AA OPTO Electronic MIS1650C Aseptic Freeze-Drying Isolator
| Brand | AA OPTO Electronic |
|---|---|
| Origin | China |
| Manufacturer Type | Authorized Distributor |
| Model | MIS1650C |
| Pricing | Upon Request |
Overview
The AA OPTO Electronic MIS1650C Aseptic Freeze-Drying Isolator is an engineered containment solution designed for sterility testing and aseptic processing of lyophilized pharmaceutical products under Grade A (ISO 5) conditions. It operates on the principle of positive-pressure unidirectional laminar airflow—compliant with Chinese Pharmacopoeia (ChP) Chapter 9204 and EU Annex 1 requirements—ensuring consistent air velocity (≥0.45 m/s ±20%), uniform particle removal, and minimized turbulence-induced cross-contamination. The isolator integrates vaporized hydrogen peroxide (VHP®) bio-decontamination via dry-steam flash-vaporization technology, eliminating condensation while achieving ≥6-log reduction of Geobacillus stearothermophilus biological indicators—validated per ISO 14644-3 and ISO/IEC 17025 protocols.
Key Features
- Positive-pressure vertical unidirectional airflow system with ≤0.15% velocity variation across the working area, ensuring ISO 5 air quality at all operational points.
- Integrated VHP generator utilizing flash-vaporization at controlled temperature and humidity setpoints; delivers uniform H₂O₂ concentration distribution (±5% CV) without surface condensation or filter saturation.
- Leak-tight construction validated to ≤0.5% vol/hr internal volume loss under 150 Pa differential pressure—tested per ISO 14644-7 Annex B using tracer gas (SF₆) decay methodology.
- Modular stainless steel 316L chamber with electropolished interior surfaces (Ra ≤ 0.4 µm), welded seams, and double-gasketed viewports meeting ASTM F2097 integrity standards.
- Touchscreen HMI with embedded PLC-based control architecture compliant with GAMP 5 Category 3 software classification and FDA 21 CFR Part 11 requirements—including audit trail, electronic signatures, role-based access control, and data integrity safeguards.
Sample Compatibility & Compliance
The MIS1650C accommodates standard freeze-dried vial formats (10–30 mL), stoppered syringes, and pre-filled cartridges during sterility testing workflows. Its glove ports (ISO 14644-7 Class 5 compatible) support ASTM D6327-compliant manipulator operation. All materials in contact with the process environment meet USP Class VI biocompatibility and ISO 10993-5 cytotoxicity requirements. System validation documentation supports compliance with EU GMP Annex 1 (2022), PIC/S PI 032-2, WHO TRS 986 Annex 2, and ICH Q5A(R2) for viral clearance verification environments.
Software & Data Management
The embedded control software provides full lifecycle data management: real-time logging of VHP cycle parameters (injection mass, dwell time, concentration decay profile), airflow velocity mapping, pressure differentials, and environmental monitoring inputs. Data export supports CSV, PDF, and XML formats with embedded digital signatures. Audit trails record user actions, parameter changes, and alarm events with timestamps traceable to NIST-traceable clocks. System backups are performed automatically to encrypted local storage and optional network-attached storage (NAS), retaining ≥36 months of raw data per ALCOA+ principles.
Applications
- Sterility testing of final lyophilized drug products per USP and Ph. Eur. 2.6.1.
- Aseptic assembly and inspection of freeze-dryer stopper trays and loading systems.
- Isolation-based microbial challenge studies supporting validation of depyrogenation tunnels and sterilization cycles.
- Environmental monitoring integration with ISO 14644-1 compliant particle counters (0.5 µm and 5.0 µm channels) and active air samplers (e.g., MAS-100 EC).
- Supporting QC release testing under cGMP conditions requiring full 21 CFR Part 11 compliance and retrospective data review capabilities.
FAQ
Does the MIS1650C support third-party environmental monitoring devices?
Yes—it features standardized Modbus TCP and RS-485 interfaces for seamless integration with calibrated particle counters, viable air samplers, and dew point sensors.
What VHP validation documentation is provided with the system?
Each unit ships with a Factory Acceptance Test (FAT) report, IQ/OQ protocol templates aligned with ASTM E2897, and a completed VHP cycle development report including BI placement maps and log-reduction verification data.
Can the isolator be configured for dual-use (sterility testing + aseptic processing)?
Yes—modular glove port layout, adjustable workbench height, and configurable utility penetrations (N₂, compressed air, vacuum) enable reconfiguration per application-specific risk assessments.
Is remote diagnostics supported?
The system includes secure VPN-enabled remote access for authorized service engineers, with session logging and multi-factor authentication per ISO/IEC 27001 controls.
