Q. We are moving from LD50 data to ADE (PDE) limits based on HBELs. This is allowing us to eliminate disposables for low-risk products. How do I know which can be manually cleaned and which needs to be in a washer? Can manual cleaning be validated? A. Many pharma and biotech companies have been moving to Health-Based Exposure Limits (HBELs) meaning Acceptable Daily Exposure … [Read more...] about Risk Based Limits and Pharmaceutical Cleaning
residue detection
Laboratory Cleaning: Eliminating Residual Nitrogen
Q. I am setting up a scientific analytical lab and wondering which of your liquid cleaning solutions is free of both phosphorus and nitrogen? A. Sounds like your concern is residual nitrogen for analysis purposes as opposed to containing elemental nitrogen. In that case, as we do for many, we recommend Liquinox® Critical Cleaning Liquid Detergent. Analytical, … [Read more...] about Laboratory Cleaning: Eliminating Residual Nitrogen
Residue Detection: Swab Method
Q. Do you have a recommended swab detection method for residual detergent? A. We most certainly do. It is suggested to use a swabbing area of 5 cm X 5 cm. Where extreme low level acceptance criteria on a low recovery residue, i.e. some product residues, it can help to use a 10X10 cm area. However, for detergent residues, you should not have to go to a 10X10 cm area in order … [Read more...] about Residue Detection: Swab Method
Perchlorate Free Detergents
Q. We are looking for a laboratory dishwasher detergent that does not contain perchlorates. One of our end users analyzes for trace levels of perchlorates, so we cannot have a detergent that has that type of impurities. A. None of our detergents contain perchlorates. However, perchlorates can be a very trace contaminant in phosphate containing detergents, even if the … [Read more...] about Perchlorate Free Detergents
Pharmaceutical Cleaning Validation – Residue Detection Method Selection
Q. What are the residue detection methods that can be used for cleaners? Does Alconox provide pharmaceutical cleaning validation information? A. A pharmaceutical cleaning validation involves residue detection method selection. Residue detection method selection for cleaners can involve specific methods for specific cleaner ingredients such as; high performance liquid … [Read more...] about Pharmaceutical Cleaning Validation – Residue Detection Method Selection