Pharmaceutical Aseptic Filling Equipment
AST’s ASEPTiCell® and GENiSYS® systems combine industry-proven technologies such as robotics and isolator-barrier systems to provide flexible pharmaceutical aseptic filling and closing of ready-to-use vials, syringes, and cartridges with a single machine. These innovative platforms use a modular design approach to provide a truly adaptive system with the capabilities and features necessary for cGMP production of clinical and commercial sterile injectable products.
The current and future wave of pharmaceutical and biotechnology products is making historical aseptic filling machine manufacturing methodologies inadequate and antiquated. Traditional production processes used for high-volume drug products are stressed to efficiently meet the production requirements of targeted medicines that dominate today’s clinical pipelines. To address the production and quality requirements these products demand, traditional production processes must be rethought and redeveloped. Recognizing these trends, AST has developed advanced automated aseptic pharmaceutical filling machines dedicated to providing flexible and efficient production of sterile injectables in vials, syringes, and cartridges.
ASEPTiCell® is a robotic pharmaceutical aseptic filling and closing system designed for commercial and clinical drug products. The system is an adaptive platform capable of filling and closing ready-to-use vials, syringes, and cartridges on a single integrated platform. The ASEPTiCell uses standard modules that can be easily configured to quickly tailor a system that meets each application’s unique requirements, without the cost of customization. Standard modules and capabilities of the system include:
- Complete “no-touch” processing of ready-to-use vials, syringes, and cartridges up to 100 containers per minute
- Modules for bag and tub opening, automatic filling and closing, lyophilization, and vial capping
- Multiple integrated barrier system options including Restricted Access Barrier Systems (RABS) and aseptic isolators
GENiSYS® R is an adaptive aseptic pharmaceutical filling and closing equipment designed specifically to address the unique processing challenges posed by small-batch applications such as cell, gene, and regenerative therapies. GENiSYS R has a unique blend of automated capabilities that maximize product yield and ensures each container is processed in strict accordance with cGMP requirements. The system has the flexibility to easily handle variations in process requirements and container options alike. With the ability to process ready-to-use vials, syringes, and cartridges, the GENiSYS R helps bring products to market quickly and cost-effectively. Some of the capabilities and features of the GENiSYS R include:
- Flexible filling and closing of ready-to-use vials, syringes, and cartridges up to 20 containers per minute
- Perform 100% fill weight check with minimal reduction in overall output
- Integrated modules for bag opening, automatic filling and closing, lyophilization and vial capping
- Multiple integrated barrier system options including Restricted Access Barrier Systems (RABS) and aseptic isolators