We offer our quality standards, which we apply to our own environment and machines as well as to our own solutions and processes, to our customers in the form of services. We continually invest in our expertise. We place quality assurance at the center of our work and guarantee it with our laboratory analyses, validations, and qualifications. So that we can meet your requirements reliably, flexibly, and efficiently.
Our laboratory services are officially accredited. We can therefore offer you accredited tests according to ISO/IEC 17025. These are valid in court. Accreditation is our key to transparency, trust, and comparability and underlines our high quality standards.
Integrity checks ensure the integrity of medical and pharmaceutical packaging using methods such as dye penetration and bubble emission tests.
Dye penetration test for porous packaging (ASTM F1929)
A dye solution is used to assess the integrity of sterile barrier seals and determine if there are any leaks in the seams of porous packaging with a diameter of 50 μm or more.
Dye penetration test for non-porous packaging (ASTM F3039)
In the case of an integrity test for non-porous sterile barrier systems, a dye solution is used to detect leaks in seams with a diameter of 50 μm or more. If the structure of the packaging permits, it is also possible to determine if there are any leaks in packaging as a whole (except seal seam) with a diameter of 10 μm or more.
Bubble emission test (ASTM F2096 / ASTM D3078)
Integrity tests are used to determine if there are any leaks in seams or in the packaging as a whole. We offer two tests: creation of positive pressure in the packaging, and creation of negative pressure in a vacuum chamber. The two tests are available for packaging with a diameter of 250 μm or more.
Visual inspection of seams (ASTM F1886 / F1886M)
A visual inspection of packaging seams is used to detect leaks with a diameter of 75 µm or more and to make any further qualitative statements about the packaging features or defects that may affect the integrity of the packaging.
Packaging and material tests evaluate critical properties such as sealed seam, puncture, and tensile strength to ensure the safety and suitability of packaging materials.
Seal strength (ASTM F88 / F88M)
The force necessary to open the seam of a packaging is calculated in order to determine the seal strength of more flexible barrier materials. The test can be used for peelable seals made of two flexible materials (e.g. peel bags) or seals made with a flexible material and a rigid material (e.g. blister packs). Both types are considered flexible if at least one component is flexible.
Tensile strength and nominal elongation at break (DIN EN ISO 527 – 1 / ‑3)
This test is used to determine the tensile strength and elongation at break of materials that are up to 1 mm thick.
Puncture resistance (DIN EN 14477 / ASTM F1306)
When testing puncture resistance, the material is punctured with a probe at a constant rate of speed. In doing so, the force, energy and elongation are determined.
Linear dimensions of packaging (ruler (ASTM F2203) and caliper (proprietary method))
The dimensions of packaging and inserts are measured using the ruler with a measurement resolution of 0.5 mm and with the caliper using a proprietary method with a resolution of 0.01 mm.
Visual assessment of packaging (proprietary method)
The visual assessment of packaging based on a proprietary method includes determining damage to the packaging and material defects based on defined criteria. These criteria are generally agreed with the client.
The climate test is used to test the resistance of packaging to extreme climatic conditions and thus confirm its reliability under real conditions of use.
Climate tests (e.g. ASTM D4332)
Climate simulations can be used to determine the ability of packaging and products to withstand extreme climate conditions. Climate change tests are also offered in which rapid temperature changes are produced in order to detect product weaknesses.
With packaging validation (performance and stability tests), we guarantee durability, resistance to damage and temperature resistance.
Stability tests (ASTM F1980)
Stability tests consist of two aging tests: In a climatic exposure test cabinet, accelerated aging takes place at increased temperature and humidity. Real-time aging is performed in a temperature and humidity-controlled room, thereby confirming the results obtained during the accelerated aging process.
Performance tests (e.g. ASTM D4169 or ISTA 3)
Performance tests for packaging mainly consists of climate conditioning and/or a transport simulation. The interaction between the packaging system and the product in response to the effects of production, sterilization, handling, storage and shipment are assessed.
Our test methods can be carried out individually or in combination. Depending on the topic, complete stability and performance testing as well as subsequent laboratory tests are required.
Shelf life, resistance against damage and temperature stability: Our packaging is carefully tested. Time and time again.
Packaging solutions for the medical device and pharmaceutical industries require the highest standards and are subject to constant quality control at Früh. Our specialists regularly test them in the laboratory under controlled conditions using outsourcing tests to ensure that they meet our quality promise at all times.
Robustness testing:
- Drop test
- Gas chromatography
- Sliding friction
- Measurement of water content
- Microscopy
- Oxygen permeability measurement
- Determination of melting point (DSC)
- Tactile measurement on our ultra-modern 3D measuring equipment
- Composite adhesion values
Our systems are qualified and our processes and packaging solutions are validated. They meet the highest standards.
We subject our qualified systems and environmental conditions as well as all production processes to continuous validation checks.
We offer our customers the following validation processes:
- Design qualification (DQ)
- Installation qualification (IQ)
- Design of experiment (DOE)
- Operational qualification (OQ)
- Performance qualification (PQ)
These comprehensive GMP-based qualifications ensure that our systems and processes not only meet the highest standards but are also regularly reviewed and updated. This continuous monitoring and improvement is part of our commitment to providing our customers with the highest quality and safety in medical device and pharmaceutical packaging.
You can find out exactly what DQ, IQ, DOE, OQ, and PQ mean here.
We offer our customers the following validation processes:
- Hygiene validation
- Process validation
- Product validation
- Sterilization validation
Detailed information on the validations can be found here.
From the first consultation to the development of the packaging to production, a project manager serves as your point of contact.
Based on the customer’s needs, we use CAD to design the desired packaging or tool. After the design has been approved, a sample is produced using a 3D printer. This allows us to show you a sample with the correct dimensions and form before the start of production.
The use of the latest EDI systems allows us to send all order-related documents electronically and in real time.
The transmitted data is converted when it is sent to and received on our site and fits entirely with your specific needs.
Communication and print approval is carried out via a cloud-based, digital print data portal. The portal enables efficient and error-free processing of projects. Print data and specifications can be saved directly in the portal and are available to all stakeholders at all times before they are archived.
We take care of all logistics for you. Products are picked up from your location and packed at our facility. Following sterilization, we return the products to you.
If necessary, the process can also take place under controlled temperature conditions.
