Reducer

Product overview
Cleanroom molded polypropylene (PP) reducer designed as a single-use fluid-path component for biotechnology and pharmaceutical processes. Manufactured in controlled cleanroom conditions within an ISO 9001 quality management facility to support aseptic fluid connections and tubing size transitions.

Standard sizes available

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

Applications

• Single-use assemblies for bioprocessing and pharmaceutical manufacturing
• Connection between different tubing diameters in disposable fluid-path systems
• Use in cleanroom and aseptic environments

Certifications

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

Advantages

• Aseptic connection suitable for single-use systems
• Facilitates process efficiency by enabling quick tubing size changes
• Single-use design reduces cleaning and validation needs

Regulatory compliance declaration

• REACH legislation compliance
• RoHS conformity
• Free from TSE/BSE contaminants
• Free from melamine, phthalates and Bisphenol A

Technical specification

• Material of construction (MOC): Polypropylene (PP)
• Sterilization: Autoclave up to 135°C for a maximum of 30 minutes; gamma irradiation up to 50 kGy
• Storage: Keep in original packaging; store in a cool, dry environment away from direct sunlight and aggressive chemicals. Recommended warehouse conditions: 5°C–40°C

Product characteristics / Technical specifications

• Product name: Cleanroom molded PP reducer
• Manufacturing environment: Produced in cleanrooms within an ISO 9001 facility
• Intended use: Single-use fluid path component for biotech and pharmaceutical industries
• Available sizes: 3/8" × 1/4", 3/8" × 1/2", 3/8" × 3/4", 1/2" × 1/4"
• Regulatory & testing: FDA 21 CFR 177.1520; USP biological reactivity tests (In Vivo & In Vitro); extractables evaluated