2˚C to 8 ˚C Cold Room Temperature Mapping and Thermal Validation
QualUs has an extensive knowledge and experience in the temperature mapping and validation of 2˚C to 8 ˚C cold rooms. Our dedicated team of validation experts can define your validation requirements, prepare protocols, execute the temperature mapping, thermal validation and provide data analysis with reports in accordance with regulatory compliance. Qualus has a proven track record with temperature mapping cold rooms for some of the largest pharmaceutical companies in Ireland. Qualus validation engineers are capable of defining your validation requirements from a regulatory perspective and from this they can prepare concise protocols and subsequent reports in either a QualUs format or in a client specific format. Cold rooms used for storing temperature sensitive goods should be temperature mapped and validated. Cold room storage is a relatively simple cold room that is commonly used to store material between 2˚C to 8 ˚C. Such cold rooms are now available commercially as walk-in chambers and are used for the storage of critical pharmaceutical products, samples, and raw materials where changes in temperature conditions may affect the quality of stored product and hence it is essential to qualify cold storage chambers under the worst-case scenarios.
Some pharmaceutical manufacturers perform only Installation Qualification (IQ) of cold rooms, Operational Qualification (OQ) and Performance Qualification (PQ) on the performance of the chamber for maintaining the desired temperature conditions.
Mapping temperature variations within the cold room.
Measuring temperature variations at each location within the coldroom.
Documenting high and low temperature fluctuations caused by the environmental control systems operating at the time of the study.
Door Open Recovery Test.
Identifying potential airflow issues that may be the cause of temperature variations.