Accelerated Aging

In order to obtain early data for the approval of your products, accelerated ageing can performed according to ASTM F1980. With storage at elevated temperature, an accelerated ageing period can be calculated using the Arrhenius equation. We perform the tests at normative 55 °C in our qualified temperature chambers. We would also be happy to help with special requirements regarding the ageing temperature. All data from accelerated ageing must be verified with data from real-time ageing. We can offer ageing at controlled 23 °C and 50 % RH or, if sufficient, at monitored room temperature.

Standards: ASTM F1980

Sealing force testing

We perform tests to measure the seal strength and peelability in our climatic laboratory at 23 °C and 50% relative humidity, in accordance with ASTM E171/E171 M and DIN EN ISO 11607-1. The performance of seal strength testing and the peelability is in accordance with ASTM F88/F88 M and DIN EN 868-5. The force required to open the packaging is measured. The peelability is evaluated, according to the requirements of ASTM F88/F88 M and EN 86805 Annex E in order to ensure the aseptic presentation of the product. The seal width is determined and assessed, in accordance with EN 868-5.

Standards: ASTM F1140/F1140 M

Burst pressure testing

Burst pressure testing in accordance with ASTM F1140/F1140 M can be used to inspect the ability of packaging to withstand increased internal pressure.

This strength test can be used to assess the entire sealing area, identifying the weakest point.

Materials:
Foil/foil peel bags
Foil/Tyvek or paper peel bags
Tyvek/paper blister packaging
Foil blister packaging
Tear-open bags or satchets

Standards: ASTM F1140/F1140 M

Integrity testing

Dye penetration test in accordance with ASTM F1929 and ASTM F3039
Seals are tested for impermeability and homogeneity. ASTM F1929 is used for testing materials with a porous side (Tyvek/paper). Packaging made of non-porous materials is tested in accordance with ASTM F3039. Sealing channels up to 50 μm are detected.

Bubble test in accordance with ASTM F2096 or ASTM E515
This test ensures the integrity of the entire packaging, secondary packaging and the sterile barrier system. The bubble test can be used to detect even the smallest areas of damage caused by storage, transportation, or improper packaging selection. The sensitivity of this test is 250 m.

Bubble emission test in accordance with ASTM D3078
During this test, non-porous packaging is immersed under water and vacuum pressure is created in a vacuum chamber. The vacuum pressure is increased slowly so the packaging expands. Leaks can be detected as they emit bubbles.

Leak test in accordance with ASTM D4991
This method is used to inspect solid containers. Containers are inspected for air bubble emissions in an ethylene-glycol mixture in a vacuum chamber.

Visual inspection in accordance with ASTM F1886/F1886 M
Visual inspection is an inexpensive, fast way to determine whether the test sample shows visible abnormalities or changes under certain criteria.

Standards: ASTM F1929, ASTM F3039, ASTM F2096, ASTM E515, ASTM D3078, ASTM D4991, ASTM F1886/F1886 M

Material testing

Tensile testing on foil materials in accordance with ASTM D882 and DIN EN 527-3
The tensile properties and elasticity of foil materials can be determined in order to assess the properties of packaging materials in accordance with ISO 11607-1. This also serves to assess the material’s suitability for a variety of sterilization methods and storage parameters.

Air permeability in accordance with Gurley pursuant to (ISO 5636-5, DIN EN ISO 11607-1, Annex C)
This method can be used first to determine the air permeability of porous materials, and second to test the air impermeability of the foil material in accordance with DIN EN ISO 11607-1 Annex C. This process makes it possible to precisely identify invisible damages and potential porosity of packaging materials used.

Printing and labeling inspection in accordance with (ASTM F2252/F2252 M)
Defined adhesive tapes are applied and removed in order to determine the durability of stickers on packaging or labels. This must be assessed, in particular, sterilization, storage, or air conditioning.

Materials:

  • Sterile bags or blister packaging
  • Medical foils
  • Tyvek / paper
  • Food-safe foils

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 in accordance with DIN EN ISO 11607

In conformity with DIN EN ISO 11607, we perform packaging validations on process, storage, and transportation stability for packaging for terminally sterilized medical devices. According to DIN EN ISO 11607-1, we perform complete full shelf-life validation and transportation validation processes for you and help you determine product families and worst case analyses.

We offer customized solutions for completing the operational qualification (OQ) and performance qualification (PQ) pursuant to ISO 11607-2 to validate the packaging process. We can also support you in determining and completing a re-validation process.

According to DIN EN ISO 11607-1, we can complete full shelf-life validation and transportation validation processes for you, and help you determine product families and worst case analyses.

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

Process validation

The manufacturing process used to produce sterile barrier systems must be validated in accordance with DIN EN ISO 11607-2. Developing and validating packaging processes is key to ensuring the integrity of a sterile barrier.

The manufacturer must submit a documented process validation program that certifies the effectiveness and reproducibility of all packaging processes. This includes shaping, sealing, and assembling pre-fabricated sterile barrier systems and packaging systems.

We can support you in completing an operational qualification (OQ) and performance qualification (PQ):

Create validation plans
Sample sizes
Determining suitable test systems
Final documentation
Re-validation

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 sterilized products in their final packaging until the time of use. The integrity and sealing force of such systems must be tested throughout the specified shelf life in order to ensure this.

We create customized validation and re-validation plans for our customers and support them in defining product and packaging families and in establishing worst-cases to be tested.

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

Medical products

Physical and mechanical tests

We can complete testing for you in accordance with international and national standards or internal specifications:

  • Flow rate measurement
  • Tensile and compression testing
  • Leak tests
  • Bending and kinking tests
  • Gravimetric measurements
  • Dimensional stability and
  • Visual inspection.

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

We complete tests in our climatic laboratory at 23 °C and 50 % relative humidity according to ASTM E171 and according to requirements.

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

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