Mar 25, 2024

Maximizing Cleanroom Efficiency: Addressing Human Factors

In the realm of cleanroom operations, humans are both a crucial asset and a potential source of contamination. Understanding and mitigating human factors are essential for maintaining optimal cleanliness and efficiency in sterile manufacturing processes. 1. Human-Induced Contamination: Humans are significant producers of particles within cleanroom environments, shedding up to 40,000 skin cells per minute and […]

Mar 25, 2024

Unlocking Efficiency: 3 Strategies for Cleanroom and Workflow Optimization

In the meticulous world of cleanroom operations, efficiency isn’t just a goal—it’s a necessity. From real-time monitoring to paperless processes, here are three key strategies to elevate workflow and streamline operations. 1. Real-time Monitoring: Contamination is inevitable, but swift detection and response can mitigate its impact. Real-time monitoring and continuous microbial monitoring bridge the gap between data collection and analysis, […]

Risk Assessment IEST
Mar 8, 2024

Performing an ICH-Q9 Risk Assessment

Performing an ICH-Q9 Risk Assessment
Mar 1, 2024

Performing an ICH-Q9 Risk Assessment

Blog Header-EV Battery Manufacturing
Dec 20, 2023

EV Battery Manufacturing: A Journey of Precision and Particle Contamination Control

The rapid rise of electric vehicles (EVs) has brought about a surge in demand for high-quality lithium-ion batteries. These batteries are the heart of EVs, providing the power needed to propel these vehicles. However, manufacturing lithium-ion batteries is a complex process that demands meticulous control over various factors, including particle contamination. Particle Contamination: A Hidden […]

Dec 19, 2023

Cleanroom Design Considerations from a NASA Engineer

Sep 22, 2022

Cleanroom Validation from URS to PQ; ISPE GAMP5 2022 Edition & V Scheme Application for Cleanroom Monitoring Systems

Sep 15, 2022

Creating A Compliant Environmental Monitoring Program

With the never ending shift towards continuous quality improvements within the manufacturing of pharmaceutical products it is worth looking at the current requirement of GMP and also 21CFR11 in the context of GAMP 5 requirements. How a Company creates, maintains, retrieves, corrects and controls data can affect product quality. How a company reacts to out […]

Jun 30, 2022

What is 21CFR11 and why is it so important in maintaining Data Integrity?

Jun 29, 2022

Questions to Ask About The Application of 21 CFR Part 11 In Your Operations

The following questions will help you ask the right questions when implementing a system thatadheres to 21CFR Part 11. It is important to satisfy the requirements of this FDA code in order toenable Data Integrity and Data Traceability as well as the electronic signatures that verify the dataas original, valid, and accurate

Oct 27, 2021

Microbiology & Bio contamination Control in Cleanrooms

Jun 29, 2021

Using a Risk Assessment to Build a Monitoring System Focusing on Data Integrity