Reliable Environmental Monitoring System

Pharmaceutical temperature mapping is vital for every company that distributes or stores pharmaceutical medicines.  When storing and distributing medicines it is vital to ensure the effectiveness of temperature-controlled storage systems, such as cool rooms, fridges, and warehouses. The reason for this is the protein is usually found in many drugs. The proteins are sensitive to changing environments and are susceptible to temperature and humidity fluctuations. Regulatory requirements and good practice determine that environment monitoring in drug storage is critical. Many vaccines and drugs require storage between 2°C and 8°C (35.6°F to 46.4°F).

Failure to store such items within the specified temperature range may affect their quality and effectiveness. In the case of vaccines, heat may speed up a decline in their potency, and freezing may cause increased reactogenicity and loss of potency. Failure to monitor and record temperatures accurately can mean that health professionals may be unaware of these potential effects on medicines, and of course their recipients. To monitor the exact temperature and humidity conditions of chemicals stored in a warehouse, pharmaceutical manufacturers need to look for a solution to easily track the temperature and humidity. Including cold and ambient storage zones. Precise monitoring makes it possible to ensure that the highly sensitive substances do not become unusable or take damage. This can not only prevent financial damage but also potentially protects customers and patients from broken products. In addition, warehouse monitoring is the legal requirement to prove that the warehouse is within any regulations and standards.

Dpstar is a temperature and humidity specialist, we provide specialized temperature mapping services for any environment. We help you deliver operational, regulatory, and quality control requirements. We distribute temperature and humidity monitoring devices from a number of the world’s leading manufacturers. Our engineers are highly experienced and can offer temperature mapping services for any required environment.  We have a range of temperature mapping services that can be tailored to suit your project requirements, saving you time and delivering cost-effective but necessary support. Our proposed solution has been engineered to provide users with a feature-rich and robust system while retaining its simplicity in its maintenance, setup, and commitment to further enhance the quality of service for our customers. Our service enables you to detect environmental fluctuations and maintain stable conditions that protect the integrity of your product.

Reliable Environmental Monitoring System

Pharmaceutical temperature mapping is vital for every company that distributes or stores pharmaceutical medicines.  When storing and distributing medicines it is vital to ensure the effectiveness of temperature-controlled storage systems, such as cool rooms, fridges, and warehouses. The reason for this is the protein is usually found in many drugs. The proteins are sensitive to changing environments and are susceptible to temperature and humidity fluctuations. Regulatory requirements and good practice determine that environment monitoring in drug storage is critical. Many vaccines and drugs require storage between 2°C and 8°C (35.6°F to 46.4°F).

Failure to store such items within the specified temperature range may affect their quality and effectiveness. In the case of vaccines, heat may speed up a decline in their potency, and freezing may cause increased reactogenicity and loss of potency. Failure to monitor and record temperatures accurately can mean that health professionals may be unaware of these potential effects on medicines, and of course their recipients. To monitor the exact temperature and humidity conditions of chemicals stored in a warehouse, pharmaceutical manufacturers need to look for a solution to easily track the temperature and humidity. Including cold and ambient storage zones. Precise monitoring makes it possible to ensure that the highly sensitive substances do not become unusable or take damage. This can not only prevent financial damage but also potentially protects customers and patients from broken products. In addition, warehouse monitoring is the legal requirement to prove that the warehouse is within any regulations and standards.

Dpstar is a temperature and humidity specialist, we provide specialized temperature mapping services for any environment. We help you deliver operational, regulatory, and quality control requirements. We distribute temperature and humidity monitoring devices from a number of the world’s leading manufacturers. Our engineers are highly experienced and can offer temperature mapping services for any required environment.  We have a range of temperature mapping services that can be tailored to suit your project requirements, saving you time and delivering cost-effective but necessary support. Our proposed solution has been engineered to provide users with a feature-rich and robust system while retaining its simplicity in its maintenance, setup, and commitment to further enhance the quality of service for our customers. Our service enables you to detect environmental fluctuations and maintain stable conditions that protect the integrity of your product.

What is Mapping?

