BD Neopak™ XSi™ Glass Prefillable Syringe
Helping you address silicone-related concerns in delivering biologics
- Overview
- Expertise
- Products & Accessories
- Resources
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.
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.
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
- 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
- BD Neopak™ XSi™ 1 mlL - Competitive Benchmark [Internal Study]. Pont-de-Claix, FR: Becton Dickinson and Company; 2020
- Neopak™ XSi™ 2.25 mL – Subvisible particles quantification by MFI / pipetting & HIAC / flushing [internal Study]. Pont-de-Claix, FR: Becton Dickinson and Company. 2019
- 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
- Neopak™ XSi™ 2.25 mL 27G STW 1/2” - Empty AGF. [internal Study].Pont-de-Claix, FR: Becton Dickinson and Company. 2019
- Neopak™ XSiT™ 1 mlL 29G TW 1/2” - Empty gliding force at 1ml. [internal Study].Pont-de-Claix, FR: Becton Dickinson and Company. 2018
- Neopak™ XSi™ 2.25 mlL 27G STW 1/2” - injection time. [internal Study].Pont-de-Claix, FR: Becton Dickinson and Company. 2019
- BD Medical Pharmaceutical systems_BD Hypak™ Glass Prefillable Syringe since 1975_BD Website
- BD Situation analysis extract [Internal document]. Pont-de-Claix, FR: Becton Dickinson and Company; 2020
- <788> PARTICULATE MATTER IN INJECTIONS - The United States Pharmacopeial Convention, current edition
- <787> SUBVISIBLE PARTICULATE MATTER IN THERAPEUTIC PROTEIN INJECTIONS - The United States Pharmacopeial Convention, current edition
- EP 2.9.19 Particulate contamination: Sub-Visible Particles - The European - Pharmacopoeia, current edition
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.
- BD Medical Pharmaceutical systems_BD Hypak™ Glass Prefillable Syringe since 1975_BD Website
- BD Situation analysis extract [Internal document]. Pont-de-Claix, FR: Becton Dickinson and Company; 2020
