Whitley A155 GMP Workstation

The A155 GMP Anaerobic Workstation* is specifically designed to be used as a clean-air isolator in processes following Good Manufacturing Practice (GMP). This is the first Whitley GMP Workstation that allows two people to work in the chamber at same time. The A155 GMP Workstation 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.

Description

Description

Lab Technologies India – Best Anaerobic Chamber Supplier

Lab Technologies India is a leading Anaerobic Chamber Supplier, catering to the diverse needs of laboratories across the country. Our state-of-the-art anaerobic chambers create an oxygen-free environment, crucial for cultivating and studying anaerobic microorganisms. With a commitment to quality and precision, we provide reliable solutions for microbiology research, clinical applications, and industrial processes. Our chambers are designed for user-friendly operation and optimal results. Lab Technologies India takes pride in delivering cutting-edge anaerobic technology, ensuring the integrity of your experiments. Partner with us to access top-tier anaerobic chambers and elevate your laboratory’s capabilities.

Buy Whitley A155 GMP Workstation from Anaerobic Chamber SupplierGlove extenders are employed during VHP (Vaporized Hydrogen Peroxide) sterilization to enable the separation of the fingers of the gauntlets throughout the sterilization cycle. This separation is crucial to prevent any blockages and ensure that the hydrogen peroxide comes into contact with all areas for effective sterilization. Notably, this represents the inaugural Whitley GMP Workstation capable of accommodating two individuals within its chamber simultaneously. This innovative A155 GMP Workstation offers Grade A air cleanliness (in accordance with EU GMP guidelines) and seamlessly integrates sterile anaerobic uni-directional airflow, positive operating pressure, and physical isolation to ensure exceptionally robust product protection. Diverging from conventional isolators that draw inlet air from the surrounding environment, this workstation operates as a fully enclosed recirculating system, thus permitting placement within a Grade D cleanroom while adhering to GMP-compliant protocols.

Every workstation undergoes rigorous testing to verify conformity with the applicable sections of ISO 14644-3. This testing is especially significant for users engaged in anaerobic processes, as it ensures adherence to GMP standards. Furthermore, our in-house laboratories conduct tests that affirm the effectiveness of the integrated HEPA-filtered uni-directional airflow system in meeting the specifications outlined in BS EN 12469:2000, specifically in safeguarding the working area against particulate and microbial contaminants.

The engineers at Don Whitley Scientific are extensively trained to conduct filter integrity (DOP) testing on HEPA filters. This expertise enables us to offer comprehensive validation services for Whitley GMP Anaerobic Chamber (Workstations). Customers who adhere to GMP processes can be reassured that they do not need to seek external specialized organizations to perform these crucial tests once their Anaerobic chamber is installed. DWS has made significant investments in acquiring the necessary equipment and providing the requisite training, offering a convenient one-stop solution. Customers can have full confidence that their Anaerobic chamber (workstation) has been tested by engineers who possess thorough training in both the operation and production of Whitley Anaerobic Chamber (Workstations).

This workstation features two built-in airlocks, positioned on either side of the main workstation chamber, offering an optimal layout for a ‘production line’ approach to work. You can choose from two sizes of airlocks: 17.5 liters or 43 liters. These airlocks have been purposefully designed to facilitate the smooth transfer of serological pipettes into the Anaerobic chamber (workstation).

Each 17.5-liter airlock is capable of holding 10 x 500ml Duran bottles, with internal dimensions measuring 197mm x 388mm x 190mm (width x depth x height). On the other hand, the 43-liter airlocks, measuring 335 x 300 x 300mm, can accommodate up to 20 x 500ml Duran bottles.

The patented oval glove ports are designed to offer unparalleled comfort, even during extended periods of use.

With internal working area dimensions measuring 2200 x 750 x 620mm (width x depth x height), the Anaerobic chamber (workstation) provides an expansive workspace that can easily accommodate equipment like centrifuges and homogenizers.

