Validation
Calibration
Commissioning
Temperature Mapping
Temperature Mapping
Temperature mapping is the gathering of temperature data at several points within a defined space, over time
The temperature data - Identifies “hot spots” and “cold spots”
- Contributes to overall compliance to 21 CFR Part 211
- Is most useful when results obtained are analyzed to determine suitability to the application
- Is most effective when gathered using an approved protocol (instructions and methodology)
- Is useful to ensure that a piece of equipment is performing as intended
Temperature mapping benefits
- Temperature conditions during a manufacturing process can have a direct impact on the quality and integrity of products
- The FDA mandates the storage of drug products and components under appropriate conditions so that the identity, strength, quality, and purity of the drug products and components are not affected
Biometrix Corporation uses the GE Kaye Validator 2000 with sheathed Type T Premium thermocouples with welded tips for all temperature mapping tests. The final document package will include a summary report, hard copies of all data, completed protocol and copies of calibration certificates of all test equipment. Relative Humidity (RH) may be mapped simultaneously with temperature for most applications
All equipment employed for temperature mapping is calibrated using NIST-traceable standards.
Request Information
|
 |
|
“We’ve used Biometrix to perform initial validation and re-validation of some of our most critical equipment since 2003. Their protocols are thorough, yet not excessive. Their validation engineers are a pleasure to work with and are always available to answer questions and provide guidance. Working with Biometrix is a respite of smooth sailing – in an environment that is demanding and often changing.”
- Validation Manager for pharmaceutical company
|
|
|
|
|