Stakeholders

One system that can scale from Development through Commercial Sales

Syn-Fill™ integrates seamlessly with existing manufacturing infrastructure, enhance data collection, and validation processes, requiring only instrument air and 208/240V power—no complex facility modifications needed.  Designed for flexible process development yet fully compliant for GMP manufacturing, it enables teams to develop, refine, and scale on a single platform.

The mobile, plug-and-play design allows for process optimization in PD labs before GMP implementation, ensuring:

• Early hands-on experience with the system before regulatory qualification
• Streamlined batch record development with real-world process insights
• Better process understanding before critical GMP production runs
• Supports many applications for stability, filling studies, animal studies, early clinical trials, and commercial production
• Scaled for You Syn-Fill™ systems can be developed to work in multiplexed format with one leader and multiple followers. As your product gains adoption and the process is scaled up, additional units can be added to your initial system to grow filling lot sizes alongside your process
• Temperature Control with an operating range of -20 to 25°C
• Real Time Monitoring and Reporting with our HMI and batch reporting provides 21CFR11 compliant data when you need it

With Syn-Fill, there’s no need for multiple filling systems—develop once, implement once, and scale effortlessly.

Contact us or send us an RFP through our contact sheet to discuss your application.  We will work with you to get the proper specifications and performance for your process.

Minimal Infrastructure, Maximum Flexibility

Syn-Fill™ eliminates the need for large cleanroom buildouts, extensive HVAC upgrades, and complex utility installations, cutting CAPEX by millions.  Designed for controlled non-classified (CNC) environments, it requires only 208/240V power and compressed gas—no specialized utilities, no permitting delays.  Installation is plug-and-play, fitting through a standard doorway and operational within days.

Lower Cost, Faster Deployment

• No RFPs, scope negotiations, or bid tabulations—ready-to-implement system
• Eliminates dedicated suites—Syn-Fill™ runs in shared facility spaces
• Reduced footprint—maintenance and access spacing can be shared with other equipment
• Faster project execution—install and validate 2 years ahead of industry benchmarks
• No HVAC or utility-driven downtime—keep production running

Built for Adaptive Filling Needs

• One system for multiple products—fill unique product batches in parallel
• Flexible Batch Size—both the fill volume and number of final filled units can be changed using modular fill manifold and automated setpoints
• Rapid configuration changes—easily swap out Syn-Fill™ units for different container formats or batch sizes
• Eliminate redundant filling systems—scale production without multiplying infrastructure
• Reduced Overhead—Less system downtime for cleaning and sterilization with easy setup and unloading
• Simplify maintenance plans—reduces calibration and maintenance burdens and eliminate support systems

Save $1M+ in project costs while accelerating time-to-market.

Phaser Solutions was founded by a group of end users and industry experts.  The equipment, corporate programs, quality systems, supply chain, fabrication, CQV, and maintenance support have been designed with regulatory compliance in mind.

Simplify implementation of a holistic Contamination Control Strategy (CCS) via closed processing.  The transfer of product in open or briefly exposed operations are recognized as having the highest risk to sterile processing.  Conversely, closed processes are regarded as one of the safest for maintaining product sterility, while also maintaining independence from the environment.  By implementation of closed processing the requirements for enhanced risk-based designs (QbD) can be addressed with a narrower focus.

The Syn-Fill™ system ensures the SISPQ of your final product through the novel mechanism of filling, automated recipes, batch reports, and elimination of risks inherent with in-house fill-finish systems.

Legacy filling approaches introduce contamination risk and variability.  Syn-Fill™ automates filling and sealing with a fully enclosed, single-use flowpath, eliminating human touchpoints.  Each batch is recorded with timestamped process data, ensuring compliance with quality standards.  Intuitive Process Reports are immediately available for review and approval.  Closed processing is recognized as the lowest risk and most favored approach to filling of sterile products.

