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
Solutions for comprehensive quality management
Uninterrupted Continuous Monitoring - with a single secure system:
- Assists you in the central monitoring of audit relevant parameters and data while minimizing your risks
- Reduces costs and facilitates efficient production processes in an FDA regulated environment, 21 CFR Part 11
- Enables prompt intervention for critical deviations or alarms during the entire pharmaceutical manufacturing process
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
- 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
- Qualify and validate your temperature sterilization process
- Validating temperature, sterilization using safe, reliable and highly accurate temperature and pressure data loggers for autoclaves.
Cleaning and disinfection
- Qualify and validate your cleaning and disinfection process
- Provides assurance that a product is correctly sterilized in the healthcare field.