Pharma treasures_ temperature mapping in pharmaceuticals

Temperature Mapping is the process of recording and mapping the temperature in a 3 dimensional space. What is the perfect humidity in a house Temperature won’t be the same everywhere,even it is in a small fridge, large cool room, freezer or warehouse and can vary by as much as 10°C from one location to another.Temperatures in the corners will most likely be different to the centre of the space being measured.

There are also “specific areas” within the cool room where the temperature also will differ such as: next to the cooling fans where the temperature will be at its coldest or close to the doors where it likely to be at its warmest.

Temperature Mapping and Temperature Monitoring are integral to the storage of pharmaceuticals because drug efficacy relies on good storage conditions.


The purpose of temperature mapping is to ensure that all areas of the process equipment or storage area achieve the required temperature. What is the perfect humidity level for a house The outcome of the test is a temperature map defining the cold spot of the process equipment or storage area.

Drug manufacturers are deeply concerned about consumer safety, product quality, and FDA compliance. What is the perfect humidity level in a house Inadequately controlled environments can lead to ineffective and spoiled medicines. What is the proper humidity in a house Most product warehouses have limited environmental control. What is the proper humidity inside a house Packaging obviously protects products against contamination and degradation from light, but the contents remain vulnerable to temperature and, in some cases,humidity. What is the proper humidity level for a house Warehouses for pharmaceutical raw materials and finished product must be maintained at controlled temperature and humidity.

” Storage areas should be designed or adapted to ensure good storage conditions. What is the proper humidity level in a home In particular, they should be clean and dry and maintained within acceptable temperature limits. What is the proper humidity level in a house Where special storage conditions are required (e.g. What is the recommended humidity in a house temperature, humidity) these should be provided, checked and monitored.”

” Large commercial refrigerators and walk-in cold rooms should be monitored with an electronic temperature-recording device that measures load temperature in one or more locations, depending on the size of the unit. What is the recommended humidity level for a home Portable data-loggers that can be downloaded onto a computer may be used instead of a fixed device. What is the recommended humidity level for a house Records should be checked daily. What is the recommended humidity level in a house Internal air temperature distribution should be mapped on installation in the empty and full state and annually thereafter under conditions of normal use. What is the right humidity level in a house Products should not be stored in areas shown by temperature mapping to present a risk (e.g. What is the right indoor humidity level in the airflow from the refrigeration unit). What is the right level of humidity in a house Condensate from chillers should not be collected inside the unit.

All warehouses should be temperature mapped to determine the temperature distribution under extremes of external temperature. What level of humidity should be in a house Mapping should be repeated every two to three years and after any significant modification to the premises, stock layout, or heating system.

3) Temperatures are higher near heaters, and especially so if fans are undersized or placed in such a way that they cannot completely mix the air;

These and other factors may create substantial temperature differences from floor to ceiling and within building zones. What should be humidity level in house In fact, variations of several degrees are common in large storage areas. What should be the humidity level in your house Mapping of a warehouse is required to assure proper conditions are maintained during all hours of operation and seasons. What should be the normal humidity in a house Two or more mappings may be required to account for seasonal conditions (i.e. What should humidity level be in a house winter & summer).

Temperature controlled storage areas in GMP facilities are usually continuously monitored by temperature probes . What should humidity level be in home These are routinely calibrated, which might suggest that this all that is needed to meet regulatory requirements.

But temperature mapping is very different from calibration/routine monitoring. What should humidity level be in house One of the key differences is the number of points the temperature is measured at in the temperature controlled area.

Mapping is not a one-time job, but an ongoing process that takes into account changes in seasons, HVAC/R modifications, warehouse layout modifications and any other significant changes to the warehouse environment.

Warehouses should be temperature mapped in the empty and full states to determine the temperature distribution under extremes of external temperature. What should humidity level be in house in winter The mapping exercise should be performed both during summer and winter in order to assess worst case scenarios, as extremes of temperature may adversely affect the temperature distribution within the warehouse storage area.

Temperature monitoring should be conducted within a normal working day rather than on a weekend as the internal temperature of the space will vary depending on how many times the coolroom or warehouse doors are opened and closed.

Temperature mapping should be repeated after significant modification to the premises, changes in stock layout or changes to the heating system. What should indoor humidity level be in summer Due considerations should also be given where the practice of turning off heating systems overnight or over weekends is employed. What should the humidity be in my house canada In general, medicinal products should not be stored next to sun facing windows, at high levels in poorly insulated stores, at high levels under or near fluorescent lights, or next to heaters. What should the humidity be in my house during summer Medicinal products should not be stored in areas shown by the temperature mapping to be unsuitable.

