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 percent of contamination events are linked to the presence of people1? That’s a pretty stark statistic, but there are ways to minimize the risk. One of the most effective is to purchase sterile cleanroom apparel that protects the environment from viable and non-viable particles. The right apparel is critical in reducing contamination risk. When choosing apparel for your cleanroom, be sure to take the recently published 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 when 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 – 7.11) Kimtech™ A5 Sterile Cleanroom Apparel is the only solution on the market that is vacuum-packed. This not only ensures the sterility of the apparel but also acts as a visual sterility breach indicator, so you can be assured that Kimtech™ A5 Apparel is sterile when you use it.
- Select apparel that is appropriate for the process and protects the product from contamination.
(ANNEX I – 7.13i) Kimtech™ A5 Sterile Cleanroom Apparel is certified as Class 1 for particle release (by Helmke Drum Test) with 96% BFE and 94% PFE ratings.
(ANNEX 1 - 7.10) Proprietary CLEAN-DON™ technology makes it easy to adopt proper gowning procedures and minimizes the risk of contamination during the donning process.
- Select garments for Grades A/B that are folded and packed to minimize contact with the outer surface when gowning.
(ANNEX I – 7.13i) Kimtech™ A5 Apparel is uniquely 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.
- Look for a base construction material that maintains ideal body conditions.
(ANNEX I – 7.13i) Kimtech™ A5 Apparel features a spunbond/meltblown/spunbond (SMS) fabric that provides strength, cloth-like comfort, and a strong barrier against both fine particles and bacteria while maximizing airflow to keep the wearer cool and comfortable.
- Take end-of-life considerations into account.
Kimtech™ Apparel is recyclable through the Right-Cycle™ program, a groundbreaking service that gives used single-use apparel and nitrile gloves a second life as flowerpots, lawn furniture, plastic shelving, and other products. The program helps to divert waste from landfill, providing cleanrooms with a sustainable apparel solution.
"For the cleanroom industry, contamination control is paramount and 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 EMEA Sales Manager with the Kimberly-Clark Professional™ Global Scientific Business. For more information, visit www.kimtech.eu.
1 Ginette Collazo. Reducing Human Error on the Manufacturing Floor. MasterControl, 2010.
2 Based on the final revision of EU GMP Annex 1: Manufacture of Sterile Medicinal Products, published by the European Commission on 22 August 2022. Annex 1 will come into operation in August 2023.
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