Monitoring for Regulatory Compliance & Product Safety
Temperature - Humidity - Moisture - Pressure - pH
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Challenges Labs & Blood Banks

The importance of Temperature as a critical control parameter for ensuring quality in Laboratories and Blood Banks is recognised by all of the regulatory authorities  e.g HPRA; MHRA; FDA and Quality Standards e.g. ISO15189 and ISO 17025

Specific challenges affect laboratories and blood banks as follows

Blood Banks

Blood packs must be stored at a certain temperature, in order to provide accurate results and avoid the risk of contamination or infection.  The temperature in Blood banks must be monitored at all times to ensure conformity with HPRA regulations.  Failure to meet these requirements poses a serious threat to patient safety.

Laboratory Temperature Monitoring

Pharmaceutical Laboratories must be temperature monitored where storage of products or samples occurs. 

Medical Laboratories (ISO15189) General Laboratories (ISO17025)

 These laboratories are required to comply with the following specific requirements in relation to temperature and humidity monitoring.

  • Samples transported to the laboratory must be checked and recorded to ensure they have been transported at the correct temperature
  • The storage temperature of samples before and after testing must be monitored and recorded to ensure that the samples are being stored at the correct temperature.
  • The temperature and humidity of the environment in which the testing is performed must be monitored and recorded
  • The temperature at which the tests are performed must be that specified by the test procedure (e.g. incubator temperatures) and  must be monitored and recorded as proof that the tests were performed at the specified temperatures.