Tag Archive | "residue detection"

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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Perchlorate Free Detergents

We are looking for a laboratory dishwasher detergent that does not contain perchlorates. One of our end users analyzes for trace levels of perchlorates, so we cannot have a detergent that has that type of impurities.

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Posted in Laboratory, Solujet, TergajetComments (0)

Detecting Residue in Cleaning Validation

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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Posted in Articles, Cosmetic, Medical Device, Pharmaceutical, ValidationComments (0)

Pharmaceutical Cleaning Validation – Residue Detection Method Selection

Q. What are the residue detection methods that can be used for cleaners? Does Alconox provide pharmaceutical validation information? A. A pharmaceutical cleaning validation involves residue detection method selection. Residue detection method selection for cleaners can involve specific methods for specific cleaner ingredients . . .

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Posted in Medical Device, PharmaceuticalComments (0)

Residue Testing with pH Strips

Q. Can I use pH paper to confirm cleaning and rinsing of labware to comply with lab accreditation requirements?

A. If you are going to use pH strips to comply with lab accreditation requirements, you need to verify that your detergents are not interfering with the strips and papers. Detergents and surface active agents can interfere with some pH paper by causing a decrease of several pH units in reading. Please test any pH paper you intend to use …

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Posted in Detergents, Environmental, Healthcare, Laboratory, Medical Device, PharmaceuticalComments Off on Residue Testing with pH Strips