M-Line: Mobile High Pressure Unit
IWT worked to execute an Atorvastatin removal test as the worst-case scenario for a potential new client. The reason for buying a new cleaning system came from failures registered during their own cleaning validation test as a result of the Atorvastatin introduction. In fact, Atorvastatin proved to be resistant to removal due to the high adhesion to the BIN walls, which are used for mixing, with a criticality around the top angles. An integrative test with dihydrate Azithromycin with sugar is requested.
What is the main object of this test? This is a performance evaluation study for the introduction of a new bin cleaning system set for all bin automatic washing used in an Oral-Solid Dose (OSD) Manufacturing Area. The efficiency of bin washing with the high pressure IWT mobile unit is evaluated by products Atorvastatin Blend and Powder Doxycycline for suspension.
Two tests are planned to do this, test 1 is as follows, BIN 2200 LT, Doxycycline, mill drain area. Test 2 is as follows, BIN 1200 LT, Atorvastatin, mill drain area.
The bin cleaning system used for this performance evaluation study is an IWT M-Line high pressure mobile washing machine. This machine allows an automatic washing cycle using purified water, which is pressurized by a piston pump with a payload of 40LPM (10GPM) with high pressure (70bar) in order to optimize the process. The surfaces of the M-Line are made of stainless steel AISI 316L. The machine is equipped with a detergent dosing system and using a flow-meter it is possible to measure the quantity of detergent and the concentration used during the cleaning phase.
The introduction of Atorvastatin API in the client production line represented an issue due to its incompatibility with the existing cleaning procedures. The investment in the M-line system, thanks to its mobile design, can mitigate the collateral infrastructural costs and represents a simpler add-on to existing and running operations.
The cleaning procedure described above is considered effective, all pieces are perfectly clean after visual inspection and the customer’s laboratory reports are exceeding the acceptance criteria. Even critical areas, such as the internal bin top corners achieved proper results.
The Atorvastatin API, which was considered the worst-case scenario either from a removal and a microbiological point of view, can be successfully processed.
The M-Line high pressure washer brings a repeatable and validate method to automate and standardize the cleaning operations in their solid manufacturing area.