Mapping refers to the process of recording the temperature and humidity levels. Mapping is a core consideration in the larger world of pharmaceutical temperature monitoring. Mapping is performed to collect temperature data within product storage areas to qualify a facility for the storage of regulated product (within a specified temperature range). Mapping uses multiple recording devices (dataloggers) to define potential weak points in climate-controlled storage areas for medicines that require holding in a specific range, a user is able to see the temperature and humidity for each chosen location of a room to create the visual plan or map of the environment or enclosure. This information can then be combined to allow comparisons of the consistency throughout an enclosure. By reviewing data provided by such tools, technicians and supervisors can identify areas where temperatures fluctuate too much for safe storage, then take steps to keep products safe in short term and address the issue in the long term.

A common assumption is that temperatures and humidity levels in autoclaves, controlled environment rooms, freezers, refrigerators, incubators, and environmental chambers are uniform throughout the space. However, temperature and humidity readings can vary significantly from one location to another. Incorrect temperature or humidity measurements can result in expensive damage to products. This must be avoided under all circumstances and steps taken immediately in the case of unintended changes in climatic conditions!

What is Mapping?

Mapping refers to the process of recording the temperature and humidity levels. Mapping is a core consideration in the larger world of pharmaceutical temperature monitoring. Mapping is performed to collect temperature data within product storage areas to qualify a facility for the storage of regulated product (within a specified temperature range). Mapping uses multiple recording devices (dataloggers) to define potential weak points in climate-controlled storage areas for medicines that require holding in a specific range, a user is able to see the temperature and humidity for each chosen location of a room to create the visual plan or map of the environment or enclosure. This information can then be combined to allow comparisons of the consistency throughout an enclosure. By reviewing data provided by such tools, technicians and supervisors can identify areas where temperatures fluctuate too much for safe storage, then take steps to keep products safe in short term and address the issue in the long term.

A common assumption is that temperatures and humidity levels in autoclaves, controlled environment rooms, freezers, refrigerators, incubators, and environmental chambers are uniform throughout the space. However, temperature and humidity readings can vary significantly from one location to another. Incorrect temperature or humidity measurements can result in expensive damage to products. This must be avoided under all circumstances and steps taken immediately in the case of unintended changes in climatic conditions!

Why Pharmaceutical Temperature Mapping is Important?

Protects Perishables

No doubt, some goods are more sensitive to temperature than others. Due to this, perishables will spoil if the proper storage conditions are not established, implemented, and maintained. If subjected to unsuitable conditions, the product could become ineffective or even harmful to consumers.

Standards Compliance

In order to proceed with temperature monitoring, it is important to maintain the standard level of temperature for the given facility. The monitoring system installed within the facility must be able to record and document the pharmaceutical temperature mapping process.

Know the Environment

Stored goods are assets. Beyond protecting your product, it’s important to know how the product reacts to environmental factors and establish optimal storage conditions. This information is necessary for those who must comply with Good Manufacturing Practice (GMP), as well as ensuring consumer safety.

Data-based Monitoring System

Having a smart and data-based monitoring system can reduce costs and improves overall productivity. This requires minimal manual intervention. Having a complete understanding of the response of your temperature control systems under non-standard conditions also helps to reduce disruption when issues arise.

HVAC Systems

Through temperature mapping, it can determine if the existing HVAC system has the capacity to control the temperature of the storage. The temperature monitoring must be conducted in extreme conditions to be encountered. This also helps if the system should be is still efficient or needs a replacement already.

Identify Areas of Risk

Collecting an environmental profile of the warehouse will help determine which areas are safe for storage and identify areas of inconsistences such as the opening and closing of doors, high shelving, or exposure to light. Once identified, these areas should either be inoperative or corrected.

Why Pharmaceutical Temperature Mapping is Important?

Protects Perishables

No doubt, some goods are more sensitive to temperature than others. Due to this, perishables will spoil if the proper storage conditions are not established, implemented, and maintained. If subjected to unsuitable conditions, the product could become ineffective or even harmful to consumers.

Standards Compliance

In order to proceed with temperature monitoring, it is important to maintain the standard level of temperature for the given facility. The monitoring system installed within the facility must be able to record and document the pharmaceutical temperature mapping process.

Know the Environment

Stored goods are assets. Beyond protecting your product, it’s important to know how the product reacts to environmental factors and establish optimal storage conditions. This information is necessary for those who must comply with Good Manufacturing Practice (GMP), as well as ensuring consumer safety.

Data-based Monitoring System

Having a smart and data-based monitoring system can reduce costs and improves overall productivity. This requires minimal manual intervention. Having a complete understanding of the response of your temperature control systems under non-standard conditions also helps to reduce disruption when issues arise.

