Packaging

The microbiological tests carried out on packaging are as follows:

  • Demonstration of microbial barrier effectiveness by immersion based on PDA Technical Report 27 (TR27) and standards NF EN ISO 11607-1 and NF EN ISO 11607-2,
  • Demonstration of microbial barrier effectiveness by microbial aerosol based on PDA Technical Report 27 (TR27) and standards NF EN ISO 11607-1 and NF EN ISO 11607-2,

The physical tests carried out on packaging are :

  • Particle counting (subvisible particles) on parenteral preparations according to European Pharmacopoeia chapter 2.9.19., methods 1 and 2 (USP-NF <788> equivalent),
  • Particle counting (subvisible particles) on ophthalmic solutions according to USP-NF <789>,
  • Particle extraction (subvisible particles) on medical devices (orthopedic implants) according to NF ISO 19227, then assay according to European Pharmacopoeia chapter 2. 9.19., methods 1 and 2 (equivalent USP-NF <788>),
  • Extraction and particle counting according to IEST-STD-CC1246E,
  • Particle control (visible particles) according to European Pharmacopoeia chapter 2.9.20.,
  • Particle counting on medical infusion devices according to ISO 8536-4, annex A,
  • Particle counting on surgical implants – active implantable medical devices according to NF EN 45502-1 and ISO 14708-1,
  • Particle counting on preassembled sterilized pre-fillable syringes in accordance with NF ISO 11040-6,
  • Particle counting on plastic containers for intravenous injections in accordance with NF EN ISO 15747,
  • Permeability testing of packaging by visual test in accordance with ASTM F1886/F1886M,
  • Determination of the peelability characteristics of complexed paper/plastic film packaging in accordance with NF EN 868-5 Annex E,
  • Permeability test on dye-coated packaging in accordance with ASTM F 1929,
  • Verification of the strength of packaging seals in accordance with NF EN 868-5 Annex D and ASTM F88/F88M,
  • Bubble emission test on flexible packaging in accordance with ASTM D3078-02,
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