Following on from training with DuPont™ on Quality Risk Management for cleanroom gowning qualification earlier this week, our Consumables & Equipment Team Leader, Rebecca Corcoran-Birtles, is keen to share more about the topic.
The new EU-GMP draft annex that is due to go live in 2020 recommends “Quality Risk Management (QRM), to ensure that microbial, particulate and pyrogen contamination associated with microbes is prevented in the final product” and states that; “processes, equipment, facilities and manufacturing activities should be managed in accordance with QRM principles that provide a proactive means of identifying, scientifically evaluating and controlling potential risks to quality.”
Sources of contamination
Garment systems should be considered as part of a holistic approach to contamination control.
If organisations spend millions on ventilation, but don’t manage the risks of humans this is likely to create a risk of contamination.
Dual risk of contamination
People and product are risks to each other and particularly during the handling of hazardous substances, garment systems should provide the correct level of protection for the wearer, as well as protecting the product from the operator.
Contamination risks that can be controlled by appropriate garment systems:
- Human contamination – skin flakes, bacteria
- Garments – particles, fibres
- Processes – operators exposed to hazardous substances
The operator must be able to work for 3 hours in the same set of cleanroom garments and garments must be qualified, through a DQ, IQ, OQ, PQ process, for intended use.
DuPont systems are limited life clothing and as such only need to be qualified at the end of their shelf-life (5 years), whereas laundered garments need to also be assessed after wash cycles to validate the point they need to be replaced.
In grade A/B areas, Isoclean garments should be worn only once, but in grade C/D areas they can be worn multiple times in one day, as long as they are not chemically contaminated.
Thanks for reading,