technical specifications genisys - ast · ast’s meticulous attention to aseptic design, selection...
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GENiSYS
• Automated processing of ready-to-fill vials, syringes and cartridges
• Accurate peristaltic and rotary piston dosing• Minimal change parts for quick change-over
between batches• Intuitive operator interface and controls
TABLETOP COMBINATION FILLING AND STOPPERING MACHINE
GENiSYSAST-INC.COM
4110 South Washington Street
Tacoma, Washington 98409
T: (253) 475-0200
Excellence in machine design & manufacturing since 1965
APPLICATIONS:• Small batch clinical & commercial manufacturing • R&D / Process Development• Compounding pharmacies
GENiSYS TECHNICAL SPECIFICATIONS
GENiSYS’ design provides advanced automated features to ensure that each and every filled container is handled with care and consistently produces a high quality product. Critical processes like filling, stoppering, container handling and nest positioning are servo controlled to accurately position and process every container during production, and to provide recipe driven flexibility.
Nests of ready-to-fill vials, syringes or cartridges are placed an X-Y table that will automatically position each container for the filling and stoppering process. Careful attention was given to the indexing motion and design to gently handle the product and to eliminate common quality challenges related to glass-to-glass and glass-on-metal contact during production.
The filling and stoppering processes maximize the use of pre-sterilized disposable tubing sets to allow the machine to be setup quickly and to minimize contamination risks. The filling and stoppering systems have integrated nozzles for inert gas purging before and after filling and can also be used during the stoppering process. The unique design of the stoppering system allows multiple syringe and cartridge insertion options including; vent-tube and vacuum stoppering.
To maximize product yield and quality GENiSYS can be integrated with an in-process weight verification system. The container is removed from the nest and placed on a high resolution load cell to accurately measure the product within the container. The dosing accuracy is calibrated if required automatically and the fill volume can be recorded in the Electronic Batch Record (EBR) system.
The vibratory bowl automatically orients and positions stoppers for repeatable pick and place operation. The vibratory system is tool-less and allows for specific bowls that orient various types of sizes and designs of pistons, stoppers and plungers.
Preparing the GENiSYS for a new container setup is an easy task. All format parts are laser marked for easy identification and required no tools. Changing over the machine can be done in under 15 minutes by a trained operator.
SPECIFICATIONSDimensions (LxWxH): 60” x 24” x 32” [1524mm x 610mm x 813mm]Containers: Pre-Sterilized Vials, Syringes & CartridgesVial Sizes: 2mL – 20mL (ISO 2R – 20R)Vial Stopper: Ø13mm & 20mm injection and lyo stoppersSyringe Sizes: 0.5mL – 20mLCartridge Sizes: 3mLProduction Rate: Up to 25 units per minutePump Options: Peristaltic & Rotary PistonFilling Volume: 0.1mL – 100mLFilling Accuracy: Up to ±0.5%Syringe/Cartridge Vacuum & Vent-TubeStoppering:Electrical Utilities: 110/230VAC – 50/60Hz.Power Consumption: Max. 1200WVacuum Utilities: 6 SCFM @ 925mbar Materials: Pharmaceutical grade stainless steel & plasticsOperator Interface: 10” high resolution color touchscreenWeight: Approx. 250kgAvailable Options: • In-process fill weight verification (IPC) • Inert gas purging • Electronic batch record (EBR) system • Isolator, RABS or LAF integration
53.5” (1359mm)
24.5
” (6
22m
m)
32”
(812
mm
)
61” (1550mm)
53.5” (1359mm)
24.5
” (6
22m
m)
32”
(812
mm
)
GENiSYS is an advanced combination tabletop filling
system for automated aseptic processing of nested,
ready-to-fill vials, syringes and cartridges. GENiSYS
provides all the automated features typical of larger scale
filling lines but in a compact footprint making it ideal for
use in small scale filling applications for R&D process
development, niche product manufacturing, clinical filling,
and compound pharmacies.
