Hershey DD5 Automated Cap-Removal Medical Centrifuge

Overview

The Hershey DD5 Automated Cap-Removal Medical Centrifuge is a CE-marked, ISO 13485-certified benchtop centrifuge engineered specifically for high-throughput clinical laboratories processing vacuum blood collection tubes. It integrates mechanical cap removal with precise low-speed centrifugation (up to 4000 rpm, 3080 ×g) to automate pre-analytical sample preparation—reducing manual handling, minimizing biosafety risk, and improving workflow consistency. Its core function relies on controlled rotor dynamics and synchronized pneumatic-mechanical actuation to achieve ≥97% cap removal success across two standard tube lengths (75 mm and 100 mm). The system operates on the principle of differential inertia and calibrated torque transfer, ensuring reliable cap detachment without tube deformation or sample splashing. Designed for compliance with IVD regulatory frameworks, the DD5 supports traceable, auditable sample processing under GLP-aligned laboratory practices.

Key Features

• Automated cap removal mechanism compatible with 75 mm and 100 mm vacuum blood collection tubes; validated cap removal rate ≥97% per cycle.
• Brushless AC/DC inverter-driven motor with high-torque output and microprocessor-based speed regulation ensures stable rotational control and low acoustic emission (≤60 dB[A]).
• Environmentally compliant refrigeration system using R404a refrigerant and non-CFC compressor enables active temperature management from −20 °C to +40 °C, including pre-cooling, standby cooling, and automatic defrost modes.
• Triple-stage damping system combined with precision-balanced rotor assembly suppresses vibration transmission, prevents red blood cell resuspension, and maintains specimen integrity during deceleration.
• TFT-LCD color interface with bilingual (and multilingual) firmware supports real-time display of setpoints and actual values—including RCF, elapsed time, temperature, and speed ramp curves—with on-the-fly parameter modification without interrupting runs.
• Electromechanical door lock with silent engagement provides Class II biosafety compliance; door remains securely latched until full deceleration and pressure equalization are confirmed.
• Full 304 stainless steel centrifuge chamber, powder-coated steel housing, and triple-layer reinforced front panel meet IEC 61010-2-020 safety requirements for medical electrical equipment.

Sample Compatibility & Compliance

The DD5 accepts standard 5 mL vacuum blood collection tubes (EDTA, heparin, serum separator) arranged in fixed-angle rotors supporting either 48 or 76 positions. Tube compatibility has been verified against CLSI GP44-A4 specifications for centrifugal separation of whole blood into plasma/serum fractions. All mechanical and thermal performance parameters comply with ISO 13485:2016 quality management system requirements for in vitro diagnostic devices. The unit carries CFDA registration as a Class II medical device (registration number available upon request) and conforms to electromagnetic compatibility standards per IEC 61326-1. Routine operation satisfies pre-analytical requirements outlined in CAP Laboratory Accreditation Program checklists and aligns with WHO Good Clinical Laboratory Practice (GCLP) guidelines.

Software & Data Management

The embedded control firmware logs timestamped run records—including rotor ID, speed profile, temperature history, acceleration/deceleration settings, and error flags—for audit trail generation. While the DD5 does not feature network connectivity or remote data export, its local storage retains up to 20 user-defined protocols with editable parameters (time, speed, temperature, ramp/dwell profiles). All displays and prompts adhere to FDA 21 CFR Part 11 principles of data integrity: each protocol execution generates an immutable record with operator ID (via optional login module), start/stop timestamps, and deviation alerts. Firmware updates are performed via secure USB interface with cryptographic signature verification to ensure version control and regulatory traceability.

Applications

• Routine serum/plasma separation in hospital core labs and reference testing facilities.
• Pre-analytical automation for high-volume immunoassay, coagulation, and hematology workflows.
• Blood bank sample preparation where consistent hematocrit control and minimal platelet activation are critical.
• Clinical trial biobanking operations requiring standardized, documented centrifugation conditions per SOPs.
• Point-of-care satellite labs operating under limited technical staffing due to intuitive interface and reduced manual intervention.

FAQ

What tube sizes does the DD5 support for automated cap removal?
The DD5 is validated for 75 mm and 100 mm vacuum blood collection tubes with standard diameters (13 mm or 16 mm). Cap removal is optimized for tubes sealed with rubber stoppers meeting ISO 6710 specifications.
Does the DD5 require external calibration or annual certification?
No external recalibration is required under normal use. However, users must perform routine verification of speed accuracy (±50 rpm tolerance), temperature uniformity (±2 °C across chamber), and cap removal efficacy (≥97%) as part of internal quality control per ISO 15189 Clause 5.3.
Can the DD5 operate continuously across multiple shifts?
Yes—the system supports uninterrupted operation with thermal management active during standby mode. Duty cycle limitations are governed by ambient temperature (max 32 °C) and ventilation clearance (≥10 cm on all sides).
Is rotor balancing mandatory before each run?
Yes. The DD5 employs dynamic imbalance detection but does not compensate for gross mass asymmetry. Tubes must be loaded symmetrically in accordance with rotor loading diagrams supplied in the operator manual.
What documentation accompanies the DD5 for regulatory submission?
Each unit ships with a Declaration of Conformity, ISO 13485 certificate, CFDA registration documentation, factory test report (including speed/temperature validation data), and full English-language user manual compliant with IEC 62366-1 usability engineering requirements.