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.
GMP regulations require specialised robust gauntlets to be used in GMP high risk processing applications. Whitley GMP Workstations can be supplied with an innovative quick change ‘BCS’ gauntlet made of non-shedding material (such as Neoprene, CSM, etc) that allows uniquely easy and rapid changing of gloves without loss of containment or atmospheric conditions. These two piece gauntlets are produced by a world leader in the production of isolator gloving systems. This order code is for the sleeve section of these gauntlets.
The BCS gauntlet improves existing glove replacement methods, which are often delicate, complex, laborious, prone to user containment errors, and often can only be replaced by users with specialised accredited training. The gauntlet provides a simple and effective quick-change method to reduce the risk of micro-tears, condition containment errors, is a much more comfortable solution for customers and can be replaced by users without the requirement for special training.
Three sizes of the glove portion are available for this gauntlet system: Sleeves, Cuffs, Gauntlets - Don Whitley Scientific (dwscientific.com)
Glove extenders are used during VHP sterilisation to allow the fingers of the gauntlets to be separated during the cycle to prevent any occlusions, ensuring the hydrogen peroxide makes contact with all areas.
* Patent applied for
- 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.