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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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