Baby Phill
Compact Aseptic Vial Filling System

Highlights

• Modular platform for automatic filling of small batch
• Aseptic environment (Grade A) – ISO5
• Containment barrier for Highly Potent drugs
• Filling speed: up to 50 pcs/min
• Filling accuracy: +/- 0.5%
• IPC 100% check weighing
• No Vial – No Fill system
• Flexible closure system compatible with Stopper / AluCap / PushFitCap
• Reject station (camera for stopper/caps)
• Plug and Play
• Illuminate™ MI: IIoT manufacturing intelligence platform and factory-floor management

BABY PHILL is conceived for any customer who need a Plug&Play technology who require a short product placement on the market. The 100% IPC control of the dosing guarantee a high quality of the final product.

The newest model of BABY PHILL has seen a deep redesign, with increased speed up to 3.000 vial/h (based on 10ml/10R and 8ml filling volume).
BABY PHILL is designed for filling of RTU ( ready to use) vials in trays.
BABY PHILL can also be connected with small vial washing machine and depyrogenation tunnel for bulk production.

Key performance values for fill finishing

	Short lead time Pre-Designed Fast manufacturing		Proven Technology Best In Class – GMP Guidelines adherence Robustness Isolators & Filling machine
	Small Footprint Compact Modular design Easy to replicate also in limited spaces		Flexibility Suitable for different Products Suitable for different Process

Product & Packaging Material

• The BABY PHILL has been specifically designed for Aseptic Liquid Filling
• It can be used for small batches, with RTU Vials in trays
• As alternative it can be linked to Washing machine & Depyrogenation tunnel, for medium size batches
• Automatic or semi automatic loading and accumulation of vials on rotating table
• Wide range of vials can be adopted, with minimum format changes and short time impact

A real smart approach

Thanks to its modular design, the filling line is available with different possible configurations in order to fulfil the requirements of different production needs.

Bag Removal & No Touch Transfer

• ORABS for Debagging & No-Touch-Transfer or Vial Washer & Depyrogenation Tunnel
• Fast Decontamination Chamber
• Easy waste bag management
• Tray Inversion System
• Manual or Automatic feeding

Vial Feeding & Rotating Table

• Manual feeding from NTT, or direct link with Washing machine & Tunnel
• Minimum and max load sensors
• Central opening for better air flow, less turbulence
• Servo driven, adjustable speed
• Easy change over of format parts
• Vial trap and reject station for upside-down vials
• Walking beam entrance with vial optical counter

Filling & Stoppering

• Linear Transport System, walking beam
• Peristaltic or Volumetric Piston Pumps, or both
• No Vial – No Fill function
• 100% IPC with Load Cells (tare & gross)
• Nitrogen Injection, during and/or after filling
• Pick & Place Stoppering System, with stopper presence detection
• Independently Servo Driven Filling function
• 1 + 1 Filling pump, for double shot filling (large volume > 20ml)
• Independent filling volume per each pump, adjustable from HMI
• Easy change over, from piston to peristaltic (both systems)
• Diving needle holder, bottom-up filling available
• Priming function included, with less product loss (fill to weight)

Capping Station

• Suitable for Flip-off, Tear-Off or Press-on Caps
• Idle Ring sealing System, less particles generation
• Partition wall between filling-stoppering & capping station, with mouse hole
• Cap presence detection No Vial – No Stopper – No Cap function
• Suitable for all format size, 2R-100R
• Pressure control during capping available as option

Reject Station & Exit on Trays

• After Cap sealing an indexing star wheel separate the good vials from the sample vials and the eventually rejected vials (no stoper; no cap; out of tolerance)
• The vials are directed to a dedicated RTP port, connected with waste bag or a sampling container
• The good product is accumulated at the machine outfeed on a removable tray

Integrated Solution With Isolator Barrier Technology

• Possibility to operate in Positive or Negative pressure regime (monitoring & alarms)
• Airborne Particulate cleanliness classification: ISO 5 for internal environment
• Laminar Air flow system (Zero Frame) for 0,45m/s
• HEPA or ULPA filtered air supply
• Recirculation up to 70% of the air flow
• Continuous Monitoring: Diff. Pressure, Temp, RH%
• Preliminary CFD Engineering Study

What makes Baby Phill special?

• Extremely reduced footprint, so it can be easily fit in your existing lab
• Plug-and-play design, suitable for fast installation and start production
• All-in-one system, so all key features are included as standard
• Different dosing systems available, peristaltic or piston pumps
• Best integration within isolation technology, as Comecer designs and manufactures both
• Fast change over between batches, to make the most of your investment and time
• Possibility to integrate and connect with Freeze Dryer System
• Outstanding value proposition, in terms of flexibility, overall quality, price and readiness on the market

Customized configurations

The Baby Phill can be configured with different upstream and downstream ancillary systems to build the complete package. From the vial loading prechamber, the washing and depyrogenation systems, to vial outlet, the different solutions are implemented in order to fully address the specific applications.

Optional equipment

• Class A Isolator or RABS
• “Speedy Glove” glove integrity testing device
• Loading chamber
• Unloading chamber lyophilizer charging/discharging
• Integrated lyophilizer
• Sterilization and depyrogenation tunnel
• Vial washing machine
• Integrated VPHP generator for automatic decontamination
• HVAC for independent air treatment (RH & T)