B+S EDM3611 Semi-Automatic Laboratory-Scale Filling System

Overview

The B+S EDM3611 is a semi-automatic, benchtop filling system engineered for precise, repeatable, and contamination-controlled liquid dispensing in regulated laboratory and pilot-scale pharmaceutical environments. Designed around a patented single-tube peristaltic pump architecture combined with a servo-driven rotary piston metering unit, the EDM3611 delivers high volumetric accuracy across a broad 0.1–100 mL range without requiring valve switching or fluid-path disassembly. Its mechanical architecture supports integration into isolators and VHP (vaporized hydrogen peroxide) decontamination cycles—fully compliant with ISO 14644-1 Class 5 (ISO Class 5) cleanroom-compatible construction, including IP54-rated electronics and stainless-steel 316L wetted surfaces. Unlike fully automated fillers, the EDM3611 maintains operator control over critical process steps—vial loading, needle positioning, and cycle initiation—while eliminating manual syringe handling and human-induced volumetric variability.

Key Features

• Patented single-hose peristaltic pump design eliminates dead-legs, reduces cleaning validation burden, and ensures full fluid-path traceability without valves or seals.
• Servo-controlled rotary piston pump provides stable, pulse-free flow with ≤±0.5% volumetric repeatability (RSD) at ≥1 mL dispense volumes under GLP-compliant operating conditions.
• Automatic syringe centering mechanism uses optical alignment and motorized XYZ adjustment to position the filling needle concentrically within syringe barrels—critical for minimizing wall contact and foam generation during low-viscosity or shear-sensitive formulations.
• 7-inch industrial-grade touchscreen HMI with multi-language support (English, German, French, Spanish), password-protected user levels (Operator, Technician, Administrator), and audit-trail-enabled event logging.
• VHP-compatible enclosure: All external panels, cable glands, and control housing meet VHP exposure requirements per Steris® and Sartorius validation protocols (up to 1,200 ppm H₂O₂, 60-min cycle).
• Modular baseplate design allows rapid reconfiguration for vial, syringe, or cartridge formats without tools—mechanical adjustments are limited to height and diameter calibrations via digital encoder inputs.

Sample Compatibility & Compliance

The EDM3611 accommodates primary containers conforming to ISO 8536-4 (glass vials), ISO 11040-4 (syringes), and USP standards. Compatible vessel dimensions include vials with diameters from 8.55 mm to 66 mm and heights from 35 mm to 136 mm; syringes ranging from 6.85 mm to 35 mm in barrel diameter and 45 mm to 160 mm in total length. The system complies with IEC 61000-6-2 (EMC immunity) and IEC 61000-6-4 (EMC emission) standards. Firmware supports 21 CFR Part 11-compliant electronic signatures and audit trails when paired with validated networked data servers. It meets essential requirements of the EU Machinery Directive 2006/42/EC and carries CE marking for laboratory equipment.

Software & Data Management

The embedded firmware (v3.2.x) records all critical process parameters—including dispense volume, pump speed, vacuum assist status, cycle timestamp, operator ID, and error codes—in encrypted SQLite databases. Data export is supported via USB 2.0 (CSV/Excel) or Ethernet TCP/IP to LIMS or MES platforms using OPC UA or Modbus TCP protocols. Optional B+S FillingSuite™ software enables method storage (up to 99 protocols), batch-level metadata tagging, and automated PDF report generation compliant with ALCOA+ principles. All electronic records retain immutable timestamps synchronized to NTP servers, satisfying FDA and EMA expectations for data integrity in GMP Annex 11 environments.

Applications

• Pre-formulation studies requiring accurate micro-to-milliliter dosing of APIs, excipients, or reference standards.
• Fill-finish development for clinical trial materials (Phase I–II), especially for cytotoxic, sterile, or cold-chain-sensitive compounds.
• QC lab use for preparing calibrated reference solutions, buffer aliquots, or dissolution media in accordance with USP Analytical Instrument Qualification guidelines.
• Supporting aseptic process simulation (media fills) under ISO 13408-1, where consistent fill weight distribution directly impacts sterility assurance level (SAL) assessment.
• Facilitating tech transfer between R&D and manufacturing by generating scalable, parameterized filling methods that map directly to production-scale peristaltic or piston-fill systems.

FAQ

Is the EDM3611 suitable for sterile filling under Grade A conditions?
Yes—when installed inside an ISO Class 5 laminar airflow workstation or RABS, and operated with VHP-decontaminated components and pre-sterilized tubing, it meets EU GMP Annex 1 requirements for aseptic processing support equipment.
Can the system be integrated with SCADA or MES platforms?
Yes—via standard Ethernet interface supporting OPC UA and Modbus TCP; B+S provides protocol documentation and configuration templates for Siemens, Rockwell, and Dassault Systèmes platforms.
What maintenance intervals are recommended for the peristaltic pump tubing?
Tubing lifetime is application-dependent; B+S recommends replacement after 500 cycles for aqueous buffers and 200 cycles for viscous or abrasive formulations—verified through in-house gravimetric testing per ASTM D471.
Does the EDM3611 support IQ/OQ/PQ documentation packages?
Yes—B+S supplies vendor-qualified IQ/OQ protocols (aligned with ASTM E2500 and ISPE GAMP5), plus PQ template worksheets for user-defined acceptance criteria and test execution.
Is remote diagnostics available?
Yes—optional Remote Support Module enables secure, encrypted technician access for firmware updates, log analysis, and real-time sensor diagnostics under ITAR-compliant network policies.