INSTRUMENTATION • ELECTRONICS
Point of measurement of the SE 605 H. In the lower left corner of the image the Memosens sensor connection is visible PROCESS FLOW
In the preparation plant, the company operates three preparation tanks with a capacity of up to 1,000l. Prior to further processing, the solution prepared in the preparation tanks must be freed from of any existing microorganism through fi ltration. For this, the tanks are pressurised resulting in the content accumulating the mobile sterile fi ltrate tanks through corresponding inlet lines and sterile fi lters. T ey are located in a plant section of zone A for which, according to the Typical Air Quality Classifi cation (WHO TRS No. 823
Annex 1), the strictest antiseptic conditions are required, including a room temperature that is almost 100 % particle-free. T en, the mobile sterile fi ltrate tanks with the fi ltered solutions are transferred to the fi lling systems where they are fi lled in primary tanks. To avoid any external contamination during this process, the sterile fi ltrate tanks are pressurised
PROCESSES, 24 TIMES A DAY T e cleaning plant is in operation up to seven days a week, around the clock. As the company produces diff erent substances even in small batches, the process-wetted plant sections are cleaned and sterilised every hour. First, the sterile fi ltrate tanks are connected to the cleaning plant and the entire process circuit
HOURLY CIP AND SIP
including the emptied tanks is rinsed with demineralised water and cleaning agents. Two installed spray balls in the tanks provide for a constant and reliable cleaning of the inside.
A toroidal conductivity sensor
integrated in the rinsing cycle is used to control the CIP procedure.
USE OF CONDUCTIVE AND INDUCTIVE CONDUCTIVITY SENSORS
For this application, the Ever Pharma Jena engineers decided on the hygienic, toroidal conductivity sensor SE 680 with Memosens protocol from Knick. Due to its design without any seals, joints and gaps as well as a dirt-repellent surface made of FDA-approved Virgin PEEK, the compact SE 680 is highly durable. T e inductive technology isn’t infl uenced by the polarisation and doesn’t require sensor surfaces that may be subject to corrosion. T e SE 680 sensor with an extremely wide measuring range of 0 to 2,000mS/cm at a resolution of 2 μS/cm monitors the entire cleaning process and must ensure that, regardless of the derivative, the primary product and residuals of the cleaning agent have completely been removed from the tank. Afterwards, the fi nal rinse with water for injection (WFI) is executed. Based on the requirements of Ever Pharma Jena, the ultrapure water in WFI quality must show a non-temperature compensated conductivity value of < 2.7 μS/cm. Higher values indicate that there are
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