quality assurance for medical technology & pharmaceutics

Holistic quality assurance for medical & pharmaceutical products

Medical and pharmaceutical products are subject to strict quality assurance requirements. These requirements include both quality management and the method for certification and approval. Anybody who wants to manufacture a medical product to be placed on the market must comply with the regulations and standards related to medical products. With Quality Analysis you have at your side an experienced partner for quality analyses.

Medical technology: highly precise, efficient solutions for your quality assurance

Based on the example of an infusion needle, we show you what our measurement and analysis methods can do for you and your quality management. Simply click the red button and order our free brochure with numerous possible applications and uses for our analysis services.

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HOLISTIC QUALITY ASSURANCE FOR THE MEDICAL & PHARMACEUTICAL INDUSTRY

For the inspection, analysis and measurement of components for medical technology used both in the body and external to the body, as well as pharmaceutical products, we use holistic solutions and, if necessary, combine our technologies for even more informative and detailed results.

We combine optical inspection with its high-resolution depiction of details down to the nanometre range with metallographic analysis: we link a high-resolution imaging analysis method to the analysis of component characteristics, defect analysis, cleanliness checks, surface metrology, as well as tactile metrology and computed tomography. With the results from these analysis methods, we help you to increase the efficiency and productivity of your manufacturing in the area of medical technology.

ANALYSIS OF BLISTERS AND PACKAGING

For primary pharmaceutical packaging such as tablet blisters, ampoules, syringes, bottles or transport packaging, we undertake the following analyses:

Wall thickness analysis with colour-coded depiction of deviations
Assembly checking for child-proof packaging
Verification and identification of particulate contamination and contaminating chemical films
Plastic analytics (TGA, DDC, GC-MS, RAMAN and FT-IR spectroscopy)
Preparation of measuring programs and adaptation of drawings
Geometric dimensional inspection: highly precise measurement of standard geometries and freeform surfaces
Preparation of initial sample test reports (ISTR/PPAP)

TESTING OF PHARMACEUTICAL PRODUCTS

For checking the quality of tablets, dragees, (transdermal) plasters and liquid medicines we offer the following analyses:

Layer thickness analysis for the analysis of the functional layers
Wall thickness analysis with colour-coded depiction of deviations
Analysis of the distribution of the active ingredient
Depiction and analysis of inclusions/foreign particles

ANALYSIS OF MEDICAL INSTRUMENTS

For medical instruments such as endoscopes or surgical devices, we offer the following analyses for quality assurance:

Preparation of measuring programs and adaptation of drawings
Geometric dimensional inspection: highly precise measurement of standard geometries and freeform surfaces
3D digitisation of the component and high-resolution depiction of specific sub-areas
Depiction of mounted states and assembly checking
Roughness measurement and depiction of surface structures
Weld seam and soldered joint analysis
Non-destructive and destructive damage and defect analysis
Verification and identification of particulate contamination and contaminating chemical films
Preparation of initial sample test reports (ISTR/PPAP)

IMPLANTS

Non-destructive and destructive analysis of medical products for implanting, e.g. dental implants or endoprosthetics:

Roughness measurement and depiction of surface structures
Verification and identification of particulate contamination and contaminating chemical films
Metallographic material testing and microstructure analysis on prepared specimen
Analysis of coatings
Optical inspection of anomalies, e.g. corrosion, wear mechanisms or notch effect
Analysis of damage mechanisms, e.g. fractures, cracks, material composition (SEM-EDX)
Geometric dimensional inspection: highly precise measurement of standard geometries and freeform surfaces
Preparation of initial sample test reports (ISTR & PPAP)
3D digitisation and high-resolution depiction of sub-areas
Volume-based analysis options for surface comparisons (nominal-actual/actual-actual comparison) or for the analysis of porosity, inclusions or cavities

STENTS

Reliable, visual inspection of the complex internal and external geometry of stents and vascular prostheses:

3D digitisation and high-resolution depiction of sub-areas
Geometric dimensional inspection: highly precise measurement of standard geometries and freeform surfaces
Geometric evaluation and surface comparisons (nominal-actual/actual-actual comparison) for identifying shape deviations
Wall thickness analysis with colour-coded depiction of deviations
Roughness measurement and depiction of surface structures
Metallographic material testing
Damage analysis for the identification of microcracks, scratches, notches or pitting
Analysis of coatings
Verification and identification of particulate contamination and contaminating chemical films

TESTING OF PRODUCTS FOR DIALYSIS, TRANSFUSION, INFUSION AND INJECTION

3D digitisation of the component and high-resolution depiction of specific sub-areas
Depiction of mounted states and assembly checking
Roughness measurement and depiction of surface structures
Non-destructive and destructive damage and defect analysis
Geometric dimensional inspection: highly precise measurement of standard geometries and freeform surfaces
Verification and identification of particulate contamination and contaminating chemical films

QUALIFICATION AND RE-QUALIFICATION OF MEDICAL PRODUCTS

Qualification of new products
Re-qualification after change or modification processes
Monitoring of process changes during the product life
Monitoring during a design change
Analysis of products incl. transport packaging and labels
Re-engineering of "old" existing components without a drawing or CAD data (reverse engineering)

QUALITY ANALYSIS,
YOUR PARTNER FOR YOUR ANALYSIS TASKS IN MEDICAL TECHNOLOGY

What can we analyse for you?
We would be pleased to advise you about the numerous possibilities and combined analysis methods.
The goal: the best, most cost-effective and most efficient analysis of your component.
Call us, we look forward to hearing from you!

Telephone: +49 7022 2796-682