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Laboratory Incubator Bacterial Incubator Shaking Incubator Co2 Incubator
Laboratory Incubator

Laboratory Incubator Validation and Qualification Service

Ellab is a provider of laboratory incubator validation and qualification services, which often include temperature and humidity mapping. A laboratory incubator is an enclosed apparatus used as a storage device for monitoring and controlling temperature, humidity, CO2 and other conditions under which a microbiological culture is being grown.

The simplest incubators are insulated boxes with an adjustable heater, typically going up to approx. 65°C. Some incubators can go slightly higher but generally to no more than 100 °C. More advanced incubators may have the ability to lower the temperature (via refrigeration), and/or the ability to control humidity or CO2 levels. This feature is specifically designed for cell growth.

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Qualification Process of Laboratory Incubator Chamber & Room

Qualification must be performed periodically to ensure that the incubator is capable of accurate and repeatable performance. A specified number of temperature and humidity or CO2 loggers are placed throughout the incubator in the pre-determined locations while taking into account the expected gradient throughout the chamber. The temperature, humidity and/or CO2 mapping is typically performed over a minimum period of 24 hours.

Potential challenges when validating an incubator are:

  • To determine the cold and warm locations of the incubator
  • To calculate and document the minimum, maximum and average humidity and CO2 and their locations
  • To monitor the humidity as well as CO2 of the incubator
  • To identify and improve temperature equilibration
  • To calculate and document the minimum, maximum and average temperatures and their locations

    Options when validating your chamber:
Bacterial Incubator

Bacterial Incubator Validation and Qualification Service

Ellab is a provider of onsite cGMP validation and qualification of bacterial incubators, which include temperature mapping. A bacterial incubator is an environmental chamber which holds a tight specification for stability and uniformity to promote the growth of biological material. These bacterial incubators provide optimal conditions for testing to see if biological indicators or any other bacterial material grows.

Since the growth test for the biological indicator is temperature sensitive, it is critical to have the environmental chamber qualified in order to stand up to FDA audits. These units have tight stability requirements in order to eliminate as much temperature variability as possible to ensure confidence that your bacterial material is truly growing or not.

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Shaking Incubator

Shaking Incubator Validation and Qualification Service

Ellab is a provider of onsite cGMP laboratory shaker incubator validation and qualification services., which includes temperature and humidity mapping. Shakers and stirrers are engineered to create homogenous mixtures in any laboratory procedure. They are capable of holding instruments without spilling the contained gels or blotted membranes, the devices operate gently, but effectively. Shakers and stirrers are an essential method of blending samples inside tubes and flasks. They are ideal for mixing samples in blood and centrifuge tubes as well as general microplate shaking. Easy-to-read displays feature time and speed, and timers can be set for pre-defined times to shut off after a certain countdown.

Yet, even though they have a universal function, not all laboratory shakers and stirrers are equal for each task. Precision in the shaking motion is critical for many lab applications. The rocking tool creates a gentle uniform mixing with its see-saw motion. 

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Qualification Process of Laboratory Shaker and Stirrer Incubators

Qualification must be performed periodically to ensure that the incubator is capable of accurate and repeatable performance. A specified number of temperature and humidity or CO2 loggers are placed throughout the incubator in the pre-determined locations while taking into account the expected gradient throughout the chamber. The temperature, humidity and/or CO2 mapping is typically performed over a minimum period of 24 hours.

Potential challenges when validating an incubator are:

  • To determine the cold and warm locations of the incubator
  • To calculate and document the minimum, maximum and average humidity and CO2 and their locations
  • To monitor the humidity as well as CO2 of the incubator
  • To identify and improve temperature equilibration
  • To calculate and document the minimum, maximum and average temperatures and their locations
Co2 Incubator

Co2 Incubator Validation and Qualification Service

Ellab is a provider of onsite cGMP CO2 incubator validation and qualification services. An incubator is an enclosed apparatus used as a storage device for controlling temperature, humidity and other conditions such as CO2 under which a microbiological culture is being grown. Incubators are not only temperature dependent as both humidity and CO2 are designed to be monitored and controlled.

The simplest incubators are insulated boxes with an adjustable heater, typically going up to approximately 65°C. Some incubators can go slightly higher but generally to no more than 100 °C. More advanced incubators may have the ability to lower the temperature (via refrigeration) and/or the ability to control humidity or CO2 levels. This feature is specifically designed for cell growth. 

Get a Quote
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