Barrier system (RABS-ISO)
Open and closed RABS
The RABS serves to physically separate the Sterile area and Grade B environment and operators.
Airex is well experienced in all area of RABS manufacturing and we are able to advise and offer any combination of RABS units specifically to suit your requirements.
Benefits
- * High quality design
- * ISO 5 Unidirectional airflow
- * cGMP-/FDA-compliant design
- * Full qualification services (FAT,IQ,OQ)
- * Integrated gloves
- * Integrated H2O2 (hydrogen peroxide) decontamination /optional for cRABS
Sterile Process Isolators
Airex sterile isolators are all customized because of the diversity of needs among industries, applications and users.
To realise customized design of the sterile isolator Airex collaborate close with our customers to fully understand the requirements.
Benefits
- * High quality design
- * ISO 5 Unidirectional airflow
- * cGMP-/FDA-compliant design
- * Full qualification services (FAT,IQ,OQ)
- * Integrated H2O2 (hydrogen peroxide) decontamination
- * CG screen® for ISO 5 Unidirectional airflow (LAF 0,45 m/s +/- 20% )
- * Automatic Leak test
- * Integrated monitoring, recording and alarming system.
Sterility test Isolator
Airex sterility test isolator is easy way for sterile examination for the quality control of a product.
Airex sterility test Isolator with product protection for sterility testing under aseptic conditions, with Airex passbox for fast decontamination and introction of the product inside the main chamber. Airex guarantee product protection is achieved between the operator and the product.
Benefits
- * High quality design
- * ISO 5 Unidirectional airflow
- * cGMP-/FDA-compliant design
- * Full qualification services (FAT,IQ,OQ)
- * Integrated H2O2 (hydrogen peroxide) decontamination
- * CG screen® for unidirectional airflow
- * Automatic pressure decay test
- * Integrated monitoring, recording and alarming system.
- * Passbox with fast decontamination
- * Integrated sterility test pump
Containment Isolator
Airex Containment Isolator can keep negative pressure inside Isolator chamber in otder to achieve operator protection from toxic material.
Airex Containment Isolator can be applied for any customer's toxic product handling achieving till OEB 5 with relevant validation method.
Benefits
- * High quality design
- * Turbulant airflow
- * cGMP-/FDA-compliant design
- * Full qualification services (FAT,IQ,OQ)
- * Customized design for any other machine integration
- * Containment Test based on OEB
- * Spray ball or washing/dry gun can be installed (Optional)