[HTML][HTML] Manufacturing of microfluidic sensors utilizing 3d printing technologies: A production system

D Khorsandi, M Nodehi, T Waqar, M Shabani… - Journal of …, 2021 - hindawi.com
3D integrated microfluid devices are a group of engineered microelectromechanical systems
(MEMS) whereby the feature size and operating range of the components are on a …

[PDF][PDF] Settle plate exposure under unidirectional airflow and the effect of weight loss upon microbial growth

T Sandle - European Journal of Parenteral & Pharmaceutical …, 2015 - researchgate.net
Settle plates play an important part in the environmental monitoring programme and for the
assessment of microbial settlement at key locations within cleanrooms, particularly when …

Hazard Analysis and Critical Control Points as a Quality Risk Management Tool in the Pharmaceutical Industry: A Systematic Review

M Chaudhary - Journal of Drug Delivery and Therapeutics, 2021 - jddtonline.info
For several years, quality risk management (QRM) has been such an integral component of
healthcare as well as pharmaceutical product manufacturing. Effectual QRM can help …

[PDF][PDF] Cleanrooms and associated controlled environments-biocontamination control: dissecting the standard

T Sandle - 2022 - researchgate.net
In 2020 a new contamination control standard has been issued, specifically focusing on
biocontamination control, titled EN 17141: 2020 “Cleanrooms and associated controlled …

Revision of viable environmental monitoring in a development pilot plant based on quality risk assessment: a case study

I Ziegler, J Borbély-Jakab, L Sugó… - PDA Journal of …, 2017 - journal.pda.org
In this case study, the principles of quality risk management were applied to review sampling
points and monitoring frequencies in the hormonal tableting unit of a formulation …

[PDF][PDF] Monitoramento ambiental aplicado à estética: uma construção prática da percepção acadêmica e alerta para os riscos biológicos

A Costa, S Curvello… - Brazilian Journal of …, 2022 - scholar.archive.org
Objetivo-Este estudo teve por objetivo promover a conscientização e percepção acadêmica
para os riscos biológicos a partir do monitoramento ambiental e de superfícies realizado no …

A Model of Risk Analysis in Analytical Methodology for Biopharmaceutical Quality Control

CL Andrade, MADLO Herrera… - PDA Journal of …, 2018 - journal.pda.org
One key quality control parameter for biopharmaceutical products is the analysis of residual
cellular DNA. To determine small amounts of DNA (around 100 pg) that may be in a …

Proposição de ferramenta para análise de risco aplicável à validação do módulo Warehouse Management na indústria farmacêutica

JSO Igarashi - 2019 - arca.fiocruz.br
As Boas Práticas (BP) aplicáveis ao segmento farmacêutico englobam a regulamentação
da cadeia farmacêutica desde a descoberta de um fármaco até a pós-comercialização do …

Project Management in Risk Analysis for Validation of Computer Systems in the Warehouse System

JL de Magalhães, JSO Igarashi, Z Hartz… - … of Research on …, 2020 - igi-global.com
The informational and digital era of Big Data presents a non-trivial and unprecedented way
in history for data and information management in organizations. Thus, to manage, protect …

[PDF][PDF] Pharmaceutical Microbiology Resources

T Sandle - researchgate.net
Risk Management Page 1 Dr. Tim Sandle Pharmaceutical Microbiology Resources: www.pharmamicroresources.com
Page 2 Introduction  Introduction to quality risk management  Definitions of risk  What is …