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Shafted Screw Assemblies

Pharmaceutical-Grade Helical Screw Assembly

Pharmaceutical-Grade Helical Screw Assembly

316L electropolished assemblies (Ra ≤0.4μm). Documentation packages meet FDA 21 CFR Part 11.
Price:Custom PricingCustomized
Pharmaceutical-Grade Helical Screw Assembly
Product Details

Pharmaceutical-Grade Helical Screw Assembly

Product Overview

Jiahe Conveying's Pharmaceutical-Grade Helical Screw Assembly is a precision-engineered conveying solution designed specifically for hygienic pharmaceutical manufacturing processes. Our cGMP-compliant screw assemblies ensure contamination-free material transfer while meeting the stringent requirements of pharmaceutical production environments.

Technical Specifications

ParameterSpecificationCompliance Standard
Material316L/316Ti Stainless SteelUSP <88> Class VI
Surface FinishRa ≤ 0.4μm (Electropolished)ASTM B912
Joint DesignContinuous Weld/Sanitary ClampASME BPE-2019
Shaft Diameter38-200mmISO 286-2
Flight Thickness3-10mmDIN 11850
CleanlinessATP ≤ 5 RLUISO 14644-1

Critical Design Features

1. Hygienic Construction

  • Fully welded continuous helix with radiused corners

  • Dead-space free design (FDA 21 CFR Part 11 compliant)

  • Self-draining geometry per EHEDG guidelines

2. Material Integrity

  • Certified 316L stainless steel with material traceability

  • Passivated surfaces (ASTM A967)

  • Non-toxic coatings available

3. Sanitary Performance

  • CIP/SIP capable designs

  • Sterilizable surfaces (validatable to 150°C)

  • Particle-free operation

Pharmaceutical Applications

API Processing

  • Powder conveying systems

  • Granulation equipment

  • Blending operations

Formulation Systems

  • Tablet press feeders

  • Capsule filling lines

  • Coating applications

Biopharma

  • Buffer preparation

  • Cell culture media handling

  • Lyophilized product transfer

Quality Documentation

  • Material Certificates (EN 10204 3.1/3.2)

  • Surface Roughness Reports

  • Welding Documentation (PQR/WPQ)

  • Cleanliness Validation

  • FDA Drug Master File (available upon request)

Customization Options

  • ATEX-compliant designs

  • Isolator-compatible configurations

  • Integrated temperature control

  • Special flight geometries

  • Validation support packages

Why Choose Our Pharmaceutical Screw Assemblies?

Full cGMP compliance documentation
Proven designs for containment applications
Reduced contamination risk through superior engineering
Technical support for validation processes

Contact our pharmaceutical engineering team for sterile conveying solutions!

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