Our largest GMP workstation: 1,800 litre capacity and the option of dual temperatures
The H155 GMP Hypoxystation is specifically designed to be used as a clean-air, hypoxic isolator in processes following Good Manufacturing Practice (GMP). This workstation allows two people to work in the chamber at same time and is specifically designed to accurately control the parameters of O2, CO2, temperature, and humidity.
Providing Grade A air cleanliness (EU GMP), this hypoxic isolator 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 H155 GMP Hypoxystation maximises the reproducibility of the cell-manufacturing processes carried out inside. Further, this 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 regarding protection of the working area from particulate and microbial contamination.
Two 17.5 litre airlocks (one at either side of the main workstation chamber) provide an ideal layout for a ‘production line’ style of working. The patented oval glove ports can be fitted with your choice of gauntlet and provide maximum comfort when used over extended periods.
With internal working area dimensions of (w x d x h): 2200 x 750 x 620mm, there is a huge amount of working space inside the workstation chamber to house equipment such as large scale bioreactors and imaging systems.
- Precise control of oxygen between 20.9% and 0.1%.
- CO2 control between 0.0% and 15%.
- 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.
- 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 hypoxic isolator is Ethernet-enabled for remote access review and control.
- Four oval ports and two airlocks allow two people to work in the chamber at the same time.
- 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.
- A fully automated de-humidification 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.
- Workstation can also be run aerobically if required.
- Range of possible decontamination protocols, including the use of vaporised hydrogen peroxide.
- IQOQPQ documentation available.
- Air sampling ports can be fitted to allow particulate monitoring systems to be connected to the workstation for continuous particulate monitoring.