SCHOTT Pharma Services

SCHOTT Pharma Services - Primary Packaging Support SCHOTT Pharma Services

SCHOTT, one of the world's leading suppliers of parenteral packaging for the Pharmaceutical industry, is widely recognised as a pioneer and proven expert in glass and materials technology with more than 125 years experience.

SCHOTT employs more than 600 individuals in the field of application-oriented research. The unique combination of specialized analytics and our expertise in materials, products, and processes enables SCHOTT pharma services to support pharmaceutical companies by finding solutions to the most challenging packaging requirements. We can help customers avoid stability issues resulting from drug/ container interaction and provide development support.

SCHOTT's analytical labs are DIN EN ISO/IEC 17025 accredited

Analytical Packaging Support

Drug Container Interaction

Particle Analysis

  • Size, number, shape, chemical composition

Continer Surface Characterisation

  • Chemical composition, e.g. tungsten quantification, contamination, alkalinity
  • Defects, delamination, corrosion
  • Surface coating and layer characterisation, wetting behavior

Protein Adsorption, Aggregation

  • Quantification and in-situ adsorption characterisation

Silicone Distribution, Free Silicone

  • Silicone layer thickness and distribution
  • Free silicone trace level quantification

Fracture, Stress, Reliability, Lifetime

  • Stress, crack, fracture analysis
  • Statistical evaluation of reliability and lifetime

Development Support

Extractables and Leachables

  • Testing according to PQRI, OINDP recommendations

Accelerated Compatibility Testing, Spiking Studies

  • Tailored accelerated aging tests to identify critical parameters causing stability issues
  • Combination of specific analytical methods e.g. surface analytics, E&L, spiking studies

Container Closure Integrity, System Performance

  • Permeability: oxygen, water vapour
  • Leakage: tip cap leakage, dye ingress, axial compression, piston vacuum
  • Sterility
  • Functionality: break away/gliding force, tip cap removal, needle pull force, needle penetration
  • Drug delivery: dead volume, delivered dose

For more information see the pdf below.

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