Case Study: A large-scale plant for the production of surgical and orthopaedic fillers in Ireland
In the area of internal raw material transportation, the same questions frequently arise: How can we introduce or discharge our products into the process gently and safely? How can we ensure smooth transport between the various processing stages? How do I handle different types of containers, such as big bags, drums, containers or sacks? These questions, among others, must be redefined repeatedly for new projects as well as for existing systems. HECHT Technologie provides the right solutions and ideas for all these challenges.
In the pharmaceutical and life sciences industries, the substances used are highly active and therefore very dangerous. For many of these substances, it is essential to adhere to OEB 5 (Occupational Exposure Band) limits to effectively protect personnel from harmful exposure. This means that an environmental contamination level of OEL (Occupational Exposure Level) < 1 µg/m3 must not be exceeded. On the other hand, there are also substances that must be protected from environmental exposure at all costs. Such sensitive materials include infant or allergen-free food products, as well as substances used in surgical procedures.
A so-called bone cement is used in many orthopaedic surgeries, but it must first be produced from several components. The leading manufacturer produces this "cement" in Ireland under the strictest cleanroom conditions. HECHT Technologie ensures the raw material supply and flawless mixing of this highly sensitive product with a fully integrated process line. All machines are manufactured to the highest stainless steel quality standards, and the surfaces have a median roughness value (Ra value) of < 0.8 µm.
For raw material handling, five big bag emptying stations with cantilever portals and containment liner systems were used. This allows for the connection of the big bags without contaminating the product. To ensure the accuracy of the mixture, some of the big bag emptying stations are placed on weighing modules and are weighed using a loss-in-weight system.
Pneumatic conveying has emerged as one of the leading methods for enclosed transport to the mixer. The top priorities are operator protection and the prevention of cross-contamination. However, the composition of the conveyed material or its moisture content also plays a role in handling. For example, with materials that have a low ignition energy, it is essential to ensure that an ignitable mixture cannot form under any circumstances, making compliance with EX-zones critical. In some cases, production may need to occur in an oxygen-free environment. Additionally, the machines' operation and cleanability should be as effortless and straightforward as possible.
The ProClean Conveyor, specifically developed to meet these needs, complies with the high GMP requirements of pharmaceutical manufacturing. At first glance, the principle of the ProClean Conveyor PCC seems only slightly different from conventional pneumatic conveying devices, which operate using either positive or negative pressure. To maintain the vacuum, the system must be operated in a closed manner. The ProClean Conveyor PCC works on the principle of plug flow, which requires less conveying air. As a result, the ProClean Conveyor operates with a relatively small filter area, which is specifically designed for this purpose.
The use of ring filter technology makes the filter body an extension of the separator vessel. This technology offers numerous advantages, from easy installation and removal to compliance with "Hygienic Design" standards. Additionally, the filter fabric is fully FDA-compliant. The durability of the filter construction and resistance to filter breakthroughs are further advantages. During the conveying process, the product-gas mixture is sucked from the input point through a hose or pipeline system and enters the separator vessel of the conveyor through the product inlet valve. Depending on the customer's requirements, the tablet press can be loaded with a specific quantity of powder using a shut-off valve or rotary valve. Tablet production is carried out using a rotary press and the corresponding powder dosing system. A key advantage of the housing cover, due to its design and construction, is the arrangement of the connections. The vacuum and compressed air units are mounted on the side of the body and do not need to be disassembled during filter replacement, cleaning, or maintenance.
Once all materials are introduced in sufficient quantities, the mixing process begins using a plowshare mixer from Lödige. After the mixing process, the finished blend is transferred to big bags for further internal processing. Filling takes place at two stations. The big bags with inner liners are filled using a liner filling head at each station. The Liner Filling Head LBK enables the closed filling of any container with an inliner. High containment, even during container changes, is achieved using protective films. When no container is connected, a protective film seals the filling head and the insertion port. Both operator and product are protected against contamination. By using these technologies, complex isolator systems can be avoided during filling. The application of these closed systems, which connect the entire manufacturing process, allows for contamination-free production. The focus is clearly on product protection, especially the prevention of cross-contamination, as filler materials for orthopaedic procedures like hip surgeries must never be contaminated. This complete manufacturing process also ensures compliance with strict containment requirements without any issues.
