Risk Based Limits and Pharmaceutical Cleaning
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.
Biocompatibility Testing for Pyrogens
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?
Pharmaceutical Cleaning: Probiotics
Q: Can you tell me if Liquinox can clean/remove pharmaceutical probiotics? We use this product to clean our packaging lines. We have a customer who is looking to have us package their probiotic product.
A: Liquinox® Critical Cleaning Liquid Detergent is an excellent emulsifier of organic and oily residues. It will do the job. Best practice, however, would be to incorporate a powerful emulsifier of organic and oily residues, along with enhanced protein removal.
Industrial Ultrasonic Cleaning 101
Find answers to questions such as: What is ultrasonic tank cleaning? Which industries employ? What Alconox brands are ideal for ultrasonic tank cleaning?
Ensuring Accurate Formulation of Liquinox Detergent
Q. I am a validation manager and we use Liquinox in multiple pieces of equipment across our manufacturing site. While witnessing our cleaning, I noticed the dilution instructions are not being followed. Instead, operators are adding some squirts/pumps/pours from the bottle into a bucket with purified water. Does Liquinox have a range of effective concentration? Do you have auto-mix ideas or other dosing solutions for customers facing this issue of accurate formulation?
