Ensuring sterility and preventing cross-contamination are critical elements of ensuring quality product production. When processing systems aren’t completely cleaned between production runs, leftover compounds, contaminant soils, and cleaning agent residue can negatively impact the safety or effectiveness your pharmaceutical drugs, biologics, or other products.
Steam-in-place (SIP) cleaning uses the thermal energy of condensing steam for a controlled time to clean and disinfect the interior surfaces of bioreactors, vessels, tanks, piping, filters, and associated fittings "in place," without costly removal of the target equipment, or time-consuming disassembly of critical production lines. High-pressure steam is repeatedly introduced into the product-contacting areas of the processing system, for sufficient duration required to reduce bioburden and neutralize contaminants.
The success of the steam cleaning is validated by thermal mapping, where temperature sensors are placed throughout the system before steam-in-place cleaning to ensure that specified temperatures and exposure times are achieved. The temperature sensors or thermocouples are typically placed throughout the system via flanges and gaskets, eliminating the need to disassemble the system.
With years of experience in steam-in-place validation, Masy BioServices can help ensure the sterility of your production facility and the corresponding safety and efficacy of your products. A pre-execution review of your production line design and evaluation of your test plan requirements will help us identify the critical areas and "problem spots" of your system, helping to ensure a successful validation of your steam-in-place sterilization.
With steam-in-place validation, Masy BioServices can confirm the successful application of steaming procedures, ensuring that pipe and vessel interiors are clean, sterile, and ready for your next processing cycle.
Contact Masy BioServices today for your steam-in-place validation needs.