Tag Archive | "inhibitory residue test"

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, ValidationComments (0)

Clean-in-place (CIP) with Citrajet Detergent

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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Posted in Citrajet, Keylajet, Pharmaceutical, Solujet, ValidationComments (0)

What is an Inhibitory Residue Test?

Q. What is an inhibitory residue test? A. The inhibitory residue test is a test of suitability of glassware for microbiology testing. Read more….

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Posted in Detergents, Environmental, LaboratoryComments Off on What is an Inhibitory Residue Test?