Preparation tank isolator for reactor charging

Ensure aseptic conditions for sterility testing and safe handling of sensitive pharmaceutical products with this dedicated isolator, designed to streamline reactor charging processes while maintaining high bio-decontamination standards.

Facilitates Aseptic Reactor Charging and Sterility Testing

The Preparation Tank Isolator from Comecer is engineered for those requiring robust sterility control in pharmaceutical and radiopharmaceutical settings. This isolator is particularly notable for its integrated Vapour Phase Hydrogen Peroxide (VPHP) decontamination system, ensuring high-level bio-decontamination.

Designed with manual and aseptic operations in mind, it supports critical processes such as reactor charging and sterility testing. The main chamber features glove ports for safe material handling, while the In&Out-Chamber functions as a rapid gassing port, enhancing workflow efficiency. Material handling is improved with shelves made from corrosion-resistant SS 316L, suitable for pharmaceutical environments, and customizable connections offer adaptability for utilities like WFI and nitrogen.

Ideal for producing sterile injectables and radiolabeled compounds, the isolator seamlessly integrates into laboratory and processing departments within pharmaceutical, biotech, and radiopharmaceutical industries. It complies with stringent aseptic conditions, ensuring that operations adhere to GMP standards. Maintenance is simplified through easily accessible components and a design that supports effective cleaning protocols.

Benefits

  • Maintains sterility to meet stringent pharmaceutical standards, protecting product integrity.
  • Enhances workflow efficiency with rapid gassing and customizable utility connections.
  • Provides corrosion-resistant material options to ensure long-term operational reliability.
  • Reduces contamination risk with VPHP bio-decontamination system, promoting safety.
  • Offers configurable design to adapt to specific laboratory and processing needs.

General


Applications
Radiopharma products,Pharmaceutical sterile products,Fine chemicals,Aseptic products,Biopharmaceuticals,Sterility testing
End products
Aseptic vaccines,Sterile injectables,Active pharmaceutical ingredients (apis),Monoclonal antibodies,Sterile testing kits,Radiolabeled compounds
Steps before
Purification,Preparation,Material Handling
Steps after
Sterilization,Packaging,Quality Control
Input ingredients
pharmaceutical sterile products,reactor materials,WFI (water for injection),compressed air,vacuum,nitrogen
Output ingredients
sterile products,decontaminated materials,aseptic reactor charged materials
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


Viewing Panel Inclination
5° from vertical
Glove Flange Size
Oval,10”
Shelves Material
SS 316L
Connections
WFI,Compressed Air,Vacuum,Nitrogen,etc.
Drain Sanitary Tank Bottom Valve
Protected by cap with holes
Air Quality Input
Class C or Class D
VPHP Generator
Included
Working Plane Slope
Sloped to drain valve
Main Chamber
With glove ports
In,Out-Chamber
Used as rapid gassing port

Operating Characteristics


Automation level
Manual / PLC / SCADA
Batch vs. continuous operation
Batch
CIP/SIP
CIP 121°C / SIP 135°C
Cleaning method
CIP / Manual

Material Compatibility


Density/particle size
0.5–2.5 g/cm³ / 50–1000 µm

Physical Characteristics


Front View Panel
Hinged with inflatable seal
Viewing Panel Angle
5° inclination from vertical
Glove Flanges
10" oval made of Polypropylene
Shelves Material
SS 316L
Shelves Customization
Additional rods,hooks available
Drain Sanitary Tank Bottom Valve
Protected by cap with holes
Working Plane
Sloped to drain valve

Custom Options


Glove flange size
Oval,10” made of PP with gloves
Shelf material
SS 316L with additional rods,hooks optional
Viewing panel
Hinged,5° inclination,inflatable seal with gas springs
Custom connection flange
For reactor connection
Utility connections
WFI,compressed air,vacuum,nitrogen
Stool adjustability
Adjustable stool available
Drain system
Sloped working plane to drain valve,cap protection
Glove support systems
Included for VPHP gas bio-decontamination process