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GMP Cleaning, Isolation and Decontamination Systems for the Pharmaceutical Industries.

Multipurpose Isolator for Aseptic Processing

ASEPTICARE: A flexible, GMP-compliant aseptic environment for modern sterile manufacturing.

Asepticare is a high performance aseptic isolator system designed for pharmaceutical and biotech companies requiring robust contamination control and GMPcompliant sterile processing.

Engineered for flexibility, reliability and operator usability, asepticare provides a fully controlled sterile environment that enhances aseptic workflows across both aseptic and aseptic-toxic processing applications.

Flexible aseptic isolator for sterile processing

The Asepticare isolator supports critical aseptic processing steps, including component preparation, sterile formulation, as well as automatic or semi‑automatic sterile filling of vials, pre‑filled syringes and IV bags. Its modular architecture enables fast installation and validation of your isolator preferred configuration adapting  to diverse production requirements, from clinical supply to commercial GMP manufacturing.

Key application areas include:

  • Aseptic component preparation and sterile transfer
  • Controlled formulation processes in sterile environments
  • Small‑batch sterile filling and finishing
  • Biotech and pharmaceutical production lines requiring high contamination control

The highest hygienic design ensures consistent GMP compliance, delivering a reliable sterile environment for critical pharmaceutical operations.

Custom integration and scalable isolator solutions

Asepticare is engineered for seamless integration with process equipment and production systems, offering adaptable control interfaces for both manual and automated sterile workflows under the highest product protection conditions (EU GMP Grade A / ISO 5).

Whether addressing complex filling lines, high‑potency product handling or scalable production demands, Asepticare provides a platform that grows with your operational requirements.

Its flexible architecture enables integration with industry-standard automation, monitoring and data management tools, ensuring control, traceable processes with measurable performance outcomes.

Asepticare - Support for your sterile manufacturing goals

With Asepticare, you benefit from IWT’s decades of expertise in aseptic isolation technology, contamination control solutions, and GMP compliant systems for pharmaceutical production.

Our commitment to quality, engineering precision and lifecycle support helps pharmaceutical manufacturers achieve operational excellence and regulatory success.

Explore how Asepticare can enhance your aseptic processing and sterile filling operations - combining robust performance with flexible configuration for future‑ready sterile manufacturing environments.

Integrated fill-finish partnership with 3P innovation

IWT Pharma collaborates with 3P innovation to deliver fully integrated, Annex 1–compliant small-batch aseptic fill-finish solutions.

By combining Asepticare isolator technology with 3P innovation filling platforms, the partnership provides a compact and modular system tailored for clinical supply, development programs and small-scale GMP manufacturing.

This integrated approach brings together proven isolator expertise and precision filling technologies to support sterile liquids, powders and complex formulations within a closed, contamination-controlled environment aligned with the latest EU GMP Annex 1 requirements.

The result is a high-performance solution that reduces project complexity while ensuring regulatory compliance and operational efficiency.


Performance: engineered for aseptic excellence

Asepticare delivers unmatched performance for aseptic and aseptic-toxic operations, combining ultimate product protection with complete operator safety.

Key performance highlights:

  • Product safeguarded by unidirectional HEPA airflow
  • Operator protection through dual-stage HEPA filtration
  • Integrated catalytic H₂O₂ neutralization for safe, fast decontamination
  • Ultra-fast, validated automatic biodecontamination cycles

Every feature ensures consistent sterility, minimal risk, and reliable manufacturing performance.

Advanced automation and digital compliance

Asepticare automation architecture is developed according to current GAMP principles and fully aligned with international regulatory requirements, including EU GMP guidelines and 21 CFR Part 11.

The system provides a modern supervisory control environment supporting both manual and automated operations, with secure data management and full process traceability.

Automation features include:

  • SCADA-based supervisory control and monitoring
  • Industrial PLC platforms (Siemens or Allen-Bradley)
  • Industrial HMI interface with touchscreen control
  • User management via Active Directory integration
  • Electronic batch reporting and decontamination reports
  • Audit trail and electronic record management
  • Electronic signature capability
  • OPC communication interface for system integration

This digital infrastructure ensures regulatory compliance while enabling efficient process control and data integrity throughout the product lifecycle.

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