Telstar has completed the design, manufacture and validation of a complex suite of 13 isolators comprising of seven production isolators and six QC Lab isolators achieving remarkable containment levels of 0.2 ng/m³ (200 picograms), specially designed to provide both operator protection from accidental release of the high potency recombinant proteins and product protection from external contamination.
A picogram is equal to one trillionth of a gram or 0.001 nanogram.
The isolator package developed for IPSEN Biopharm, is installed in a recently upgraded cleanroom facility located in their UK Wrexham manufacturing site, and the isolators offer probably the highest operator protection level to date within the pharmaceutical industry, it says.
The set of 13 isolators were designed with a “once-through airflow” regime and include safe change inlet and exhaust filters integrated within the cleanroom in a very restrictive area and are connected to a dedicated HVAC system. This proved a technical challenge for the Telstar team who worked closely with the building contractors on site to successfully achieve the requirements of the client.
The isolators shared many common design details favored by the client from Telstar’s previous contract with the client. These details included clamped visor frames, to provide a more robust gullwing design to support to larger than normal dimensional visors and panel filters with safe change housings to provide the necessary increased flow rate but also enable the filters to be safely changed in and out locally, without risks of secondary exposure.
In addition, contained transfer ports were included to maintain the low level occupational exposure limit during transfer of product and removal of liquid and solid waste from the isolators. The equipment has now been successfully commissioned and tested in accordance with the principles of GMP for pharmaceuticals as set out by ISPE baseline guide for commissioning and qualification Volume 5.
The isolators are specifically designed to contain a liquid biotoxin (BSL-4), which has an OEL of 0.2 ng/m³ and the isolator mechanical design strength is designed to withstand pressures of -2500Pa to +2500Pa.
The new isolators have a once-through
All the isolator units are designed for bio - decontamination using hydrogen peroxide and are connected to a common manifold fed from one vaporized hydrogen peroxide delivery system, which is interfaced with each isolator over a central PLC communications system, enabling the isolators to be decontaminated individually, or if required together.
This is the second major project developed by Telstar for IPSEN Biopharm. The company previously designed and installed six bespoke bio isolators for a new laboratory area which also reached the demanding containment level of 0.2ng/m³, (200 picograms), which is exceptionally challenging operator exposure level within the isolator manufacturing industry.