Warehouse Temperature Mapping Validation Services
SIERRA offers effective evaluation and validation of a warehouse's HVAC system to determine the design's suitability for the storage of materials with these requirements.
The results are evaluated for approval of the space's intended use, and are also analyzed to document the warm and cold locations of each area for the effective placement of monitoring sensors to ensure continued compliance.
For perishable products / goods such as medical supplies and pharmaceuticals, it is essential that the temperature and humidity of warehouses in which they are stored are attentively controlled.
Variations in humidity and temperature may have disastrous consequences if they cause things such as medicines to become ineffective, or alter the quality of sensitive products.
Temperature and Humidity Mapping: Regulations have been put in place by the FDA/ICH to ensure warehouses storing pharmaceutical products and other temperature controlled equipment are “Mapped” and “Monitored”. The purpose of mapping is to identify Hot Spots, to understand how the internal temperature is affected by climatic changes and to better manage the product or process. This should be conducted at least once in the summer and once in the winter.
Warehouses: Using the portable USB based Temperature & Humidity data loggers, a complete temperature profile or heat distribution, can be performed totemperature5 guarantee product integrity. First, an evaluation of the storage area is prepared. This is to identify potential hot or cold spots, such as windows or HVAC vents. The number of data loggers to be used is then determined based on the evaluation and area of the storage location. They are then programmed and placed in the pre-determined locations. Typically, the data logger’s record up to one week before the data is analyzed. Once the test period is over, the data loggers are retrieved and the data is downloaded. Multiple tests can be performed to ensure consistent results.
Sierra uses highly accurate Temperature and Humidity data loggers that can produce a full thermal profile without the need to manually record readings. Downloaded information can automatically calculate min/max, averages, means, MKT, as well as standard deviation. This Temperature and Humidity validation ensures compliance and enables proper use of the warehouses, refrigerators, freezers, stability chambers and autoclaves that handle products affected by temperatures. A temperature mapping survey will plainly reveal.
• Anomalies in the chilling or heating system
• Power outages
• Effects of door openings
• Effects of introducing goods
• Presence of personnel
• Time until recovery of set temperature and much more
Our current customers include:
• Pharmaceutical production
• Pharmaceutical R&D companies.
• Pharmaceutical storage facilities and networks.
• Food manufacture and storage facilities.
• Hospitals, Pharmacy departments, Pathology departments & Blood Banks.
• Private Hospital