Page 34 – A3P – Pharmaceutical & Biotechnology Industry

La Vague 54

Cluster consolidation strategies for solid oral forms in multi-product establishments.

July 2017 La Vague n°54 Cleaning validation Summary & ArticlesDownload number Summary ✻ Cluster consolidation strategies for solid oral forms in multi-product establishments Biocidal regulations applied to the disinfectants used [...]

La Vague 54

Biocidal regulations applied to the disinfectants used in the pharmaceutical industry: all you need to know…

July 2017 La Vague n°54 Cleaning validation Download number Summary ✻ Cluster consolidation strategies for solid oral forms in multi-product establishments Biocidal regulations applied to the disinfectants used in the [...]

La Vague 54

Cryogenics is the study and production of low temperatures

July 2017 La Vague n°54 Cleaning validation Download number Summary ✻ Cluster consolidation strategies for solid oral forms in multi-product establishments Biocidal regulations applied to the disinfectants used in the [...]

La Vague 54

Cleaning Validation for biotechnological substances : What acceptance criteria ?

July 2017 La Vague n°54 Cleaning validation Download number Summary ✻ Cluster consolidation strategies for solid oral forms in multi-product establishments Biocidal regulations applied to the disinfectants used in the [...]

La Vague 54

“Health-based approach” implementation for setting limits in cleaning validation for Vaccines/Biotech

July 2017 La Vague n°54 Cleaning validation Download number Summary ✻ Cluster consolidation strategies for solid oral forms in multi-product establishments Biocidal regulations applied to the disinfectants used in the [...]

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La Vague 53

Low Endotoxin Recovery (LER) is today one of authorities serious concerns regarding pyrogen testing

Low Endotoxin Recovery (LER), initially described by Chen and Vinther in 2013, is a phenomenon occurring in protein formulations that is characterized by efficient masking of Lipopolysaccharides (LPS/endotoxin). Depending on the protein – buffer characteristics, the temperature – and time – dependent masking effect can lead to complete non-detectability of LPS, which might present a serious risk for the patient. At first being interpreted as a purely artefactual event occurring in testing laboratories, LER is today one of FDAs serious concerns regarding pyrogen testing.