Article Text

Science- and risk-based strategy to qualify prefillable autoclavable syringes as primary packaging material
  1. Karin Larmené-Beld1,
  2. Rommert Wijnsma1,
  3. Albert Kuiper1,
  4. Stefan van Berkel1,
  5. Henri Robben1,
  6. Katja Taxis2,
  7. Henderik Frijlink3
  1. 1Clinical Pharmacy, Isala Hospitals, Zwolle, The Netherlands
  2. 2Unit of PharmacoTherapy, Epidemiology & PharmacoEconomics, Groningen Research Institute of Pharmacy, University of Groningen, Groningen, The Netherlands
  3. 3Department of Pharmaceutical Technology and Biopharmacy, University of Groningen, Groningen, The Netherlands
  1. Correspondence to Karin Larmené-Beld, Department of Clinical Pharmacy, Isala hospital, Zwolle, The Netherlands; k.h.m.beld{at}isala.nl

Abstract

Objectives To develop a science and risk based strategy to qualify a prefillable autoclavable cyclic olefin polymer (COP) syringe as a container for multiple drug products in a hospital pharmacy setting

Methods Different extraction studies were performed with different solution characteristics: phosphate buffer batches (Na2HPO4 / NaH2PO4 in NaCl 0.9%) at different pH values, NaCl 0.9% batches, isopropyl alcohol (IPA) 5% in water and batches with Water For Injections (WFI) at different pH values. The filled syringes were terminally sterilised. The syringes were stored at room temperature (20°C±5°C).

Following different monographs of the European Pharmacopoeia several tests were performed on the different batches. Analyses were performed at t=0, 1, 2, 3, 4, 5, 6, 9, 12, 18, 24 and 36 months for the general tests. For the subvisible particles, sterility and closure integrity a bracketing scheme was applied during 36 months.

Results Low levels of extractables were measured for the different solutions. The test for subvisible particles, sterility and closure integrity all met predefined requirements. In the 5mL and 50mL syringes different concentrations of silicon were measured. Overall higher silicon concentrations were measured for the 50mL syringes.

Conclusions The chosen strategy for the qualification program provided an adequate understanding about the extractables that could leak from the syringes. The cyclic olefin polymer syringes including stopper and tip cap were found to be suitable as primary packaging materials for the production of water based products.

  • drug manufacturing / preparation / compounding
  • Good Manufacturing Practice (GMP)
  • sterile production
  • drug stability
  • validation preparation process
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