Esco WDCI Series Weighing and Dispensing Containment Isolators

Overview

The Esco WDCI Series Weighing and Dispensing Containment Isolators are engineered for high-integrity containment during the handling, weighing, and dispensing of potent compounds—including cytotoxic drugs, highly active pharmaceutical ingredients (HPAIs), and hazardous research materials. Designed in accordance with ISO 14644-7 for cleanroom isolator classification and aligned with USP , , and FDA guidance on aseptic processing and operator protection, the WDCI system employs a controlled negative-pressure environment to prevent cross-contamination between the operator and the process chamber. Its unidirectional turbulent airflow architecture—operating at low face velocity—ensures effective particle control while minimizing energy consumption and operator fatigue. The isolator integrates a vibration-damped granite weighing platform, precision-engineered glove ports with safe-change mechanisms, and fully sealed, weld-seam-free 316 stainless steel construction to support GMP-compliant operations under GLP and 21 CFR Part 11–aligned workflows.

Key Features

• Monolithic 316 stainless steel chamber fabricated via full orbital welding with radius-rounded internal corners (R ≥ 15 mm) to eliminate particle traps and facilitate CIP/WIP validation.
• ISO 14644-7–certified pressure integrity testing protocol with automated pressure decay monitoring (±0.5 Pa resolution) for real-time leak detection and audit-ready documentation.
• USP-compliant Class 6 (ISO Class 5 background with ISO Class 7 working zone) containment performance achieved through dual H14 HEPA filtration: inlet filters with PVC-coated cartridge housings and exhaust filters with 316 stainless steel push-in frames enabling in-situ replacement without breaching containment.
• Glove port system featuring quick-release, gas-tight sealing collars and integrated glove change station with nitrogen purging capability to maintain negative pressure during glove replacement.
• Vibration-isolated black granite weighing platform (flatness ≤ ±0.02 mm/m²) mounted directly to the isolator base structure—designed for compatibility with analytical balances up to 0.1 µg readability.
• Externally mounted LED lighting system (≥650 lux at work surface) with IP65-rated fixtures located outside the chamber to eliminate shadow zones and simplify cleaning validation.
• Hydraulic height-adjustable support frame (range: 2.08–2.36 m total height) enabling ergonomic operator positioning per ISO/TR 12967 and NIOSH lifting guidelines.
• 6-inch color HMI touchscreen controller (Siemens SIMATIC S7-based) with CE marking, multi-level user access control, and configurable alarm logging compliant with ALCOA+ data integrity principles.

Sample Compatibility & Compliance

The WDCI series accommodates solid powders, lyophilized APIs, and low-volatility suspensions across batch sizes ranging from milligram-scale R&D to multi-kilogram manufacturing steps. All models meet EU GMP Annex 1 (2022) requirements for closed-system containment and are validated for use in facilities operating under FDA 21 CFR Part 211, Health Canada GMP, and PMDA JPAL standards. The isolator’s passive and active sealing architecture—including gasketed RTP interfaces (Alpha/Beta variants, Ø190–460 mm), sterile barrier transfer ports, and optional drainable floor pans—supports full-cycle cleaning validation per ASTM E2894 and PDA Technical Report No. 75. Surface finish specifications (Ra ≤ 0.4 µm external, ≤ 0.6 µm internal) conform to ASME BPE-2022 hygienic design criteria.

Software & Data Management

The embedded control system records all critical parameters—including chamber pressure differential (±0.1 Pa), airflow volume (21–75 m³/hr), filter delta-P, lighting status, and glove integrity test results—in tamper-evident, time-stamped audit trails. Data export is supported via USB or Ethernet (Modbus TCP/IP) in CSV or PDF format, with optional integration into LIMS or MES platforms. Electronic signatures, role-based permissions, and configurable password policies comply with 21 CFR Part 11 Subpart C requirements for electronic records and signatures. All firmware updates undergo formal change control and are traceable to revision-controlled release notes.

Applications

• Weighing and dispensing of oncology APIs and hormone-active substances in API manufacturing suites.
• Formulation development of low-dose solid oral dosage forms requiring nanogram-level accuracy.
• Handling of sensitizing compounds during preclinical toxicology studies.
• Compounding of sterile preparations under USP and compliance frameworks.
• Containment transfer of intermediates between isolator-linked equipment (e.g., milling, granulation, or drying units).

FAQ

What regulatory standards does the WDCI series comply with?

The WDCI meets ISO 14644-7, USP /, EU GMP Annex 1 (2022), and FDA guidance for containment of hazardous drugs. It supports validation against ASTM E2894 and PDA TR75.

Can the isolator be integrated with existing facility HVAC or SCADA systems?

Yes—via Modbus TCP/IP or 4–20 mA analog I/O, enabling remote pressure setpoint adjustment, alarm forwarding, and centralized event logging.

Is CIP/WIP functionality available as standard or optional?

CIP spray nozzles and WIP spray guns are factory-installed options; drainable floor pans and sloped chamber bases are standard on all models.

What is the maximum allowable particulate challenge for routine integrity testing?

The system is qualified for leak detection down to 1 × 10⁻⁶ m³/s using pressure decay methodology per ISO 14644-7 Annex B.

Are glove ports compatible with industry-standard glove materials?

Yes—the flange interface accepts standard 0.5 mm thick butyl, nitrile, or chloroprene gloves certified to EN 374-3 and ASTM D6978.