When beginning cleaning validation, a company must identify the residues to be tested and then select the best detection method. Alconox Inc. is here to help. We provide validation guidance and we also provide technical support via Downloadable Whitepapers. Here is an excerpt about Identifying Residue and Selecting a Detection Method: Before you start identifying … [Read more...] about Detecting Residue in Cleaning Validation
Q: We are advising a mid-sized pharmaceutical company. If we use multiple cleaning agents within a facility, the cleaning program may be a bit difficult to manage (chances are that the operators may use the incorrect cleaning agent for the product) and also the cleaning validation will be a more complex exercise. What would you recommend for general cleaning? Which is … [Read more...] about One Detergent to Clean Them All?
Q. How do you determine acceptable residue limits when performing a cleaning validation? A. All Alconox Inc. cleaners have an oral LD50 of greater than 500 mg/Kg acceptable residue limit. Alconox®, Liquinox® and Citranox® all have an oral LD50 of greater than 5 g/Kg. If you calculate 1/1000 of the LD50 as a potential residue in a dose of the pharmaceutical, knowing the … [Read more...] about Determining Acceptable Residue Limits
Q. Does Alconox, Inc. offer validation consultants to provide validation tech support? A. Yes, Alconox can provide valuable consulting and information to medical device manufacturers. Our critical cleaning experts can discuss validation concerns such as techniques for determining acceptable residual levels and analytical methods for residue quantitation. Alconox, Inc. … [Read more...] about Medical Device Cleaning Validation Consultant
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?