Sterility testing isolator for aseptic environments

Ensure aseptic conditions and process integrity during sterility testing with an isolator designed for precise decontamination and controlled environments, essential for safeguarding sensitive pharmaceutical and biotech production.

Ensures Sterility in Testing Environments

The Sterility Testing Isolator from Fabtech Technologies is engineered for pharmaceutical, biopharmaceutical, and healthcare industries, offering a controlled aseptic environment for sterility tests and bio-decontamination processes. Constructed with durable SS 316L, it features ISO 5 Grade A laminar airflow, ensuring an ultra-clean workspace. Its standard setup includes a pass box with dual glove ports, a main chamber with quad glove ports, and a glove integrity tester, accommodating both manual and high-speed operations. Compatible with VHP decontamination, the isolator supports on-demand process equipment and particle counter integration, enhancing operational efficiency. Opt for multiple chamber configurations to tailor the isolator to your production needs. With password-protected authorization levels, it adheres to stringent compliance requirements, making it ideal for sterility testing of vaccines, monoclonal antibodies, and sterile medical devices.

Benefits

  • Maintains aseptic conditions to minimize contamination risks in sterile drug production.
  • Enhances operational efficiency with customizable chamber configurations and glove integrity testing.
  • Integrates seamlessly into existing production lines with on-demand equipment and particle counter options.
  • Supports compliance with ISO 5 Grade A classification for pharmaceutical and biotech applications.
  • Provides enhanced security and process control with multi-level password-protected access.

General


Applications
Biopharmaceuticals,Healthcare products,Pharmaceuticals
End products
Sterile injectable drugs,Vaccines,Monoclonal antibodies,Sterile medical devices,Aseptic pharmaceutical formulations
Steps before
Aseptic Preparation,Product Load,Environmental Monitoring
Steps after
Product Removal,Sterility Confirmation,Decontamination
Input ingredients
VHP for decontamination,H2O2 decontamination,Sterility test samples
Output ingredients
Aseptic environment,Decontaminated process equipment,Sterility test results
Market info

Technical Specifications


Construction Material
SS 316L
Airflow Classification
ISO 5 Grade A
Glove Ports
Main chamber
Decontamination Method
VHP compatible,H2O2 optional
Ergonomics
Customizable
Configuration Options
Multiple chambers
Process Equipment Integration
On-demand
Particle Counter
Online integration
Authorization Levels
Password protected

Operating Characteristics


Working Mechanism
Aseptic Environment with VHP Decontamination
Automation Level
PLC Controlled
Cleaning Method
H2O2 Decontamination Optional
Batch vs. Continuous Operation
Batch
Glove Integrity Tester
Standard Inclusion
Customization Options
Multiple Chamber Configuration
Authorization Levels
Password Protection
Airflow Control
Laminar Airflow ISO 5 Grade A

Material Compatibility


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


ISO Standards
ISO 5 Grade A classification

Physical Characteristics


Footprint
Customizable per client requirement
Material construction
SS 316L
Chamber configuration
Multiple chamber options available
Glove Ports
Pass Box (2 Glove Ports),Main Chamber (4 Glove Ports)
Customizable ergonomics
Yes
Integration options
Process equipment and online particle counter
Airflow classification
ISO 5 Grade A

Custom Options


Material
SS 316L
Ergonomic design
Customizable
Chamber configuration
Multiple options
Glove ports
2 and 4
Decontamination option
H2O2 / VHP
Pass Box
Standard
Password protection
Multiple authorization levels
Online particle counter integration
Included
Process equipment integration
On-demand