Whitley A135 GMP Isolator

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GMP isolator providing sterile uni-directional airflow under strict anaerobic conditions

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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 Isolator (GB Patent No. 2593277) 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 pictured isolator features the larger, 43 litre airlock (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.

Thorough testing

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 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.

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 Isolators. 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.

Potential applications

Example applications for this isolator include faecal microbiota transplant; probiotics manufacture; bacteria manufacture; biopharmaceuticals and microbiome therapeutics.

Gauntlets

GMP regulations require specialised robust gauntlets to be used in GMP high risk processing applications. Whitley GMP Isolators 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.

Glove Extenders

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 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 standard H14 HEPA filter is better than 99.995% efficient at the most penetrating particle size (MPPS), and the upgraded U15 ULPA filter is better than 99.99995% efficient at the MPPS. DWS HEPA and ULPA filters are packed with 33 pleats per decimetre to ensure we achieve the required downflow rate.
The GMP Isolator 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 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 (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 isolator can also be run aerobically if required.
Range of possible decontamination protocols, including the use of vaporised hydrogen peroxide.
IQOQ documentation available.