Temperature Mapping
Temperature mapping is the process of mapping the differences and changes in temperature which occur within a single temperature controlled system due to influences like opening doors, proximity to cooling fans, personnel movement, the quantity of products being stored at any given time.
As regulators increase their emphasis on GMP requirements for controlled thermal storage requirements, the definitive method to demonstrate that all controlled storage equipment, or storage areas, stay within the specified limits is through a thorough Temperature Mapping Study.
ReguLogix Solutions exhibits the equipments and experienced professionals to help you achieve compliance in this area.
Why do Temperature Mapping?
Clause 3.19 of the PIC/S GMP guide states:
"Storage areas should be designed or adapted to ensure good storage conditions. In particular, they should be clean and dry and maintained within acceptable temperature limits. Where special storage conditions are required (e.g. temperature, humidity) these should be provided, checked and monitored."
A temperature mapping exercise is expected to collect the following information:
The impact of interventions (door openings / power failures, etc.)
Identification of hot and cold spots
Variation of temperature at a single point
Temperature variation across the area
Length of time of any temperature excursions
Why ReguLogix Solutions for Temperature Mapping Study..?
ReguLogix Solutions helps to meet your compliance obligations at effective cost.
Temperature mapping can be a costly exercise. With multiple probe locations required it can be expensive to purchase and maintain the necessary equipment.
ReguLogix Solutions can provide all the necessary equipment and calibration data for your temperature mapping study, so that you don't have to buy, maintain and know how to use it.
Temperature Mapping Study comprises four broad activities:
Protocol development
Trial execution
Data analysis
Reporting
ReguLogix Solutions can all of these services, as well as an ongoing mapping service after the initial protocol development.
Our Temperature Mapping Services include:
Freezers, Ultra Low Freezers, and Control Rate Freezers
Refrigerators
Incubtors
Cold Rooms
Autoclaves
Ovens
Stability Rooms
Stability Chambers
Warehouse Storage Facilities and more