BD Hylok™ Glass Prefillable Syringe for Intravenous Drugs

Integrate the BD Hylok™ Glass Prefillable Syringe into your generic drug launch or Life Cycle Management strategy.

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Overview

Do you know, approximately 92% of hospital stakeholders* in a study were willing to use prefilled syringes for multiple drugs?1 In fact, transitioning a fixed dose drug from its vial or ampoules format to a prefilled syringe (PFS) can serve as a differentiation strategy in a market dominated by vials and ampoules.2,3

hylock prefillable syringe C PS PSP 0117 0005
  • hylock prefillable syringe C PS PSP 0117 0005
  • hylock prefillable syringe C PS PSP 201790860
  • hylock prefillable syringe C PS PSP 201790858
  • hylock prefillable syringe C PS PSP 201790844
  • hylock prefillable syringe C PS PSP 201790856
Features and Benefits

BD Hylok™ Glass Prefillable Syringe features focused on connection performance

  • Screw-on tip cap is preferred by users over a standard clip-on tip cap4**
  • Validated for connection with commonly used Needleless Access Devices5‡
  • Strongly affi xed Luer-Lock Adaptor6+
  • Sizes from 1 mlL to 10 ml§§ with different tip cap formulations plunger rods and stoppers. Validated for steam sterilization7++

BD Hylok™ Glass Prefillable Syringe Benefits

  • BD Hylok™ supports your prefilled syringe “First-Mover” strategy with usability data from Human Factors and reports on compatibility with intravenous connectors. 8‡‡
  • This data can help you streamline your drug filing process and address relevant questions from regulatory bodies on combination product usability. ‡‡
  • Moreover, the connection performance of BD Hylok™ for intravenous applications is verified in Human Factor studies.
  • Intuitive screw-on tip cap is preferred by users over a standard clip-on tip cap.4**
  • Positively tested for connection with commonly used Needle Less Access Devices including Luer Activated Valve or Pin Activated IV connectors.5‡
  • Strongly affixed Luer-Lock Adaptor.6+
  • Sizes from 1 mIL to 10 ml§§ with different tip cap formulations, plunger rods and stoppers. Verified for steam sterilization.7++

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Endnotes

* Stakeholder respondents include risk managers & infection control nurses, intensive care nurses, business/department managers, pharmacists, and anesthesiologists included in a quantitative survey (n=147) on “Drivers of use of prefilled syringes” conducted in UK, France and Germany.

** First use, without Instructions For Use.

BD tested compatibility with the small-bore connectors or NLADs (Needle Less Access Devices) is in relation to ISO 80369-7:2016 in July 2021. BD cannot guarantee that compatibility in relation to ISO 80369-7:2016 will remain if product changes are or have been made by the relevant connector manufacturer(s) since the time of testing. BD is not responsible for any product variability related to the connectors/NLADs.

‡‡ “First-Mover” refers to being first-to-market in a geography with a drug-prefilled syringe combination.
- Reports referred are for BD Hylok™ glass prefillable syringe summary data on compatibility with intravenous connectors.
- Summary of results can be provided; more information is available on request.
- Human factor studies for BD Hylok™ were conducted with Water-for-Injection.

+ Comparable products indicate 3 widely used glass prefillable syringe brands with Plastic Rigid Tip Cap (PRTC) based design.

++ Terminal steam sterilization cycles at 121°C/2cycles/20 min. Functional tests relating to closure system and luer-lock adaptor connectivity with a minimum sample size of n=30 were conducted to verify resistance of BD Hylok™ glass prefillable syringe to steam sterilization.

§ Human factor results from 320 manual infusions performed by nurses: No luer lock adaptor rotation or disconnection and no syringe clogging was observed during infusion. This statement is with reference to connection of the prefilled syringe with intravenous catheters by trained clinical users in a clinical environment and as defined in the Human Factors.

§§ 1 mlL, 3ml, and 5ml formats are available. Frequently used sizes between 1.25 ml to 10 ml are currently under development.

References

1. Drivers of use of prefilled syringes [Internal study, n=147], Le Pont-de-Claix, France; Becton, Dickinson and Company, 2018.

2. Considerations and Options for Prefilled Syringes [External study - White paper], Illinois, USA; Baxter Healthcare Corporation, 2019.

3. Based on extracted IQVIA - Smart MIDAS Datapack 2019.

4. A simulated study of usability of BD Hylok™ [internal report]. Pont-de-Claix, FR: Becton Dickinson and Company; 2015.

5. Assessment of ISO80369-7 connectivity performance for BD HYLOK(TM) syringes and IV connectors. Le Pont-de-Claix, France; Becton, Dickinson and Company, 2021. Tests were conducted for commonly used NLADs in the US market for the following sections: §6.1 – Fluid leakage, §6.2 – Sub-atmospheric pressure air leakage, §6.3 – Stress cracking, §6.4 – Resistance to separation from axial load, §6.5 – Resistance to separation from unscrewing, §6.6 – Resistance to overriding.

6. BD Hylok™ and BD Hylok™ competitor syringes performance evaluation [Internal reports, n=30 for both]. Pont-de-Claix, FR: Becton Dickinson and Company; 2018.

7. BD Hylok™ Design verification results [Internal Report]. Pont-de-Claix, Becton Dickinson and Company, 2019.

8. System Integration Challenges in Combination Products for Injectable Drugs [Internal study], Le Pont-de-Claix, France; Becton Dickinson and Company, 2019.

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