Pharmaceutical isolator for contamination control
Ensure sterility and safety in pharmaceutical manufacturing with advanced isolation and contamination control, vital for handling high-potency ingredients and maintaining aseptic environments throughout critical processes like filling and dispensing.
Ensures Sterile Containment and Decontamination
The FCIS Pharmaceutical Isolator from Fedegari is engineered to address the stringent requirements of contamination control in biopharmaceutical environments. This isolator utilizes Fedegari’s proprietary Hydrogen Peroxide Vaporizer (FHPV) to maintain sterile conditions essential for aseptic filling and handling of high-potent ingredients. It employs a barrier system to separate operators from sensitive processes, ensuring compliance with FDA and GMP standards. The FCIS is designed for high-value formulations like sterile injectable drugs and APIs for vaccines. Its modular design can be customized, and the Thema4 process controller facilitates integration with SCADA systems. The unit features AISI stainless steel chambers with a double-gasket system for safety and H14 HEPA filters for air filtration. Operating within a grade A environment, it minimizes cross-contamination risks and operational costs by excluding proprietary consumables.
Benefits
- Ensures aseptic environments, reducing contamination risk in sterile product manufacturing.
- Lowers operational expenses by eliminating the need for proprietary consumables.
- Customizable design fits specific process requirements, enhancing flexibility.
- Provides process repeatability with constant vapor concentration monitoring.
- Meets international regulatory standards, facilitating global pharmaceutical compliance.
- Applications
- Api,Biopharmaceuticals,Pharmaceutical powder,High potent ingredients
- End products
- Sterile injectable drugs,Active pharmaceutical ingredients (apis) for vaccines,Antibody-drug conjugates,Biologic drug formulations,Hormonal tablets,High-potency active pharmaceutical ingredients (hpapis),Chemotherapy medications
- Steps before
- Biohazard handling,Powder dispensing,Preparation of API,Material transfer
- Steps after
- Aseptic filling,Sterile unloading,Contamination control,Product packaging
- Input ingredients
- API,High Potent Ingredients,Containers,Material
- Output ingredients
- Sterile materials,Aseptic products,Decontaminated surfaces
- Market info
- Fedegari is known for manufacturing high-quality sterilization and contamination control equipment for the pharmaceutical and biotech industries, offering engineered-to-order solutions with a strong reputation for innovation, reliability, and customer support.
- Material
- AISI stainless steel
- Surface Finishing
- Bright annealed (Ra ≤ 0.4 μm)
- Pressure Decay Leak Test
- Integrated
- Filtration System
- H14 HEPA filter
- Hydrogen Peroxide Vaporizer
- Fedegari HPV
- Vapor Concentration Monitoring
- ± 15 ppm
- Doors Protection
- Double gaskets system
- Automation
- Thema4 Process Controller
- Working mechanism
- Isolation with barrier technology
- Integrated steps
- Automatic decontamination cycle
- CIP/SIP capability
- Integrated Hydrogen Peroxide Vaporizer (HPV)
- Batch vs. continuous operation
- Batch
- Automation level
- Thema4 process controller,PLC
- Airflow control
- Filtered by H14 HEPA filter
- Cleaning method
- Chemical decontamination with H₂O₂
- Contamination Control
- Aseptic barrier isolation
- Biological compatibility
- FDA,EMA,WHO compliance
- Cleanability
- Easy to clean due to stainless steel
- Corrosive resistance (e.g. acids)
- AISI stainless steel
- Abrasion resistance
- Smooth surface with bright annealed finishing
- GMP Compliance
- EU cGMP,US cGMP,WHO
- FDA Materials
- Compliant for non-metallic components in contact with process fluids
- EN Standards
- EN 55011,EN IEC 61000-4-2,EN IEC 61000-4-4,EN IEC 60204-1
- European Directives
- 2014/30/EU,2014/35/EU,2006/95/EC
- UL Certification
- UL 508A,UL 61010-1
- NFPA Standards
- NFPA-79,NFPA 70
- Chamber material
- AISI stainless steel
- Surface finishing
- Bright annealed,Ra ≤ 0.4 μm
- Door sealing system
- Double gaskets
- Modular design
- Customizable and modular unit
- Size classification
- ISO5 US cGMP grade area (A)
- Modular design
- Customizable and modular unit manufactured according to customer's needs
- Control panel type
- Thema4 process controller
- Integration possibilities
- Integration with Thema4,SCADA,and MES systems
- Storage configuration
- Bespoke racking and storage to suit customer’s application