Airs AWF900-DS Bag-in/Bag-Out (BIBO) Precision Balance Enclosure with Vibration Isolation
| Brand | Airs |
|---|---|
| Origin | Shanghai, China |
| Manufacturer Type | Direct Manufacturer |
| Country of Origin | China |
| Model | AWF900-DS |
| Pricing | Upon Request |
Overview
The Airs AWF900-DS Bag-in/Bag-Out (BIBO) Precision Balance Enclosure is an engineered containment solution designed for high-integrity weighing operations in occupational exposure band (OEB) Level 5 environments—where airborne hazardous materials (e.g., potent APIs, cytotoxic compounds, or nanomaterials) demand strict operator and environmental protection. Unlike conventional balance hoods or laminar flow workstations, the AWF900-DS integrates a fully sealed BIBO filtration module with a vibration-isolated weighing platform, enabling both ultra-low particulate exposure and metrologically stable mass measurements. Its core principle relies on negative-pressure containment combined with HEPA filtration (≥99.995% @ 0.3 µm), where all airflow passes through dual-stage HEPA filters housed within a welded stainless-steel BIBO chamber. During filter maintenance, the entire filter assembly is isolated inside a certified TPU (thermoplastic polyurethane) safety bag—eliminating direct contact with contaminated media and preventing aerosol release. This architecture complies with the fundamental containment requirements of ISO 14644-1 Class 5 cleanroom air quality at the balance pan level and supports alignment with OEB 5 risk mitigation frameworks per ICH Q5C and USP .
Key Features
- Fully welded 316L stainless-steel BIBO chamber with integrated lower-seal HEPA mounting—prevents bypass leakage and ensures zero unfiltered air recirculation
- TPU-based BIBO bags (0.3 mm thickness, UV- and chemical-resistant) featuring dual drawstring closure, integrated waste-collection pouch, and ASTM F1670/F1671-compliant barrier performance
- Vibration-isolation base compliant with ISO 25316:2015 for precision balances (±0.5 µm displacement damping across 1–100 Hz)
- Real-time differential pressure monitoring (±1 Pa resolution) across pre-filter, main HEPA, and exhaust stages—with audible/visual alarms for filter saturation or seal breach
- Touchscreen HMI with configurable access levels (operator, technician, administrator) and audit-trail logging per FDA 21 CFR Part 11 requirements
- Modular airflow design supporting face velocity adjustment (0.45–0.55 m/s) and optional integration with building HVAC via dedicated exhaust duct interface (DN160)
Sample Compatibility & Compliance
The AWF900-DS accommodates standard analytical balances (up to 350 mm × 250 mm footprint) and microbalances requiring sub-microgram resolution. It is validated for use with powders, lyophilized solids, and low-volatility active substances classified under OEB 5 (e.g., carmustine, thalidomide analogues). Regulatory alignment includes JG/T 385–2012 (Chinese standard for laboratory fume hoods and containment enclosures), EN 14175–6:2021 (performance testing of local exhaust ventilation), and compatibility with GLP/GMP documentation workflows. Filter change procedures are qualified per ISO 14644-3 Annex B and support full traceability—including batch-lot recording of HEPA units and bag serial numbers.
Software & Data Management
Embedded firmware provides continuous logging of operational parameters: static pressure differentials, total airflow volume, runtime hours, alarm history, and user authentication events. Data export is supported via USB 2.0 or Ethernet (Modbus TCP) to LIMS or electronic lab notebooks (ELN). All critical events—including door interlock status, filter replacement cycles, and calibration prompts—are time-stamped with digital signatures and stored locally for ≥12 months. The system supports role-based permissions and encrypted backup to external NAS devices, fulfilling ALCOA+ data integrity principles.
Applications
- Weighing of highly potent active pharmaceutical ingredients (HPAPIs) during R&D and clinical batch manufacturing
- Formulation development involving oncology compounds, hormonal agents, or gene therapy vectors
- Reference standard preparation in accredited reference material laboratories (ISO/IEC 17034)
- Stability study sample handling under cGMP Annex 1 (2022) Category 4 containment requirements
- Academic toxicology research involving inhalable nanomaterials or radio-labeled tracers
FAQ
Does the AWF900-DS require external ducting?
Yes—exhaust must be connected to a dedicated, balanced building exhaust system with backdraft prevention. Recirculation mode is not supported due to OEB 5 containment requirements.
What HEPA filter specifications are compatible?
Certified H14 grade HEPA filters (EN 1822-1:2019) with aluminum frame, gasketed edge seal, and ≤1.5 Pa initial resistance at rated airflow.
Can the unit be validated for IQ/OQ/PQ?
Yes—Airs provides URS-aligned validation protocols, test templates, and commissioning support for GMP environments.
Is the TPU bag supplied with each filter replacement kit?
Yes—each OEM filter kit includes two certified TPU BIBO bags, one for installation and one for spent filter containment.
How often must the vibration isolation system be recalibrated?
No routine recalibration is required; however, periodic verification using ISO 25316-compliant laser interferometry is recommended every 12 months or after relocation.