This workstation is well-suited for a variety of applications, including but not limited to: faecal microbiota transplant, probiotics manufacturing, bacteria manufacturing, live biotherapeutics, biopharmaceuticals, and microbiome therapeutics.

Anaerobic Chamber SupplierGauntlets

In compliance with GMP regulations for high-risk processing applications, specialized and robust gauntlets are a necessity. Whitley GMP Workstations offer an innovative solution with the “BCS” gauntlet, crafted from non-shedding materials like Neoprene or CSM. This unique design enables exceptionally quick and easy glove changes without compromising containment or atmospheric conditions. These two-piece gauntlets are manufactured by a global leader in isolator gloving systems. The provided order code pertains to the sleeve section of these gauntlets.

The BCS gauntlet represents a significant improvement over existing glove replacement methods, which are often fragile, intricate, labor-intensive, susceptible to user containment errors, and typically necessitate users with specialized accredited training for replacement. This gauntlet offers a straightforward and efficient quick-change method, substantially reducing the risk of micro-tears and containment errors. Moreover, it provides a much more comfortable solution for customers and can be easily replaced by users without the need for special training.

For this gauntlet system, there are three sizes available for the glove portion: sleeves, cuffs, and gauntlets. You can find more information on this system on the Lab Technologies India website (www.labtechnologies.in).

Glove Extenders

Glove extenders are employed during VHP (Vaporized Hydrogen Peroxide) sterilization to enable the separation of the fingers of the gauntlets throughout the sterilization cycle. This separation is crucial to prevent any blockages and ensure that the hydrogen peroxide comes into contact with all areas for effective sterilization.

Overview

Overview

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.

An optional HEPA Filtered Airlock is also available, which includes the incorporation of a H14 HEPA filter to ensure 100% reduction in airborne particulate in the airlock over the course of the cycle. This ensures Grade A particulate counts in the main chamber are not compromised.

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.

  • 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.
Specifications

Specifications

Capacity Litres 1800
Port Airlock Capacity 10 x 500ml Duran bottles in each airlock
Airlock Size (litres) 17.5
Porthole System Manual
Gas Supplies ANO2 / N2
Footswitch Wireless
Auto Sleeve Gassing Included
Internal Mains Sockets Included
Inspection Lamp Available
AN02 Conditions Monitor Available
Data Logging Available
Airlock Cycle Time (seconds) 2 minutes
Extra Cable Glands Available
Automatic Dehumidifier Included
Removable Front Included
Trolley Available Included
Vacuum Take Off Available
Temperature Range 4°C above ambient up to 45°C
Touchscreen Control Yes
Remote Access Included
HEPA As Standard
Dimensions (W/D/H mm) 2940 / 1130 / 1080
Weight (lbs/kgs) 1298 / 590
Options

Options

A01745 Hydrogen/Mixed Gas Regulator
A01748 Nitrogen Regulator
A02810 IQOQ with DOP and Filter Face Testing
A02945 Cable Gland
A06102 Vacuum Take-off Port
A06107 Gas Sample Port
A06109 Data Logging
A06128 Large Cable Gland
A06132 Particle Counter Connection Port
A06135 Multiple Cable Port
A07200 Data Logging
A07218 Whitley Enhanced Biological Containment System
A08167 Multiple Cable Port (Extra Large)
A08802 Email Alert Option – Anaerobic
A09480 GMP Workstation IP55 Splash Proof Socket
A09530 ULPA Filter Option
A09532 A135 GMP Anaerobic Conditions Monitoring Option
A10001 HEPA Filtered Airlock
DAR2022 Air Sampler Connection Port
DWVHP0312011 VHP M100 Biodecontamination Closed Loop System 21 CFR
L00040 Temperature Mapping
L00050 Single Point Temperature Calibration
Reviews (0)

Reviews

There are no reviews yet.

Be the first to review “Whitley A155 GMP Workstation”

Your email address will not be published. Required fields are marked *