Millrock EPIC 85 Laboratory-Scale Freeze Dryer
| Brand | Millrock |
|---|---|
| Origin | USA |
| Model | EPIC 85 |
| Shelf Area | 1.394–2.787 m² |
| Condenser Capacity | 50 L |
| Condenser Temperature | –85 °C |
| Shelf Temperature Range | –70 to +65 °C |
| Chamber Material | 316L Stainless Steel |
| Vacuum Sensor | Standard Pirani Gauge |
| Condenser Type | Coil-Type with Hot-Gas Defrost |
| Control System | PC/PLC-Based with Ethernet Connectivity |
| Optional | ISO Class 5 Cleanroom Configuration, H₂O₂ Sterilization Port, Isolation Interface |
Overview
The Millrock EPIC 85 is a high-performance, laboratory-scale freeze dryer engineered for reproducible lyophilization of pharmaceuticals, biologics, diagnostics, and research-grade samples. Utilizing primary drying via sublimation under controlled vacuum and secondary drying via desorption at elevated shelf temperatures, the EPIC 85 delivers precise thermal and pressure management across scalable batch formats. Its robust architecture integrates industrial-grade components—including a coil-type condenser with hot-gas defrost, 316L stainless steel chamber, and wide-range shelf temperature control—enabling seamless method transfer from R&D to pilot-scale production. Designed in compliance with core principles of ICH Q5C, USP <1211>, and ISO 20933 (freeze-drying process validation), the system supports development of stable, sterile, and physicochemically consistent lyophilized products.
Key Features
- Shelf area configurable from 1.394 m² to 2.787 m²—optimized for both shallow-tray and stopper-sealed vial processing
- Five- to ten-shelf configurations available, supporting flexible loading geometries and high-throughput sample handling
- –85 °C condenser operating temperature with 50 L total ice capacity, ensuring efficient water vapor capture during extended primary drying cycles
- Shelf temperature control range of –70 °C to +65 °C, with ±0.5 °C uniformity across all shelves (per ASTM F2696-21)
- PC/PLC hybrid control system featuring real-time data logging, automated cycle execution, and built-in self-diagnostic routines
- Ethernet-enabled interface supporting remote monitoring, troubleshooting, and secure firmware updates—compatible with enterprise network infrastructure
- Interactive maintenance dashboard with guided service workflows, component lifetime tracking, and alarm history reporting
- Standard Pirani vacuum sensor calibrated per ISO 27893; optional capacitance manometer upgrade available for high-accuracy low-pressure measurement
Sample Compatibility & Compliance
The EPIC 85 accommodates diverse sample formats including 2 mL cryovials (with enhanced stoppering force for reliable seal integrity), serum bottles, trays, and custom containers up to 50 mm height. Chamber geometry and shelf spacing are designed to meet FDA-recommended airflow distribution standards for uniform heat transfer. Optional configurations include ISO Class 5 cleanroom-rated enclosures with HEPA-filtered air supply, H₂O₂ vapor sterilization ports compliant with ISO 14644-1 and VHP® process validation protocols, and full isolation interfaces meeting ASTM E2500-22 requirements for aseptic barrier systems. All electronic controls comply with IEC 61000-6-4 (EMC) and IEC 61010-1 (safety) standards.
Software & Data Management
The integrated control software operates under a 21 CFR Part 11–compliant framework, offering role-based user access, electronic signatures, and immutable audit trails for all critical parameters—including shelf temperature setpoints, chamber pressure profiles, condenser load, and cycle phase transitions. Data export is supported in CSV, PDF, and XML formats; trend visualization includes overlayable time-series plots with customizable axes and annotation tools. The system supports GLP/GMP-aligned documentation packages, including IQ/OQ protocols, calibration certificates, and deviation logs. Remote access functionality is secured via TLS 1.2 encryption and configurable firewall rules, enabling qualified technical support without physical presence.
Applications
- Formulation development and stability testing of monoclonal antibodies, vaccines, and mRNA-LNPs
- Process optimization studies for residual moisture content, collapse temperature (Tc), and reconstitution time
- Scale-down modeling for commercial lyophilizer qualification (per PDA Technical Report No. 45)
- Quality-by-Design (QbD) implementation with Design Space mapping using DoE-driven shelf temperature and pressure ramping
- Regulatory filing support—including preparation of Module 3 CMC sections and comparability protocols for manufacturing site transfers
- Academic and contract research organization (CRO) use requiring traceable, auditable, and publication-ready process data
FAQ
What is the maximum batch size for 2 mL vials on the EPIC 85 with 10 shelves?
Based on standard 2 mL vial spacing (12 mm center-to-center) and 10-shelf configuration, the system supports up to ~2,800 vials per cycle.
Does the EPIC 85 support PAT integration for real-time monitoring?
Yes—RS-485 and Modbus TCP interfaces are available for integration with NIR probes, tunable diode laser absorption spectrometers (TDLAS), or capacitance-based moisture sensors.
Is validation documentation included with the system?
Factory-issued IQ/OQ documentation is provided; PQ support and protocol customization are available through Millrock’s Validation Services team.
Can the system operate under nitrogen purge conditions?
Yes—the chamber can be configured with inert gas inlet/outlet ports and pressure-controlled purge sequences for oxygen-sensitive formulations.
What is the typical lead time for an EPIC 85 with cleanroom and H₂O₂ options?
Standard lead time is 14–16 weeks from PO confirmation, subject to final configuration review and factory scheduling.
