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Laminated Rubber Stoppers

Design of our components has been developed in a way to achieve highest standards in product functionality, right fit with containers securing container-closure integrity of the system.

Laminated rubber stoppers with superior properties for any application

The FluroTec® laminated on the drug contact area prevents drug interaction and provides excellent stability. In addition, the film provides a high level of adsorption resistance and other characteristics necessary in drug formulations. This makes this product suitable for a wide range of applications, including liquid and powder formulations, lyophilized formulations and infusion solutions.

Characteristics

  • Low Adsorption
  • Chemical Inactivity
  • Enhanced Drug/Closure Compatibility
  • Gas Permeation Resistance
  • Low moisture absorption
  • Lubricity for Excellent

Applications

  • Liquid preparations
  • Powdered preparations
  • Lyophilization preparations
  • Infusion preparations

Handling and storage recommendations

  • DAIKYO RSV®
    (Ready to Sterilize Validated)
  • DAIKYO RUV®
    (Ready to Use Validated)

Selected materials for high quality products

To achieve global standards of safety and security, we are particularly selective regarding the materials we use, carefully selecting the best materials for each application, and using the best formulations to deliver products of the highest quality.

Rubber stoppers for vials

D21-7S

  • Chlorinated butyl rubber
  • Low elution of organic and metal ions
  • Excellent coring resistance

D777-1

  • Butyl rubber
  • Low moisture content
  • Low moisture adsorption

Pistons and nozzle caps

D21-7H & D21-7HW

  • Chlorinated butyl rubber
  • Improved BLE and sealability
  • Low leaching, low volatile matter levels
  • Zinc and BHT-free
  • For needle shields (syringe with needle)

D7-4

  • Ethylene Propylene Diene Rubber (EPDM)
  • Ethylene oxide gas (ETO) sterilizable and gas permeable
  • Can be steam or electron beam sterilized
  • Zinc-free

High level of quality control combined with automation in ISO clean room manufacturing environment reduces risk for our customers.

Daikyo products are manufactured in a clean room with strictly controlled levels of cleanliness. To prevent the risk of contamination by bacteria or foreign substances and guarantee quality, many processes are automated. In addition to JP,EP,USP, we have established strict shipment criteria and a quality control system that conforms to GMP standards.

OUR BRANDS

DAIKYO RSV®

Validated WFI washing process with regulatory filings in respective regions allows our customers to reduce operational footprint of washing at respective sites.

Full DMF regulatory support at FDA and Health Canada supports global operations of our customers. The range of regulator support in China is instantly expanding.

DAIKYO RUV®

Autoclave sterilization in our ISO 5 clean room

Full DMF regulatory support at FDA and Health Canada supports global operations of our customers. The range of regulator support in China is instantly expanding.

DAIKYO D SIGMA

Daikyo’s superior quality

0.01mm² Vision inspection specification
100% automated verification of critical function dimensions
Includes ISO8871-3 visible particulate testing
Tighter AQL

ISO Clean room environment suitable for manufacturing pharmaceutical and medical packaging

We conduct rigorous manufacturing and quality control to fulfill our responsibilities as a primary container manufacturer in direct contact with pharmaceutical products.

Three-stage washing process to clean the rubber stoppers.

We use our own RO water and WFI in our ISO 7 clean room. The cleaning is performed over three stages: pre-washing, main-washing and the final-rinsing.

Pre-washing

Main-washing

  • Alkaline treatment
  • Acid neutralization
  • WFI washing

Final-rinsing

  • Shower washing
  • Drying

Vision inspection that can detect particles smaller than 0.05mm²

100% vision inspection to remove any foreign matter measuring 0.05mm² or more.

Daikyo RUV®s undergo in-house autoclave sterilization

We conduct autoclave sterilization via a proprietary ISO 5 standard process. Sterility is assured by parametric release.

Compounding & Mixing

ISO Class 7 or 8
Clean
Room

  • Pre-forming
  • Molding
  • RB2-coating
  • Sheet inspection
  • Trimming

ISO Class 7
Clean Room

  • Washing & Drying
  • Final Appearance Test
  • Packaging

ISO Class 5
Clean
Room

  • Autoclave sterilization

Packing

Daikyo RSV🄬 is registered or trademarks of DAIKYO SEIKO,LTD. in the United states and other jurisdiction.
Daikyo RUV🄬 is registered or trademarks of DAIKYO SEIKO,LTD. in the United states and other jurisdiction.

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