BD Neopak™ XSi™ Glass Prefillable Syringe

Helping you address silicone-related concerns in delivering biologics

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Overview

BD Neopak™ XSi™ Glass Prefillable Syringes have been designed for improved integrity of the lubricant layer, reducing the subvisible particle level of biologic formulations , particularly for drugs that may be very sensitive to silicone oil.1 The BD Neopak™ XSi™ minimizes sub-visible particle generation,1,2,3,4* helping you achieve compliance with standards,10,11,12 for particulates, even when using formulations reactive to conventional silicone and/or higher drug concentrations.

*As compared to conventional liquid silicone lubrication.

Features

Benefits

Helping you address silicone-related concerns in delivering biologics:

  • Minimizes sub-visible particle generation,1,2,3,4* helping you achieve compliance with standards,10,11,12 for particulates, even when using formulations reactive to conventional silicone and/or higher drug concentrations.
  • Stabilizes the silicone lubricant layer & mechanical properties.1,2,5,6,7
  • Does not introduce new chemistryµ
  • Designed to have no impact on manufacturing and fill and finish lines, avoiding additional costs associated with PFS switch.

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Footnotes

µ XSi™ does not introduce new chemical substances or molecule entity and only modifies the distribution of chemical functions which already exists in PDMS (Polydimethylsiloxane) silicone

References

  1. Depaz et al. Cross-Linked Silicone Coating: A Novel Prefilled Syringe Technology That Reduces Subvisible Particles and Maintains Compatibility with Biologics JOURNAL OF PHARMACEUTICAL SCIENCES 103:1384–1393, 2014
  2. BD Neopak™ XSi™ 1 mlL - Competitive Benchmark [Internal Study]. Pont-de-Claix, FR: Becton Dickinson and Company; 2020
  3. Neopak™ XSi™ 2.25 mL – Subvisible particles quantification by MFI / pipetting & HIAC / flushing [internal Study]. Pont-de-Claix, FR: Becton Dickinson and Company. 2019
  4. Neopak™ XSi™ 1 mlL 29 G TW & 27STW 1/2” RNS BD260 – Subvisible particles [internal Study]. Pont-de-Claix, FR: Becton Dickinson and Company. 2019
  5. Neopak™ XSi™ 2.25 mL 27G STW 1/2” - Empty AGF. [internal Study].Pont-de-Claix, FR: Becton Dickinson and Company. 2019
  6. Neopak™ XSiT™ 1 mlL 29G TW 1/2” - Empty gliding force at 1ml. [internal Study].Pont-de-Claix, FR: Becton Dickinson and Company. 2018
  7. Neopak™ XSi™ 2.25 mlL 27G STW 1/2” - injection time. [internal Study].Pont-de-Claix, FR: Becton Dickinson and Company. 2019
  8. BD Medical Pharmaceutical systems_BD Hypak™ Glass Prefillable Syringe since 1975_BD Website
  9. BD Situation analysis extract [Internal document]. Pont-de-Claix, FR: Becton Dickinson and Company; 2020
  10. <788> PARTICULATE MATTER IN INJECTIONS - The United States Pharmacopeial Convention, current edition
  11. <787> SUBVISIBLE PARTICULATE MATTER IN THERAPEUTIC PROTEIN INJECTIONS - The United States Pharmacopeial Convention, current edition
  12. EP 2.9.19 Particulate contamination: Sub-Visible Particles - The European - Pharmacopoeia, current edition

Expertise 

BD expertise in the BD Neopak™ XSi™ Glass Prefillable Syringe

  • BD partnering in combination product development with the biopharmaceutical industry for 40 years.1
  • Glass used as reference material for vast majority of biologic drugs prefillable syringes.2

 

BD XSi™ is built on BD Neopak™ Glass Prefillable Syringe

  • Compatible with existing manufacturing and inspection technologies and practices
  • Supports single PFS platform approach.

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References

  1. BD Medical Pharmaceutical systems_BD Hypak™ Glass Prefillable Syringe since 1975_BD Website
  2. BD Situation analysis extract [Internal document]. Pont-de-Claix, FR: Becton Dickinson and Company; 2020

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