Analysis and test laboratory for the Pharmaceutical Industry

The 6NAPSE Group characterizes your pharmaceutical products and qualifies your packaging.

These tests can be carried out on any pharmaceutical product and packaging: bottles, syringes, tubes, pill boxes, tablets / capsules, sachets, blisters, spray bottles, cartons, etc.

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Pharmaceutical product

Characterization of pharmaceutical products and validation of medicine

Characterization of foreign bodies and failure analysis: identification of the morphology, nature and source of contamination within the framework of analysis of deposits and particles
Nanoparticles characterization
Chemical analysis
- ICH-Q3D elemental analysis
- Verification of the heavy metal content of pharmaceutical products
Analysis according to the Pharmacopoeia: quality control of pharmaceutical products and drugs
Characterization of powders and particle size analysis
Aging tests on pharmaceutical products
Drug stability study and verification of container-content interaction between a bottle and a pharmaceutical product

Pharmaceutical packaging

Validation of pharmaceutical packaging throughout the logistics cycle

Materials analysis
- Surface analysis
- Mechanical characterization
- Thickness measurement
- Change of appearance
- Resistance of paints and coatings
Failure expertise
- Rouging
- Corrosion
- Fractography
Environmental tests
- Climatic and hot/cold/humid
- Thermal shock
- Salt spray
- UV/QSUN
- Chemical resistance (bulk tests)
Qualification tests
- Transport and logistics test
- Storage, fall, vibration, sealing
R&D support for the Pharmaceutical Industry

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6NAPSE Group assets

Analyses et Surface laboratory of the 6NAPSE Group has COFRAC accreditation (n°1-1720) for the sampling and characterization of foreign bodies (particles, fibres) by Scanning Electron Microscopy coupled with X-ray Microanalysis (SEM-EDX) , stereoscopy and infrared microscopy (IRTF).
(scope available on www.cofrac.fr)

Reactivity: emergency possibility 1-3 working days
Materials database of several thousand references

Applications

Expertise of failure and identification of particles on syringes, vials and tablets / capsules
Qualification for the transport of all types of packaging (e.g. bags, boxes)
Validation of vaccine safety

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Custom Protocols:
standards ISTA, ASTM, NF EN 868, ISO 11607

Analyses et Surface from 6NAPSE Group is member of Polepharma, French pharmaceutical industry cluster.