Last year was a challenging year for the cleanroom apparel market, which was hit with changes in the PPE directive along with a call for more environmentally-friendly solutions. Charlotte Alldis rounds up 2017 most significant product launches providing a solution to these complex issues
Striking a balance between comfort and quality is essential for businesses supplying personal protective equipment (PPE). Such demands call for innovation and at the start of the year, Dupont launched its Tyvek IsoClean single-use clothing range. Because the range is single-use, the garments do not require any additional treatment such as laundering or sterilisation which often affects the fabric properties.
Manufactured in cleanroom conditions according to the highest manufacturing standards, DuPont’s apparel provides a high level of cleanliness thanks not only to the clean-processing carried out before sterilisation, but also due to the double packaging, which helps when transfering garments into clean areas. The company said that the design of the garment has been optimised for contamination-free dressing and the garment folding pattern facilitates aseptic gowning.
Similarly, specialist in personnel protection solutions, Ansell, launched a new disposable glove in 2017. According to the company, the Microflex 93-260 is the thinnest chemical resistant, single-use glove available on the market. The glove has three layers: an exterior nitrile layer that protects against organic solvents, a soft neoprene middle layer that provides acid/base resistance, and an interior layer that provides a continual dry feel. The glove is only 0.19 mm thick, providing tactility and dexterity whilst also offering a high-level of protection against chemicals.
Despite gloves being a cheap commodity item, they remain an important area of research and innovation for companies providing PPE. It is well-known among healthcare professionals that worker’s hands are the most common indirect vehicle for cross-contamination. To address this issue, Polyco Healthline re-evaluated the glove dispensing box and its role in facilitating cross-contamination.
It found that traditional glove boxes run the risk of healthcare associated infections by presenting the gloves randomly from the dispenser, so healthcare workers have no option than to touch the glove’s critical surfaces; and being so tightly packed, an estimated 10% of gloves spill on the floor, which once contaminated, are pushed back in the box. To avoid these issues, the company launched a new glove box design. By automating the packing process, the gloves are packed with an interleaving fold so hat the gloves are presented uniformly via the exterior cuff of the glove, rather than any critical surface. Plus, the company says that the folding technique ensures that gloves cannot spill from the box.
The demand for single-use apparel can only be a reflection of the ever-stricter regulations that govern the cleanroom sector. Most notably, this year saw the announcement that the PPE directive will be superseded by the European Regulation (EU) 2016/425, effective 21 April 2018. The PPE regulation is mandatory and therefore in the PPE industry, it is a legal requirement to comply. The previous directive focused on manufacturers placing products in the market, however the new regulation involves the whole supply chain. Importers of PPE must ensure appropriate conformity assessment procedures have been carried out by the manufacturer; in turn, distributors of PPE must verify that it bears the CE marking accompanied by instructions in a language understood by end-users. The new regulation affects cleanroom clothing gloves and masks. Interestingly, the change in regulation also affects the medical devices directive. Since some masks can be both PPE and medical devices, the product must meet both sets of requirements.
Reusable polyester cleanroom clothing is typically not certified as PPE because they are subjected to multiple cycles of wearing, laundering and sterilisation which impacts the barrier properties and durability of the fabric during the garment life cycle. This single-use property represents a challenge for cleanroom garment manufacturers, as well as the environment. To address the issue, Kimberly-Clark launched the RightCycle programme for businesses using its apparel items, which collects the used apparel and up-cycles them into eco-friendly products, such as furniture and bike racks. According to the report Global Cleanroom Apparels Market 2018-2022 by Research and Markets, the trend for eco-friendly disposables is gaining momentum and more sustainable PPE options will become available in future.