The Whitley H155 GMP Workstation* is specifically designed to be used as an oxygen controlled isolator in processes following Good Manufacturing Practice (GMP). These workstations provide Grade A air cleanliness (EU GMP) and combine sterile unidirectional airflow, positive operating pressure, and physical isolation to provide highly effective product protection for ATMP production.
Due to being compact, completely closed, re-circulating isolator systems, these workstations can be housed in a Grade D Cleanroom during GMP compliant use - much more cost-efficient than creating a full cascade system.
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 unidirectional 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. Levels of atmospheric cleanliness within the Whitley GMP Workstation greatly exceed the industry standard of ISO Class 5 (EU GMP Grade A), both at rest an in operation, due to the unidirectional airflow, HEPA filtration, and highly efficient fan system.
The full colour touchscreen interface allows easy monitoring of all parameters simultaneously. Alarms and notices are also displayed on this screen. Individual user logins can be programmed via the interface to restrict access to some levels of functionality.
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 Workstations. 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.
There is an enormous 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.
The BCS gauntlet improves existing glove replacement methods, which are often delicate, complex, laborious, and prone to user containment errors. The gauntlet provides a simple and effective quick-change method to reduce the risk of micro-tears. It is a much more comfortable solution for customers and can be replaced by users without the requirement for special accredited 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.
Whitley oxygen controlled isolators are designed to be modular and can be configured in different ways to suit the needs of your process. Three-way airlocks are available to 'join' the workstations and enable samples and equipment to be transferred between units and to and from the laboratory without compromising internal conditions. For more information, please see the Whitley GMP Processing Suite.
* Patent pending
- Precise oxygen control (between 0.1% and 20.9%) and CO2 control (between 0.0% and 15.0%).
- Precise control of humidity (up to 80% RH) and temperature (ambient to 40°C).
- H14 HEPA filters remove all particulate providing better than 99.995% efficiency (MMPS).
- 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).
- Two sizes of airlock available: 17.5 litres or 43 litres.
- 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.
- 'Standby' feature (Eco mode) automatically decreases fan speed when the chamber is at rest to optimise energy efficiency.
- 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 bench 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.
- Full IQ/OQ documentation available.