Multiple mechanisms emerge when sample tubing of any length is placed between the sampling location and the particle counter inlet probe. By standardizing set-up variation where possible, these mechanisms are further classified into their principal loss mechanisms.
Data Trending and Alert/Action Levels definition are new requirements in the latest EU GMP Annex 1, Revision 12 draft. Trends allow you to quickly and easily identify changes in your cleanroom data and leverage this to make effective decisions, changes, and adjustments often before problems occur. Here we discuss three…
O Anexo 1 das BPF da UE fornece orientação sobre como escolher pontos de amostragem eficazes para salas limpas. Definições Os pontos de amostragem de sala limpa incluem contadores de partículas e monitores microbiológicos. Identificação de áreas críticas por análise HACCP e entendimento do processo Escolha pontos dentro das áreas…
Science vs standardization: justification vs blindly following rules. The new auditors’ expectations for a cleanroom monitoring plan Annex 1 requires designing an effective contamination control strategy (CCS) based on a scientific assessment to understand the process and to apply risk management principles. The latest Annex 1 draft frequently uses the…