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One of the biggest challenges in designing cleanroom doors for the pharmaceutical industry is in creating a sturdy door with a high hygienic performance that is light and easy to clean.
Lloyd Dalton. Manager, Marketing, at DortekOne of the biggest challenges in designing cleanroom doors for the pharmaceutical industry is creating a sturdy door with a high hygienic performance that is light and easy to clean. These factors need to be considered when designing hygienic doors for all areas, but in a cleanroom environment, one of the most important considerations is the weight of the door. Manufacturing a door that complies with fire regulation can add weight to the initial product, which can make it very difficult to open. The differential air pressures within cleanrooms also exacerbate this problem so it is important to consider whether automated access control needs to be fitted to each door.
Overall, the most important factor to consider when designing a cleanroom door is the material used. At Dortek, we manufacture our cleanroom doors from GRP (glass reinforced polyester). The closed cell, inorganic nature of GRP means that it has an excellent hygienic performance. It is also lighter and easier to repair than other materials.
Previously, timber, laminate, steel and GRP were all available to the pharmaceutical industry for the manufacture of doors. Whilst timber doors are still in place in some pharmaceutical facilities, hygiene regulation now prohibits their use in many areas and it is rare to see one in a modern cleanroom
Today, steel and GRP doors are now the main choices available to the pharmaceutical industry. In areas where hygiene is important, there is really no comparison between the two; in every aspect, I believe that GRP doors perform much better than their steel counterparts, and our customers that have specified GRP never go back to steel. In fact, many of the major pharmaceutical companies have already begun to replace their existing steel doors with GRP before the end of their lifecycle because of the poor performance both in terms of ease of use and hygienic performance.
GRP doors comply to all latest GMP requirements in pharmaceutical and nutritional facilities, and because of their smooth, seamless construction, are easy to clean and do not harbour bacteria. GRP doors are completely water resistant, and will not warp, rust or rot when exposed to the prolonged use of disinfectants, chlorine releasing agents and VHP (vaporised hydrogen peroxide).
The construction of steel doors leaves seams and crevices, particularly around vision panels and the top and edges of doors. These harbour bacteria and are difficult to clean, compromising the hygienic performance of the door, and jeopardising the cleanliness of materials and the validity of any research conducted in the cleanroom. They can also oxidise when exposed to regular cleaning regimes.
GRP doors are also easier to use on a day-to-day basis than their steel counterparts. The biggest complaint we hear about steel doors from our pharmaceutical clients, however, revolves around ease of use. The weight and hinging arrangement (piano hinges in some situations) make steel doors extremely difficult to operate, especially when fire rated. Whether fire rated or not, GRP doors typically weigh much less than steel doors, and differential air pressures have much less effect on their ease of use.
GRP doors are also much better value than steel doors when lifecycle costs are factored in. Depending on the type of structure, steel doors will often require additional heavy steelwork to reinforce the door opening before installation. In heavy traffic areas, doors are subject to a lot of wear and tear. The surfaces of steel doors mark very easily and require regular maintenance to ensure hygienic performance is not compromised. Also, should a steel door suffer impact damage, it can easily dent and cannot be repaired in situ. Any repairs/replacement must take place during very expensive facility shutdowns where time is at a premium.
Door openings for GRP doors require lining as with any door, but no additional steelwork is required. They do not need decoration, and suffer less wear on both hinges and door closers. Similarly, GRP doors flex under impact and do not dent. If damaged, they can be easily repaired whilst still in place and are extremely unlikely to need replacing during a normal lifecycle.
Moving forward, we are currently looking to develop new products across both our core hygienic doors business and the fumigation sector. With Dortek’s recent investment in BDL, a specialist in VHP solutions, we hope to further expand the scope of our service offerings to customers. VHP is a “dry” decontaminant that is both non-residual and active against a wide range of surface and airborne bacterial, viral and fungal contaminants. VHP systems can be used to decontaminate a whole cleanroom or be integrated into laminar flow cabinets and isolators, providing a controlled and validated decontamination solution in virtually any area used during aseptic processing. As such, we will also be looking to promote and expand the use of VHP to our customers.