The A155 GMP Anaerobic Isolator (GB Patent No. 2593277) is specifically designed to be used as a clean-air isolator in processes following Good Manufacturing Practice (GMP). This GMP Isolator allows two people to work in the chamber at same time. The A155 GMP Isolator provides Grade A air cleanliness (EU GMP) and combines sterile anaerobic 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.
Each workstation is tested to ensure compliance with the relevant portions of ISO 14644-3. This will be of special interest to users conducting anaerobic processes that must comply with GMP requirements. In addition, tests carried out in our own laboratories confirm the integral HEPA filtered uni-directional airflow system meets the requirements set out in BS EN 12469:2000 with regard to protection of the working area from particulate and microbial contamination.
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 Anaerobic 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.
This workstation is equipped with two integral airlocks (one at either side of the main workstation chamber) providing an ideal layout for a ‘production line’ style of working. Two sizes of airlock are available: 17.5 litres or 43 litres. These airlocks have been specifically designed to aid the transfer of serological pipettes into the workstation. Each 17.5 litre airlock is capable of accommodating 10 x 500ml Duran bottles and the internal dimensions are 197mm x 388mm x 190mm (W x D x H). The 43 litre airlocks (measuring 335 x 300 x 300mm) can each accommodate up to 20 x 500ml Duran bottles.
The patented oval glove ports 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 centrifuges and homogenisers.
Example applications for this workstation include: faecal microbiota transplant; probiotics manufacture; bacteria manufacture; live biotherapeutics; biopharmaceuticals; and microbiome therapeutics.
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, 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.
- This workstation 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.
- Whitley Intelligent Monitoring continually measures atmospheric down flow to ensure optimised filter performance.
- ‘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, 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.
- Four oval, sleeved 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.
- IQOQ documentation available.
- Air sampling ports can be fitted to allow particulate monitoring systems to be connected to the workstation for continuous particulate monitoring.