Large Horizontal Pharma Peeler Sterilized with Vaporized Hydrogen Peroxide
Large Horizontal Pharma Peeler, Sterilized with Vaporized Hydrogen Peroxide
A primary Chinese pharmaceutical manufacturer was outfitting a new plant that produced antibiotics under U.S. and European regulations. The customer had very large volumes and wanted a cheaper solution for sterilization. They needed pharma peeler centrifuges that could be sterilized in place using Vaporized Hydrogen Peroxide (VHP) technology, an unusual method, which made the project challenging.
In order to get the volume needed, we suggested three of our largest peeler centrifuges designed specifically for the pharmaceutical industry – the HX/GMP 1750/920 model in AISI 316L, providing 5 m2 of filtering surface each.
Even with the machines’ size, the process areas, including the rear of the basket and the shaft seal, were fully accessible and inspectable. Following cGMP design, there were no product stagnation zones and screws and threads within the process chambers were kept to a minimum. All surfaces in contact with the product had Ra 0.2 electropolishing finishing, and a laser cake detector was used in order to avoid contact with the product. Furthermore, the machines had endless filter cloths, which were thermo-welded, making them easy to replace and clean.
In addition to standard machine features, we addressed the specific project needs by ensuring the complete removal of the residual heel cake via a nitrogen pressure system from the external part of the basket (“blow back”), which optimized nitrogen consumption. The machines’ CIP systems eliminated contamination between products through the use of the Washing Machine Effect and spray balls. Finally, the centrifuges were completely sterilized using the desired VHP system.
The centrifuges have been in operation since 2016. For each machine, the CIP system was validated through a Riboflavin test, and the SIP system resulted in 100% sterilization with the VHP process. Controls allow for specific recipes for each product. The cake laser controls the cake thickness during the load and wash phase, and optimizes the washing liquid quantity based on the amount of product in the basket. Overall, these features made CAPEX and OPEX cheaper for the customer.