The H135 GMP Hypoxystation* is specifically designed to be used as a clean-air isolator in processes following Good Manufacturing Practice (GMP). This workstation provides Grade A air cleanliness (EU GMP) and combines sterile hypoxic laminar airflow, positive operating pressure, and physical isolation to provide highly effective product protection. Due to being a completely closed, re-circulating, isolator system, this workstation can be housed in a Grade D cleanroom during GMP compliant use.
The full-time environmental control offered by the H135 GMP Hypoxystation maximises the reproducibility of the cell-manufacturing processes carried out inside. Further, this hypoxic isolator is designed to be modular and can be combined in different ways to form a production line that ensures that the cell-culture environment is never broken from the beginning to the end of the manufacturing process.
Each workstation is tested to ensure compliance with the relevant portions of ISO 14644-3. In addition, tests carried out in our own laboratories confirm the integral HEPA filtered laminar flow system meets the requirements set out in BS EN 12469:2000 with regard to protection of the working area from particulate and microbial contamination.
Two sizes of airlock are available for this workstation: one is 17.5 litres and provides for the effective transfer of up to 10 x 500ml Duran bottles (or items of a similar size) to and from the chamber in just 60 seconds. The airlock’s internal dimensions are 197mm x 388mm x 190mm (W x D x H). The larger airlock is 43 litres (measuring 335 x 300 x 300mm) providing effective transfer for items of equipment or for up to 20 x 500ml Duran bottles in just 5 minutes.
The patented oval glove ports provide maximum comfort when used over extended periods.
Don Whitley Scientific engineers are trained to carry out filter integrity (DOP) testing on HEPA filters. This allows us to provide full validation on Whitley GMP Hypoxic Workstations (Hypoxystations). Customers who work to GMP processes can rest assured that they don’t have to source their own external, specialist organisations to perform these important tests once their workstation has been installed. DWS has invested in the relevant equipment and training to provide this one-stop solution. Customers can have the confidence that their workstation has been tested by engineers who are fully trained in the operation and manufacture of Whitley Workstations.
With internal working area dimensions of (w x d x h): 1075 x 750 x 608mm, there is a generous amount of working space inside the workstation chamber to house equipment such as large scale bioreactors and imaging systems.
If you need to aspirate biological liquid waste from inside the chamber, order with a Vacuum Take-off Port and the Whitley AsPROvac for the perfect package.