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PHARMACEUTICAL

PLAJEX™ 2.25 ml with Tapered Needle
for Biotech Formulations

PLAJEX™ 2.25 ml with Tapered Needle
for Biotech Formulations

Description

PLAJEX™ Ready-to-Fill Polymer Syringe for Biotech Formulations

PLAJEX™ 2.25 ml with tapered needle provides pharmaceutical manufacturers with a next-generation primary container platform solution for complex biotech formulation.

Characteristics

Silicone oil-free Syringe with Tapered Needle for Biotech Formulations

Integrating Terumo’s proprietary Tapered Needle technology, PLAJEX™ 2.25ml Tapered Needle comes nested and sterilized, ready for filling and finishing today’s most challenging high-viscosity biotech formulations. Offering excellent strength and clarity, and Terumo’s proprietary i-coating™ on the stopper, the silicone oil-free syringe system is designed to preserve and deliver sensitive biotech formulations1

Engineered for smooth drug product integration throughout development and manufacturing, PLAJEX™ for biotech solutions help manage project risk and accelerate time to market for challenging PFS products.

Tapered Needle

Tapered needle is a conically shaped needle enabled by Terumo’s proprietary needle cannula manufacturing technology. It has a smaller diameter at the tip (patient side) and larger diameter at the bottom (drug side) to improve injectability while keeping a needle size of only 29G at the point of patient contact2.

i-coating™

i-coating™ is Terumo’s proprietary coating which is applied to the surface of the stopper and bonded to the substrate. It is not a laminate and it remains flexible with the substrate. i-coating™ provides a silicone oil-free container for drug products requiring lower reactive surfaces. This thin surface coating provides a consistent and predictable gliding force for the syringe and stopper container closure1.

Next generation solution for challenging biotech formulations

  • Keep sensitive drugs stable
  • Inject high volume and high viscous formulations, and compatibility with certain commercial injection devices
  • Smooth filling process integration
  • Manufacturing process development support
  • With Terumo’s contract manufacturing service or with our industry network
  • Regulatory and documentation support

Preparation


General Specifications

PLAJEX™


Specification Description
Syringe barrel material Cyclo Olefin Polymer (COP)
Syringe size 2.25 ml Reference to ISO 11040-6: 20192
Needle options 29G 1/2” Tapered needle
27G 1/2” Thin Wall needle (straight)
Syringe barrel lubrication Silicone oil-free
Needle shield Rigid needle shield
Chloro butyl-diene blend polymer, Polypropylene
Flange shape Cut flange
Reference to ISO 11040-6: 2019
Barrel packaging 10 x 10 Nest/Tub format (100 syringes per tub)
Barrel sterilization Autoclave (Steam)
Reference to EN ISO 17665-1: 2006
Plunger stopper i-coating™ stopper
Reference to ISO 11040-5: 2012
Chloro butyl rubber (CIIR) with silicone resin coating
Stopper packaging Double Tyvek® bag or Rapid Transfer Port bag
Stopper sterilization Autoclave (Steam)
Reference to EN ISO 17665-1: 2006
Plunger rod Polypropylene

Global Solutions

PLAJEX™ 2.25 ml with Tapered Needles are available to drug product manufacturers globally. For more information about product availability, specifications, and applicable standards, download our data sheet or contact your Terumo representative today.

Please note that some products may not be available in all regions, reach out to your local Terumo Medical Care Solutions - Pharmaceutical Solutions Division contact for details. All brand names are trademarks or registered trademarks owned by TERUMO CORPORATION, its affiliates, or unrelated third parties.

Downloads

Relevant product information
Terumo Biotech Brochure

References

1. Functional Evaluation and Characterization of a Newly Developed Silicone Oil-Free Prefillable Syringe System, Yoshino et al. (2014) J Pharm Sci, 103, 1520-1528

2. Advantages of a tapered needle for use in pre-filled biopharmaceutical products, Terumo internal study (March 2019)

Let’s Find Your Best Solution

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

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