TechNotes

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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Q. Our pharmaceutical company is transferring product manufacture to a different one our facilities. We used a CIP cleaning process with Citrajet and are going to have to perform validation and verification tests again. What information do we need for our testing? Chemical properties might be helpful as well as the science on how this chemical works. We would also need information on disposal and the requirements for allowing this to flow to normal process drains.

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Alconox Inc.’s Director of Technical Marketing and Commercial Development, Michael Moussourakis, sat down at the Oral Solid Dosage Symposium 2017 with Pharma’s Almanac TV’s, Mark Allen, to discuss how globalization is influencing the latest trends on cleaning validation. Click here to watch the video and hear how the growing market for CDMO Cleaning Validation training, and the opportunities in cleaning non-critical single use technology.

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When beginning cleaning validation, a company must identify the residues to be tested and then select the best detection method. Alconox Inc. is here to help. We provide validation service support

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Q. Currently using Alconox, but are considering a switch to liquinox. We have seen less residuals with Liquinox, which is desireable. What are the recommendations and concerns with switching from Alconox to Liquinox? What are the difference in ingredients between the two?
A. Alconox and Liquinox are functionally equivalent cleaners, but are not chemically identical. Click to learn more and access the Liquinox and Alconox msds.

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Have a critical cleaning challenge? There’s an App for that!! Alconox, Inc. the critical cleaning experts, launches its first ever application to put your cleaning needs and detergent selection information right at your fingertips.

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Q. We are attempting to validate our glassware washing process and found trace contaminants of phenol remaining after the washing process. Is there another detergent that is able to remove phenol better then Liquinox®?

A. In general, for manual cleaning, Liquinox® should be an excellent choice for removal of phenol residues. For very low level trace analysis, additional rinsing may be required. For routine laboratory cleaning, a triple rinse is typically used. For trace analysis, a 6 time rinse with purified water is typically used. For extreme low level trace analysis . . .

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Q. I am planning to use Luminox, to clean pharmaceutical packaging production equipment (automated filling machines, liquid blenders, etc.) , but I am not sure that it is certified for pharmaceutical industry and can be used industry leaders.

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Q. Does Alconox, Inc. offer validation consultants to provide validation tech support?
A. Alconox, Inc. provides support for regulatory-compliant cleaning validations which includes lot number traceability of all cleaners and ingredients, cleaner toxicity and reactivity/degradation information, shelf-life testing, residue sampling, detection methods and written cleaning procedures.

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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.

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