February 10th and 11th….Come join Michael Moussourakis, Senior Director, Alconox Inc. and several other industry experts at the PharmaEd Resources Inc. Cleaning Validation Virtual Summit, 2021.
Alconox Inc. cleaners that are used to clean pharmaceutical, biotech, medical, food and other regulated industries product contact surfaces, in good manufacturing practice (GMP) validated environments, need certificates of analysis obtained and kept on file. These certificates of analysis (COA) can document the analysis of a specific lot of detergent and verify that it conforms to the manufacturer’s specifications. Confirming that the detergent has not changed.
The critical micelle concentration is the minimum concentration at which the emulsifiers in a detergent will coalesce in to membrane structures of globes, rods or sheets with their hydrophobic (water hating) ends on the inside of the membrane and their hydrophilic (water loving) ends on the outside such that hydrophobic oily residues can be emulsified inside these membrane structures. Micelles are further elaborated on below. If you are below the critical micelle concentration, you do not have effective emulsifying of oily residues.
Q: How would we best clean shampoo from our tanks and piping lines? We find it is building up and formation of difficult to remove films and masses.
A: While detergents/soaps like those found in shampoos are of course water soluble, the emollients, fragrances, and other components meant to be left behind (in your hair) can be quite a challenge to remove form equipment. Especially as it builds over time.
Q: We are a mid-sized medical device company and are looking at reviewing and optimizing our supply chain. Our goal is to move towards a culture of risk mitigation of our raw materials. As a consumer of your detergents, what is Alconox Inc. doing to ensure consistent supply chain?
A: Thank you for the question as it is both important, and certainly an area of deserved focus and scrutiny from regulatory bodies. Ensuring a continuous supply of drug, medical device or laboratory products requires a dependable supply of raw materials….