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Temperature monitoring

Validation of temperature controlled storage and transportation

Why validate?

Validation of temperature controlled storage and transportation is important because if healthcare products are not stored under specified conditions, stability may be compromised and shelf life reduced. Stability is compromised by temperature extremes or fluctuation. High temperatures increase the rate of degradation and decrease its shelf life. Inappropriately low temperatures may cause harm. For example, refrigeration may cause extreme viscosity in some liquid drugs and cause crystallization and precipitation in others. Freezing can denature proteins and can cause less soluble polymorphic states of some drugs to form.

The “cold chain” involves all of the storage and transport facilities necessary to ship a product requiring controlled low-temperature storage from the manufacturer to the end user. Thus the whole cold chain should be controlled and validated including transportation requirements. 

Temperature control is also required for freezers, “cool” storage i.e. ‘between 8°C and 15°C’, ambient temperatures and for incubators e.g. ‘between 30°C and 35°C’. 

Statutory and ethical requirements

There are several statutory and ethical requirements (listed below) which govern the storage of medicinal products, blood banks and departments responsible for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells. 

  • RPSGB Code of Ethics 
  • The Blood Safety and Quality Regulations 2005 
  • Directive 2004/23/EC 
  • Good Manufacturing Practice and Good Distribution Practice  i.e. MHRA Rules and Guidance for pharmaceutical Manufacturers and Distributors – “Orange Guide” 
  • Quality Assurance of Aseptic Preparation Services Fourth Edition 

 

Frequency of monitoring 

The “Orange Guide” indicates that: 

"Internal air temperature distribution should be mapped on installation in the empty and full state and annually thereafter under conditions of normal use." 

Validation work carried out by RDH QA

We currently carry out temperature control validation work for a number of customers including for pharmaceutical applications and blood banks. This includes the following types of work:

  • Temperature distribution mapping for new devices and for regular annual validation programs
  • Cold chain transportation validation


Figure 1. Example of temperature distribution graphical and probe position presentations

 

 

pharmacy qa monitoring

If you require more information please contact Marc Sutton (Head of QC) on direct telephone number 01332 787950 or via e-mail marc.sutton@nhs.net. Alternatively contact Kate Pegg (Deputy Head of QC) on direct telephone number 01332 787949 or via e-mail kate.pegg@nhs.net 

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