Q. We have consulted your continuous exposure compatibility information that was sent to us for one of your detergents on various materials. We were wondering about the details of conditions used in formulating this documented info, such as temperature, detergent concentration, and period of time in which these observations were made. A. It is important to keep in mind that … [Read more...] about Detergent Compatibility Information
The pharmaceutical industry relies heavily on clean in place (CIP) systems because: operators are not required to enter classified areas to perform pharmaceutical cleaning process difficult to access areas can be cleaned production time between production runs is minimized recycling the cleaner can reduce cost Equipment used in pharmaceutical manufacturing … [Read more...] about Pharmaceutical Cleaning: Choosing CIP Detergent
Q. Are Alconox products FDA approved cleaners or detergents? Our customers need to clean pharmaceutical manufacturing equipment and medical device surfaces in compliance with Good Manufacturing Practices requiring a cleaning validation that shows that no interfering residues were left. The use of a US Food and Drug Administration (FDA) approved cleaner is desired. A. The … [Read more...] about FDA approved cleaners or detergents
Q. Why is critical cleaning necessary for the pharmaceutical industry? Are Alconox brand cleaners formulated to be used in the pharmaceutical industry? A. All pharmaceutical products, prescription and over-the-counter, available for use in the U.S. must be produced according to the FDA's cGMP regulations. These guidelines are in accordance with Finished Pharmaceuticals … [Read more...] about Critical Cleaning in the Pharmaceutical Industry
Q. What is pharmaceutical cleaning validation? What information can Alconox, Inc provide to support pharmaceutical cleaning validation? A. Cleaning validation is the methodology used to assure that a cleaning process removes any residues of the active pharmaceutical ingredients (API) of the product manufactured, as well as any residual cleaning agent utilized in the cleaning … [Read more...] about What is Pharmaceutical Cleaning Validation?