Laminar flow hood for aseptic preparation

Ensure aseptic conditions for sterile injectable drug preparation with this advanced laminar flow hood, providing precise filtration and containment to maintain product purity and safety throughout the production process.

Facilitates Aseptic Preparation and Filtration

The FHR SSC Hood with Laminar Flow, offered by Comecer, is expertly engineered to provide aseptic containment for pharmaceutical and radiopharmaceutical applications. This equipment is distinguished by its use of a HEPA filtration system, ensuring a laminar air flow within class A environments, crucial for maintaining sterility during the preparation of non-radioactive pharmaceuticals and radiochemistry reagents. With its robust AISI 304 stainless steel construction and Scotch-BriteTM surfaces, the hood is designed for durability and easy cleaning. The perforated workbench made of AISI 316L stainless steel facilitates effective air recuperation, enhancing air quality to meet stringent ISO5 and GMP standards. Designed for integration into pharmaceutical production lines, it supports manual, bench-top operations, making it ideal for producing sterile injectable drugs, aseptic vials, IV infusion bags, and radiopharmaceutical intermediates. The hood’s automation includes an alarm system for filter blockage, maintaining operational efficiency and safety. Compliance with EC electrical standards underlines its suitability for critical laboratory and processing environments in the pharmaceutical and nuclear medicine industries.

Benefits

  • Ensures product sterility with GMP-compliant laminar flow and ISO5 cleanroom conditions.
  • Enhances operational safety with alarm systems for filter blockage detection.
  • Facilitates quick cleaning and air quality recovery through a removable perforated workbench design.
  • Supports integration into pharmaceutical production lines, optimizing workflow efficiency.
  • Maintains superior air purification, crucial for producing sterile pharmaceuticals and radiopharmaceuticals.

General


Applications
Pharmaceutical production lines,Radiochemistry reagents,Non-radioactive pharmaceuticals,Aseptic materials
End products
Sterile injectable drugs,Aseptic vials,Radiopharmaceutical intermediates,Iv infusion bags,Pharmaceutical tablets in sterile packaging
Steps before
Material preparation,Reagent setup,Raw material inspection
Steps after
Sterilization,Material transfer,Post-production inspection
Input ingredients
non-radioactive materials,air,reagents for synthesis modules,aseptic materials
Output ingredients
filtered air,aseptic conditions,sterile environment
Market info
Comecer is known for manufacturing advanced containment and isolation systems, particularly in the pharmaceutical and nuclear medicine sectors, with expertise in custom-engineered equipment, ensuring high safety and compliance standards.

Technical Specifications


Classification
GMP Class A,ISO 5
Airflow Pattern
Vertical Laminar Flow
Air Speed
0.36 to 0.54 m/sec
Filtration System
HEPA Filter
Material Type
AISI 304,AISI 316L Stainless Steel
Front Panel Thickness
10 mm acrylic
Lighting
Neon Lighting
Air Extraction Method
Fan with Grille
Welding Technique
Arc Welding
Door Type
Frontal Acrylic Door

Operating Characteristics


Airflow direction
Vertical laminar flow
Airflow speed
0.36 to 0.54 m/sec
Aseptic conditions
Class A environment,GMP compliant
Automation level
Manual operation with alarm warning
Filtration system
HEPA filter
Containment level
Non-radioactive material processing

Material Compatibility


Abrasion resistance
AISI 304/316L stainless steel
Biological compatibility
Suitable for aseptic conditions
Cleanability
Easily cleanable,removable work surface
Corrosive resistance (e.g. acids)
AISI 304/316L stainless steel


GMP Compliance
Annex 1 Class A
ISO Cleanroom Classification
ISO 5

Physical Characteristics


Frontal opening
Acrylic door (10 mm thickness)
Side panels
Clear acrylic panels (10 mm thickness)
Material
AISI 304 stainless steel
Work surface
Perforated AISI 316L stainless steel

Custom Options


Frontal opening type
Acrylic door with clear panels
Filtration system
HEPA filter
Lighting type
Neon lighting
Material of construction
AISI 304 and 316L stainless steel
Surface finish
Scotch-BriteTM surfaces
Alarm system
Alarm warning light for filter blockage
Lock system
Technical compartment with door and key lock
Airflow type
Laminar vertical flow
Panel material
Plexiglas / Acrylic