Milling Technology High-Containment in the High Mountains: Chilean Pharmaceutical Manufacturer Uses HPAI Production Plant
Where do you look to find someone with the initiative to precisely install a sophisticated high-tech system in the country which the locals say is “at the end of the earth”? An initiative such as this is anchored in the heads of visionaries who are undeterred by borders and barriers.
It was back in 1992 that I first set foot on this fertile ground situated between the Andes and the Pacific Ocean. At that time, the topic on people’s lips was mostly the consequences of dictatorship. Nowadays, Chile is politically and economically stable. This fact, among others, has helped to ensure a friendly working relationship there between a local pharmaceutical manufacturer and Frewitt.
This situation wasn’t to be your typical “business as usual” case. This company, which is focusing on an expansion strategy and joined forces with a pharmaceutical corporation, needed a partner for complete solutions. Planning, engineering, design and installation were all to be provided by the same firm, which had to be an expert in the field of milling technology — an ideal prerequisite for Frewitt. The Chilean pharmaceutical manufacturer had decided to make sensitive and challenging products and had therefore opted to create a brand-new process. Because it would have to be possible to process products containing HPAIs (highly potent active ingredients) on the planned system, the process would have to be closed.
The system would have to be fully mobile, as well as adaptable to the buildings or rooms. The Chilean company also required flexibility in the process, along with compliance with a high OEB level. It also wanted a solution which enabled connecting, transporting and cleaning of containers, drums, conveyors and glove boxes in the easiest way possible. Flexibility was a must for the batches and containers too: It had to be possible to connect containers with capacities of 300, 600 and 1,000 l to the exact same storage system. Once the system was complete, it was to be accepted in the Frewitt factory (FAT) and then on the customer’s premises (SAT).
Probably the most important difference compared to a conventional procedural system is the closed process in those places where product is transferred from one process module to another. In the system described, product transfer from the container, to the vacuum conveyor, to the mill, to the vacuum conveyor and so on is considered “problematic” in this sense, as is the manual product supply into the closed process in particular. Frewitt was therefore keen to integrate its Profi-Flex system, which it developed itself, into the system. Profi-Flex is a flexible containment system which can be used for the dust-free addition of product to the process without contaminating the operator space. Unobstructed access to the machine’s tools and components was to make working under high-containment conditions easier. The material coming into contact with the product also had to be easy to dispose of and clean. The active and passive valves which the customer wanted assembled at the container outlet and the drum inlet would also serve to ensure cleaner product transfer. Last but not least, product discharge into the operator space was to be effectively prevented due to the pressure equalisation in the drum and the product residue being cleaned from the filter using Profi-Clean.