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Dean Clark
Dean Clark October 29, 2018

The Importance of the Cleanroom Glove Manufacturing Process

BioClean cleanroom glove manufacturing isn’t a quick or simple process; there are many stages to ensure the gloves, which are delivered to your door, meet the highest standard and cleanroom grade.

Stage 1 – Glove Former Preparation

BioClean glove formers are meticulously prepared, going through numerous acid, water and alkaline washes, as well as heavy brushing to ensure they are particle free. The formers are then dipped into coagulant which is made up of calcium nitrate and a powder-free chemical (which will aid the glove being stripped off the former). The coagulant aids the pick-up of the raw material at the next stage.

Stage 2 – Glove Dipping Process

This stage is the process of ‘dipping’ the formers into the raw material (latex, nitrile or polychloroprene) to make the final BioClean gloves. The raw material is kept at a low temperature in state-of-the-art dipping tanks to stop the raw material becoming destabilized. Once the formers have been dipped they pass through the gelling oven to partially solidify the raw material onto the formers. They then go through extensive leaching in hot water tanks in order to remove the water-soluble processing chemicals. The gloves are then beaded before entering the vulcanization oven. After the gloves are fully vulcanized they then proceed to the next stage.

Stage 3 – On-line Chlorination & Stripping

The gloves are cooled, after the high temperatures of vulcanized drying oven, by going through three cooling tanks, and then passing through on-line chlorination (water containing chlorine). The chlorine reacts with the surface of the glove and changes the molecular structure, turning it from extremely tacky to silky smooth, this enables quick and easy donning (as this will be the inside of the glove)! The gloves are then semi-automatically stripped from the formers. When the gloves are completely stripped from the former they will be the correct way round. After stripping, BioClean gloves undergoes extensive testing and further off-line chlorination.

Stage 4 – Glove Testing

BioClean cleanroom gloves go through watertight testing where they are filled with a litre of water and left for a couple of minutes. The operator then squeezes the gloves to ensure there are no holes (a hole can be so small that the amount of water escaping is almost undetectable unless the filled glove is squeezed). The gloves strength is then tested on a tensile testing machine to establish the force at break and elongation. Although powder-free, the outside surface of the glove (which was the inside when on the former) still needs to be chlorinated which is achieved by off-line chlorination. The gloves are put into a chlorinator, with water containing chlorine, to chlorinate the outside surface. The chlorine reacts with the surface of the gloves and changes the molecular structure, turning them from extremely tacky to smooth - the higher the concentration of the chlorine the smoother the glove becomes. The gloves are then thoroughly rinsed before going to the cleanroom for final processing.

Stage 5 – Cleanroom Processing

After chlorination, the gloves are put into a double sided 100kg stainless steel washing machine, from outside the cleanroom. After a minimum of 3 washes in di-ionized, UV treated water, filtered to 0.2 micron, the gloves are removed from the washing machine on the cleanroom side, put into a dryer and dried using very high quality HEPA filtered air. Meanwhile, the EasyTear PE glove pouches are printed with lot number, expiry date and size using IPA resistant ink. After drying the gloves are then taken into our own ISO Class 4 or 5 cleanroom for packing.

Stage 6 – Cleanroom Packing

Following the dipping, drying, chlorination, testing and processing, the end of the gloves journey is near! The final stage is packing which takes place within our ISO Class 4 or 5 cleanrooms where the air is filtered through ultra-low particulate (ULPA) air filters in the ceiling with 550 air changes an hour; that’s a change of air every six seconds! The air flows through holes in the floor then up between the wall panels and back through the ULPA filters. Before being pair-packed, the gloves will have a final inspection over a lightbox before they are packed into an PE inner wallet marked with L & R (hand specific gloves only) for easy recognition when donning. The inner wallet is then put into a PE EasyTear pouch which is vacuum sealed. Ten pouches (of sterile gloves) are packed into an EasyTear outer bag, the packer ID is put on the outer bag for easy traceability and an irradiation dot will be placed on the outside of the outer bag, the outer bag is then impulse sealed. The outer bags are then packed into a carton liner, the full carton liner is then placed in the pass box of the cleanroom and the hatch closed before they are collected from the other side. The full carton liner is then put into a carton which is taped on all edges to ensure it is sealed completely ready for sterilization and shipping to our customers… this completes the end of the BioClean glove journey.