SummaryBased on Modular-Lab PharmTracer cassette technology for tracer production without cross-contamination, the Modular-Lab Dispensing Unit provides aseptic, closed-path dispensing into up to six vials plus one QC vial. Systems and cassettes are configured to customer requirements.
Key Features- Fully automated accurate dispensing
- Customized cassettes including vials, sterile filters and consumables per user requirements
- No pump or pressure required for dispensing
- Full traceability of the dispensing process
- Filter integrity test supported (with additional module)
- Upgradeable modular design for future expansions
IntroductionThe Modular-Lab Dispensing Unit enables aseptic dosing into vials in a controlled environment (Class C / Class 10,000) using single-use dispensing cassettes that maintain a closed, sterile fluid path. The unit is available as a stand-alone device or as an add-on module to a Modular-Lab PharmTracer synthesis system to add dispensing functionality.
TechnologyThe system includes a Syringe Module (SYM), an SLM-2 module (2-fold Modular-Lab PharmTracer module) as standard, a control unit and PC for stand-alone operation. Capacity extension from 4 to 6 vials is achieved by adding an SLM-1 module. Adding an additional SLM-1 enables automated cassette pressure and sterile filter integrity testing. The system supports dilution of activity and measurement of active solution volume using an external activity detector and a Detector Shielding Module (DSM). The detector can be calibrated for specific isotopes and covers a wide measurement range.
CassettesSingle-use cassettes are assembled under GMP-compliant clean-room conditions, gamma-sterilized and double vacuum-packed. Consumables are chemical-resistant and tested for compatibility with specific syntheses. Materials are free of animal-derived components and cassettes have a shelf life of 18 months. As single-use items, no cleaning or sanitation routines are required. Dispensing cassettes provide a completely closed fluid path and include vials, sterile filters and spikes; only one connection to the stock vial or synthesizer is required. Cassettes can be produced in small batches to customer specifications.
CE ConformityCE conformity certificates are available.
Characteristics / Technical specifications- Product name / model: Modular-Lab Dispensing Unit
- Intended use: Aseptic vial dispensing into up to 6 vials + 1 QC vial
- Fluid path: Closed and sterile via single-use dispensing cassettes
- Modules: Syringe Module (SYM), SLM-2 (2-fold), optional SLM-1 for extension and integrity testing
- Dispensing mode: Fully automated, accurate; stand-alone or add-on to Modular-Lab PharmTracer
- Filter integrity test: Supported (automated with additional module)
- Activity measurement: Supported via external detector and Detector Shielding Module (DSM); detector calibratable for isotopes
- Cassette production: GMP clean-room assembled; gamma sterilized; double vacuum-packed
- Cassette materials: Chemical resistant; free of animal-derived components
- Cassette shelf life: 18 months
- Consumables included: Vials, sterile filters, spikes, etc., provided in cassette
- Customization: Cassettes and configuration customizable to customer needs
- Traceability: Full process traceability implemented
- Upgradeability: Modular design allows future extensions