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Temperature Mapping Study Company Maldives

//Temperature Mapping Study Company Maldives

Vacker Maldives serves the whole of Maldives by providing Temperature Mapping Study Company Maldives in Malé, Hithadhoo, Kulhudhuffushi, Thinadhoo, Naifaru, Hulhumale, etc.

What is a Temperature Mapping Study as per SFDA?

Maldives Food and Drug Authority (SFDA) specifies that all pharmaceutical companies have to carry out temperature mapping study. This is required for all assets such as warehouses, cold rooms, refrigerators, vans, reefers etc., which are used for storage and transportation of medicines. The principle is that a temperature mapping study can ensure that they are able to maintain proper temperature, so that the medicines are safely stored. Certain medicines are stored between 15 to 25°C and certain others between 2 to 8°C. Hence, a pharmaceutical warehouse has to be certified for 15-25°C after temperature mapping study. Similarly, a cold room has to be certified for 2-8°C and so on. SFDA requires temperature mapping study for all new facilities and existing facilities.

Diffusion of temperature and humidity varies across a region, with certain areas being more humid or having higher temperatures in comparison to certain other areas within the same region. Temperature sensitive products stored in such areas will hence have an uneven distribution of temperature and humidity, leading to deterioration in the effectiveness of certain products.

Temperature Mapping Study Company Maldives is the process of recording, mapping and analyzing the temperature distribution within a region. It includes a detailed analysis of temperature and humidity in storage areas of temperature-sensitive goods and their transportation, while adhering to GMP (Good Manufacturing Practices) and GDP (Good Distribution Practices) protocols. A temperature distribution map is generated that defines the cold spots and hot spots in such areas. These analysis reports are then used to provide recommendations or remedies for an improved uniform atmospheric condition.

Maldives being the home to Maldives Food and Drug Authority (SFDA), it is but natural that it takes food and drug administration activities very seriously. SFDA recommends temperature mapping study and temperature qualification study for storage and transportation facilities used for temperature sensitive products such as medicines, vaccines, etc.

Procedure

Temperature mapping study company Maldives is carried out in the following stages:

  • Temperature data loggers are placed evenly at diverse locations within a region.
  • The recording of temperature takes place unattended, for a predefined duration, usually a few days or weeks depending on the application or asset type.
  • The collected data is then used to analyze and interpret the distribution of temperature and humidity in the area and remedial suggestions, some listed below, are provided:
    1. The products’ position within the room needs to reshuffled, keeping in consideration the cold and hot spots.
    2. Real time monitoring can be carried out by installing real time temperature monitoring systems.
    3. Relocation of heating devices, racks and shelves, etc. to improve air circulation.
    4. Installation of AC units or humidifiers and dehumidifiers if needed.

 

Why is Temperature Mapping Study company Maldives needed?

It is required that temperature-sensitive goods such as vaccines, medicines, pharmaceutical products, etc., be stored in regions where temperature and humidity is distributed uniformly. Medicines and vaccines, for instance, need to be stored at certain recommended temperature limits, non-compliance to which results in decreased efficacy. Since this is a condition caused due to the deviation from the recommended limits while storage or transportation, the end user and distributor remain totally unaware of its decreased effectiveness and the underlying cause.

VacMap – Vacker Global’s temperature mapping software:

Vacker group of companies’ growing expertise in successfully performing temperature and mapping studies over the years, lead to the development of VacMap. It is a software that can be used by clients to carry out temperature and humidity studies themselves, by analyzing the various reports or results generated by it.

We also impart a complete training for the entire process of temperature mapping, qualification and validation and offer services in areas or sectors of Maldives such as Malé, Hithadhoo, Kulhudhuffushi, Thinadhoo, Naifaru, Hulhumale, etc. The training will guide you through the data logger installation details and in deciding the most optimum locations in which they should to be placed for achieving better performance.

Temperature Mapping company Maldives study kit:

We also supply a kit that facilitates temperature mapping which customers can perform on their own. This kit consists of a set of data loggers used to monitor temperature and humidity levels. Each data logger is supplied with a calibration certificate that is valid for a duration of one year beginning from the supply date. The kit also consists of an instruction manual to guide you through the process.

Applicable sectors or areas:

Temperature mapping study company Maldives offers services and products in areas such as Malé, Hithadhoo, Kulhudhuffushi, Thinadhoo, Naifaru, Hulhumale, etc. and in the following sectors:

  • Cold rooms, warehouses and refrigerators: Both temperature and humidity have to be matched.
  • Reefers, vans, boxes and containers: Only temperature needs to be mapped as humidity cannot be regulated.

Temperature Mapping Study synonyms:

  • Thermal mapping study
  • Temperature distribution study
  • T-mapping
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