Roberto Greselin offers six tips for selecting cleanroom apparel
To avoid contamination in the cleanroom, you have to manage its primary source: the presence of people. Did you know that 70 to 80% of contamination events are linked to the presence of people?¹
That’s a pretty stark statistic. But there are ways to minimise the risk. One of the most effective is to purchase sterile cleanroom apparel that protects the environment from viable particles, and non-viable particles. The right apparel is critical to reducing contamination risk. When choosing apparel for your cleanroom, be sure to take the EU GMP Annex I updates² into account. These more stringent guidelines can be addressed by selecting well-designed, sterile single-use cleanroom apparel.
Here are six tips to keep in mind before selecting cleanroom apparel:
Understand the advantages of single-use garments
Sterile single-use garments, such as Kimtech A5 apparel, are engineered to reduce contamination risk and offer significantly higher bacterial filtration efficiency (BFE) ratings and particle filtration efficiency (PFE) ratings.
Look for sterility and packaging integrity (Annex I – 7.12)
Kimtech A5 sterile cleanroom apparel is vacuum-packed. This not only ensures the sterility of the apparel but also acts as a visual sterility breach indicator, so users can be assured that the apparel is sterile when they use it.
Select apparel that is appropriate for the process and protects the product from contamination (ANNEX I – 7.11)
The Kimtech range is certified as Class 1 for particle release (Helmke Drum Test) with 96% BFE and 94% Particle Filtration Efficiency (PFE). Proprietary Clean-Don technology makes it easy to adopt proper gowning procedures and minimises the risk of contamination during the donning process.
Select garments for Grades A/B that are folded and packed to minimise contact with the outer surface when gowning (ANNEX I – 7.14i)
Kimtech A5 apparel is configured with inside-out folding and built-in snaps that automatically release as the garment is put on, lowering the risk of it touching the floor. A blue line indicator along the inside of the garment guides the operator throughout the donning process and helps them avoid touching the outside of the garment.
Look for a base construction material that maintains ideal body conditions (ANNEX I – 7.13)
The Kimtech range features a spunbond/meltblown/spunbond (SMS) fabric that provides strength, cloth-like comfort, and a strong barrier against both fine particles and bacteria while maximising airflow to keep the wearer cool and comfortable.
Take end-of-life considerations into account
Kimtech apparel is recyclable through the RightCycle programme, a service that gives used single-use apparel and nitrile gloves a second life as flowerpots, lawn furniture, plastic shelving, and other products. The programme helps to divert waste from the landfill, providing cleanrooms with a sustainable apparel solution.
For the cleanroom industry, contamination control is paramount. Performance failure of cleanroom garments can be a primary cause of alerts. To protect your process, you need to use the most reliable protective apparel available. The risks of contamination are simply too great. Not all garments perform equally when it comes to holding in particles and bacteria. That’s why it’s essential to choose a garment that offers consistent performance.
Roberto Greselin is with the Kimberly-Clark Professional Global Scientific Business
¹ Ginette Collazo. “Reducing Human Error on the Manufacturing Floor.” MasterControl, 2010.
² The Current EU GMP Annex 1, Manufacture of Sterile Medicinal Products, is under revision by the EMA Inspector Working Group. The latest revision draft has expanded the annex from 16 to over 50 pages and includes new requirements as well as additional detail related to many of the requirements presented in the current version of Annex 1.