GENiSYS’ compact footprint and design makes integrating
the system with an isolator, RABS or LAF cabinet simple
and is available with standard isolator-barrier options.
AST’s meticulous attention to aseptic design, selection of
the materials and surfaces has been done to ensure that
the system meets cGMP standards for aseptic processing.
GENiSYS features AST View providing fully integrated
operator controls that are 21 CFR Part 11 compliant. The
10” high resolution color touchscreen interface provides
the operator intuitive control of all automated functions
for the system. From the interface the operator can
access system recipes, instructional SOP’s, a complete
troubleshooting guide, and an optional Electronic Batch
Record (EBR) system that records all processing data
during production.
GENiSYS TABLETOP COMBINATION FILLING AND STOPPERING MACHINE
• Up to 25 containers per minute• Fast and easy change-over• High accuracy product dosing• Optional fully integrated in-process weight check system• Automated processing of ready-to-fill vials, syringes & cartridges
KEY FEATURES& BENEFITS
• Multiple syringe and cartridge stoppering options• Compact footprint• 21 CFR Part 11 compliant• Option available for isolator integration• High resolution color touchscreen interface
• No tools need for format changes• Optional Electronic Batch Record (EBR) System• IQ/OQ documentation can be provided
GENiSYS can be integrated with peristaltic or rotary piston pumps for accurate and
gentle product dosing. The design of the dosing system was careful considered to
minimize product waste and is the only tabletop system available with an integrated
In-Process Control (IPC) system that can automatically weigh the volume of the dosed
container. The IPC system can perform statistical to 100% weighing of each container
filled. The pumps integrated with the IPC system minimize product waste common to
the beginning and end of batch operations.
GENiSYS offers the most flexible stoppering options available for plugging and closing vials, syringes and cartridges for
a tabletop machine. Its unique design allows for syringes and cartridge pistons to be inserted using vacuum or vent-tube
options, and vials can be fully or partially stoppered. By offering conventional stoppering processes at a bench scale, makes
tech transfer and scale-up simple and straight forward.
GENiSYS is an advanced combination tabletop filling
system for automated aseptic processing of nested,
ready-to-fill vials, syringes and cartridges. GENiSYS
provides all the automated features typical of larger scale
filling lines but in a compact footprint making it ideal for
use in small scale filling applications for R&D process
development, niche product manufacturing, clinical filling,
and compound pharmacies.
GENiSYS’ compact footprint and design makes integrating
the system with an isolator, RABS or LAF cabinet simple
and is available with standard isolator-barrier options.
AST’s meticulous attention to aseptic design, selection of
the materials and surfaces has been done to ensure that
the system meets cGMP standards for aseptic processing.
GENiSYS features AST View providing fully integrated
operator controls that are 21 CFR Part 11 compliant. The
10” high resolution color touchscreen interface provides
the operator intuitive control of all automated functions
for the system. From the interface the operator can
access system recipes, instructional SOP’s, a complete
troubleshooting guide, and an optional Electronic Batch
Record (EBR) system that records all processing data
during production.
GENiSYS TABLETOP COMBINATION FILLING AND STOPPERING MACHINE
• Up to 25 containers per minute• Fast and easy change-over• High accuracy product dosing• Optional fully integrated in-process weight check system• Automated processing of ready-to-fill vials, syringes & cartridges
KEY FEATURES& BENEFITS
• Multiple syringe and cartridge stoppering options• Compact footprint• 21 CFR Part 11 compliant• Option available for isolator integration• High resolution color touchscreen interface
• No tools need for format changes• Optional Electronic Batch Record (EBR) System• IQ/OQ documentation can be provided
GENiSYS can be integrated with peristaltic or rotary piston pumps for accurate and
gentle product dosing. The design of the dosing system was careful considered to
minimize product waste and is the only tabletop system available with an integrated
In-Process Control (IPC) system that can automatically weigh the volume of the dosed
container. The IPC system can perform statistical to 100% weighing of each container
filled. The pumps integrated with the IPC system minimize product waste common to
the beginning and end of batch operations.
