Superior Performance Characteristics Lineup

Superior Performance Characteristics Lineup

About Flurotec Closures

Daikyo Flurotec applied to the drug contact side of pharmaceutical closures greatly reduces interaction between the drug and the closure. Laminations also provide excellent sorption resistance properties. Flurotec closures provide outstanding performance for a range of applications, including lyophilization drugs, infusion products, and liquid and powdered drugs.

CHARACTERISTICS

  • Low Adsorption
  • Chemical Inactivity
  • Enhanced Drug/Closure Compatibility
  • Gas Permeation Resistance
  • Low moisture absorption
  • Lubricity for Excellent Machinability (eliminates closure sticking and clumping)

APPLICATIONS

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

HANDLING and STORAGE RECOMMENDATIONS

  • Open in dust and static free-area (clean room) only, when taking out the contents from inside container.
  • Do not expose the contents to direct sunlight and intense ultraviolet rays.

DAIKYO RSV (Ready to Sterilize Validated)

Pharmaceutical manufacturers choosing highly-valued DAIKYO RSV (Ready to Sterilize Validated)
components can streamline their operations by eliminating many of the processes related to closure preparation, so they can shorten cycle times and reduce costs.
Daikyo washes the components in WFI and packages the washed products in a STERIlizableBAG for delivery. The durable bag is designed to stand up to high-pressure steam sterilization.
Before products are shipped, Daikyo performs all necessary tests of endotoxin, bioburden and particulate matter in addition to regular compendial tests.

PRODUCT OUTLINE

  • Validated processes from washing to inspection.
  • Pre-forming through packaging performed in a cleanroom.
  • 100% automated vision inspection ensures a high level of foreign matter removal.
  • Drug Master File with FDA and Health Canada (describes processes from washing to packaging).

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