Telstar has completed design, manufacture and validation services of a complex suite of thirteen isolators.
Comprising seven production isolators and six quality control (QC) lab isolators, the complex achieves containment levels of 0.2ng/m鲁 (200 picograms). It is specially designed to provide both operator protection from accidental release of the high-potency recombinant proteins and product protection from external contamination.
Developed for IPSEN Biopharm, the isolator package is installed in a recently upgraded cleanroom facility located in the Wrexham manufacturing site.
The set of 13 isolators were designed with a once-through airflow regime and include safe change inlets and exhaust filters integrated within the cleanroom in a very restrictive area. They are also connected to a dedicated heating, ventilation and air conditioning (HVAC) system. This proved a technical challenge for the Telstar team, which worked closely with the building contractors on site to successfully achieve the requirements of the client.
The isolators shared many common design details favoured by the client from Telstar鈥檚 previous contract with the client. These details included clamped visor frames to provide a more robust gullwing design to provide 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 good manufacturing practice (GMP) for pharmaceuticals as set out by the International Society for Pharmaceutical Engineering (ISPE) Baseline Guide for Commissioning and Qualification Volume 5.
The isolators are specifically designed to contain a liquid biotoxin (BSL -4), which has an occupational exposure limit (OEL) of 0.2ng/m鲁. The isolator mechanical design strength is designed to withstand pressures of -2,500Pa to 2,500Pa.
All the 聽isolator units are designed for bio-decontamination using hydrogen peroxide and are connected to a common manifold fed from one vaporised hydrogen peroxide delivery system, which is interfaced with each isolator over a central programmable logic controller (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/m鲁, (200 picograms), which is exceptionally challenging operator exposure level within the isolator manufacturing industry.