The use of aqueous cleaning in medical device manufacturing can provide numerous benefits in terms of efficacy, minimal surface contact and reduced residue potential, and easier cleaning validation.
Getting the best results from any cleaner requires proper mixing and cleaning procedures. This whitepaper includes mixing directions for each type of Alconox, Inc. aqueous cleaning detergent. It also describes methods for monitoring cleaner performance.
Cleaning validation or verification is a necessary regulatory compliance step in medical device manufacturing and reprocessing. Support from the cleaner manufacturer can save time and money when establishing either cleaning validation or cleaning verification processes. This white paper outlines the basics of cleaning validation and how the cleaner manufacturer can help simplify and speed up the process, as well as support ongoing maintenance of the validated or verified state.
Cleaning validation is a necessary and time-consuming part of manufacturing pharmaceuticals. The validation process can be expedited and the cost reduced if the cleaner supplier can provide support — ultimately allowing pharmaceuticals to get to market faster and at a lower cost. This paper outlines the basics of cleaning validation and discusses the support services you should seek from your critical cleaning products supplier to optimize your cleaning validation process.
Water is one of the most widely used raw materials in the pharmaceutical plant. Several grades of water are used throughout the plant. One grade, Water for Injection (WFI), is water purified by reverse osmosis or distillation as specified by the United States Pharmacopeia (USP). Specific tests for Conductivity apply to WFI Water produced on site for manufacturing purposes.
Biopharmaceutical Chromatography Systems are designed for separating and purifying proteins and bio-engineered products. The systems must maintain a hygienic design. Wetted surface finish must be < 20 μinch Ra and material traceability is important to maintain system integrity. pH measurement plays an important role in the purification process, providing feedback control of buffer and effluent feed through the column. The system’s wetted components must withstand Cleaned in Place (CIP) and Steamed in Place (SIP) cycles, which can stress a sensor with high heat and caustic. The pH sensor must be able to make accurate and stable pH measurements after the cleaning cycles.
In fermentation and cell culture, one of the most critical process challenges is to maintain the optimal pH level. Fermentation process utilizes a living organism such as a yeast, bacteria, or fungus strain to produce an active ingredient. Fermentation process is normally shorter in duration (2-7 days). Cell culture is a process in which a mammalian cell is grown to produce the active ingredient. The cell culture process is typically longer (2-8 weeks).