Problem Locations:Large open spaces present a considerable challenge when working to maintain a consistent temperature or temperature/humidity level. What should the humidity be in my house uk Problem spots include:

* Temperatures will tend to be higher near heaters, if fans are undersized or improperly placed they will be incapable of mixing the heated air effectively.

Data loggers need to be strategically placed within the 3 dimensional space to map temperatures along a horizontal, vertical and depth plain as well as in locations that are likely to have temperature variations.Studies have shown that a spacing of every 100 to 300 feet in an open warehouse plan, without walls to block airflow, is adequate enough to accurately represent readings that are meaningful. What should the humidity level be in a home A distance of greater than every 300 feet may yield data that does not accurately reflect conditions in the warehouse space, while spacing data loggers closer than every 100 feet will result in extra data that adds no value while creating extra work.

Step 2 – Determining Sample Frequency:The key to determining sample frequency is to not take too many or too few samples. What should the humidity level be in a house Too many samples will create too much data making analysis cumbersome and difficult. What should the humidity level be in my home Too few samples will not adequately represent changes in the warehouse environment. What should the humidity level be in my house In most warehouses, one temperature or temperature and humidity sample every 15 minutes (for aperiod of one to two weeks) should adequately evaluate temperature trends.

Step 3 – Establish Data Logger Criteria and Select:Temperature and Temperature/Humidity Data Loggers come with many features. What should the humidity level be in your house The goal is to select the data logger that will most effectively monitor your warehouse. What should the ideal humidity level be in my house Key features you should consider are:

Data Capacity: Data Capacity determines how many readings or sample points can be taken by a logger before memory is full. What would cause high humidity in a house The more sample points a logger has, the more readings it can store.

Monitoring Range and Accuracy: Be sure to select a data logger with a temperature range that can monitor temperatures even in the most extreme of cases. Whats the normal humidity level in a house +/-2oF and +/-2% RH should be adequate for most warehouse mapping situations. Acceptable humidity level in home For refrigerated storage areas or locations requiring tighter tolerances, data loggers with an accuracy of +/-.5 oF should be selected.

Step 4 – Place Data Loggers at Pre Determined Points:Be sure to document the location of each data logger and label each data logger to ensure that it is repeatedly placed in the same location.

Step 5 – Retrieve and download Logged Data: Once the loggers have been placed and data has been collected, collect the data loggers and transfer the logged data computer.

Mean Kinetic Temperature is a calculated fixed temperature that simulates the effects of temperature variations over a period of time. Acceptable humidity levels in a house It expresses the cumulative thermal stress experienced by a product at varying temperatures during storage and distribution.In addition to calculating MKT it is also recommended that Min and Max temperatures should be monitored carefully and that the location and the time of day at which they occur should be recorded. Acceptable humidity levels in house uk Any trends should be investigated.

Step 6 – Document Processes and Repeat:After completion of first mapping, be sure to place the data loggers back in their original locations throughout the warehouse and make sure to document each and every step used.

Step 7 – Data Logger Maintenance and Calibrations:Over time the most robust data loggers can drift causing inconsistencies in recorded data thus requiring regular calibration in order to ensure accurate readings.

It is recommended that each data logger be calibrated at least every 12 months. Acceptable humidity levels indoors In addition, it is prudent to request before and after readings when calibrating each data logger so corrections can be made to previously logged and mapped data.

Best practice recommends sending the data logger to a NIST certified calibration facility, and to the original manufacturer for calibration whenever possible.

The graphs and charts and on-site observations become part of a complete report that notes any undesirable temperature or humidity patterns and recommends potential remedies.The report contains copies of all sensor calibration certificates, questionnaires, and other information used to complete the study. Average humidity in a home If the mapping study indicates undesirable conditions, facility owners can take a wide range of measures, depending on the problems’ severity. Best humidity level for home in summer They include:

Temperature mapping can be an extremely powerful tool to aid in regulatory compliance and create possible cost savings via implemented improvements and efficiencies. Best humidity level for home in winter The key is to carefully analyze the warehouse space to ensure proper placement of data loggers, document logger locations and mapping processes.

This blog is written by Don Jacob,I ’ve been blogging for almost six years, with a great enthusiasm to gain and share knowledge by spending hours and hours and hours in literature searching and reading. Best humidity level in a house I do enjoying this,

Please understand that the articles posted in this blog is gathered from different sources and may not be 100% scientifically authenticated .But I tried to be fair and trustworthy while researching and posting each and every topics.