Hirschmann opus® Precision Mini Liquid Filler

Overview

The Hirschmann opus® Precision Mini Liquid Filler is an engineered benchtop liquid dispensing system designed for reproducible, low-volume to mid-volume aseptic filling in pharmaceutical development, bioprocess R&D, and analytical laboratory settings. Unlike conventional peristaltic or piston-based fillers, the opus® employs a precision stepper-motor-driven positive displacement mechanism with integrated high-resolution optical encoders and closed-loop volume feedback—ensuring volumetric accuracy independent of fluid viscosity, density, or temperature drift within operational limits. Its architecture eliminates consumable tubing, seals, or syringes, thereby removing a primary source of variability and contamination risk in GMP-adjacent workflows. The system is purpose-built for scale-down continuity between discovery-stage formulation and clinical-phase manufacturing, supporting seamless transition from 10 µL assay plate preparation to 500 mL buffer or media filling for pilot bioreactor runs.

Key Features

• High-accuracy dispensing across five orders of magnitude: validated performance from 10 µL to 500 mL per dispense, with ≤0.5% relative standard deviation (RSD) under ISO 8655-6 test conditions.
• Chemically inert wetted path constructed entirely from USP Class VI-certified fluoropolymers (PTFE, ETFE), sapphire nozzles, and 316L stainless steel actuation components—resistant to aqua regia, concentrated HNO₃/HF mixtures, and organic solvents.
• Autoclavable at 121 °C / 20 min (EN 285 compliant), enabling full-cycle steam sterilization without disassembly; validated for ≥50 autoclave cycles with no measurable change in calibration or surface integrity.
• Touchscreen HMI with intuitive graphical workflow editor—supports up to 99 programmable methods, including multi-step sequences with variable aspiration/dispense speeds, pause intervals, and tip rinse protocols.
• Modular dispensing interface: compatible with fixed-length rigid discharge tubes (100–600 mm), flexible PTFE capillary tips, or direct bottle-neck mounting via universal adapter base; accommodates containers from 5 mL vials to 5 L carboys.
• No consumables required—no tubing replacement, no syringe recalibration, no seal lubrication—reducing total cost of ownership and eliminating batch-to-batch variability introduced by wear-prone components.

Sample Compatibility & Compliance

The opus® Mini Filler is suitable for aqueous buffers, cell culture media, protein solutions, small-molecule APIs in solution, and viscous formulations up to 500 cP. It complies with ISO 9001:2015 quality management requirements and meets material biocompatibility criteria per ISO 10993-5 and USP . All firmware and calibration records adhere to ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available). Optional audit trail logging and electronic signature support align with FDA 21 CFR Part 11 and EU Annex 11 for regulated environments. CE marking confirms conformity with the EU Machinery Directive 2006/42/EC and Electromagnetic Compatibility Directive 2014/30/EU.

Software & Data Management

The embedded control software supports method export/import via USB-C, CSV-based batch record generation, and real-time dispense log capture (timestamp, volume, error code, operator ID). Optional Ethernet connectivity enables integration into LabVantage, STARLIMS, or custom MES platforms via Modbus TCP or RESTful API. All calibration data—including gravimetric verification reports per ISO 8655—are digitally signed and stored with cryptographic hash integrity checks. Firmware updates are delivered as signed binary packages with SHA-256 verification prior to installation.

Applications

• Aseptic filling of clinical trial materials: vial filling for Phase I/II stability studies, lyophilization pre-conditioning, and reference standard aliquoting.
• Media and reagent preparation: precise dispensing of selective growth media into flasks, bioreactor seed trains, and QC testing plates.
• Formulation development: serial dilution series for solubility screening, excipient compatibility testing, and dose-ranging studies.
• GMP-adjacent process validation: bridging lab-scale dispensing to commercial filling line parameters using identical volumetric traceability.
• Biobanking: cryovial array filling with minimal headspace variation and no carryover between samples.

FAQ

Is the opus® Mini Filler compliant with FDA 21 CFR Part 11 for electronic records and signatures?
Yes—when configured with audit trail and user authentication modules, it satisfies predicate rule requirements for electronic records retention and signature verification.
Can the system be validated for use in a GMP environment?
Yes—Hirschmann provides IQ/OQ documentation templates, calibration certificates traceable to NIST standards, and vendor-supported PQ protocol development.
What maintenance is required beyond routine cleaning?
None—the system has no scheduled maintenance intervals; only periodic gravimetric accuracy verification per internal SOP or ISO 8655-6 is recommended every 6 months.
Does it support sterile filtration inline during dispensing?
No—sterile filtration must occur upstream; however, the fully autoclavable fluid path allows post-filtration aseptic transfer without secondary sterilization steps.
How is volume calibration performed and verified?
Calibration uses gravimetric measurement against certified analytical balances (±0.01 mg resolution); each unit ships with a certificate of calibration valid for 12 months under standard operating conditions.