English Product Name

Overview

The Jihepu SPH-3432 Triple-Layer High-Capacity Orbital Shaker is an engineered solution for large-scale microbial culture, fermentation process development, and biopharmaceutical seed train expansion under controlled ambient or externally regulated temperature environments. Unlike water-bath shakers, the SPH-3432 operates as a non-thermostatic orbital platform system—designed for integration into dedicated climate-controlled rooms (e.g., ISO Class 7 cleanrooms or validated incubation suites) where precise air temperature uniformity is maintained independently. Its triple-layer architecture enables simultaneous handling of up to 450 × 500 mL Erlenmeyer flasks or 168 × 1000 mL vessels per run, supporting high-throughput strain screening, media optimization, and upstream process qualification in compliance with ICH Q5D and USP guidelines for cell culture scalability. The unit employs a single-axis eccentric drive mechanism—a patented mechanical architecture that eliminates phase drift between layers and ensures synchronous, low-vibration orbital motion (20–25 dB(A) noise level at 1 m distance), critical for long-duration aerobic cultivations requiring minimal shear stress.

Key Features

• Triple independent shaking platforms (each 1080 × 680 mm), rigidly mounted on a monolithic cast-iron frame reinforced with structural steel channels and angle iron—ensuring torsional rigidity under full-load dynamic conditions.
• PID microprocessor control with eight-segment programmable protocol: each segment allows independent setpoints for speed (50–250 rpm) and duration (1 min–500 h), enabling multi-phase growth curves (e.g., lag-phase acceleration → exponential-phase stabilization → stationary-phase deceleration).
• High-precision frequency regulation: ±1 rpm speed stability across full load range (0–450 kg), achieved via closed-loop encoder feedback and adaptive torque compensation from the brushless AC inverter motor (1.1 kW continuous rating).
• Dual-stage safety architecture: (1) Electrical—separate residual-current circuit breaker (30 mA trip threshold) and thermal-magnetic overload relay; (2) Operational—real-time RPM monitoring with dual-threshold overspeed alarm (audible buzzer + red LED strobe) and automatic shutdown if deviation exceeds ±3 rpm for >5 s.
• Soft-start circuitry limits inrush current and prevents flask contents splashing during startup; motor ramp-up follows logarithmic acceleration profile (0–250 rpm in 12 s), minimizing meniscus disruption in low-viscosity broth.
• Nonvolatile memory retains last-used parameters—including speed, timer, and program sequence—even after power interruption; “power-resume” function restarts paused protocols automatically upon grid recovery.

Sample Compatibility & Compliance

The SPH-3432 accommodates standard microbiological and bioprocess vessels including glass and PETG Erlenmeyer flasks (50–1000 mL), baffled culture bottles, and stainless-steel bioreactor seed bags (up to 2 L). Platform clamping systems support both universal rubber matting and custom aluminum flask holders (optional accessories). All structural components comply with ISO 9001:2015 manufacturing controls. While the shaker itself lacks integrated temperature regulation, its mechanical design meets ASTM E1249-18 requirements for orbital shaker performance verification when operated within validated environmental chambers. Documentation packages include Factory Acceptance Test (FAT) reports covering vibration spectrum analysis (FFT-accelerometer data), speed linearity calibration certificates, and electrical safety test records (dielectric withstand, insulation resistance).

Software & Data Management

The embedded controller provides local LCD interface only—no USB, Ethernet, or wireless connectivity. This intentional design minimizes cybersecurity exposure and aligns with GMP Annex 11 principles for legacy equipment in qualified production environments. All operational logs—including start/stop timestamps, actual vs. setpoint RPM traces (sampled at 1 Hz), and alarm event history—are stored in internal flash memory (10,000-event capacity) and exportable via RS-232 serial port to external SCADA or LIMS systems using Modbus RTU protocol. Audit trail functionality satisfies FDA 21 CFR Part 11 requirements for electronic records when paired with validated third-party data acquisition software.

Applications

• Biopharmaceutical upstream processing: inoculum expansion for CHO, HEK293, and microbial expression systems (E. coli, P. pastoris) prior to bioreactor transfer.
• Industrial enzyme production: high-density cultivation of filamentous fungi (Aspergillus, Trichoderma) under oxygen-limited but agitation-optimized conditions.
• Environmental microbiology: enrichment cultures for heterotrophic plate count (HPC) and coliform assays per EPA Method 1604.
• Vaccine development: adjuvant formulation mixing and antigen adsorption kinetics studies requiring consistent orbital shear profiles.
• Academic research: reproducible scaling of fermentation parameters from shake-flask to pilot bioreactor using the “constant power input per unit volume” correlation method (based on Rushton’s dimensionless number framework).

FAQ

Is the SPH-3432 suitable for use inside a CO₂ incubator?

No. The unit is not rated for humidified, CO₂-enriched atmospheres. It must be installed in dry, temperature-stabilized rooms (recommended ambient: 15–30°C, RH <70%).

Can the three platforms operate at different speeds simultaneously?

No. All platforms are mechanically coupled to a single drive shaft and operate synchronously at identical RPM.

What maintenance intervals are recommended for the drive system?

The sealed SKF deep-groove ball bearings require no lubrication for 20,000 hours of continuous operation. Annual inspection of belt tension (if equipped with optional timing belt upgrade) and fastener torque verification is advised.

Does the unit meet electromagnetic compatibility (EMC) standards for laboratory use?

Yes. It complies with EN 61326-1:2013 for laboratory equipment, with conducted emissions below Class B limits and immunity to 3 V/m RF fields (80 MHz–1 GHz).

Is validation documentation available for IQ/OQ protocols?

Yes. Jihepu provides a complete URS-aligned validation support package—including test scripts, blank forms, and acceptance criteria aligned with ASTM E2500-13 and EU GMP Annex 15—upon request.