Hypoxystation H155 GMP

Hypoxystation H155 GMP


Our largest GMP workstation: 1,800 litre capacity and the option of dual temperatures.
Options and Specs
Whitley Workstation H155 GMP Workstation
 

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.

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.

Each workstation is tested by an independent organisation to ensure compliance with 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 regarding protection of the working area from particulate and microbial contamination.

Two 17.5 litre airlocks (one at either side of the main workstation chamber) provide an ideal layout for a ‘production line’ style of working. 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.


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Whitley Workstation H155 GMP Workstation

Features:

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.

 

Options:


Trolley
Our custom-designed trolley frees up bench space and allows the chamber to be moved. The trolleys are built with high quality tubular steel and smooth rolling lockable wheels. They offer a sturdy and stable frame to support your use of our anaerobic and microaerophilic workstations.
See Details

IQOQPQ
The Installation Qualification and Operational Qualification (IQ/OQ) is based on a dynamic document that is tailored to meet the needs of each specific customer. The Performance Qualification (PQ) document is prepared through close collaboration with the customer to ensure it is suitable for the particular application.

Cable Gland
Cable glands allow cables and probes to be introduced into a Whitley Workstation without compromising internal conditions. A small cable gland is available with a clamping range between 3 - 7mm in diameter.

Large Cable Gland
Cable glands allow cables and probes to be introduced into a Whitley Workstation without compromising internal conditions. Cable glands are available in a variety of sizes to suit different cable diameters and cables with moulded connectors. A large cable gland with a clamping range of 18 – 25 mm in diameter is available. This gland can also be supplied with a reducer that can be drilled to suit smaller cable diameters.

Data Logging
This feature will allow the last 31 days of workstation temperature, humidity and chamber pressure conditions to be recorded for traceability or reference. This information is displayed on the touch screen in graphical format. The recorded data can be downloaded in a few seconds via the USB interface to a memory stick and imported into a spreadsheet for further analysis. Information from the Event Log can also be downloaded - USB stick included to facilitate this.

Data Logging with Oxygen Profiling
This option allows the user to record the data from the environmental parameters inside the workstation AND allows the user to pre-programme different oxygen levels. The user can determine how long the workstation atmosphere remains at a particular oxygen level and when to adjust to higher or lower oxygen concentrations.

Temperature Mapping
This is essential when a laboratory must demonstrate that temperature performance could directly or indirectly affect results. It provides independent, UKAS-accredited testing and supporting certification. The process comprises calibration of the workstation temperature sensor and a comprehensive temperature profile of the entire working and incubation area. Data is collected from up to 12 sensors, traceable to national standards, positioned throughout the workstation chamber. This is preferably a factory-based test but it can be performed on-site if necessary.

Single Point Temperature Calibration
This is essential when a laboratory must demonstrate that temperature performance could directly or indirectly affect results. It provides independent, UKAS-accredited testing and supporting certification. It also confirms, through measurements taken from a single position within the workstation incubation area, using a calibrated temperature probe traceable to national standards, that the workstation temperature is controlled and displayed within specified tolerances.

Specs:

Capacity (Liters) 1800.00
Port Airlock Capacity 10 x 500ml Duran bottles in each airlock
Airlock Size (liters) 17.50
Porthole System Manual
Gas Supplies CO2, N2, Air
Footswitch Wireless
Auto Sleeve Gassing Included
Internal Mains Sockets Included
Inspection Lamp Available
Data Logging Available
Airlock Cycle Time (seconds) 60
Extra Cable Glands Available
Automatic Dehumidifier Included
Removable Front Included
Trolley Available Included
CO2 Monitoring Included
Vacuum Take Off Available
O2 Profiling Available
HEPA As Standard
Remote Access Included
Temperature Range 4°C above ambient to 45°C
Dimensions (W/D/H mm) 2940 / 1130 / 1080
Weight (lbs/kgs) 1298 / 590