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Absence of bacterial endotoxins

LAL (Lysate of Limulus Amaebocytes) test

Regulatory reference: USP85.
Claim: Absence of bacterial endotoxins
Application field: Medical devices: raw ingredients and finished products.
Description of the test: Lysate of limulus amaebocytes (LAL) is an acqueous extract obtained by Limulus polyphemus amaebocytes. The LAL reacts strongly to endotoxins in Gram-negative bacterial membranes (lypopolysacchartides), resulting in coagulation. This property is exploited in the LAL test to detect endotoxins.
Posted in Raw materials for medical devices, Absence of bacterial endotoxins, Claim for medical devices

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Abich obtained ACCREDIA certification

 
The ACCREDIA Certification, issued by the Italian Accreditation body ACCREDIA, certifies that the Abich Laboratory complies with the requirements of the UNI CEI EN ISO / IEC 17025: 2018 standard for tests on surgical masks. Accredited tests are Bacterial Filtration Efficiency (BFE) and Microbial Cleanliness (Bioburden).
 
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