- Oxygen control between 20.9% and 0.1%
- CO2 control between 0.0% and 15.0%
- HEPA filter face velocity/uniformity of laminar flow and Dispersed Oil Particulate (DOP) tests are carried out in accordance with ISO14644-3 to validate system integrity and performance. All tests are performed by an independent organisation.
- Whitley Intelligent Monitoring continually measures atmospheric down flow to ensure optimised filter performance.
- ‘Standby’ feature automatically decreases fan speed when the chamber is at rest to maximise energy efficiency.
- H14 HEPA filtered airlock removes all particulate and stops any from entering the main workstation chamber
- The large workstation chamber is perfect for accommodating a variety of items of equipment, which can be installed and removed via the removable front (fitted as standard).
- A password protected full colour touch screen interface allows easy monitoring of all parameters simultaneously. Alarms and status notices are also displayed.
- This workstation is Ethernet-enabled for remote access review and control.
- Data logging system records all monitored parameters every 60 seconds
- The Event Log lists events showing the date and time they occurred. The log retains information for 100 days and can be downloaded if the Data Logging option has been purchased.
- Air sampling ports can be fitted to allow particulate monitoring systems to be connected to the workstation for continuous particulate monitoring.
- A fully automated dehumidification system is included as standard. It does not require any operator intervention.
- A bespoke trolley with heavy-duty castors is provided as standard. A trolley not only saves desk space but is also useful for ease of mobility for service and maintenance.
- Other optional features are available to tailor the system to your requirements.
- Range of possible decontamination protocols, including the use of vaporised hydrogen peroxide.
- IQOQPQ documentation available.
Don Whitley Scientific has over 40 years of experience in the design and manufacture of controlled atmosphere workstations, and in 2013 developed the Whitley Internal HEPA Filtration System, primarily to serve our research customers. In collaboration with customers running GMP licensed facilities, we have now developed a GMP capable workstation that combines sterile laminar airflow with the ability to control atmospheric oxygen content from ambient down to 0.1%.
The H135 GMP Hypoxystation* is the latest workstation to be added to the DWS range, and is specifically designed to be used as a clean-air isolator in processes following Good Manufacturing Practice (GMP). This new workstation provides Grade A air cleanliness (EU GMP) and combines sterile 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, the H135 GMP Hypoxystation 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.
An optional HEPA Filtered Airlock is also available, which includes the incorporation of a H14 HEPA filter to ensure 100% reduction in airborne particulate in the airlock over the course of the cycle. This ensures Grade A particulate counts in the main chamber are not compromised.
Each workstation is tested by an independent organisation to ensure compliance with 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.
The 17.5 litre airlock provides effective transfer for up to 10 x 500ml Duran bottles to and from the workstation in just 60 seconds. The patented oval glove ports provide maximum comfort when used over extended periods.
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.
* Patent applied for