Congruence Medical Solutions LLC

Microliter Dosing Syringe

OVERVIEW
APPLICATIONS
CUSTOMIZE
DATA
SPECIFICATIONS
Making Any Syringe a Microliter Dosing Syringe™

The Microliter Dosing Syringe (MDS) platform is the award-winning1, new gold standard for microliter volume injections. It can deliver a single injection of 5-150μL, and is suitable for ophthalmic injections, cell and gene therapy and other applications.

Compared to just standard syringes, it delivers more accurate, precise microliter doses, is user preferred, and shown to be easy to use2. This versatile platform incorporates standard, ISO 11040 compliant pre-fillable syringes and has a wide array of customization options.

An image of the Microliter Dosing Syringe with a needle attached
1Congruence’s MDS was the Recipient of 2019 Drug Delivery Innovation Award from Parenteral Drug Association (PDA) in partnership with Santen Pharmaceutical, Inc.
innovation award
Configurations
  • Disposable, Single-Use, Single-Dose (5μl – 150μl)
  • User controls injection speed
  • Dose setting options: Pre-set (factory-set) or User-set
  • Drug filling options: Pre-filled or User-filled (from a vial)
  • Incorporates standard, third-party, ISO 11040 compliant prefillable syringes
  • No user-assembly required

Key Benefits
  • High accuracy: +/-2.5μl
  • Easy to Use
    • Controlled priming and air bubble removal in one simple step
    • One-handed operation possible
    • Can deliver highly viscous drugs with up to 75% reduced injection force (vs standard syringe)2
    • User Preferred (90% eye surgeons prefer MDS vs syringe2)
  • Reduces drug waste
  • Amplifies user injection stroke
  • No syringe barrel printing required

Availability
  • IP Protected
  • Samples available for clinical/preclinical use
Applications

The MDS platform is suitable for applications involving a single injection of 5 through 150 microliters.

Current standard practice is to use a milliliter dosing syringe for a microliter dose volume. Inherent in this approach is inaccurate, imprecise microliter injection volume. Larger volume syringes are also not suitable for injection of viscous formulations. Lack of resolution results in poor user control, and hence results in significant drug waste. The MDS addresses these needs. 

One key area where these issues converge is ophthalmology. Congruence’s MDS can be used to address these needs, and can deliver a variety of drugs (such as anti-VEGF) via several routes including Intravitreal, Subretinal, Subtenon, Suprachoroidal and Intracameral.

Other applications include Localized delivery, Cell & Gene Therapies, Long-acting formulations and Potent therapeutics, as well as various others.

Customize
The MDS platform has 4 possible core configurations, enabling versatile use across the drug lifecycle (including various stages of drug development) and/or across multiple drugs in a portfolio.

Key configuration choices are:
  • Drug Filling: Pre-filled (syringe is primary drug container) or User-filled (Vial is primary drug container)
  • Dose Setting: Pre-set (fixed dose, no user choice) or User-Set (2-4 Dose volume options)

Note: In order to ensure highest quality drug contact materials, the MDS incorporates pre-fillable syringes even if the drug is not prefilled in the syringe.

Other customization options include:
  • Choice of various ISO 11040 compliant standard syringes:
    • Siliconized, silicone-free or lubrication free
    • 0.5mL or 1mL long; Type I Borosilicate glass or polymer (CoC or CoP)
    • Luer-lock or staked needle (staked needle for non-ophthalmic applications only)
  • Intended dose volume(s)
  • Accommodation for wide range of drug viscosities
  • External look and feel
  • Other based on route of administration

If you are interested in other customization and configuration options to meet your specific needs, please contact us.
Data
Graph showing accuracy and precision microliter dosing by MDS
The MDS has been shown to deliver accurate, precise volume as low as 5 microliters with standard pre-fillable syringes. Up to 25 times greater dosing accuracy than a standard syringe.2
Summative human factors studies have shown clinicians’ ability to deliver an accurate, precise microliter size dose with the MDS, as well as high overall acceptance and preference (vs standard syringe)2

Additional data available upon request

Specifications
Key Needs Addressed Microliter, Viscous, Minimize Drug Waste
Device Type Manual Syringe Injector
User Profile HCPs, Retina Surgeons
Administration Route Subcutaneous, Intraocular (various)
Primary Container ISO 11040 compliant 0.5mL or 1mL long standard prefilled glass or polymer syringes. (Vial for user-filled)
Usage Single Dose; Disposable
Dosage Type Fixed or user selects from 2-4 dose* options
Dose Volume 5μl – 150μl
Viscosity Up to 3000cP
Injection Time User Controlled
Priming & Dose Setting Controlled, Simple Dial Turn (combined user step)
Needle Attachment User attached for ophthalmic applications, staked needle option available for others
Needle Safety N/A
Injection Feedback Visual, tactile indicators
WP DataTables

Instructions for use available upon request

2 Congruence study data