robocell - Gloveless filling machine for syringes, vials and cartridges

The robocell is ideal for pharmaceutical small-batch production, research and development, as well as CDMO environments. Its modular design, available in three standard configurations (optional capping, lyo loading, and renesting), allows for flexible adaptation to your specific needs.

Use cases:

• Filling small to medium batch sizes
• Individual batches and campaigns

The robocell is optimized for filling:

• Synthetic drugs (small molecules)
• Biological drugs (large molecules)
• Antibody-drug conjugates (ADCs)
• Orphan drugs
• Advanced therapy medicinal products (ATMPs), including cell and gene therapies

With the highest level of operator and product protection, the robocell meets all regulatory requirements for containment and aseptic processing, including various OEB and BSL levels.

The robocell offers maximum flexibility in pre-sterilized container selection:

• Syringes
• Cartridges
• Vials

Closure options include traditional stoppers, plungers, and alternative closures (e.g. push-fit caps), ensuring you're prepared for future demands.

The robocell was developed in parallel with the introduction of Annex 1, ensuring that all requirements are fully integrated into its design. Key features include:

• Integrated concept of filling line and isolator
• Continuous first air principle with laminar airflow
• Elimination of human interventions within the aseptic core
• Use of intelligent robotic solutions
• Safe aseptic transfer of indirect product-contact parts
• Support for a holistic Contamination Control Strategy (CCS)

The robocell combines proven technologies with future-oriented developments:

• Fast and reliable decontamination through optimized hygienic design and patented skanfog^® technology
• Optimized airflow circulation following the first air principle
• Evidence-based design through CFD analysis and validation with smoke studies
• Room-to-room ventilation system with integrated filtration stages and configurable pressure zones

In aseptic environments, humans are the greatest source of contamination and errors. The robocell was reimagined from the ground up to completely eliminate human interventions in core aseptic processes, maximizing sterility and process safety.

Automation design innovations include:

• Automated transfer of indirect product-contact parts after the decontamination cycle
• Automated installation of single-use filling paths and sterile filtration (including PUPSIT)
• Automated transfer and distribution of sedimentation plates
• Automated handling of active and passive viable air monitoring

All process steps are safeguarded by 100% in-process controls, virtually eliminating product loss. Additionally, lyophilization loading without glass-to-glass contact reliably prevents damage.