Pharmaceutical laboratory isolator Customized process isolator

for highly potent active pharmaceutical ingredientsasepticsterile

Overview
Customized isolator systems designed for aseptic and aseptic‑to‑toxic process steps in (bio‑)pharmaceutical and API manufacturing. Engineered to combine validated sterility, flexible process integration and optional containment up to OEB 6.

Key features

• Validated sterility via robust H₂O₂ decontamination (skanfog micro‑nebulization or SIS vaporization), HEPA H14 filtration and controlled unidirectional airflow.
• Proven >6‑log decontamination on complex surfaces and catalytic H₂O₂ decomposition for safe exhaust.
• Modular integration for scales, mixing vessels, dosing pumps, single‑use assemblies and robotic systems.
• Validated material transfer: rapid transfer ports (RTPs), decontamination airlocks and validated transfer interfaces.
• Flexible pressure cascade: overpressure for aseptic operations, underpressure for highly potent substances.
• SCADA/PLC control, audit trail and GMP‑compliant data recording for regulatory traceability.

Applications

• Aseptic manufacturing steps for (bio‑)pharmaceuticals, sterile APIs and sterile drug product processing.
• Powder handling: weighing, formulation, blending, compounding and closed transfers.
• Support operations: sterile sampling, sterile connections, component transfer and open product handling within a controlled environment.

Process workflow (typical steps)

• Material introduction via RTPs or rapid decontamination airlocks followed by H₂O₂ decontamination.
• Transfer to workstations or integrated dosing/feeding units with validated interfaces.
• High‑precision weighing and dosing using integrated scales and closed transfer solutions.
• Aseptic formulation/compounding with in‑chamber mixing vessels or single‑use assemblies.
• Continuous monitoring of airflow, particle counts and pressure differentials during processing.
• Validated transfer to downstream sterile filtration, bulk storage or aseptic filling.

Automation

• Integration of robotic systems to automate repetitive tasks and reduce manual interventions.
• HMI with Beckhoff IPC and multitouch display; PLC control (Siemens or Allen‑Bradley) and SCADA (WinCC, Zenon, FactoryTalk).
• IT integration: Active Directory, audit trails and alignment with 21 CFR Part 11 / GAMP for data integrity.

Regulatory assurance

• Designed and validated to current EU‑GMP guidelines including Annex 1; full documentation to support IQ/OQ/PQ and regulatory submissions.
• End‑to‑end sterility assurance strategy: validated decontamination, glove management, transfer concepts and monitoring procedures.

Product highlights

• Modular architecture enabling phased installations and addition of process equipment and automation.
• Early‑stage project support: concept studies, CFD airflow analysis and cleaning strategy development.
• Advanced air handling with HEPA H14 filters, unidirectional flow and catalytic H₂O₂ decomposition for rapid safe exhaust.

Technical specifications

• Working chamber classification: EU‑GMP Grade A (ISO 5).
• Decontamination: H₂O₂ (skanfog micro‑nebulization or SIS vaporization); validated >6‑log on complex surfaces.
• Filtration: HEPA H14 covering process area.
• Airflow: unidirectional, CFD‑optimized flow design.
• Exhaust: direct to room with SKAN nanox catalyst for H₂O₂ decomposition.
• Pressure concept: flexible cascades; overpressure for aseptic, underpressure for potent handling.
• Containment: optional up to OEB 6.
• Material transfer: RTPs, rapid decontamination airlocks and validated transfer solutions.
• Automation & control: HMI (Beckhoff IPC + multitouch), PLC (Siemens/Allen‑Bradley), SCADA (WinCC, Zenon, FactoryTalk); 21 CFR Part 11 compliance and GMP data recording.
• Process integrations: scales, mixing vessels, dosing pumps, single‑use systems, robotic systems and integrated process workstations.