Pharmaceutical products must be able to demonstrate perfect quality. This applies to the research laboratory and the production of medicines, as well as the storage of sensitive substances.
Strict regulations and directives apply, e.g. the ISO 9001, GxP, GMP (Good Manufacturing Practice), GLP (Good Laboratory Practice), or 21 CFR Part 11.
Transport
Most pharmaceuticals must be continuously transported at defined upper and lower temperature and humidity limit values, along the entire supply chain.
- Control of the cold chain during delivery
- Protection from unnoticed gaps in the cold chain during the entire distribution path
- monitor and document simply, securely and compliantly with all common standards, guidelines and regulations
Freeze-drying
- Qualification of the plate temperature with five measuring points per plate
- Measurement of the plate temperature with testo 190 T3/T4 or testo 191 T3/T4 plus probe holder for freeze-drying
- Steam in Place (SIP): Subsequent sterilization of the system with superheated steam under specified time and temperature conditions
Sterilization
- Physical and biological evidence that the sterilization method is suitable for the product
- The validity of the procedure must be verified regularly, e.g. when it comes to steam sterilization in autoclaves by temperature data loggers (lethality rate), pressure data loggers (saturated steam quality) and biological indicators
- Positioning the data logger’s probe tip in the core of the item being sterilized
Cleaning and disinfection
- Placement of the data logger measuring tips on the surfaces of the products
- Measurement must be reproducible
- The user must be able to prove whether the degree of disinfection (A0 value) has been reached or not
Laboratories
From the monitoring of temperature in critical processes to the testing and monitoring of all air conditioning parameters: At Testo, you’ll find the right measurement technology to ensure the required quality in laboratory surroundings.
- Uninterrupted humidity and temperature monitoring with data loggers
- Ensure the comparability of measurement and research results
Cleanroom
Cleanrooms require precise measurement methods in order to be qualified according to their areas of application and quality requirements.
- Ensuring a uniform cleanroom environment
- Strict adherence to defined conditions
- Qualification and calibration
