Don Whitley Scientific has over 40 years of experience in the design and manufacture of anaerobic cabinets, 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 innovative uni-directional airflow technology, and successfully added this feature to an anaerobic workstation to create a unique product offering: a uni-directional airflow workstation that allows users to process samples under strict anaerobic conditions.
The A135 GMP Anaerobic Workstation is specifically designed to be used as a clean-air isolator in processes following Good Manufacturing Practice (GMP). This microbiology isolator provides Grade A air cleanliness (EU GMP), combining sterile uni-directional airflow, positive operating pressure, and physical isolation to provide highly effective product protection. Unlike traditional isolators that use inlet air from the surrounding room, this workstation is a fully closed recirculating system so can be housed in a Grade D cleanroom during GMP compliant use.
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 2 minutes. The dimensions of this airlock 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.
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 centrifuges and homogenisers. The patented oval glove ports provide maximum comfort when used over extended periods.
A135 GMP Anaerobic Workstation Features:
- This Grade A anaerobic isolator maintains strict anaerobic conditions, operating from two gas supplies for the most effective and efficient running costs.
- HEPA filter face velocity/uniformity of uni-directional airflow 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.
- The GMP Workstation exceeds the requirements of Grade A air cleanliness (EU GMP) and ISO 14644-1 Class 3 both at rest and in operation.
- Whitley Intelligent Monitoring continually measures atmospheric downflow to ensure optimised filter performance.
- The ‘Standby’ feature (ECO mode) 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 (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 monitoring systems to be connected to the workstation for continuous particulate monitoring and microbial air sampling.
- 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 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.
- The workstation can also be run aerobically if required.
- Range of possible decontamination protocols, including the use of vaporised hydrogen peroxide.