Fortuna POLYFIX Model 1 Bottle Top Dispenser

Overview

The Fortuna POLYFIX Model 1 Bottle Top Dispenser is a manually operated, ISO 8655–compliant liquid handling instrument engineered for precision, repeatability, and chemical resilience in routine laboratory workflows. Designed and manufactured in Germany under stringent quality control protocols, this dispenser operates on a positive-displacement principle: rotation of the ergonomic handle drives a precisely ground glass piston within a borosilicate glass cylinder, generating controlled volumetric displacement without reliance on springs or elastomeric seals. This architecture eliminates metal ion leaching, minimizes hysteresis, and ensures consistent delivery across repeated cycles—critical for quantitative transfer of reagents in analytical chemistry, QC testing, and preparative applications. Its calibration is traceable to the Physikalisch-Technische Bundesanstalt (PTB), Germany’s national metrology institute, and conforms to ISO 8655–3 for piston-operated dispensers. The device is rated for continuous operation between 15 °C and 50 °C and withstands autoclaving at 121 °C / 1 bar, supporting GLP-compliant cleaning validation.

Key Features

• Ambidextrous ergonomic handle with tactile volume-setting dial—enables rapid macro- and micro-adjustments without tools
• Transparent, graduation-marked borosilicate glass cylinder (PP-jacketed) for real-time visual confirmation of fill level and dispensing progress
• High-tolerance glass piston with matte-finished surface interface, ensuring low-friction movement and minimal carryover
• Chemically inert wetted materials: PTFE sealing elements, borosilicate glass body, crystal glass sight window, nickel-alloy spring-free valve components, and food-grade polypropylene housing
• Integrated PP valve block with no metallic springs—eliminates corrosion risk and prevents contamination in trace-metal-sensitive assays
• Standard GL32 thread interface; optional GL32-to-GL40 and GL32-to-GL45 adapters provided for broad bottle compatibility
• Minimalist mechanical architecture—fewer parts simplify disassembly, cleaning, and maintenance in accordance with ISO/IEC 17025 internal procedure requirements

Sample Compatibility & Compliance

The POLYFIX Model 1 is validated for use with aqueous solutions, organic solvents (e.g., acetone, ethanol, chloroform), weak and strong mineral acids (including HCl and HNO₃), and alkaline solutions (e.g., NaOH, KOH). It is not recommended for hydrofluoric acid (HF) or fuming nitric/sulfuric acids—applications requiring HF resistance are addressed by the Fortuna OPTIFIX HF series, which employs all-PTFE construction and sapphire valves. All wetted components comply with USP Class VI and EU Directive 2002/72/EC for plastic materials in contact with pharmaceuticals. Device calibration adheres to ISO 8655–3 and is documented per PTB’s accredited methodology using distilled water at 20 °C. Performance data—including accuracy (≤0.3%) and coefficient of variation (≤0.1%)—are specified at full-scale capacity (50 mL) and remain within tolerance across the 10–50 mL operating range. The unit supports audit readiness for FDA 21 CFR Part 11–aligned environments when paired with Fortuna’s optional electronic logbook software.

Software & Data Management

While the POLYFIX Model 1 is a manual, non-electronic instrument, its design integrates seamlessly into digitally governed laboratories. Each unit ships with a unique serial number and a PTB-traceable calibration certificate detailing measurement uncertainty at defined points (10 mL, 25 mL, 50 mL). These certificates are compatible with LIMS and ELN platforms via PDF import or barcode-scanned metadata capture. Fortuna provides downloadable SOP templates aligned with ISO/IEC 17025 and GMP Annex 15 for periodic verification, user training, and calibration interval management. Optional digital tools—including the Fortuna Calibration Manager desktop application—enable storage of historical performance data, trend analysis of dispensing variance over time, and automated generation of compliance reports for internal audits or regulatory inspections (e.g., ISO 9001, ISO 13485, or MHRA assessments).

Applications

• Preparation of standard solutions and calibration standards in environmental testing labs (EPA Method 502.2, ISO 11843)
• Accurate reagent addition during titration, spectrophotometric assay setup, and HPLC mobile phase preparation
• QC release testing of pharmaceutical intermediates where volumetric consistency directly impacts assay validity
• Dilution series generation for ELISA, PCR master mix assembly, and microbiological media preparation
• Controlled solvent transfer in synthetic chemistry workflows involving air-sensitive or hygroscopic reagents
• Use in teaching laboratories where durability, intuitive operation, and transparency of function support pedagogical objectives

FAQ

Is the POLYFIX Model 1 suitable for hydrofluoric acid (HF)?

No. HF requires the Fortuna OPTIFIX HF series, which features all-PTFE construction and sapphire valve components.
Can this dispenser be autoclaved?

Yes—fully assembled units are rated for steam sterilization at 121 °C / 1 bar for 20 minutes, per DIN EN 285.
What is the recalibration interval recommendation?

Fortuna recommends verification every 6 months for routine use, or prior to critical assays—documented per ISO/IEC 17025 clause 6.4.10.
Does it meet ISO 8655 requirements?

Yes—calibrated per ISO 8655–3 using PTB-traceable methodology; certificate includes expanded uncertainty (k=2) at 20 °C.
Are replacement parts available separately?

Yes—glass cylinders, pistons, PTFE seals, and PP valve blocks are stocked globally and supplied with batch-specific certification.