HVAC Systems

Through temperature mapping, it can determine if the existing HVAC system has the capacity to control the temperature of the storage. The temperature monitoring must be conducted in extreme conditions to be encountered. This also helps if the system should be is still efficient or needs a replacement already.

Identify Areas of Risk

Collecting an environmental profile of the warehouse will help determine which areas are safe for storage and identify areas of inconsistences such as the opening and closing of doors, high shelving, or exposure to light. Once identified, these areas should either be inoperative or corrected.

The Temperature Mapping Processes

Monitoring systems should be planned and documented according to the scientific rationales shown by the temperature mapping procedure. This development strategy should then be reviewed and qualified (IQ, OQ and PQ) to pharmaceutical standards. The purpose of process validation is to establish documented evidence that the production equipment is correctly installed, operates according to requirements, and performs safely. Sensors should be placed around the products, around major potential temperature influences such as doors and cooling fans, and at different heights, especially in larger chambers. The type of space or unit being tested, as well as user requirements, will determine the number of loggers used, placement, and duration. Distributing loggers throughout the testing area will provide a detailed understanding of the performance of the space.

Warehouse

For warehouses, having information about the building’s external conditions is vital to effective pharmaceutical temperature mapping and monitoring, as warehouses typically have more directly external faces and walls than cool rooms and fridges, which mostly operate within an internal environment. It is common for warehouses to be mapped over a full year to make sure that all external conditions are accounted for in the data. This will also help determine where to place the permanent monitoring systems, as some parts of the chamber may be more influenced during specific seasons.

Warehouse

For warehouses, having information about the building’s external conditions is vital to effective pharmaceutical temperature mapping and monitoring, as warehouses typically have more directly external faces and walls than cool rooms and fridges, which mostly operate within an internal environment. It is common for warehouses to be mapped over a full year to make sure that all external conditions are accounted for in the data. This will also help determine where to place the permanent monitoring systems, as some parts of the chamber may be more influenced during specific seasons.

Coolrooms

For temperature-controlled rooms such as cold rooms and fridges, it can be sufficient to map the system once, based on the fact that the external environment is a controlled one. However, it is advisable to make sure that the HVAC systems of these buildings or environments are not heavily influenced by other external forces that could change their temperatures significantly. The mapping of a cool room in a warehouse should take into account the fluctuation in the warehouse temperatures and conduct the tests during its most extreme levels.

Coolrooms

For temperature-controlled rooms such as cold rooms and fridges, it can be sufficient to map the system once, based on the fact that the external environment is a controlled one. However, it is advisable to make sure that the HVAC systems of these buildings or environments are not heavily influenced by other external forces that could change their temperatures significantly. The mapping of a cool room in a warehouse should take into account the fluctuation in the warehouse temperatures and conduct the tests during its most extreme levels.

Load testing

Load testing is another important part of the temperature mapping process. Load testing investigates how expected product levels interact with individual temperature-controlled chambers. Things to take into account are whether the product will arrive in the required condition or if cooling is necessary, as this can dramatically alter the temperature in the chamber. Testing should verify whether the chamber can cope with the maximum specified load arriving all at once to then be cooled. If it can operate properly in this situation, as well as operating effectively at full capacity, the chamber can be considered sufficiently load tested.

Load testing

Load testing is another important part of the temperature mapping process. Load testing investigates how expected product levels interact with individual temperature-controlled chambers. Things to take into account are whether the product will arrive in the required condition or if cooling is necessary, as this can dramatically alter the temperature in the chamber. Testing should verify whether the chamber can cope with the maximum specified load arriving all at once to then be cooled. If it can operate properly in this situation, as well as operating effectively at full capacity, the chamber can be considered sufficiently load tested.

What are the challenges in pharmaceutical?

When it comes to medications, they require specific temperatures during the process. The process of these medications involves going through manufacturing, transportation, and storage. Ideally, the temperature of most medications is between 68°F to 77°F. Temperature is a crucial factor in pharmaceutical storage. It can directly affect the effectiveness of pharmaceutical products. The temperature could easily trigger a chemical reaction and change the chemical properties of the products. Health professionals can be unaware of the potential effects on medicines if there is no accurate monitoring and recording of the temperatures. This won’t bode well if taken by a patient. Instead of curing, it might deliver another unwelcomed illness.

