Product Description
Parker’s SciLog® Filter & Dispense Bottle System is an automated, single-use filter and dispense bottle system for bulk drug substance (BDS) processing. Designed for biopharmaceutical and life sciences manufacturing, it combines bulk filtration, in-line filter integrity testing, and gravimetric bottle filling in a single compact platform, helping standardize fill operations and reduce operator intervention.
This fully automated system uses a closed single-use flow path and sterile connections to support aseptic bulk drug filtration and bottle filling in standard cleanroom environments, without the need for a flow cabinet or additional environmental monitoring. Automated recipes manage filter flushing, equilibration, integrity testing, constant rate/constant pressure filtration, dispensing, and recovery, delivering consistent results and electronic process records.
The SciLog Filter & Dispense Bottle System is engineered to fill 1–20 L bottles and can process up to 1000 x 20 L bottles per pump manifold, while recovering approximately 99% of product from the dispensing spine. Validated shipping bottle assemblies with patented sealing technology and protective transport caps minimize foaming, protect crimped tubing, and provide validated integrity down to very low temperatures, supporting reliable frozen storage and shipment.
Single-use manifolds are constructed from biopharmaceutical-grade materials including platinum-cured silicone, polypropylene, polysulfone, Pharmapure, and polycarbonate, with options for silicone, TPE, or PVC tubing to match process requirements. Integrated SciPres pressure sensors, high-precision peristaltic and diaphragm pumps, and SciSoft software (21 CFR Part 11 compliant) provide robust monitoring, control, and data integrity, making the system well suited for clinical through commercial BDS bulk fill applications.
Key Features
- Automated, single-use filter and dispense bottle system for BDS bulk fill processes
- Integrates bulk filtration, in-line filter integrity testing, and gravimetric bottle dispensing in one platform
- Closed, sterile single-use flow path supports aseptic operation in standard cleanrooms
- Fills 1–20 L bottles and can process up to 1000 x 20 L bottles per pump manifold
- High product recovery with automated reverse-flow and purge, targeting ~99% recovery from the dispensing spine
- Validated bottle and closure design to reduce foaming, protect tubing, and support low-temperature shipping
- SciSoft control software with configurable recipes and electronic batch records, compliant with 21 CFR Part 11
- Integrated single-use pressure sensors for in-line monitoring and automated filter integrity testing
- Compact, ergonomic frame with removable bottle trays for quick manifold and format changeover
- Electrical and safety design meeting CE/UL/CSA requirements, with RoHS and REACH compliant materials
Typical Applications
The SciLog Filter & Dispense Bottle System is designed for automated, closed-system bulk drug substance bottle filling in biopharmaceutical manufacturing. Typical uses include:
- Bulk drug substance (BDS) filtration and bottle filling for biologics and vaccines
- Final bulk filtration and dispense prior to frozen storage and shipment
- Aseptic filling of high-value intermediates into 1–20 L bottles
- Clinical and commercial bioprocessing operations requiring automated, 21 CFR 11 compliant batch records
- Life sciences and biopharma facilities looking to standardize multi-shift bulk fill operations
Specifications
| System Type | Automated bulk filtration and bottle filling system for BDS applications |
|---|---|
| Dimensions | 83 in L x 36 in W x 75 in H |
| Fill Volume Range | 1 L to 20 L bottles |
| Bottles per Manifold | Up to 1000 x 20 L bottles before dispensing pump manifold replacement |
| Product Recovery | Designed for approximately 99% recovery from dispensing spine |
| Filtration Pump | Quattroflow 1200 SU, 1.8–18 L/min |
| Dispensing Pump Options | Watson Marlow peristaltic 0.1–12 L/min, Masterflex peristaltic 0.1–17 L/min |
| Operating Temperature | 4 °C to 40 °C |
| Flow Path Materials | Platinum cured silicone, Polypropylene, Polysulfone, Pharmapure, Polycarbonate |
| Tubing Options | Silicone, Thermoplastic elastomer (TPE), PVC |
| In-line Sensing | 2 x SciPres II single-use pressure sensors |
| Software | SciSoft user interface, 21 CFR Part 11 compliant |
| Control & Automation | PLC-based control with single or batch operation and configurable recipes |
| Connection to Plant Systems | OPC, Profibus, or Ethernet IP to plant control systems (e.g., DCS/SCADA) |
| Electrical Requirements | 100–240 V single phase (additional voltages available on request) |
| Pneumatic Requirements | 90 psi instrument air or nitrogen |