Q. What is the shelf life of the Liquinox concentrate? A. Liquinox conforms to its 2 year shelf life under typical laboratory storage conditions…
Q. What is a surfactant? A. Surfactant is short for “surface active agent,” it is an organic molecule with a hydrophobic (water-hating/oil-loving) end and a hydrophilic (water-loving) end.
Q. Does Alconox provide information on calculating cleaning agent safety based limits?
A. Cleaning agent safety based limits are typically calculated from a safety factor of an acceptable daily intake (ADI), a (1/1000 or more) reduction of an LD50 preferably by the same route of administration, or reproductive hazard levels. Alconox, Inc Pharmaceutical Cleaning Validation References PDF has an entire section dedicated to cleaning agent safety based limits.
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….
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 (ADE) or Permitted Daily Exposure (PDE) limits as detergent residue limits.