Semi-automatic filling machine spectra M1

computer-controlledperistalticmodular

Overview
spectra M1 is an isolated AT-Closed Vial® filling system designed for isolated fill and finish operations for small GMP batches. The unit enables a fully closed aseptic filling process with a capacity up to 150 vials per hour and filling volumes from 0.1 ml to 45 ml.

Key data

• Containers: AT-Closed Vial®
• Output: Up to 150 vials/hour
• Filling volume range: 0.1–45 ml
• Filling line type: AT (AT-Closed Vial® technology)

Application

• Closed aseptic filling for clinical and small-scale GMP manufacturing of injectable drugs
• Adaptable to cell and gene therapy workflows
• R&D and small-batch production with modular configurable layouts

Fill finish ecosystem
The AT-Closed Vial® ecosystem enables a fully closed aseptic filling process. Core components: AT-Closed Vial® primary packaging, AT-Cap closure, compatible filling lines and the AT-Assembly single-use system for sterile liquid transfer. All components are aligned for contamination-controlled, scalable processes.

Main features

• Semi-automated operation for efficient small-batch processing
• Isolator with integrated skanfog H2O2 decontamination and nanox catalyst for validated sterility
• Compliance support: Annex 1-oriented process design and 21 CFR Part 11 features
• Operator and product protection via safe-change filters and isolator architecture
• Validated AT-Closed Vial® process ensuring Container Closure Integrity (CCI)
• High filling accuracy: peristaltic pump with integrated weighing cell
• Tool-less format changeovers for different vial sizes
• Automated skanfog for reduced decontamination downtime

Process (simplified)

• 1. Material introduction via rapid decontamination airlock
• 2. Product connection through the AT-Port, allowing external cooling/mixing
• 3. Filling: vials on supports are pierced and filled by peristaltic pump; integrated weighing cell used for calibration
• 4. Laser resealing: ~1-second laser shot to restore container integrity
• 5. Capping and monitoring: snap-fit AT-Cap applied; batch data displayed on built-in screen
• 6. Exit: filled vials removed continuously through controlled laminar airflow exit

Product highlights

• Minimized contamination risk: AT-Closed Vial® remains functionally closed throughout filling
• Designed for smooth scale-up from R&D to GMP without changing the core process
• Short validated decontamination cycles using skanfog H2O2 micro-nebulization (approx. 1 hour)

Regulatory & validation

• Annex 1-compliant process design to minimize interventions
• CCI validated using dye ingress, CT and headspace analysis
• Delivered with validation master plan and complete test package for AT-Closed Vial®
• Automation/SCADA includes batch tracking, audit trail, electronic records & signatures

FAQ summary

• Main application: aseptic filling of injectable drugs in small GMP batches
• AT-Closed Vial® role: secure filling, laser resealing and snap-fit capping to ensure CCI
• Regulatory standards: GMP, Annex 1 and 21 CFR Part 11 compliant automation features
• Aseptic-toxic capability: isolator configurable for operator/product protection, suitable for oncology drugs

Specifications

• Model: spectra M1
• Brand: SKAN
• Output: Up to 150 AT-Closed Vial® per hour
• Filling volume: 0.1 ml to 45 ml
• Containers supported: AT-Closed Vial®
• Filling principle: peristaltic pump with integrated weighing cell
• Filling line: AT (AT-Closed Vial® technology)
• Working chamber cleanliness: Grade A (ISO 5)
• Cleanroom requirement: Grade C/D
• Decontamination: integrated skanfog H2O2 system and nanox catalyst
• Transfer systems: AT-Port and rapid airlock with integrated H2O2 decontamination
• Consumables: single-use AT-Assembly fluid paths
• Resealing: laser resealing (~1-second)
• Closure: snap-fit AT-Cap
• Automation/SCADA: batch tracking, audit trail, electronic records & signatures
• Compliance: Annex 1-oriented design; 21 CFR Part 11 support; GAMP-compliant automation
• Validation support: validation master plan and full test package
• Format changes: tool-less format changeovers