testo Saveris for Life Science and Pharmaceuticals
It is pertinent that life science companies can demonstrate to regulatory agencies, like the FDA, the quality of their products during the entire manufacturing process of injectable or ingestible human and animal products. The regulatory requirements now also apply to the research and development and the production of pharmaceuticals, as well as the storage and transport of sensitive substances and raw materials.
The strict regulations and directives that apply to the entire manufacturing process are as follows:
• ISO 9001
• cGxP, cGMP (Current Good Manufacturing Practice), GLP (Good Laboratory Practice), GDP (Good Documentation Practices), etc
• 21 CFR Part 11, Electronic Records/Electronic Signatures
Climate monitoring solution
The ambient conditions that drugs, blood products or vaccines are kept in have to be constantly monitored and documented.
- Use our climate monitoring system
- Guarantee product quality by the help of continuous monitoring of humidity and temperature
pH measurement
Measuring instruments for pH value are above all used in the chemical, pharmaceutical industry.
- Discover the processes of many chemical and biochemical reactions
- Determine the pH value in semi-solid and viscoplastic media as well as in liquids
Temperature monitoring
- Temperature monitoring in compliance with CDC, FDA, and USP guidance
- Ensuring the highest level of protection for temperature sensitive products
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
