High-Polish Sanitary Pump for Pharma Use

Product Overview

The High-Polish Sanitary Pump for Pharma Use sets the benchmark for hygienic fluid transfer in pharmaceutical manufacturing, combining exceptional precision with uncompromising cleanliness standards. Engineered to meet current GMP standards (2025) and ASME BPE requirements, this progressive cavity pump features internal surfaces with an ultra-smooth Ra 1.6-3.2μm polished finish that eliminates particle entrapment and facilitates complete cleaning. Constructed entirely from 316L stainless steel with pharmaceutical-grade elastomers (EPDM, FKM), it ensures absolute product purity with zero risk of contamination. The pump delivers a flow rate range of 20-350 L/h with consistent pressure performance (up to 0.6MPa), making it ideal for transferring sensitive pharmaceutical formulations, active pharmaceutical ingredients (APIs), and sterile solutions. Its unique open pin joint design uses the pumped product for lubrication, eliminating cross-contamination risks from external lubricants – a critical feature for aseptic processing environments.

Product Features

Ultra-Hygienic Construction

Ra 1.6μm electropolished internal surfaces (Ra 0.8μm option available)

Crevice-free design with continuous welds (≤0.3mm weld bead)

Self-draining configuration with 100% drainability under gravity

Smooth product contact surfaces without threads or recesses

Pharmaceutical-Grade Performance

Pulse-free flow ensuring gentle product handling

High volumetric efficiency (>95%) across entire flow range

Shear-sensitive design for fragile formulations

Minimal product hold-up volume (<50mL) for complete product recovery

Advanced Sterilization Capability

Fully compatible with CIP (Clean-in-Place) and SIP (Sterilize-in-Place)

Rated for 134°C steam sterilization (30 minutes at 134°C, 0.2MPa)

Pressure decay testing capability for leak verification

Thermally stable seals maintaining integrity through sterilization cycles

Reliable & Easy Maintenance

Tool-free disassembly for quick cleaning and inspection

Modular design with interchangeable rotors and stators

Predictive maintenance sensors monitoring seal integrity

Stainless steel IP69K-rated motor housing for washdown environments

Applications

Aseptic Pharmaceutical Production

API transfer between processing stages

Sterile formulation preparation

Vaccine and biologic product handling

Parenteral solution transfer (injectables)

Biopharmaceutical Processing

Cell culture media transfer

Fermentation broth handling

Purification process steps

Buffer and reagent distribution

Specialty Pharmaceutical Applications

Ophthalmic solution transfer

Topical cream and ointment pumping

Controlled-release formulation handling

Radio-pharmaceutical transfer systems

The pump's ability to handle both Newtonian and non-Newtonian fluids with viscosities up to 10,000 cP makes it versatile across multiple pharmaceutical processing stages, from raw material handling to final product filling.

FAQ

What polishing standards does it meet?

The pump exceeds ASME BPE 2025 surface finish requirements with an internal polish of Ra 1.6μm as standard, with Ra 0.8μm available for critical applications requiring ultra-smooth surfaces.

How is cross-contamination prevented?

The unique open pin joint design uses the pumped product for lubrication instead of external oils or greases. All elastomers are pharmaceutical-grade and meet USP Class VI requirements for biological safety.

What validation documentation is provided?

Each pump includes:

Material certification (3.1.B test reports for all metallic components)

Surface finish verification reports

CIP/SIP validation protocols

FAT (Factory Acceptance Test) documentation

Design qualification (DQ) and installation qualification (IQ) templates