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PLAJEX™ 0.5ml Luer Lock Silicone oil-free syringe
for challenging low dose applications

PLAJEX™ 0.5ml Luer Lock Silicone oil-free syringe
for challenging low dose applications

Description

PLAJEX™ 0.5ml Luer Lock Silicone oil-free syringe for challenging low dose applications

This latest addition to our PLAJEX™ Ready-to Fill Polymer Syringe is designed to meet you, your users, and your patients’ needs, offering a best-in-class solution for challenging low dose pre-filled syringe products such as intravitreal injection drugs.

Designed to:

  • Optimize patient safety
  • Ensure dose accuracy
  • Provide a best-in-class user experience
  • Accelerate development and market timelines
  • Optimise the total cost of ownership

Characteristics

0.5ml Luer Lock Silicone oil-free syringe

We know the challenges you face in developing drug products for ophthalmic delivery. You need a primary container that ensures dose accuracy, assures patient safety, minimizes infection risk and any potential of contamination to the eye. All aspects of the combined formulation and device must be integrated precisely to create a better experience for clinicians and patients. At the same time, you need a flexible solution that is straightforward to develop, shortening your time-to-market.

Optimized for patient safety

  • Eliminates the need of silicone oil in the syringe system, helping to prevent silicone oil to be injected to patients which is known to cause silicone oil droplet formation in their eyes
  • Inject high volume and high viscous formulations, and compatibility with certain commercial injection devices
  • Enables your drug product to fulfil the USP <789> Particulate Matter in Ophthalmic Solutions

Ensuring dose accuracy

  • Clear dose mark for dose confirmation – enables consistent injection of full volume
  • Tight dimensional tolerance - polymer molding technology provides tight dimensional tolerance for accurate dosing
  • Easy-to-use grip – syringe design and ergonomic finger grip ensures a firm hold on the device reducing handling issues and risk

Enhanced user experience

  • provides consistent and predictable break-loose and glide forces
  • Finger grip - with ergonomic design and backstop function
  • Easy grip twist-off tip cap and integrated Luer Lock - for secure needle connection in accordance with ISO 80369-7

Smooth development and commercialization

  • Technical support – for a smooth fill and finish integration with our established relationship with major CMOs and filling equipment suppliers
  • Documentation support – technical reports, certificates, and regulatory documents at each phase of your development project

Optimized total cost of ownership

  • Tight dimensional tolerance and low residual volume – enable you to minimize overfill and optimize your manufacturing cost
  • High quality product and service – support smooth development and commercialization of your product and hence optimize your project cost

Preparation


General Specification

PLAJEX™


Specification Description
Syringe barrel material Cyclo Olefin Polymer (COP)
Syringe size 2.25 ml Reference to ISO 11040-6: 20192
Syringe barrel lubrication None: Silicone oil-free
Dose mark Ink-printed dose mark
Luer lock Integrated Luer Lock tip
ISO 80369-7 compliant
Flange shape Cut flange
Reference to ISO 11040-6: 2019
Twist-off tip cap
  • Rubber component
  • Rigid component
Chlorobutyl rubber (CIIR)
Polypropylene
Plunger stopper i-coating™ stopper
Reference to ISO 11040-5: 2012
Chloro butyl rubber (CIIR) with silicone resin coating
Packaging Barrel: 10 x 10 Nest/Tub format (100 syringes per tub)
Plunger stopper: Double Tyvek® bag or Rapid Transfer Port bag
Sterilization Barrel: Autoclave (Steam)
Plunger stopper: Autoclave (Steam)
Plunger rod Polypropylene
Finger grip Finger grip extension with backstop function,
Acrylonitrile Butadiene Styrene (ABS) polymer

Global Solutions

Please note that some products may not be available in all regions, check with your local TERUMO Pharmaceuticals Solutions contact for details.



Let’s Find Your Best Solution

Innovation and creativity are central to Terumo Pharmaceutical Solutions’ value proposition. Our expert teams lead the industry in developing and manufacturing advanced, high-performing infusion and injection technologies for all parenteral applications.


Downloads

Relevant product information
Terumo - PLAJEX Ophthalmic.pdf

Let’s Find Your Best Solution

Innovation and creativity are central to Terumo Pharmaceutical Solutions’ value proposition. Our expert teams lead the industry in developing and manufacturing advanced, high-performing infusion and injection technologies for all parenteral applications.

Contact Us