• 21 CFR 11 Compliant
• Safety – Reduced risk of contamination
  • Syn-Fill™ systems perform integrity testing prior to being connected to the bulk product, to mitigate risk of contamination.
  • Reduce risk of bulk product loss during shipment by implementing in-house filling
  • Filling occurs in a fully closed system with no manual interventions
  • Pre-Cleaned and sterilized assemblies provided with COC using validated gamma cycles
• Identity – Closed process filling eliminates risk of:
  • Cross contamination from other products or lots
  • Environmental contaminants
  • Carryover cleaning/sanitizing/sterilizing agents
  • Particulates from pumps, seals, spallation
  • Particulates from equipment (e.g., vibration of stoppers, running of conveyors, bellows)
  • Leaks in HEPA filters
  • Chemical contaminants in makeup air
  • Leaks in enclosures/glove ports
• Strength –
  • Due to the degassing the full batch is well mixed prior to filling.
  • Synchronous filling eliminates start-middle-end batch variations
• Potency –
  • Synchronous filling enables the shortest process times to minimize environmental impacts for temperature sensitive products.
  • Syn-Fill™ can be used in controlled temperature environments down to -20°C
  • Filling can be performed across a broad range of speeds to ensure shear effects on sensitive products are minimized.
• Quality –
  • 21 CFR 11 Compliant Automated System w/ batch report generation enables process consistency, while generating all necessary batch data with minimal effort and maximum traceability
  • Each manifold is pre-cleaned/sterilized with a CoA to ensure compliance prior to the start of the batch. This reduces the burden of tracking the cleaning and sterilization of components, expiry dating, routine re-qualifications/validations (see more in QAV section ) and potential issues with consistency.
  • Real-time in-process and alarm data logging simplifies batch release. Talk to our automation specialists about developing batch reports with benchmarked trend graphs and exceptions listed up front in easy-to-use format, ready for release by exception programs to reduce time to patients

Phaser has developed a baseline commissioning, qualification, and validation package for the Syn-Fill™ systems consisting of FAT, SAT, IOQ, PQ, and Media Fill Protocols.  As necessary, we can work with you to get the protocols modified to match your system’s customizations and develop leveraging strategies that can ultimately reduce the overall cost and time for the equipment CQV.

By implementing a Syn-Fill™ system you won’t have to:

• Perform as rigorous of Facility/Environmental qualification – Syn-Fill™ can be operated in a controlled non-classified space (CNC)
• Implement a Parts Washer and Autoclave:
  • No equipment C&Q
  • No cleaning/sterilization cycle development
  • No figuring out what a master load is and updating if processes change
  • No monitoring protocols or annual reports
  • No development of binders for operations to fill out
  • No routine requalification and revalidations (no false positive BIs, Fo calculations, failed cal in/outs)
• Develop and validate cleaning and sterilization of the Isolator/RABs

Reduce QC Workload and Improve Sterility Assurance

• Less Samples—Synchronous batch filling does not require redundant beginning, middle, and end sampling to have samples that are representative of the whole batch.
• Reduced Environmental Monitoring— and trending needed for closed process monitoring
• Improved Safety—Eliminate the risk of needle sticks, accidental contaminations, and sub-aliquoting

Headcount & Operating Costs Reduced Via:

• Fewer personnel required for operation
• Training time is minimal, and the system requires only basic operator intervention
• Shorter processing times
• Less support activities required (CIP, Sterilization, COP, Autoclaving, Gowning)
• Reduced QC and environmental sample testing

Facility throughput – Operations is tasked with trying to figure out how to get more throughput from the facility without interruption to production.

• Synchronous filling outpaces even multiple needle filling systems
• Minimal setup and line clearance time due to use of disposable flow paths
• Automated plunger positioning and simultaneous filling improve efficiency over manual or semi-automated methods
• Installation possible without interruption to ongoing facility operations
• Expandable to meet your current and future needs
• Flexible to enable systems to be swapped out easily for multiple product facilities

Simplified Operation, Reliable Performance, Less Downtime

Syn-Fill™ is designed to make manufacturing easier, safer, and more efficient.  By automating plunger control and sealing, it eliminates manual handling, reducing strain and fatigue.  Operators can set up and run the system with minimal training, while intuitive HMI-guided workflows ensure a smooth process from start to finish.  With fewer moving parts and built-in process reporting, maintenance is minimal, and uptime is maximized.

