Rotronic is proud to be able to offer an increasing range of products and services to meet the demands of our customers. The requirements for mapping especially thermal mapping are increasing dramatically in food, pharma and cosmetics production and transport industries.
But what is Thermal Mapping?
Mapping is the process of determining the temperature and often humidity gradients within a defined space. It is a vital process when the product is regulated by government agencies such as the US Food & Drug Administration (FDA) or the European Medicines Agency (EMA). Regulated materials must not exceed strict storage conditions. Fixed limits will typically exist for humidity and temperature both in terms of the absolute value and also the allowable rates of change. Mapping serves as a baseline for proving compliance within the storage spaces.
The reason for increasing regulatory compliance is to ensure products do not spoil or otherwise degrade during production, storage and transport. Warehouses are notorious for having warm or cold spots that are outside of the regular control specification. A proper mapping study serves to locate these spots and either modify or avoid the problem area. Similar problems can occur during transportation so increasingly transport is at least monitored if not fully controlled and mapped.
At 4.3 million square feet, the largest warehouse in the world is the Boeing Everett factory in Everett, WA USA. It was originally designed to construct the Boeing 747.
An FDA Form 483 is issued to a company’s management at the conclusion of an inspection when an investigator(s) has observed any conditions that in their judgement may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.
Mapping in General
A mapping strategy is needed for several reasons. It is important for regulators or quality managers to understand the philosophy employed for the mapping. A documented strategy will decrease questions from any regulators reviewing your mapping study. The strategy document also helps them understand the data that is produced by the mapping process. The document acts as a tool for collaboration as other people may suggest ideas that will make your study produce better data or make your effort more efficient.
As the mapping study progresses from start to finish, the strategy document acts as your reference guide, ensuring you remain true to the agreed upon process and do not make changes that will negatively affect the study. A typical strategy is usually comprised of a few written paragraphs that includes a description of the warehouse space, the type of equipment used, the number of sensors to be used, a general idea of the sensor placement, and the duration of the study. It is not unusual for the mapping strategy to change as it evolves. Writing a detailed document at the early stages of the project may cause re-writes that can increase the total length of the project. It is usually more efficient to fully document the warehouse mapping project after the strategy is agreed. Think of the strategy document as a proposal for your mapping team or the approval team so they can buy into and understand your mapping strategy. It may also facilitate the final approval stage, later in the project, because the auditor already understands the warehouse mapping project.
Continuous Monitoring After the Warehouse Mapping
Continuous monitoring is a best practice within controlled and regulated spaces. The mapping study will determine the hot and cold zones for “worst case” sensor placement. These worst case locations should be considered when installing a permanent, continuous monitoring system. The number of sensors used for a permanent system will be far fewer than what is required for the mapping study. In some cases, continuous monitoring may require only a few sensors once the problem areas have been determined through the mapping study. A continuous monitoring system offers peace of mind as product components, manufacturing space, or storage space are maintained and on record as meeting specified environmental conditions.
If you have any queries regarding warehouse mapping feel to get in touch and we will be happy to discuss!
Dr Jeremy Wingate