards: ASTM F88 / F88 M, ASTM E171 / E171 M, DIN EN 868-5, DIN EN ISO 11607-1

Burst pressure test

The burst pressure test according to ASTM F1140 / F1140 M can be used to examine the ability of packaging to withstand increased internal pressure.

With this strength test, the entire area of the sealed seam can be assessed and the weakest area can be identified.


Standard: ASTM F1140 / F 1140M

Integrity check

The integrity of the sterile barrier must be assessed in the various stages of the life cycle. To check the integrity of the sealed seam, the dye penetration test according to ASTM F1929 and ASTM F3039 or the visual inspection according to ASTM F1886 / F1886 M are used.

The seal is checked for impermeability and homogeneity. ASTM F1929 is used to check materials with a porous side (Tyvek / paper), and ASTM F3039 for packaging made of non-porous material. Sealing channels up to 50 µm are detected.

The visual inspection in accordance with ASTM F1886 / F1886M inspection can be used to quickly and inexpensively determine whether the test sample has leaks, channels in the seal seam or other visible abnormalities under certain criteria.

The following methods can be used to check the integrity of the entire packaging, secondary packaging and sterile barrier:

The bubble test in accordance with ASTM F 2096 can determine the smallest damage caused by storage, transport or the selection of unsuitable packaging. The sensitivity of this test is 250 µm. This method can be used for almost all materials and sizes of packaging.

In the Bubble Emission Test according to ASTM D3078, non-porous packaging is immersed in water and a negative pressure is applied in a vacuum chamber. The vacuum is slowly increased so that the packaging expands. In this way, leaks can be detected via escaping air bubbles.

Solid container verification is verified according to ASTM D4991. The container is examined for air bubbles in an ethylene-glycol-water mixture in a vacuum chamber.


Standards: ASTM F1929, ASTM F3039, ASTM F2096, ASTM D3078, ASTM D4991, ASTM F1886 / F1886M

Material testing

Tensile test on film material according to ASTM D882 and DIN EN ISO 527-3

In order to evaluate the material properties of the packaging material in accordance with ISO 11607-1, the tensile properties and elasticity of film material can be determined. This is also used to evaluate the suitability of the material for various sterilization methods and storage parameters.

Gurley air permeability according to ISO 5636-5, DIN EN ISO 11607-1 Appendix C.

With this method, on the one hand, the air permeability of porous material can be determined; on the other hand, the air impermeability of the film material is tested according to DIN EN ISO 11607-1 Appendix C. This method allows the determination of invisible damage to the material and an assessment of the air permeability.

Checking of printing and labeling according to ASTM F2252 / F2252 M

By applying and removing defined adhesive tape, the durability of prints on the packaging or on labels is determined. This is to be assessed in particular after sterilization, storage or after air conditioning.


Standards: ASTM D882, ASTM F2252 / F2252 M, DIN EN ISO 527-3, DIN EN ISO 11607-1, ISO 5636-5

Packaging validation

“Sterile products through validated packaging”

Packaging validation according to DIN EN ISO 11607

In accordance with DIN EN ISO 11607, we carry out packaging validations for process, storage and transport stability for medical products to be sterilized in the final packaging.

To validate the packaging process, we offer individual solutions for carrying out the functional assessment (OQ) and performance assessment (PQ) in accordance with ISO 11607-2 and support you in determining and carrying out the revalidation.

In accordance with DIN EN ISO 11607-1, we carry out complete shelf-life validations and transport validations for you and help you to define product families and worst-case analyzes.


Standards: DIN EN ISO 11607-1, DIN EN ISO 11607-2

Process validation

According to DIN EN ISO 11607-2, the manufacturing process of a sterile barrier system must be validated. The development and validation of packaging processes is critical to ensuring the integrity of a sterile barrier.

The manufacturer must submit a documented process validation program that demonstrates the effectiveness and reproducibility of all packaging processes. This includes shaping, sealing and the assembly of prefabricated sterile barrier systems, sterile barrier systems and packaging systems.

We support you in the implementation of the functional assessment (OQ) and the performance assessment (PQ):

  • Creation of validation plans
  • Definition of suitable test systems
  • Final documentation
  • Revalidations


Standards: DIN EN ISO 11607-1, DIN EN ISO 11607-2

Shelf-life validation

According to DIN EN ISO 11607-1, sterile barrier systems must maintain the sterility of the product to be sterilized in the final packaging until the time of use. To ensure this, the integrity and the sealing force must be checked over the duration of the specified shelf life.

Shelf-life validation from PAConsult: We create individual validation and revalidation plans for our customers and support them in the definition of product and packaging families as well as in the definition of the worst-case scenario.


Standards: DIN EN ISO 11607-1, DIN EN ISO 11607-2

Medical devices

Physical and mechanical tests

We check for you according to international and national standards or internal specifications:

  • Flow measurement
  • Tensile and compression testing
  • Leak tests
  • Bending and kink testing
  • Gravimetric measurement
  • Dimensional accuracy
  • Visual inspection

We would be happy to develop and validate methods for mechanical functional testing for special medical devices or internal specifications.

According to the requirements, we carry out the tests in our climate laboratory at 23 ° C and 50% RH in accordance with ASTM E171.


Selection of standards: DIN EN ISO 8536-4, DIN EN 1615, DIN 13097-4, DIN EN ISO 1135-4, DIN EN ISO 3826-1, DIN EN ISO 10555-1, DIN EN ISO 7864, DIN EN ISO 7886-1

Training courses and seminars

We offer training courses and seminars by our experts on the subject of packaging validation and medical devices as well as regulatory requirements.

New seminar dates will be announced on our homepage. If you need a tailor-made training course, we can carry it out on site or online.

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