Medical storage

Validation applications for product storage in climate controlled storage areas

Category: Blog
Date: November 23, 2021

The global world economy is taking on an increasingly prominent role in our contemporary society. Products from defining sectors such as the pharmaceutical industry, biotechnology or micro-electronics are becoming increasingly important and are therefore shipped all over the world. Given the criticality of many of these products, it is of great importance that they are always stored and transported in the right conditions. To ensure safety throughout the entire supply chain, many of these products are subject to stringent transport and handling regulations. Good Distribution Practice (GDP) regulations help to qualify product storage areas. Quality assurance must assure the entire supply cycle to be effective, that’s why GDP is indispensable. The regulations apply to all pharmaceutical and biotech companies and their logistics partners, responsible for shipment and more importantly: storage. The storage of critical medicinal products in climate controlled warehouses will therefore be the central focus point of this article.

Validating storage areas for medicinal products

The numerous global regulations require manufacturers and transporters to be constantly attentive to the environmental aspects of the products. For this reason, they have to perform stability tests on a regular basis in order to determine the appropriate storage conditions. This is particularly the case for storage areas with medicinal products that require certain classifications to comply with customer quality regulations. The problem that many companies struggle with is the fact that many regulations offer little guidance on how to perform appropriate temperature and humidity mapping. For example, companies often do not know how many sensors they need to evaluate a particular space. In addition, these regulations often don't mention anything about the locations of these sensors either. This is where today's cleanroom providers can add extra value to their services by providing adequate sensor placement.

At ABN Cleanroom Technology, we have an in-house validation team that is constantly working on performing quality processes and validation activities. Thanks to our pre-engineered building blocks approach, determining the location and number of sensors for validation applications is fully integrated into our cleanroom design. This way, we can ensure thorough quality management since we can always validate swiftly. By starting with a risk-based approach, we expose every risk and its possible consequences. Moreover, ABN meets the requirements of well-trained employees, a solid documentation system and validated software. Our pre-engineered building blocks eliminate the need to start any study from scratch for a new critical validation activity.

3D BIM-models generate optimal insights

Our experience shows us that every combination between environment and product is unique. The pre-engineered building blocks allow us to easily adapt to the various requirements that are constantly demanded. For an effective temperature mapping in storage areas for pharmaceutical companies, we place the sensors in the storage area that will experience the highest and lowest temperatures. Mapping ‘extreme’ temperatures combined with adequate particle counting captures the worst-case conditions of the space and helps us collect data from the entire climate controlled warehouse in order to make data driven decisions to guarantee the best cleanliness classifications. At ABN Cleanroom Technology, we always consult with the customer about their storage specifications in order to identify the appropriate mapping requirements.

When storage areas become larger, it is much more efficient to map only the locations where the critical products are actually stored. Depending on the surface of the storage space, the heatsources and the airflow within the building, measuring points can be added. By working with our 3D BIM-models and Digital Twin designs, we always get an optimal view of the environment and we can determine exactly where the measurement points should be. This Design for Validation approach is also part of our pre-engineering mind-set.

From our experience as a cleanroom provider, we can tell that validation is an important component of a successful compliance strategy. Our mapping strategies allow us to create an accurate profile of the environment in which critical products are stored and shows which measures are needed to meet the GDP requirements. From the information we receive from temperature and humidity mapping activities, we generate data-driven insights that allow us to continuously monitor the controlled areas. Because our modular building blocks are fully pre-engineered, we include the monitoring of temperature, humidity and other parameters right from the early stages of a project. This way, we create an efficient validation strategy so you can always be sure that your controlled storage facility is compliant with regulations.

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