Next-Generation Containment Isolators for Pharmaceutical Processing
Containment isolators are a specialized type of pharmaceutical isolators, designed to provide controlled environments for safely handling high-potency active pharmaceutical ingredients (HPAPI), toxic substances, hydrophobic and/or potent compounds in pharmaceutical processing. They must ensure operator safety, product integrity, and compliance with global regulatory standards by preventing exposure to hazardous compounds while ensuring pharmaceutical product quality.
Key Features & Benefits of FPS Pharma Containment Isolators
FPS Pharma containment isolators are custom engineered to exactly meet customers’ requirements. Thanks to the unique design, ergonomics and integrated systems, FPS Pharma ensures utmost safety and seamless integration into existing processes and equipment.
Smart by design:
- Tailored engineered to meet customer’s requirements and to ensure seamless integration into pharmaceutical production plant and process equipment.
- Compact and ergonomic design to optimize space while ensuring the best comfort for operators.
- Efficient equipment integration for enhanced operability.
- ATEX / IECEx or NFPA compliance for explosion-proof environments.
- Equipped with gloves or fully robotics for optimal handling depending on the process.
Inspection-Proof Compliance for Global Regulatory Standards
Regulatory compliance is non-negotiable in pharmaceutical processing. FPS containment isolators guarantee:
- Inspection-proof compliance with global standards, including FDA, EMA, OSHA, ISO 14644 ISPE Containment Guidelines, NIOSH Guidelines and cGMP regulations for flawless inspections and faster regulatory approvals.
- Highest containment levels (up to OEB 7), FPS Pharma superior containment minimizes exposure risks for operators, ensuring a safe work environment.
- Impeccable installation and full validation (IQ/OQ/PQ) at customer’s site.
Superior Containment & Cross-Contamination Prevention
FPS high containment isolators feature advanced airflow distribution and smart cleaning designs to eliminate cross-contamination risks.
- HEPA or ULPA filters to ensure air purity.
- Easy cleaning processes (integrated CIP or WIP depending on customer’s requirements) to minimize downtime.
- Best-in-class protection during critical operations, from 10 μg/m³ to single-digit nanogram levels and even below.
Advanced Process Control, Robotics & Technology Integration
FPS containment isolators incorporate cutting-edge technology to enhance efficiency and monitoring capabilities in pharmaceutical processing.
- Full process control with precise real-time monitoring of critical internal conditions.
- Integrated advanced features such as automation, AI voice-control, robotics, and real-time monitoring systems.
Industry Applications & Specialized Containment Isolators
HPAPI & ADC Production
FPS has established itself as a trusted partner for leading pharmaceutical manufacturers and CDMOs worldwide through long-term collaboration and a deep understanding of customers’ specific HPAPI and ADC manufacturing. Also FPS has close partnerships with OEMs of pharmaceutical process equipment and designs isolators that integrate their systems.
Whether scaling up from small-volume or managing large-volume production, these isolators are ideal for every pharmaceutical application such as:
- Laboratory applications
- Sampling
- Weighing and dispensing
- Reactor Charging
- Filtration & Drying
- Process vessels charging / discharging
- ANFD (Agitated Nutsche Filter Dryers)
- Milling
- Micronization
- Formulation
- Packaging
- Primary Function: containment isolators provide a physical barrier to protect operators against hazardous compounds and potent APIs, while aseptic isolators ensure sterile drug production to ensure product sterility by preventing its contamination.
- Crucial in HPAPI processing, ADC manufacturing, and pharmaceutical potent formulation, rather than general cleanroom operations.
- Pressure Control: operate under negative pressure to prevent hazardous leaks, whereas aseptic isolators use positive pressure for sterility.
