Biotechnology

Q. We use Tergazyme to clean our TFF cassettes and it’s working well. However, we are moving to CIP cleaning in an automated, high pressure environment and are worried about foaming. Do we stick with Tergazyme or is there a better detergent we should use?

A. Tergazyme® Enzyme-Active Powdered Detergent is of an excellent choice for cleaning TFF cassettes. Even as you move to more high pressure, automated CIP method, Tergazyme detergent will likely continue to work well. That’s because….

Q. What is the best way to monitor for bath life extension?
A.To avoid potential for cross contamination, only freshly made up cleaning solutions should be used for the highest levels of critical cleaning. In general, a pH change of 1 unit towards neutral indicates an exhausted cleaning solution. Bath life can be extended. Learn How.

Q. How can Alconox detergents assist with our movement to continuous bioprocessing? A: Continuous bioprocessing is an exciting newcomer to the biotech realm. It has been used in industries such as food and chemicals for some time, effectively so. With improvements in cell culture perfusion, and the many forms of disposable technologies on the market, footprints can be reduced making continuous processing for biotech products a reality for many applications.

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.    

Your detergents have corresponding biocompatibility data. Our medical devices must be pyrogen and endotoxin free. Someone mentioned that biocompatibility tested detergents, like yours, will be free of organic residues like endotoxins and pyrogens. Is this true?