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Biopharmaceutical connector
for the pharmaceutical industryautoclavableY

Biopharmaceutical connector - Ami Polymer Pvt Ltd - for the pharmaceutical industry / autoclavable / Y
Biopharmaceutical connector - Ami Polymer Pvt Ltd - for the pharmaceutical industry / autoclavable / Y
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Characteristics

Applications
for biopharmaceutical, for the pharmaceutical industry
Other characteristics
polypropylene, autoclavable, disposable, Y

Description

Product Overview
  • Cleanroom molded PP Y-connector designed for single-use fluid path assemblies in biotechnology and pharmaceutical applications. Manufactured in cleanroom conditions within an ISO 9001 quality system.


Standard Size Available
  • 3/4" X 3/4" X 3/4"
  • 1/2" X 1/2" X 1/2"
  • 3/8" X 3/8" X 3/8"
  • 1/4" X 1/4" X 1/4"


Applications
  • Integration in single-use assemblies and manifolds.
  • Fitting solution for bioprocessing and pharmaceutical fluid handling.
  • Tubing connections for sterile fluid transfer.


Certifications / Tests
  • FDA 21 CFR 177.1520 (food-contact assessment)
  • USP 88 Biological reactivity tests, In Vivo
  • USP 87 Biological reactivity tests, In Vitro
  • Extractables study performed


Advantages
  • Aseptic connection for single-use workflows
  • Facilitates process efficiencies in disposable systems
  • Eliminates cleaning/sterilization between runs


Regulatory compliance Declaration
  • REACH
  • RoHS
  • TSE/BSE controls
  • Melamine screening
  • Phthalates screening
  • Bisphenol A screening


Technical Specification
  • Material of construction: Polypropylene (PP)
  • Sterilization compatibility: Autoclave up to 135°C for maximum 30 minutes; gamma irradiation up to 50 kGy
  • Manufacturing environment: Cleanroom production under ISO 9001 quality management
  • Storage: Keep in original packaging in a cool, dry place away from direct sunlight and aggressive chemicals. Recommended warehouse range: 5°C–40°C.


Characteristics / Technical specifications
  • Product type: Molded Y-connector for single-use fluid path
  • Intended use: Tubing connections in biotechnology and pharmaceutical single-use assemblies
  • Available sizes: 3/4" X 3/4" X 3/4", 1/2" X 1/2" X 1/2", 3/8" X 3/8" X 3/8", 1/4" X 1/4" X 1/4"
  • Regulatory/test coverage: FDA 21 CFR 177.1520, USP 88 (In Vivo), USP 87 (In Vitro), extractables assessment
  • Sterilization methods supported: Autoclave (≤135°C, max 30 min) and gamma irradiation (up to 50 kGy)
  • Storage recommendation: Store in original packaging, avoid stress and harsh chemicals; maintain 5°C–40°C when possible

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Single-Use Assemblies System

*Prices are pre-tax. They exclude delivery charges and customs duties and do not include additional charges for installation or activation options. Prices are indicative only and may vary by country, with changes to the cost of raw materials and exchange rates.