Aseptic isolator

for quality controlfor the pharmaceutical industryfor sterility testing

Overview
The Envair Technology sterility test isolator is designed for sterile processing and sterility testing routines that require an internal sterile environment with EU GMP Grade A air over the workspace while providing a degree of operator protection. This system is widely used by manufacturers of liquid medicinal products and independent sterility test companies.

Purpose and typical applications

• Sterile processing and sterility testing for pharmaceutical QC.
• Aseptic testing in pharmaceutical manufacturing and independent testing laboratories.

Design and compliance
The isolator is monitored, controlled and alarmed to provide and maintain strict internal environmental conditions within the isolator workspace, ensuring required cleanliness levels. The equipment is designed and manufactured following current Good Manufacturing Practice (cGMP) and GAMP 5 guidelines and conforms to applicable industrial equipment directives.

Key Features

• Unidirectional HEPA filtered supply airflow at 0.45 m/s (EU GMP Grade A airflow).
• Integrated sterility test pump, flush with chamber base.
• Siemens S7 PLC control system with HMI touchscreen display for control and monitoring.
• Automatic inflating silicone seals on main chamber and hatch doors.
• Integrated Vapourised Hydrogen Peroxide (VHP) decontamination system capable of achieving a 6-log reduction of microbiological spores.
• Rapid decontamination cycle times with independent chamber decontamination cycles.
• Integrated viable and non-viable air sampling controlled via the HMI touchscreen display.
• CFR 21 Part 11 compliant for electronic records and signatures.
• Flexible design and chamber layouts to suit project requirements.

Additional information
The isolator provides environmental control, operator protection and validated decontamination capability; control, alarm and sampling functions are integrated to support sterility assurance and regulatory compliance.