Bespoke aseptic isolators designed for production environments don’t meet the needs of small-scale uses. For compounding, quality control, sterility testing, dispensing, weighing or R&D work, a standalone Isolator can offer the best balance between features, flexibility and cost.
The Steriline Standalone Isolator is designed to work with sterile products, either toxic or not-toxic, and grants the highest safety levels for both product and operator.
Practical features include stainless steel walls with high level surface finishing for ease of cleaning and sanitization, and an optional integrated VHP (Vaporized Hydrogen Peroxide) generator for the sanitization cycle.
Standalone Isolators maintain an ISO 5 with either unidirectional or turbulent air flow according to your process needs. The isolator is equipped with fans and HEPA filters to supply sterile air, and exhaust air is also filtered by “Bag-In-Bag-Out” HEPA filters with easy access for maintenance.
RTP ports enable In-Out product and waste transfer without compromising safety or risking sterility failure. Full cycle automation is controlled via touch screen HMI, with control and visibility on production, decontamination, and aeration phases, as well as integrity testing and maintenance.
With a 2% or less leak rate, Steriline Isolators are engineered to be fully compliant with all relevant cGMP, GAMP and 21CFR Part11 requirements.