Nitritex highlights the importance of cleanroom gloves for the cleanroom & medical industry
By: Nitritex Group LTD
Perceived wisdom is that gloves used in medical environments are sterile, as the purpose of medical gloves is to prevent cross infection from the clinician or surgeon to the patient. Surely, therefore, medical gloves must be very clean. This is a misconception Nitritex explains that the ultimate purpose of sterilizing surgical gloves to be used in operating theatres is to prevent infection from bacteria which would otherwise be present on the gloves. Contrary to the belief of many, the standard BioClean dispenser boxed examination rubber gloves, as supplied by Nitritex and used in medical and dental environments, are NOTsterile, and all they can do is prevent cross infection between the wearer of the gloves and the patient. The patient is not in any way protected from the multiple bacteria that are already present on the gloves.
All medical gloves are either powdered or powder-free, whether they are latex gloves or nitrile gloves. Whilst in the past, powder-free gloves were made by washing them in chlorine off-line, in the interest of economy, nowadays virtually all powder-free medical gloves are either chlorinated or polymer coated whilst still on the dipping line. As gloves are produced inside out, this chlorination or polymer coating process takes place on what will become the INSIDE of the glove, allowing the wearers to easily don them.
To aid the stripping of powder-free latex rubber gloves and nitrile gloves from the ceramic formers, Nitritex uses anti-tack chemicals in the coagulant tank to effectively coat the formers before they dip into the latex. This allows the rubber latex gloves to be stripped easily from the formers and dropped into large plastic bags or baskets. Nitritex’s BioClean brand medical examination gloves will then go straight into the packing room to be packed intodispenser boxes and then into cartons whilst surgical gloves will go through a process of cuffing, packing in paper wallets, sealing in paper pouches and then packing into boxes and cartons prior to being sent for sterilization.
Dipping lines are not in the cleanest of atmospheres in the first place. If a particle counter were used to measure the number of particles per cubic foot of air in a gloves manufacturing area, the result would be in the millions. The workers on the lines, including those stripping the gloves from the lines, wear standard cotton or polycotton clothing that lints everywhere. Many workers change their clothes infrequently so they are dirty. They rarely wear face masks and never wear goggles as the atmosphere is just too warm. Many workers have bare arms exposed . There is very low discipline in the factory area meaning that even caps over the head are frequently not correctly worn. All this leads to contamination of the gloves prior to and during packing. For the non-sterile gloves, the contamination will be particles and bacteria. For the sterile, it will be sterile dirt.
Pharmaceutical manufacturers will normally require sterile rubber gloves, but in addition to the sterility, rubber glovesare requiredto be low in particulates, especially when making injectables. There are many ways for particles to end up on rubber gloves. They can be human skin cells which are shed in vast numbers, eye lashes, body hair, dust, insects and fibres from the clothes. As a result, surgical gloves will frequently have high particle counts, albeit sterile particles.
As a further indication of the lack of concern for particles in medical environments, the packaging for standard sterile surgicalglovesshould be given consideration. They are packed in paper inner wallets which arethen, traditionally, sealed intopaper pouches that have atendency to shed particles whenpeeled open. The sealed pouchesare then further packed intocardboard boxes and then into cartons. Ordinary paper willparticulate and so is generally not allowed into the cleanroom area. Incontrast to the paper packing of surgical gloves, BioClean sterile cleanroom gloves (http://www.bioclean.com/
In contrast to medical gloves, most cleanroom gloves go through a second chlorination process off-line and are not touched by bare hands thereafter. This process kills virtually all the bacteria on the gloves. Whether the gloves go through this off-line process or not, ALL cleanroom gloves will go through a multiple washing process in a cleanroom, in deionized filtered water, be dried with clean filtered air in the cleanroom in cleanroom dryers and then packed in the cleanroom. All workers in the cleanroom are covered head-to-toe in non-linting, cleanroom-washed polyester clothing and they wear face masks and goggles. There is little to no skin or hair exposed to cause contamination. There is also a great deal of discipline in the cleanroom to make sure that ALL workers adhere strictly to cleanroom protocol. As a result, even non-sterile cleanroom gloves have low to zero bioburden. In addition, the air in the cleanrooms is filtered through ULPA or HEPA filters with up to 650 air changes per hour. As a result, if a measurement ofthe number of particles in, say, an ISO Class 4 cleanroom like the one used by Nitritex, the result would be between zero and 10 particles per cubic foot of air (of 0.5 microns and above) compared with the millions present in the glove manufacturing environment.
BioClean, the flagship cleanroom consumables brand of UK based Nitritex Ltd, has been leading the way in the cleanroom consumables segment since 1996. Products marketed under the BioClean brand (gloves, goggles, headgear, garments and accessories)
Company Name – Nitritex Ltd
Global Brand – BioClean – Cleanroom Consumables
Telephone Number - +60 3 5569 3857/3859
Fax number - +60 3 5569 3862
Email Address - email@example.com
Website – my.bioclean.com