Whitley H155 GMP Hypoxystation

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Whitley H155 GMP Hypoxystation

Our largest GMP workstation: 1,800 litre capacity and the option of dual temperatures

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The H155 GMP Hypoxystation* is specifically designed to be used as a clean-air, hypoxic isolator in processes following Good Manufacturing Practice (GMP). This workstation allows two people to work in the chamber at same time and is specifically designed to accurately control the parameters of O2, CO2, temperature, and humidity.

Providing Grade A air cleanliness (EU GMP), this hypoxic isolator combines sterile laminar airflow, positive operating pressure, and physical isolation, to provide highly effective product protection. Due to being a completely closed, re-circulating, isolator system, this workstation can be housed in a Grade D cleanroom during GMP compliant use.

The full-time environmental control offered by the H155 GMP Hypoxystation maximises the reproducibility of the cell-manufacturing processes carried out inside. Further, this Hypoxystation is designed to be modular and can be combined in different ways to form a production line that ensures that the cell-culture environment is never broken from the beginning to the end of the manufacturing process.

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 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.

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 can be fitted with your choice of gauntlet and 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 large scale bioreactors and imaging systems.

Gauntlets

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. 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 - Don Whitley Scientific (dwscientific.com) 

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.

* Patent pending

  • Precise control of oxygen between 20.9% and 0.1%.
  • CO2 control between 0.0% and 15%.
  • HEPA filter face velocity/uniformity of laminar flow 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 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 hypoxic isolator is Ethernet-enabled for remote access review and control.
  • Four oval 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.
  • IQOQPQ documentation available.
  • Air sampling ports can be fitted to allow particulate monitoring systems to be connected to the workstation for continuous particulate monitoring.

View Specification

Specifications

Capacity Litres
1800.00
Port Airlock Capacity
10 x 500ml Duran bottles in each airlock
Airlock Size (litres)
17.50
Porthole System
Manual
Gas Supplies
CO2, N2, Air
Footswitch
Wireless
Auto Sleeve Gassing
Included
Internal Mains Sockets
Available
Inspection Lamp
Available
Data Logging
Available
Extra Cable Glands
Available
Automatic Dehumidifier
Included
Removable Front
Included
Trolley Available
Included
Co2 Monitoring
Included
Vacuum Take Off
Available
O2 Profiling
Available
Touchscreen Control
Yes
Remote Access
Included
HEPA
As Standard
Dimensions (W/D/H mm)
2940 / 1130 / 1080
Weight (lbs/kgs)
1298 / 590
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