Man walking in cleanroom small

Risk management

Science-Based Quality Risk Management

What does it mean for cleanrooms?

Risk management for cleanrooms is a “systematic application of management policies, procedures, and practices to the task of identifying, assessing, controlling and monitoring risks”. It is typically an iterative process. Risk management should be based on good science and product & process understanding. Qualitative or quantitative techniques may be used.

Risk management should reduce risks to an acceptable level because a complete elimination of risk is neither practical nor necessary. It is ABN’s belief that modular and pre-engineered cleanroom design reduces risk to an absolute minimum considering the reuse of knowledge and data, opposed to projects that are constantly designed from scratch.

ICH Q9 Quality Risk Management Approach

The ICH Q9 guideline provides principles and examples of tools for quality risk management that can be applied to different aspects of pharmaceutical quality. ICH Q9 describes a systematic approach to quality risk management and is used as basis of the Quality Risk Management Approach.

The emphasis on each component of the framework might differ from case to case, but a robust process will incorporate consideration of all the elements at a level of detail that is commensurate with the specific risk. ABN Cleanroom engineers possess a deep knowledge of the ICH Q9 guideline and embed the Quality Risk Management Approach in our modular VIX concept.

Risk management tools

ABN Cleanroom features

Questions about our pre-engineered cleanroom thinking?

We’re happy to talk cleanrooms, the benefits of pre-engineered cleanroom design, and can help you get started with your concept or project. Simply contact us. We’ve helped companies as small as startups to the global pharma companies figure out the best fit for their production process. We can help you too.

Where to find our pre-engineered & modular cleanroom concepts?

Want to do some research on your own?

Case study
08/11/2019

Customer Interview at PANNOC (Dutch): “Kiezen voor modulair design bij omvormen cleanroom”

Met cleanroom designs waarbij modulariteit en pre-engineering centraal staan, toont ABN Cleanroom Technology bij farmaceutisch producent Pannoc dat het omvormen van een bestaande cleanroom niet nodeloos complex moet zijn. De verbouwing van de productiezones op de site in Olen verliep volgens een pre-engineering aanpak en dat heeft zo zijn voordelen.
Whitepaper
10/02/2020

Reliability boost in pre-engineered cleanrooms with fault tree analyses

Imagine the possibility of telling you now about future problems with your assets or processes. Ever thought what you would be willing to pay for that type of foresight? Quite an investment for sure. You can anticipate problems before they happen and reduce the risk of failure. That is what Failure Mode Effect Analysis (FMEA) and Fault Tree Analysis (FTA) can do.
Whitepaper
24/07/2020

Darwin would favor modular cleanroom design

Today’s cleanroom concepts are evolving towards a modular design approach in order to meet rapidly changing needs in cleanroom technology business. Cleanroom concepts that adapt easily to these changing needs will keep evolving. If your business requires a classified space, we hold on to modularity.