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

The quantity of products stored

Proximity to doors that are frequently opened

Distance from cooling fans

Body heat from personnel working in the space

Air circulation within the space

Heat radiating from machinery, devices, and more

What are the challenges in pharmaceutical?

When it comes to medications, they require specific temperatures during the process. The process of these medications involves going through manufacturing, transportation, and storage. Ideally, the temperature of most medications is between 68°F to 77°F. Temperature is a crucial factor in pharmaceutical storage. It can directly affect the effectiveness of pharmaceutical products. The temperature could easily trigger a chemical reaction and change the chemical properties of the products. Health professionals can be unaware of the potential effects on medicines if there is no accurate monitoring and recording of the temperatures. This won’t bode well if taken by a patient. Instead of curing, it might deliver another unwelcomed illness.

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

The quantity of products stored

Proximity to doors that are frequently opened

Distance from cooling fans

Body heat from personnel working in the space

Air circulation within the space

Heat radiating from machinery, devices, and more

Qualification & Validation

For perishable products/goods such as medical supplies and pharmaceuticals, it is essential that the temperature and humidity of warehouses in which they are stored are attentively controlled. Variations in humidity and temperature may have disastrous consequences if they cause things such as medicines to become ineffective, or alter the quality of sensitive products. Thermal validation establishes the temperature distribution across the being mapped and locates any hot or cold spots. The data collected provides an essential source of information to ensure that all products are correctly stored within their labeled temperature range(s). Based on the results of the thermal validation, decisions can be made regarding permanent monitoring solutions to safeguard your products or samples consistently. There are many different regulations we could apply, but they have the same concept on one topic. If you are working with pharmaceutical products and want to comply with GMP/GDP Guidelines, then you must qualify the facilities including product, handle, store and transport.

What is Qualification?

According to GMP/GDP Guidelines, qualification is the process to prove the facility, system, supplier & room fulfills the intended purpose. In a simple explanation, if the equipment is used in to produce, handle, store and transport pharmaceutical products, a qualification must demonstrate the equipment is fit to use. For example, if the fridge must maintain 2°C to 8°C, the qualification is to certified the fridge is consistently maintaining the temperature range 2°C to 8°C. As a result, the qualification always starts with the intended purpose and continues with an evaluation and documentation.

What is Validation?

According to GMP/GDP Guidelines, validation ensures the process or activity has the expected result and outcome. In Malaysia, National Pharmaceutical Regulatory Agency (NPRA) stated all quality-relevant processes must be validated to ensure the maintenance of high standards quality and integrity of the distribution processes. In validation, the first part of the validation is to define the expected results and the second part is to verify and document the process delivers the expected results. For example, if you are storing pharmaceutical products in a warehouse, you will need qualified staff to perform according to the SOP, and you will also need specific equipment to ensure the goods are stored accordingly. In validation, all of the mentioned above should be considered in performing validation.

Mapping Area

Mapping area may be any place where pharmaceutical ingredients can be stored or processed for any unit operation. Here is an overview of the applications where temperature monitoring is crucial:

Refrigerators

Freezers

Ovens

Test chambers

Warehouses

Incubators

Autoclaves

Laboratories

Cold rooms

Transportation

Mapping Area

Mapping area may be any place where pharmaceutical ingredients can be stored or processed for any unit operation. Here is an overview of the applications where temperature monitoring is crucial:

Refrigerators

Freezers

Ovens

Test chambers

Warehouses

Incubators

Autoclaves

Laboratories

Cold rooms

Transportation

Our Success Story

Continuous Mapping in Pharmaceutical Warehouses

Our client decided to perform thermal mapping studies to qualify storage environments according to regulatory guidance. The results of these studies would then be used to design the long-term monitoring systems for the warehouses. They require a system that can be stretched to the extremes of environmental conditions. To ensure compliance, they must have reporting capabilities that prove adherence to regulatory requirements. These reports must satisfy the global regulatory inspectors that visit their facilities throughout the year. The company needs to manage the overall product quality throughout the supply chain and adhere to current Good Manufacturing Practices (cGMP). Combined with their own Quality standards, this compliance guarantees that all members and their customers receive the highest quality and safest products available.

