Tubular Glass

In cooperation with Taisei Kako, Japan, Gerresheimer offers a new and innovative drug delivery system made of COP (cyclic olefin polymer) to the worldwide market.

ClearJect™ - high end prefillable plastic syringe systems made from COP

Along with newly developed drugs, the requirements towards prefillable syringes are changing dramatically. As classic glass syringes can have some restrictions when it comes to highly demanding pharmaceutical or biopharmaceutical drug products, developers are in search of alternatives. ClearJect™ syringes were developed to meet these requirements.

ClearJect™ syringes are made from COP (cyclic olefin polymer) and provide features new to the world of prefillable syringe systems.

Basic features

• Glass like transparency
• Tighter dimensional tolerances compared to glass
• High break resistance
• Inert surface

ClearJect™ syringe product portfolio

• 1.0 ml Luerlock and Luercone syringes
• 2.25 ml Luerlock and Luercone syringes
• 5.0 ml Luerlock and Luercone syringes
• Delivered ready-to-use as TasPack™ (Taisei Kako Advanced Sterile Packaging)
• Gamma sterilized
• Standardized tub/nest packaging for optimum processing at filling lines
• Compliant with Ph. Eur.,USP and JP

Plunger stoppers and tip caps

• Plunger stoppers made from chlorobutyl rubber formulation (gamma resistant)
• Compliant with Ph. Eur.,USP and JP
• Supplier Sumitomo Rubber Industries Ltd.

Plunger rods

• Made from PP or PS

Fingergrips and backstops

• Made from PP

ClearJect™ manufacturing and processing

• Japanese production quality in accordance to cGMP requirements
• Production line under ISO 8 clean room conditions
• Fully automated manufacturing - 100% camera controlled
• 100% on-line controlled siliconization process
• Packaging under clean room conditions

Available certificates and documents

• ISO 9001 and ISO 14001 certification
• Production in accordance to ISO 13485
• Product specifications
  
  • ClearJect™ syringes
  • elastomer components
  • plunger rods
• In-house monograph for COP material
• Extractable study for COP material
• DMF for ClearJect™ and TasPack™ material and processing
• DMF for elastomer components
• Formulation characteristics for elastomer components
• Validated process regarding sterilization, shelf life, transport
• Technical Bulletin
• Other studies on request

Advantages regarding drug interaction

• Reduced oxygen transmission compared to other plastics
• High pH tolerance, reduced pH-shift
• Little surface activity due to low hygroscopic properties
• No metal ion leakage
• Tungsten free
• Low extractables and leachables

Sales and support
ClearJect™ TasPack™ prefillable syringes are manufactured by Taisei Kako Co., Ltd., Japan. Gerresheimer Bünde, Germany is responsible for technical support and sales in EU and the Americas.
^{The description ClearJect™Taspack™ for COP-based syringes is a trademark owned by Taisei Kako Co. Ltd, who manufactures these products.}

For further information please contact our technical support team.
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