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Home > Activities by sector > Healthcare > Pharmaceutical and biotechnology industry

Pharmaceutical and biotechnology industry

Your missions

LNE helps you rise up to challenges regarding:

  • - Competitiveness
  • - Innovation and R&D
  • - Conformity

Services offered by LNE

Competitiveness: a unique contact for all your certification applications

Environmental impact, safety of staff, quality control See details  

  • • Quality-Safety-Environment Certification (QSE): ISO 9001 / OHSAS 18001 / ISO 14001

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Quality of materials and equipment See details  

  • ISO 15378: Primary packaging materials for medicinal products
  • ISO 22716: Good Manufacturing Practices for cosmetics

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Innovation and r&d: personalized accompaniment

Technical assistance, technical and regulatory assistance and information before design

Drafting of specifications for prototypes, validation of performance, organisation of monitoring in production

Customized development tests: See details  

  • Development of reference benches, measurement and testing methods for innovative equipment and materials

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Conformity: a multidisciplinary expertise

Tests in accordance with standards and other reference documents in force See details  

  • Mechanical stress testing of packaging (falls, shocks, vibrations, acceleration…) – Transport Simulation Test (ISTA)
  • Climatic tests and ageing resistance
  • Physical and chemical tests: salting out (silicone …), permeability, packaging performance, dosage (phthalates, heavy metals…)

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Calibration and measurements in laboratory and/or on site: See details  

  • Calibration of measuring instruments
  • Verifications in accordance with standards or other reference documents in force (GMP, specifications from your customers…):
    • - Air quality measurements (industrial air and compressed air, clean rooms, dust, particles, oil, humidity, pollutants…)
    • - Climatic and temperature chambers
  • Uncertainty calculations (R&D production, Maths Stats)
  • Training and accompaniment

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Training: See details  

  • • LNE’s internal or joint training programmes enable manufacturers and health establishments to control the specificities of standards and regulations of French and international markets. Courses are aimed at quality managers, auditors, engineers and industry and health establishments technicians.
  • • Feel free to consult our training course catalogue and subscribe online.

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LNE certifies primary packaging
of medicinal products in accordance
with standard ISO 15378