Expert Report on automated climate monitoring byTesto

BOTH PHARMACEUTICAL and medical technology products directly influence the health and well-being of patients and users.

Efficacy, identity and purity are therefore the most important quality attributes applied to these products. In order to guarantee the required quality, the monitoring of the climate parameters of temperature (°C) and relative humidity (%RH) assume a key role in production and storage. There are also detailed requirements for this in directives and standards. In order to be able to meet the requirements of a wide range of measuring tasks, automated monitoring systems need to be implemented effectively at critical application areas in the pharma sector.

Objectives of climate monitoring

The raw materials and substances involved, and also the end products, are very sensitive to the wrong climatic conditions, such as temperature and humidity. However, it is not only the drugs per se, or their constituents, that are at risk when stored outside the permissible temperature range, their storage containers or packaging are also affected.

• Major fluctuations in temperature can cause hairline cracks in ampoules and glass containers.

• This can lead to contaminations and even loss of sterility.

• Too humid storage conditions can negatively influence the quality of drugs.

• Damp packaging or blurred and illegible labeling can also occur

• Development of mould on and inside the boxes is also possible.

For these reasons, constant monitoring and documentation of the prevailing climate parameters in the relevant areas are indispensable and they are controlled by a really wide range of regulations and legal requirements. These for instance include

• Specifications of the World Health Organization (WHO) regarding Good Storage Practice (GSP)

• Requirements of the German Ordinance on the Manufacture of Medicinal Products and Active Pharmaceutical Ingredients (AMWHV),