Aseptic filling isolator for small cgmp batches
Guarantee aseptic integrity for small-scale batches with this isolator, offering rapid decontamination and precise filling for personalized medicine and vaccine production. Perfectly integrating into existing lines, it enhances operational efficiency while ensuring compliance with stringent cleanliness standards.
Performs Aseptic Filling, Sealing, and Capping
The Pure M1 from SKAN Group and Aseptic Technologies is an isolated fill & finish unit engineered for the precise aseptic filling of small and extra-small cGMP batches. This unit integrates the AT-Closed Vial® technology within the Pure isolator shell by SKAN, combining manual filling equipment, a rapid material airlock, and an exit laminar airflow system. Ideal for biopharmaceutical, cell, and gene therapy applications, the Pure M1 efficiently handles tasks such as filling, sealing, and capping, producing end-products like personalized medicine vials and cell therapy infusions.
Featuring a peristaltic pump dosing system calibrated by an integrated weighing cell, the Pure M1 ensures high dosing accuracy. The unit requires no connection to the HVAC system and offers fast decontamination cycles using innovative H2O2 techniques. Its intuitive batch status tracking is displayed live, enhancing operational transparency.
Designed with process ergonomics in mind, the Pure M1 facilitates seamless integration into GMP environments without extensive infrastructure modifications. It adheres to all necessary compliance and validation procedures, ensuring reliable and consistent performance in contamination-sensitive settings.
Benefits
- Enhances contamination control with integrated isolator technology, ensuring product safety.
- Streamlines small batch production with rapid setup and operation, saving time.
- Minimizes infrastructure modifications by eliminating HVAC connection requirements.
- Boosts dosing accuracy and consistency with precise peristaltic pump and weighing cell integration.
- Simplifies in-house aseptic filling and capping processes, reducing outsourcing dependency.
- Applications
- Cell,Next generation biologics,Compounding,Biopharmaceuticals,Gene therapy,Aseptic filling
- End products
- Gene therapy injectables,Cell therapy infusions,Oncology drug formulations,Monoclonal antibodies,Custom pharmaceutical compounding solutions,Personalized medicine vials,Pre-filled aseptic syringes,Small batch vaccines
- Steps before
- Product preparation,Aseptic liquid connection setup,Material decontamination
- Steps after
- Vial sealing,Capping,Final inspection,Batch status recording,Packaging
- Input ingredients
- bulk product,AT-Closed Vial®,AT-CryoBox™,AT-Cap™,fluid path AT-Filling Kit™,aseptic liquid connector,AT-Port™ System
- Output ingredients
- filled vials,AT-CryoBox™
- Market info
- Aseptic Technologies is known for its innovative solutions in the field of aseptic filling and finishing systems. They specialize in advanced equipment designed for sterile manufacturing processes, particularly in the pharmaceutical and biotech industries.
- Batch size
- Small and extra-small cGMP batches
- Filling volume
- 0.1 ml to 50 ml
- Automation
- Semi-automated
- Decontamination cycle
- Fast H₂O₂ decontamination
- Batch status tracking
- Live demonstration on built-in screen
- Connection to bulk product
- Aseptic liquid connector
- Filling method
- AT-Closed Vial® technology
- Isolator design
- Ergonomic and space-saving
- Working mechanism
- Semi-automated filling
- Batch vs. continuous operation
- Batch
- Automated process steps
- Filling and capping
- Decontamination cycles
- Fast cycles with H2O2
- Ergonomic design
- Space saving
- Integration level
- Plug and play
- Biological compatibility
- cGMP compliant
- Cleanability
- Validated cleaning procedures
- GMP Compliance
- Yes
- ISO Cleanroom Classification
- ISO 7 / ISO 8
- Compact footprint
- Yes
- Machine footprint
- Space-saving design
- Control panel type
- Built-in screen
- Discharge method
- Exit laminar airflow
- Ergonomic design
- Yes
- Control panel type
- Built-in screen
- Discharge method
- Continuous exit laminar airflow
- Compact footprint
- Space-saving design