What are temperature mapping services?
Today’s pharmaceutical manufacturing and supply chain management organizations are responsible for having a clear understanding and knowledge of the processes that may impact product quality and patient safety. Having a clear picture of the temperature profiles of critical storage equipment and warehouses is very important and critical for managing risk to product quality and patient safety.
A pharmaceutical company’s control of the storage and distribution conditions of environmentally sensitive pharmaceutical products is trending as a key area of focus for global regulators’ risk-based assessments of a manufacturer’s supply chain management practices. It is imperative that an organization’s supply chain management have reliable knowledge and understanding of the controls they have in place to assure the quality of their products from the warehouse to the point of use by patients (i.e., patient safety).
USP <1079>, Good Storage and Shipping Practices, provides general guidance concerning storing, distributing, and shipping of pharmaceutical products. It presents procedures to maintain proper storage environments for raw materials and finished drug products to ensure the quality of the product until it reaches the final user (i.e., the patient). USP <1079> points out that all equipment used for recording, monitoring, and maintaining temperatures and humidity conditions should be calibrated on a regular basis. This calibration should be based on NIST or international standards.
US<1079> specifies that temperature (and humidity if / as applicable) data for warehouses should be collected using a number of temperature measuring / recording instruments placed throughout the warehouse in divided sections and should record the maximum and minimum temperatures during a 24-hour period for a total of three consecutive 24-hour periods. Observation of the temperature variations in critical storage equipment and warehouses should be made over a period of time to establish a ‘meaningful temperature profile’, including the temperature variation under different conditions (i.e., empty and / or loaded). This data provides invaluable information as to where various products should and should not be stored.
Many factors need to be considered to ensure that the executed temperature mapping study establishes a ‘meaningful temperature profile’, such as the:
• Geographic location
• Size / volume / layout of the space
• Number, location and type of racks and pallets
• Number, location and type of measuring instruments
• Size and location of HVAC / AHU supply and return ducts (i.e., adequacy of air circulation coverage)
• Number, location and control capability of HVAC control sensors
• Location of ceiling recirculating fans
• Location of loading docks, space heaters, sun-facing walls, doors, windows, and low ceilings or roofs
• Data measurement interval and overall duration of study
Depending on the type of products stored, the specific measuring instrument technology required for assessing a critical storage environment may be different. For example, the need for the highest precision, most accurate device may not be warranted for a warehouse with a very wide range of temperature variation or a high temperature limit acceptance criteria. The final strategy (and cost) for temperature mapping a given warehouse should be selected as a part of a risk-based assessment for the specific project.
Having a well written validation plan and / or protocol to clearly define the scope, strategy and requirements of your temperature mapping study is critical to obtaining a ‘meaningful temperature profile’ of your critical storage equipment and warehouses. Today’s industry recognized temperature profiling best-practice recommends that warehouse mapping be performed at or near external temperature extremes during both the summer and winter. The number of sensors used must be adequate to assess temperature uniformity and areas of suspected hot and cold temperature. The protocol should specify precise number and location of data loggers and a maximum distance between sensors depending on the size of the warehouse. The temperature profile report should identify any areas or rack locations that are not within the acceptance criteria specified in the protocol.
How can Compliance Team help with our Temperature Mapping Services?
Contact CTI for information on CTI’s Temperature Mapping Contract Service and for risk-based strategies and solutions for your specific needs.