ENV connector

for biopharmaceuticalfor the pharmaceutical industrystraight

Product overview
Clean Room molded PP straight connector designed for single-use fluid path applications in biotechnology and pharmaceutical manufacturing. Manufactured in cleanrooms in a facility operating an ISO 9001 quality management system. Suitable for aseptic single-use assemblies where extractables and biocompatibility are critical.

Standard Size Available

• 3/4" X 3/4"
• 1/4" X 1/4"
• 3/8" X 3/8"
• 1/2" X 1/2"

Applications

• Single-use assembly and tubing connections
• Bioprocessing and pharmaceutical fluid transfer
• Disposable fluid path components in GMP environments

Certifications

• FDA 21 CFR 177.1520 (food contact test)
• USP <88> Biological reactivity tests, In Vivo
• USP <87> Biological reactivity tests, In Vitro
• Extractables study performed

Advantage

• Aseptic connection for single-use systems
• Improves process efficiency by eliminating cleaning and sterilization cycles
• Designed for compatibility with common tubing

Regulatory compliance Declaration

• REACH
• RoHS
• TSE/BSE
• Melamine
• Phthalates
• Bisphenol A

Technical Specification

• MOC: Polypropylene
• Sterilization: Autoclave up to 135°C for max 30 minutes; Gamma irradiation up to 50 KGy
• Storage: Keep in original packaging in a cool, dry place away from direct sunlight and aggressive chemicals; recommended warehouse conditions 5°C–40°C

caractéristiques / spécifications techniques

• Material of Construction (MOC): Polypropylene
• Sterilization methods: Autoclave ≤135°C (≤30 minutes); Gamma irradiation ≤50 KGy
• Storage and handling: Store in original packaging; avoid mechanical stress and contaminants
• Available sizes: 3/4" X 3/4", 1/4" X 1/4", 3/8" X 3/8", 1/2" X 1/2"
• Intended use: Single-use fluid path component for biotechnology and pharmaceutical industries
• Manufacturing: Produced in cleanrooms; facility certified to ISO 9001
• Regulatory & safety: Conforms to listed FDA and USP tests; subject to extractables evaluation