To ensure our client continue to improve the quality of their products and meet regulatory guidelines, the company must monitor and alarm the temperature and relative humidity of storage areas and warehouses. In the past, they used data loggers to measure and record temperature and humidity. The logger history was then manually downloaded for review and archiving. However, because this process is time-consuming and inefficient, they are looking for a better solution. The temperature and humidity of warehouse areas must maintain to specified levels. They require an enterprise-wide solution that can enable multiple users at different locations to manage their respective monitored areas remotely. Users must also have the ability to receive and respond to alarm notifications and run reports on demand. Some data loggers must be placed in hard-to-reach locations where it is not feasible to wire power and Ethernet connection. Ideally, data loggers could connect to the network via wireless or hard-wired Ethernet connectivity, or a combination of both.

The viewLinc monitoring system was installed in their warehouse to evaluate its performance before standardizing the system companywide. The system worked great, with the viewLinc Continuous Monitoring System installed in the company’s storage areas, managers at each site can view critical areas in real time, as well as receive alarm notification via PC, phone and pager. Alarm messages can be sent to personnel based upon their areas of responsibility and ability to respond. For example, regulatory personnel receive communication alarms and distribution center personnel receive out-of-limit alarms. The viewLinc system simplifies and centralizes temperature and humidity monitoring. Meanwhile, the design of viewLinc software is perfectly suited to the operating environments of their storage and warehouse areas.

The viewLinc software, as part of Vaisala’s Continuous Monitoring System, provides secure, permission-based access from any PC on existing network. Flexible, user-selectable notification options allow alarms to be sent via e-mail or text to PCs and mobile phones. viewLinc provides complete data integrity with redundant recording. Data logger histories are stored on the server data base, in the user’s PC and each data logger’s memory at the point of measurement. viewLinc reporting is compliant with FDA 21 CFR Part 11, with audit trail and several graphing/reporting options. In accordance with regulatory guidance, the viewLinc system has full IQ/OQ validation protocols.

Our client’s system administrators can now assign permissions for viewing data, setting thresholds, and acknowledging alarms to personnel. Alarms can be scheduled by day, time, and person. Monitored points can be named based on location making it easy to respond to alerts of out of tolerance conditions. Triple redundant recording provides total data protection: no single point of failure including network or power outage will result in lost data. Industry-best sensor stability is ensured with Vaisala’s comprehensive and economical re-calibration program.

Customer Benefits 

Temperature mapping can reveal vital information about the performance of your building or equipment, which can validate proper operation or identify and resolve any deficiencies. Temperature mapping offers several benefits, including:

Access to real-time information

User friendly software

Preserve the integrity of your stock and your data

Utilise your recorded data for reporting and analysis

Eliminate paper with digitised documentation

Accredited, compliant, and up-to-date with all requirements

Identification of the warmest and coldest storage locations

Alerting via email and SMS, alert/exception handling tools and alert reports

Customer Benefits 

Temperature mapping can reveal vital information about the performance of your building or equipment, which can validate proper operation or identify and resolve any deficiencies. Temperature mapping offers several benefits, including:

Access to real-time information

User friendly software

Preserve the integrity of your stock and your data

Utilise your recorded data for reporting and analysis

Eliminate paper with digitised documentation

Accredited, compliant, and up-to-date with all requirements

Identification of the warmest and coldest storage locations

Alerting via email and SMS, alert/exception handling tools and alert reports

We Help You Achieve & Maintain Compliance & Consistency

The pharmaceutical industry requires a very accurate control of the air characteristics: in fact, temperature and humidity affect significantly the operating conditions of the environments where chemical processes occur. The rate of many chemical reactions also depends on the air humidity level. A strict control of this parameter, therefore, results in better process control and consequently in higher efficiency.

Thanks to our experience, we can advise you the solution that meets your needs. We thus have a perfect traceability of the temperatures and humidity in real time and can justify the quality of our service to our clients. With extremely fast access to the relevant data, your staff can quickly identify issues and respond as necessary, correcting temperatures and engaging in maintenance to return an affected area to the proper levels of heat and humidity. We provide you with the peace of mind that your study is carried out to the required standards and regulatory requirements.

Get In Touch With Our Experts Today!

Dpstar Group
No 35, Jalan OP ½, Pusat Perdagangan One Puchong,
Off Jalan Puchong, 47160 Puchong,
Selangor Darul Ehsan, Malaysia.
Email: [email protected]

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