Wednesday, July 12, 2017

Temperature Mapping Services Guide


What is Temperature Mapping?

         Many industrial, laboratory and manufacturing processes deal with products that are temperature-sensitive, like foods, pharmaceuticals etc. Maintaining prescribed temperature all around the controlled space is a vital aspect for these processes. Measuring and mapping temperature at different points of the controlled space and maintaining them within a range adhering to thermal compliance norms is essential.
         Apart from work-environments, temperature mapping is useful for ensuring temperature-controlled storage systems like cold storage units, warehouses, refrigerators and the like. This calls for cooling the entire space effectively.

Definition of Temperature Mapping :

           Temperature mapping is the process of mapping the frequency of temperature fluctuations, differences and the range of temperature within a controlled space, over a period of time. It can locate areas where the maximum temperature fluctuations occur and analyze the source of the variations.

Reasons for Temperature change and need for Mapping :

           In a temperature-controlled environment, the temperature at different points can vary by up to 10°C. Typically, the central area maintains a nearly constant temperature, while areas surrounding the cooling fans, access points and the edges tend to fluctuate a lot. Another factor that influences the internal temperature is seasonal changes of weather, especially in a warehouse. Therefore, Temperature Mapping is a critical input to the the above process.

Temperature in a particular space can be affected by a number of factors, which include:

  •  Proximity to doors that are frequently opened
  •  Distance from cooling fans
  •  Air circulation within the space
  •  The quantity of products stored in the area
  •  Body heat from personnel working in the space
  •  Heat radiating from machinery and devices, and more

Purpose and Importance of Temperature Mapping :

         The purpose of temperature mapping is to ascertain the variation of temperature, not just within a controlled system as a whole, but at different points within the enclosed space. A fluctuation of even a few degrees can have severe consequences for processes where temperature-control qualification is a critical aspect of maintaining quality.

Some of these processes include:

   · Fresh and treated foods
   · Medication
   · Vaccines
   · Dairy products
   · Meat products

These products, and the systems they are processed within the controlled space, require a strict control over the refrigeration and air-conditioning systems, to make sure the temperature is maintained within an acceptable range to prevent spoilage or contamination.

What are Temperature Mapping Services and Why are they Required?

            Regulatory authorities like the FDA and Health Canada have increased the pressure on drug and pharmaceuticals manufacturers to comply with GMP (Good Manufacturing Process) guidelines and requirements for temperature-controlled storage. Compounded by the elimination of financial risks related to equipment failure, they have become a vital part of consumer safety as well as losses associated with product quality or associated failures within storage and logistics operations.
           Todays pharmaceutical manufacturing and SCM (Supply Chain Management) organizations have a greater responsibility than ever before. They need to have a clear understanding of the processes that could impact product quality or consumer safety, as well as every aspect of the procedure involved.
           Creating a temperature profile of critical storage equipment or locations is essential, and a critical part of managing risks related to product quality and increasing consumer safety. To balance the returns on your investment, you may have to balance these elements combined with the costs of packaging and your environmental monitoring programs, against your staffing requirements.