Temperature mapping is a mandatory requirement whenever regulatory controlled product is being manufactured, and thermal processing or storage is involved (heating or cooling). The individual Operational Qualification (OQ) of the equipment in use, must call for heat distribution; temperature mapping, studies of the actual heating or cooling process area used (Cabinet, Room or container). This study must verify that all product will be subject to the same thermal environmental conditions; no matter where the product is situated within the processing compartment. This verification is mandatory and applies to all environmental process and storage equipment such as; mixers, ovens, freezers, hot rooms, cold rooms, sterilizers, warehouses, delivery vans, transport containers, stability chambers, freeze dryers and incubators
Medival provide services to the vide ranges of Temperature and Humidity monitoring for Storage areas, ovens, freezers, hot rooms, cold rooms, sterilizers, warehouses, delivery vans, transport containers, stability chambers, freeze dryers and incubators.
Mapping Study shall be conducted as per regulatory guidelines (WHO TRS-961) with following features.
Traceability to national and international standards such as HTM 2010.
CFR21 Part 11 compliant software.
Robust quality system including ISO 9001:2008.
Highly accurate data loggers with definite error less than 0.2 degree.
21 CFR part 11 compiled Data logging software’s complete mapping report with statistical analysis.
Protocol development
Temperature mapping
Data analysis
Reporting
If you have any specific questions about us or any of our services, get incontact with us.