GENiSYS offers the most flexible stoppering options available for plugging and closing vials, syringes and cartridges for
a tabletop machine. Its unique design allows for syringes and cartridge pistons to be inserted using vacuum or vent-tube
options, and vials can be fully or partially stoppered. By offering conventional stoppering processes at a bench scale, makes
tech transfer and scale-up simple and straight forward.
GENiSYS
• Automated processing of ready-to-fill vials, syringes and cartridges
• Accurate peristaltic and rotary piston dosing• Minimal change parts for quick change-over
between batches• Intuitive operator interface and controls
TABLETOP COMBINATION FILLING AND STOPPERING MACHINE
GENiSYSAST-INC.COM
4110 South Washington Street
Tacoma, Washington 98409
T: (253) 475-0200
Excellence in machine design & manufacturing since 1965
APPLICATIONS:• Small batch clinical & commercial manufacturing • R&D / Process Development• Compounding pharmacies
GENiSYS TECHNICAL SPECIFICATIONS
GENiSYS’ design provides advanced automated features to ensure that each and every filled container is handled with care and consistently produces a high quality product. Critical processes like filling, stoppering, container handling and nest positioning are servo controlled to accurately position and process every container during production, and to provide recipe driven flexibility.
Nests of ready-to-fill vials, syringes or cartridges are placed an X-Y table that will automatically position each container for the filling and stoppering process. Careful attention was given to the indexing motion and design to gently handle the product and to eliminate common quality challenges related to glass-to-glass and glass-on-metal contact during production.
The filling and stoppering processes maximize the use of pre-sterilized disposable tubing sets to allow the machine to be setup quickly and to minimize contamination risks. The filling and stoppering systems have integrated nozzles for inert gas purging before and after filling and can also be used during the stoppering process. The unique design of the stoppering system allows multiple syringe and cartridge insertion options including; vent-tube and vacuum stoppering.
To maximize product yield and quality GENiSYS can be integrated with an in-process weight verification system. The container is removed from the nest and placed on a high resolution load cell to accurately measure the product within the container. The dosing accuracy is calibrated if required automatically and the fill volume can be recorded in the Electronic Batch Record (EBR) system.
The vibratory bowl automatically orients and positions stoppers for repeatable pick and place operation. The vibratory system is tool-less and allows for specific bowls that orient various types of sizes and designs of pistons, stoppers and plungers.
Preparing the GENiSYS for a new container setup is an easy task. All format parts are laser marked for easy identification and required no tools. Changing over the machine can be done in under 15 minutes by a trained operator.
SPECIFICATIONSDimensions (LxWxH): 60” x 24” x 32” [1524mm x 610mm x 813mm]Containers: Pre-Sterilized Vials, Syringes & CartridgesVial Sizes: 2mL – 20mL (ISO 2R – 20R)Vial Stopper: Ø13mm & 20mm injection and lyo stoppersSyringe Sizes: 0.5mL – 20mLCartridge Sizes: 3mLProduction Rate: Up to 25 units per minutePump Options: Peristaltic & Rotary PistonFilling Volume: 0.1mL – 100mLFilling Accuracy: Up to ±0.5%Syringe/Cartridge Vacuum & Vent-TubeStoppering:Electrical Utilities: 110/230VAC – 50/60Hz.Power Consumption: Max. 1200WVacuum Utilities: 6 SCFM @ 925mbar Materials: Pharmaceutical grade stainless steel & plasticsOperator Interface: 10” high resolution color touchscreenWeight: Approx. 250kgAvailable Options: • In-process fill weight verification (IPC) • Inert gas purging • Electronic batch record (EBR) system • Isolator, RABS or LAF integration
53.5” (1359mm)
24.5
” (6
22m
m)
32”
(812
mm
)
61” (1550mm)
53.5” (1359mm)
24.5
” (6
22m
m)
32”
(812
mm
)