Easy to Learn, Easy to Use

• No manual plunger pulling or hand-sealing—reduces operator fatigue and repetitive motion strain
• HMI-guided workflows—step-by-step interface ensures smooth operation with less than an hour of training
• No specialized expertise needed—operators can quickly become proficient with minimal supervision

Reliable and Low-Maintenance

• Fewer moving parts = fewer failures—reduces downtime and simplifies maintenance
• Automated process monitoring—real-time tracking of pressure, fill volume, and sealing parameters
• Intelligent process reports—highlights operational issues before they impact production

Better Workplace, Smoother Production

• Quieter, cleaner, and safer—enclosed system reduces contamination risks and improves working conditions
• Fast changeovers—single-use components allow for quick batch transitions with no cleaning validation
• Consistent, repeatable performance—ensures every unit meets quality standards without operator variability

Less manual work, fewer disruptions, and a smoother, more efficient production process.

Reduce Costs, Accelerate Revenue, Scale Without Limits

Syn-Fill™ delivers a higher return on investment by cutting facility costs, reducing labor expenses, and eliminating the compliance risks associated with traditional isolator-based filling.  Its modular, scalable design moves effortlessly from early-stage development to full commercial production without costly infrastructure upgrades or long implementation timelines.

Lower Capital & Operating Costs

• No need for isolators, large cleanrooms, or extensive HVAC upgrades—eliminates multimillion-dollar facility investments
• Cuts labor costs—minimal operator intervention and reduced specialized staffing requirements
• Single-use system—no CIP/SIP cycles, no downtime for cleaning and re-tooling between runs

Faster Time-to-Market

• Deploy and validate in months, not years—start production faster and reduce time to profitability
• Seamless tech transfer from R&D to commercial scale—one filling approach that is inexpensive and fast enough to implement in early stages and robust/compliant enough for scaled production without need for process changes and associated filings
• Adapt on demand—reconfigure Syn-Fill™ for different batch sizes and container formats without facility modifications

Scalable Growth Without Bottlenecks

• Flexible manufacturing footprint—operate in shared or multi-product spaces without dedicated suites
• Parallel batch processing—increase throughput without adding infrastructure
• Risk-free expansion—grow capacity without long lead times or excessive CAPEX

Reduce capital spend, scale with agility, and bring products to market years ahead of competitors.

Higher Operator Safety and Lower Environmental Impact

SAFETY: The Syn-Fill™ comes pre-cleaned and sterilized, and does not require a cleanroom for maintaining sterility. The benefit of this for Personnel Safety includes:

• Chemical
  • Don’t need to be exposed to cleaning chemicals (e.g. Vaporized Hydrogen Peroxide, Isopropanol, Ethanol, Hydroxides, Acids, Ozone)
  • Don’t need to be exposed to facility cleaning agents (VesPhene, SPORKlenz, PAA)
• Physical
  • No need for physical sanitization technologies (e.g., Steaming, depyrogenation tunnels, UVB lights)
  • Interlocking doors that prevent operators from accessing the moving components to minimize risk of pinch points
  • Fully automated system reduces chances of crossing paths with
  • No need for operators to get on a ladder or platform to clean above tall isolator systems
  • No need for maintenance technicians to be on the roof to perform maintenance on air handlers
  • No washroom with slippery floors creating tripping and falling hazards
• Hazardous Products

The Syn-Fill™ system can be used for filling of Hazardous products (Chemicals, Radioactive substances, and Highly active substances). Using a closed manifold and automated operations, the system can be setup quickly with minimal risk of exposure, filled with minimal duration, and no personnel need to be adjacent to the system during filling.  At disconnection, the integrity of the final containers and the filling manifold are maintained, keeping the product segregated from the operator/environment.

ENVIRONMENTAL IMPACT:

• Less Utilities
  • With an already clean and sterile closed assembly, there is no need for using parts washers, ultrasonic baths, autoclaves, depyrogenation tunnels, water For Injection/purified water systems, CIP skids, and other equipment/steps that have high demand for water and energy.
  • With a closed process system, cleanrooms are necessary for maintaining sterility, which can result in reduced HVAC energy requirements
• Less Discharge
  • Without cleaning and sterilization there is less wastewater and no need for venting of vaporized hydrogen peroxide to rooftops
  • No risk of environmental release of hazardous products