Thanks to Extract Technology’s previous experience in providing Aseptic Isolators worldwide, along with the strong brand identity, Extract was recently chosen as the supplier of choice in providing two Aseptic Formulation isolators for a NASDAQ-listed client, one of the top 5 pharmaceutical generics manufacturers in the world.
The company was tasked to create a positive pressure isolator with an ‘EU Grade A’ environment whilst safeguarding the operator and outside environment from the highly toxic API guaranteeing less than 0.1ug/m3 OEL. The process involved weighing and dispensing of the API via a drum utilising two off two-decimal-place scales within each isolator.
The isolators had proven VPHP (Vapour Phase Hydrogen Peroxide**) fully integrated gassing systems on-board capable of providing a 〖10〗^6 reduction in bacterial spore population using Bacillus Stearothermophilus challenge.
The chamber was designed with UDAF (Uni-Directional AirFlow) supplied via terminal filters with the exhaust airflow being drawn through the working surface therefore minimising turbulence and increasing sterility assurance at the point of dispensing.
Along with the requirements above, the isolators also included temperature and humidity control by means of on board cooling and a dedicated air handling system for the supply air.
An additional challenge was to create an oxygen reduced atmosphere for one specific product to be processed. Therefore the isolators were designed with a nitrogen purge system which fulfilled the criteria. Processing different products introduces the risk of cross-contamination so the isolators also incorporated full CIP and wash down capabilities to decontaminate the chamber of all products prior to bio decontamination.
Additional Requirements included:
* Environment Recipes – varying recipe parameters can be edited so that the client can configure the exact environment required for varying products.
* Due to the nature of the process the fully integrated isolators come with castors for mobility.
* RTP Alpha in the side wall for contained docking of clients canisters for waste collection (waste being empty product bags from drums).
* On-board HMI (human machine interface) and control panel.
* Monitoring, controlling & recording of all major environment parameters (temp, humidity, particle counting) via an audit trail chart recorder to 21CFR Part 11.