0 Procalme Measuring & Control Equipment-Dubai, UAE

    • Mapping & Validation Services

    Regulatory authorities like the FDA and Health Canada have increased the pressure on drug and pharma manufacturers to comply with GMP 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 the product quality or associated failures within storage and logistics operations.

    Today’s pharmaceutical manufacturing and SCM (supply chain management) organizations have a greater responsibility than ever before. They need to have a clear understanding of processes that could impact product quality or patient 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 patient safety. To balance the returns from your investment, you may have to balance these elements combined with the costs of packaging and your environmental monitoring programs, against your staffing requirements.

    PROCAL performs Temperature Mapping in below key steps !!!

    • Create an adequate validation plan with protocols that incorporate a logical and scientific method that justifies each step.
    • Identify areas that can affect quality, along with risk and develop a temperature mapping protocol to determine the locations for sensors.
    • These locations should be able to eliminate the probability of products being affected due to temperature variance.



    • Select the technologies that are suited for the job, like a data logger, stability chamber and others.
    • Set up equipment for mapping and conducting tests in conditions that the system may be exposed to.
    • Develop a comprehensive report describing the results and summarize the actions that must be taken to prevent temperature-related issues.

    Warehouse & Storage Areas Mapping


    If a warehouse is large, there is a greater risk of temperature fluctuation throughout the space. Smaller warehouses heat up more quickly, which possesses much risk to the product stored inside. Each warehouse is constructed with varied dimensions, so it is necessary to have a basic understanding of the particular environment prior to beginning the mapping process and identify areas that are at risk of unacceptable variations.

    Following necessary impacts has to be considered:

    • Volume of space and HVAC demands.
    • Temperature gradients from cooler air near the floor and warmer air near the warehouse ceiling..
    • Fans, Air conditioners or space heaters that may create pockets of warm or cold air
    • Layout of shelving and racks to identify any airflow obstruction
    • High traffic areas, windows, doors or loading docks
    • Seasonal temperature changes or extreme weather events

    Cold Room, Freezer, Chiller – Mapping & Validation


    Cold rooms used for storing temperature-sensitive goods should be mapped and validated. Cold storage is a relatively simple cold room that is commonly used to store material between 1˚C to 10 ˚C. Cold Rooms now available are commercially known as walk-in chambers and are used for the storage of critical pharmaceutical products, samples, and raw materials where variation in temperature will affect the quality of stored items in terms of their appearance (color), consistency, potency, and impurity levels.

    Some pharmaceutical manufacturers perform only Installation Qualification (IQ) of cold rooms, but the Operational Qualification (OQ) and Performance Qualification (PQ) is also essential because data-based conclusions should be arrived at by challenging the system for all the attributes that may have bearing on the performance of the chamber for maintaining the desired temperature conditions.

    Results of Mapping and Validation will be as follows:

    • Mapping temperature variations within the cold room..
    • Measuring temperature variations at each location within the chose area, by day of the week, and time of day.
    • Documenting high and low temperature fluctuations caused by the environmental control systems operating at the time of the study.
    • Identifying potential airflow issues that may be the cause of temperature variations.

    Stability Chambers & Incubators Mapping


    Periodic mapping of conditions within environmental chambers is critical for compliance in FDA-regulated applications, where validation of conditions such as temperature, and sometimes humidity, is mandated. Stability testing of pharmaceutical products is an essential method of determining “shelf life” (i.e. expiration dates) and storage conditions. A stability test period can range 6 to-12 months depending on the protocol. The test period including the temperature and humidity (RH) conditions are determined based on ICH (International Conference of Harmonization) guidelines. ICH test conditions can be one of the following: 25 C / 40% RH, 25 C / 60% RH, 30 C / 65% RH or 40 C / 75% RH. ICH requires conditional tolerances of +/-2 C and +/- 5% RH.