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PLAJEX™ and K-Pack® II Needle

PLAJEX™ Ready-to-Fill Polymer Syringe and
K-Pack® II Needle

PLAJEX™ Ready-to-Fill Polymer Syringe and K-Pack® II Needle

Description

PLAJEX™ Ready-to-Fill Polymer Syringe and K-Pack® II Needle

PLAJEX™ Ready-to-Fill Polymer Syringes and K-Pack® II Needles offer aesthetics partners a durable Cyclo Olefin Polymer (COP) syringe ready to be combined with Extra-Thin and Ultra-Thin Wall needles targeting at a more comfortable administration of today’s aesthetic formulations1.

Characterstics

Ready to Fill, Ready for Patient Comfort

Integrating an ISO 80369-7 compliant1 Luer Lock with a robust polymer syringe, PLAJEX™ solutions come nested and sterilized, ready for filling and finishing. Offering excellent strength and clarity, Terumo Pharmaceutical Solutions’ proprietary molding process and advance materials result in fewer possible defects.

PLAJEX™ Pre-Fillable Syringes with Luer Lock offer the needle compatibility and quality needed to meet parenteral delivery challenges.

Unlocking therapeutic potential

  • Carefully crafted Luer Lock mechanism provides a precise and secure connection according to ISO 80369-72.
  • Advanced Cyclo Olefin Polymer (COP) syringe provides excellent strength and clarity

Engineered for automated manufacturing environments

  • Less fragile compared with glass
  • COP eliminates glass particle contamination sources
  • Steam sterilized, syringes are nested and ready for filling and finishing in controlled environments

Regulatory and Quality Aspects

PLAJEX™

  • Compatible with ISO 80369-7 compliant devices
  • Steam sterilized, syringes are nested and ready for filling and finishing in controlled environments
  • High break resistance

High break resistance

  • Color-coded, tamper evident labels with 2D-barcode
  • Designed for procedure tray kitting
  • Ready for full 360° camera inspection for quality and inventory control
  • Sterility assurance (at least 10-6 (EN 556-1))

General Specification

PLAJEX™


Specification Description
Syringe barrel material Cyclo Olefin Polymer (COP)
Syringe size 1 ml long, 2.25 ml ISO 11040-6 compliant3
Syringe barrel lubrication Silicone Oil Optional: 1 ml long silicone oil-free
Luer Lock Integrated moulded Luer Lock ISO 80369-7 compliant
Twist-off tip cap
- Rubber component
- Rigid component

Chlorobutyl rubber (CIIR)
Polypropylene
Flange shape Cut flange
Reference to ISO 11040-6
Plunger stopper Chlorobutyl rubber (CIIR) Reference to ISO 11040-5
Optional: 1ml long i-coatingTM (silicone resin coating)
Packaging Barrel: 10 x 10 Nest/Tub format (100 syringes per tub)
Plunger stopper: Double Tyvek® bag
Optional: 1 ml long i-coating™ stopper in Rapid Transfer Port bag
Sterilization Barrel: Autoclave (Steam)
Plunger stopper: Autoclave (Steam)
Plunger rod Polypropylene
Optional Finger grip extension (Backstop)

K-Pack® II Needle


Specification Description
Needle Point T-SharpTM Triple-bevel lancet point
Cannulae Stainless steel X5CrNi 18-10
Hub Polypropylene
Individual packaging Rigid polypropylene
Sterilization Ethylene Oxide

Global Solutions


PLAJEX™ Syringes with Luer Lock 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, check with your local TERUMO Pharmaceuticals Solutions contact for details.

Downloads

Relevant product information
One solution, One expert Datasheet

References

1 2 3 Data on file

Let’s Find Your Aesthetics 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.

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