Cleanroom and pharmaceutical logistics solutions: pharmaceutical logistics, storage and the supply chain
Published on: July 15, 2021 / Update from: July 16, 2021 - Author: Konrad Wolfenstein
Pharmaceutical logistics – special area of logistics and intralogistics – Image: Xpert.Digital / paulista|Shutterstock.com
Pharmaceutical logistics – A lot of effort for sensitive substances
Not all logistics are the same. This becomes particularly clear when considering the many transport and storage requirements of pharmaceutical products. After all, a temperature-sensitive serum has completely different requirements than, for example, a painkiller. In addition, no other globally operating industry is confronted with such different national requirements for manufacturing and sales as the pharmaceutical industry.
Challenges from all sides
Distribution and storage of an extensive range of items with a wide variety of requirement profiles, compliance with strict government regulations and constant cost pressure are just some of the challenges that pharmaceutical logistics have to face. From the producer of the raw materials to the manufacturer and wholesaler to the end customer, the logistics chain must meet the highest standards at all stages.
It is therefore no wonder that the pharmaceutical industry's supply chain is constantly in flux. Global production and sales as well as the outsourcing of entire service sectors have led to logistics chains becoming increasingly complex. Control and transparency of the supply chain quickly fall by the wayside, as most companies' classic ERP systems are primarily designed for controlling internal business processes.
At the same time, the expansion of procurement and distribution networks across national borders, market shifts by generic drug manufacturers and an increase in temperature-controlled products are creating high market dynamics, which are further increasing the cost pressure on companies.
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Complex logistics chain for pharmaceutical companies
The logistics chain is complicated by strict government regulations (GDP guidelines, Good Distribution Practice). The specifications for transport and storage equipment and operations are described there based on acceptance criteria. In order to comply with these, pharmaceutical logistics companies have to extensively convert their transport and storage capacities, which becomes clear in the logistics chain described below.
Special measures at the production site
The complex requirements begin with the storage of preliminary products in the production facilities. Based on the nature of the materials, they must be placed in different locations with differently equipped devices.
The goods are usually either in
- conventional rack warehouses or automated high-bay and carousel warehouses
- in warehouses with special climate technology to protect sensitive items and materials
accommodated.
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- Buffer storage for the manufacturing industry
- High-bay warehouse consulting & planning: Automatic high-bay warehouse – optimize pallet warehouse fully automatically – warehouse optimization
At the start of production, the preliminary products are called up, stored and transported to the production facility. Due to the high order density, the required precision and the time-critical processing of the materials, this largely happens automatically and is controlled and monitored by the companies' ERP systems. Once the process is complete, the items are temporarily stored or made ready for shipment.
Transportation to the distribution center
The next hurdle is the organization of the often international shipping of the products to the various storage locations. Since the items have different requirement profiles in terms of handling, this results in an almost unmanageable number of individual transport options, which presents everyone in intralogistics with an extremely complex task. A task that would not be possible without precise software monitoring.
When transported by ship or plane, refrigerated containers specially developed for the requirements of the pharmaceutical industry are used. For example, in accordance with the applicable EU regulations for pharmaceutical transport (EU-GDP), medicines must be constantly transported in a temperature range between 15 and 25°C. Temperatures between 2 and 8°C apply for critical shipments.
If the goods are finally brought to the centers by truck, special trailers are used that are equipped in accordance with the current GDP guidelines. This includes entire thermal trailers and fully temperature-controlled trucks for the delivery of sensitive goods. To transport mixed items with different requirements, vehicles are used that are equipped with special thermoboxes to hold the temperature-sensitive products.
Storage in the distribution center
The items are temporarily stored here before they are picked and made ready for shipment if necessary for transport to the end user.
On average, these central warehouses hold between 30,000 and 50,000 SKUs. The basis for the selection and design of the storage facility is compliance with the strict GDP regulations. Particular attention is paid to ensuring cold chains and clean conditions in the automated storage and retrieval solutions.
The most important aspect is the climate function of the devices. The required range ranges from -25 degrees to +60 degrees Celsius. For example, +60 degrees is required for plastics or adhesive technology, +5 degrees for vaccines and insulin and -25 degrees for enzymes or serum. In order to ensure constant temperatures inside the multi-insulated storage and retrieval systems, sealed airlock doors minimize the exchange of air during storage and retrieval. Cooling takes place in an energy-saving manner using refrigerants such as carbon dioxide or propane.
For the storage of particularly vulnerable substances and liquids, equipment must be provided that clean room conditions . These substances must be separated safely and dust-free from less susceptible and possibly contaminated substances in the warehouse using integrated high-speed doors. In addition, the air lock function is very important because it minimizes the direct exchange of air between the inside and outside of the device. The storage systems have two doors for this purpose. If a shelf comes from the inside, the front door remains closed, only the back door opens. The tray moves into the removal area, then the rear door closes and only now does the front door open. This means there is no continuous air flow. Ventilation technology plays a crucial role here. Only controlled air flow ensures the necessary clean room conditions inside the devices.
also has very high requirements traceability On the one hand, this is due to the high-quality products. On the other hand, the chemical and biological processes must take place so safely that they do not endanger anyone. Material flow as well as storage and retrieval are therefore subject to several control mechanisms. For example, when picking goods, a pick-by-light display can show the employee exactly what they should take from the supply system. He can also confirm the removal by hand and check the barcode using a reader.
For these reasons, different storage systems are often installed in parallel in distribution centers for pharmaceutical products. For example, in addition to high-bay warehouses with space for thousands of Euro pallets and automatic small parts warehouses for ready-to-ship pharmaceutical packages, there are separate cold and deep-freeze storage rooms or storage lift systems with a cooling function or a clean room atmosphere. In addition, multifunctional, software-supported picking areas are arranged where the items can be packed efficiently and in a resource-saving manner.
However, the high level of automation not only serves efficiency, but also consumer and patient protection. The GDP guidelines aim, among other things, at compliance with defined storage periods under specified environmental conditions, precise quality management and the complete traceability of the items. All requirements that can be met without any compromises when using fully automatic storage systems or automatic small parts warehouses . Of course, the desired zero-error strategy can only be achieved if all hardware and software components are precisely coordinated with one another.
Suitable for:
Transport to the end customer
If a decentralized interim storage facility is not used, the items are transported directly distribution center Requirements for cooling or dust protection are also present here. However, in view of the more precisely specified buyers, there is usually a lower range of items on the last section, which makes it easier to select the means of transport to be used.
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outlook
The challenges described make it clear that pharmaceutical logistics is an area that can only be operated with a lot of precision and effort. And it is to be expected that the hurdles will become even higher in the future due to increasing cost-increasing factors such as ever stricter government regulations, increasing global competition and the expansion of the range of offers. It is therefore not surprising that many companies come to the conclusion that they should outsource parts of the logistics chain to external service providers for efficiency reasons or enter into collaborations with other companies.
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Konrad Wolfenstein
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