Temperature Mapping Services
Sierra Instrumentation & Controls, a leader in data logger technology solutions offers a variety of validation services to assist customers in complying with regulations and meeting accreditation standards.
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 effected 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.
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 effected by temperatures.A temperature mapping survey will plainly reveal
Anomalies in the chilling or heating system
Effects of door openings
Effects of introducing goods
Presence of personnel
Time until recovery of set temperature and much more
Autoclaves: Using the portable USB dataloggers with internal RTD sensor or Paperless Recorder with thermocouple wires autoclave validation is made simple, fast temperature3and accurate temperature response. An empty chamber distribution test is performed for the Operational Qualification process. This test determines the uniformity of the chamber. The data loggers are calibrated before and after testing to ensure accuracy.Tests are then performed with loads to determine which load items are the most difficult to sterilize and the location within the autoclave
Stability Chambers: Most stability chamber conditions are held at 25°C, 60%RH and 40°C, 75%RH, but can vary depending on the product. It is important to ensure that temperature4this environment is maintained and stable throughout the chamber. Using the portable USB based data loggers the entire chamber can be mapped for identification of hot or cold spots. This results in the proper usage of the stability chamber, saving time and money in products and samples.
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 loggers 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.
Refrigerated Cold Chain Truck: Using the portable USB based Temperature & Humidity data loggers, a complete temperature profile or heat distribution is performed to guarantee temperature6product integrity. Potential hot or cold spots are identified , such as windows or Air Conditioning Vents. Typically, the data loggers record up 2-3 days of data 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.
We shall provide a professional report that contains copies of all the calibration certificates, Temperature and Humidity Trend Maps and Charts.The documentation shall be complete showing the details of the study, and the results for future use. Best of all, you will have peace of mind, since you will know that your space is being maintained at the appropriate temperature.
You’re in safe hands! – 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