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Requirements

Environmental monitoring along with sterility testing processes are critical to laboratory quality control and regulation compliance. Strict environmental monitoring requirements are set by the professional bodies’ codes of practice and guidance documents to improve working practices and safety in labs, such as FDA 21 CFR Part 11, GLPs and CAP.

 

The ability to monitor multiple parameters within these strict guidelines is critical for various laboratory applications typically including:

  • Ambient room conditions
  • Thermal Cyclers
  • Refrigerators, freezers & Cryogenic (for more information about cold storage, click here)
  • Incubators (for more information about incubation, click here)
  • Oxygen Depletion/Nitrogen Safety
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Nitrogen Safety in Laboratories

  • Laboratories that need Liquid Nitrogen (LN2) Dewar’s for biological sample storage, should also be equipped with Oxygen sensors to protect staff from potentially fatal oxygen deficient environments.
  • Products that detect O2 should be carefully considered when lives are at risk. Understanding the speed of effects of Nitrogen exposure to humans will assist in choosing the right equipment for your staff.
  • Exposure to Nitrogen
  • If the lids on the storage Dewar’s are left open or ajar for prolonged periods or a leak develops there is a risk of a build-up of gas in the vicinity. The gas: Nitrogen is colourless, odourless, and tasteless. This invisiblegas is not only undetectable to staff, but occupies approximately 700 times the volume of the liquid, and creates an immediate threat to life.
  • Nitrogen is heavier than air, therefore will rise from the floor, rapidly displacing the oxygen within the room. Anyone unknowingly exposed to this atmosphere would become unconscious after only two short breaths.
  • Due to the dangerous working environments, laboratory technicians are required to follow strict guidelines set out by their organization.
  • Though guidelines are in place there have still been several cases around the world in recent years of laboratory technicians accidentally dying from this silent killer and companies go to great lengths to avoid staff fatalities.

 

Challenges

Cold storage

Qualification, Validation and Monitoring of cold storage freezers/tanks generally fall into three main categories: Standard, low and ultra-low. Freezers/cabinets require specific materials for probe stability and accuracy. Ellab offer a range of varying temperature probes for each temperature validation and monitoring application. Learn more about cold storage, here)

 

Thermal Cycler

Thermal cyclers / PCR machines or DNA amplifiers most commonly require temperature monitoring to assist with validation of environments. Accuracy and real-time data are crucial for this.

 

Incubation

Usually validation of incubators does not pose any special challenges because the parameters to be controlled are relatively easy to match. The temperatures are modest, and no pressure measurements are needed. The range of Ellab’s temperature and temperature/RH% LAB data loggers can also be used. To simplify the operation, the LED indicators on the LAB sensors will provide the operator with instant information on logger status.

 

Environmental monitoring for incubators poses slightly different challenges to ensure various environmental factors are accurately recorded often including temperature, humidity and CO2. Our range of sensors offer multiple variations for each of these measuring parameters assisting with the vast environmental monitoring needs for many applications such as cell growth.

Cold Storage

Wireless solutions solve many of the challenges presented during each stage of the cold storage process. A centralized monitoring system allows data to be collected from all cold storage areas, so that users benefit from gap-free data throughout the entire cold chain, whilst also maintaining a clear record of data for auditing purposes. (for more information specifically relating to cold storage control, click here)

Nitrogen safety

Wall mounted gas safety devices for monitoring oxygen and carbon dioxide are a cost-effective, quick and easy method to identify when environments containing nitrogen become dangerous. When linked to alarm beacons immediate alerts can trigger staff to react and either remove themselves or others from potentially hazardous areas.

 

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Choosing the Right Equipment for Laboratory environmental monitoring

Both wireless data loggers and Hanwell Pro and IceSpy systems are a suitable choice when looking for comprehensive measurement solutions.

These wireless data loggers can be used simultaneously for multiple measurements within single or multiple zones and sites.

Retrieve real-time temperature, humidity, CO2, Differential Pressure and other measurements through one flexible and secure software solution.

Complete IQ and OQ protocols and custom protocols assist in national regulatory compliance requirements while audit-ready reporting tools provide automated and clear data for action to be taken when needed.

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Environmental Monitoring

Temperature – Ellab’s vast range of temperature transmitters are ideal for fridges at 2°C – 8°C, freezers with temperatures down to -20°C, -30°C,- 40°C & -80°C and also cryogenic storage at -150°C and-200°C.

 

Humidity – Throughout many pharmaceutical processes (research, development, manufacture and distribution) the effects of ambient humidity can have detrimental effects on product quality, yield, visual appearance and shelf-life of pharmaceutical drugs. Ellab’s range of precision RH/T transmitters provide high-accuracy and reliability.

 

CO2 – The Ellab CO2 transmitters with combined CO2 and temperature are highly sensitive transmitters measuring 0-5% and 0-10% levels with an LCD display and has been used within laboratory incubators for many years providing accurate tools to monitor environments and send alarms that can assist with maintaining an essential stable environment.

 

The above transmitters can be in use simultaneously and data transferred in real-time to EMS for historical data collection and alerts via email, SMS and mobile app.

Oxygen depletion for environments containing nitrogen

Ellabs monitoring equipment is already logging LN2’s Dewar containing biological samples uses highly accurate Type T Thermocouple probes provides independent and continuous logging to a centralized software.

 

Users of the equipment can simply combine hardwired oxygen depletion detection to create a comprehensive recording solution to multiple environmental conditions including O2 depletion.

 

The use of hardwired oxygen depletion sensors in this instance is critical due to the life-threatening working conditions.  Wireless technology in these instances will not trigger the alarms in the seconds required to evacuate or correct dangerously effected areas. Hardwired solutions like this provides the operators with instant visibility of any threat with visual and audible indication.  Repeater units are often placed outside the room to stop staff entering when the conditions are unsuitable.

 

Many companies want to monitor in their central software any excursions in Oxygen levels so that they have auditable records available.  Therefore, once a hardwired oxygen depletion system is in place, wireless monitoring systems can be used to collect data from each area for auditable purposes too.

 

The oxygen depletion sensors also have an analogue 4-20mA output that can be connected to a standard Hanwell wireless transmitter for the recording of the data into the central software.

Guidelines

Laboratories are required to adhere to a number of regulations and guidelines commonly used across most countries, including Good Laboratory Practice (GLP) and CAP.

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EMS Software Reports

Laboratories

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Temperature
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Temperature & Humidity
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