Although a new process for the customer, Extract Technology was selected based upon its experience in delivering high quality, cost effective, reliable standard solutions for sterility testing.
The design delivered Unidirectional Airflow within the main chamber and airlock of Extract’s SteriPharm, giving a EU GMP Grade A (Iso14644-7:2004) environment. This was implemented to enable sterility testing and in-process transfer of additional material with the required traceable data needed for their validation.
Extract Technology integrated the necessary viable and non-viable particle monitoring within the machine along with the use of a 21CFRPart 11 validated paperless (touch screen) chart recorder to enable the customer to review each stage of the cycle in full detail.
Working closely with the customer Extract Technology designed custom racking to suit the customer specific load requirements and develop the Bio-decontamination cycle required, ensuring a repeatable full Log6 bacterial spore population reduction and with the most efficient use of the Vaporized Hydrogen Peroxide kill media.
The isolator was fitted into an existing small laboratory room – the compact size still complete with its fully integrated hydrogen peroxide gas generator along with the standard features of safe-change exhaust HEPA filters, PLC/HMI, H2O2 room monitor, and automatic pressure decay testing that made this the perfect solution for the customer.
The equipment was validated using BI challenge to ensure the system that left our dedicated test facility gave reliable and repeatable operational performance.