Отраслевые стандарты

Будучи авторитетом для лабораторий, университетов, клиник и производственных объектов по всему миру, Beckman Coulter Life Sciences помогает клиентам соблюдать применимые стандарты, установленные органами управления и государственными учреждениями.


EU GMP Annex 1 Guidance for the manufacturing of sterile medicinal products
ICH Q2 Is an expert working group with representation from the United States, European and Japanese Pharmacopoeias.
ISO 11171 Liquid particle counting calibration and performance guidelines for acceptable operation
EU IVD-Regulation (IVDR) IVDR 2022 is a marathon, not a sprint. We will help you go the distance.
ISO 14644 Cleanliness in cleanrooms and clean zones, addressing specifications and rules for certification

$laser-diffraction-particle-2017-05$ ISO 21501 For determination of particle size distribution for single-particle light-interaction methods
USP <643> Represents the general method for measuring total organic carbon (TOC) in water used for pharmaceutical applications
21 CFR Part 11 Mandates the conditions under which electronic records must be generated and defended



USP <787> Particle counting analysis techniques for measuring contamination and specifying limits
USP <788>, <787> and EP2.9.19 Defining allowable limits of sub-visible particulates in parenteral formulations
USP <790> Guidance on visible particulates in products intended for parenteral administration
EP 2.2.44 Chapter 2.2.44 of the European Pharmacopoeia describes the procedures used to qualify a chosen method for analyzing total organic carbon (TOC)—and the interpretation of results in limit tests.