Archive | Biotechnology

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.    

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Posted in Biotechnology, Pharmaceutical, Validation0 Comments

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?

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Posted in Biotechnology, Medical Device, Pharmaceutical0 Comments

Cleaning Pharmaceutical 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. 

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Posted in Biotechnology, Liquinox, Pharmaceutical, Tergazyme0 Comments

closed bioprocessing

Closed Bioprocessing Cleaning Recommendations

Q: We are a mid sized small biomolecule drug manufacturer and currently use several Alconox, Inc. products in our cleanroom and manufacturing suites.  We are looking at implement (functionally) closed bioprocessing.  Are there any recommendations you can provide?
A: Some time ago, I heard a senior executive of a large biotech company express a desire to produce drugs in a “conference room.”  That day is pretty much here. 

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Posted in Biotechnology, Pharmaceutical0 Comments

disposal

Disposal of Alconox, Inc. Detergents

What is the proper way to dispose of your detergents? Detergent disposal in a proper manner is an integral part of a robust cleaning program regardless of scale or industry. Alconox, Inc. detergents are biodegradable….

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Posted in Aerospace, Alcojet, Alconox, Alcotabs, Biotechnology, Citrajet, Citranox, Cosmetic, Detergent 8, Detergents, Detojet, Electronic, Environmental, Filter, Food & Beverage, Foodservice, Healthcare, Laboratory, Liquinox, Luminox, Medical Device, Metalworking & Precision Manufacturing, Pharmaceutical, Solujet, Tergajet, Tergazyme0 Comments

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?

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Posted in Alconox, Biotechnology, Citranox, Cosmetic, Detonox, Environmental, Healthcare, Liquinox, Manual Lab Cleaning, Medical Device, Pharmaceutical0 Comments

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?

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Posted in Biotechnology, Cosmetic, Liquinox, Medical Device, Pharmaceutical0 Comments

Water Spots on Stainless? Improve Blowing Process

Q. White spots appear on our stainless steel parts the day after cleaning with Alconox. Right after we clean them, they are dry and visually clean. So, is this next-day residue from the Alconox detergent? If not, can you tell us why this is happening? A. It is fairly unlikely that visually clean parts have Alconox residues suddenly appearing the next day.  In addition to Alconox being free rinsing, any residue that did not get rinsed for whatever reason, would be visible fairly immediately.

Most people in similar situations, even though the parts appear “dry and visually clean,” find that the spots are from water.

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Posted in Alconox, Biotechnology, Foodservice, Healthcare, Laboratory, Manual Lab Cleaning, Medical Device, Metalworking & Precision Manufacturing, Pharmaceutical0 Comments

How Does Tergazyme Enzyme Detergent Work?

Q:  You recently sent a sample of Tergazyme detergent for a tough cleaning challenge and it worked better than anything we had previously tried. I realize this must be due to the enzyme component. What information can you provide me on how enzyme detergents work, so I can share it with our decision makers / executives who want to better understand why this detergent got such different results?

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Posted in Biotechnology, Foodservice, Healthcare, Laboratory, Manual Lab Cleaning, Medical Device, Pharmaceutical, Tattoo, Tergazyme0 Comments

Removing Protein in Pharmaceutical and Biotech Manufacturing

Q. How do you remove protein out of pipes, centrifuges and tanks in a CIP environment with water temperatures averaging 20C?

A. In a cooler temperature environment, consider adding an enzymatic cleaner to your alkaline/acidic CIP routine. A product like Tergazyme® Enzyme-Active Powdered Detergent, which contains both protease and surfactants, is not only efficient at removing the biofilm, but will also slow down the formation of biofilm and allow the regular cleaning cycle to clean effectively for more cycles.

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Posted in Biotechnology, Pharmaceutical, Tergazyme0 Comments