Cleanroom air filtration unit for pharmaceutical production
Ensure sterile integrity in your manufacturing process with customizable cleanroom filtration solutions, ideal for maintaining contamination control during critical sampling and dispensing operations.
Controls Contamination and Provides Cleanroom Isolation
The FMF Unidirectional Flow Fan Filter Modules from Fedegari provide an essential solution for maintaining cleanroom environments essential in pharmaceutical and bio-pharmaceutical industries. This modular system utilizes vertical airflow to protect critical areas, ensuring ISO 5 cleanliness (Grade A – EU CGMP) by maintaining higher pressure inside the cleanroom than its surroundings, preventing contamination for processes such as injectable medication production and API isolation. With AISI 304 stainless steel casings, these units offer flexibility in installation, including options for suspension, ceiling grid mounting, or support legs. FMF integrates seamlessly with existing systems, allowing customizable configurations to meet specific production requirements.
Each module employs G3/G4 efficiency pre-filters, alongside H14 efficiency filters, optimizing airflow control and ensuring precise particulate containment. Designed for integration and customization, Fedegari’s FMF modules boast compliance with international standards, including GMP and FDA guidelines, ensuring safe and efficient operations across various applications. Enhanced energy efficiency is achieved through the use of efficient fans and adjustable airflow features, contributing to a reduced total cost of ownership. These units are perfect for pharmaceutical manufacturers concerned with maintaining stringent contamination control and sterile production conditions.
Benefits
- Maintains ISO 5 cleanroom conditions, preventing contamination and ensuring product purity.
- Customizable installations accommodate unique production layouts for optimal space utilization.
- Reduces energy costs with efficient airflow management and adjustable fan speeds.
- Compliant with GMP and FDA standards, ensuring regulatory adherence for pharmaceutical applications.
- Enhances operational efficiency with modular design for seamless integration into existing systems.
- Applications
- Chemicals,Biopharmaceuticals,Pharmaceutical powder,Fine chemicals
- End products
- Bulk antibiotics,Antiseptic solutions,Cytotoxic compounds,Lyophilized drugs,Chemical reagents,Active pharmaceutical ingredients (apis),Sterile powders,Injectable medications,Vaccine components
- Steps before
- Sampling,Dispensing,Contamination control preparation
- Steps after
- Sterility testing,Bio decontamination,Aseptic packaging
- Input ingredients
- pharmaceutical powders,biohazard materials,contaminated air,non-sterile equipment
- Output ingredients
- clean air,sterile equipment,contained pharmaceutical powders,isolated biohazards
- 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.
- Airflow type
- Unidirectional vertical
- Cleanroom Classification
- ISO 5 / Grade A
- Material
- AISI 304 stainless steel
- Filter Efficiency
- G3/G4 disposable synthetic fibre,H14
- Airflow Control
- Adjustable
- Filtration Stages
- Three-stage
- Pressure Drop Reduction
- 50%
- Size Variability
- Modular
- Total Cost of Ownership Reduction
- 40%
- Airflow direction
- Vertical unidirectional
- Air cleanliness classification
- ISO 5 (Grade A)
- Pressure control
- Higher pressure than surrounding environment
- Energy efficiency
- -40% Total Cost of Ownership
- Automation level
- Adjustable airflows
- Customization
- Modular units for tailor-made solutions
- Contamination control
- Operator,product,and environment protection
- Bio-pharmaceutical Loads
- Powders,Biohazard
- ISO 14644-1
- Class ISO 5
- EU GMP
- Grade A
- FDA compliance
- Non-metallic component contact
- European Directives
- 2014/30/EU,2014/35/EU,2006/95/EC
- European Standards
- EN 55011,EN IEC 61000-4-2,EN IEC 61000-4-4,EN IEC 60204-1
- GMP Compliance
- 21 CFR Part 210,211,11
- UL Certification
- UL 508A,UL 61010-1
- NFPA
- NFPA 70,NFPA-79
- Material
- AISI 304 stainless steel
- Footprint Type
- Modular design
- Assembly Options
- Suspended,fitted on false ceiling grids,or on supporting legs
- Filtration Stages
- Three-stage filtration
- Plenum Design
- Compact ceiling and rear plenum
- Airflow Direction
- Vertical unidirectional airflow
- Modular design
- Customizable shape
- Assembly options
- Suspended,fitted on false ceiling grids,supporting legs
- Adjustable airflow
- Individual adjustable airflows
- Fan type
- Efficient fans
- Prefilter customization
- Bag-in,Bag-out pre-filter replacement