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An Iris Valve (diaphragm valve) is a flexible, hygienic passthrough solution for biopharmaceutical cleanrooms, ideal for secure hose and cable entry. Its sleeve creates an airtight seal around hoses, reducing air leakage in positive pressure environments. For years, Romynox sold traditional iris valves from biopharma suppliers. However, clients often reported issues: rubber sleeves wore out under the high pressure needed for a seal, leading to frequent, costly valve replacements. Many cleanroom operators, often women, found the valves too heavy to lift and close fully, causing leaks. Large handles required to operate these valves also limited how many could fit in the cleanroom for ingredient transport. To address these issues ManGo was requested to come up with better solutions and develop the best iris valve in the market.
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Designing an iris valve for bio-pharmaceutical cleanrooms involves navigating stringent material and functional requirements to meet the high standards of cleanliness, durability and ease of use in sensitive environments. A key aspect of our development was carefully selecting materials that could withstand the rigorous sterilization demands of bio-pharma cleanrooms. We conducted extensive autoclave tests in our workshop to validate the compatibility of materials, ensuring they remained intact and effective after repeated exposure to sterilization cycles and cleaning agents like ethanol, hydrogen peroxide, isopropyl alcohol and actisan. This process allowed us to identify optimal materials that not only met certification requirements but also offered easy-to-replace components, minimizing contamination risks and enhancing longevity.
Since space is limited in cleanrooms, the new Iris Valve was designed to be compact, allowing multiple valves to be installed closely without compromising performance. Traditional valves use a large single handle, making them heavy to operate and often resulting in incomplete sealing. Our new design incorporates a newly developed mechanism that requires much less force, featuring two smaller handles to distribute effort between both hands. User feedback is provided through a rattling sound when opening and closing the valve. Additionally, a hand operated metal bracket on top serves as a clear and functional breaking mechanism, ensuring a reliable seal over time.
Designed with sustainability in mind, the Iris Valve is made from 100% biopharmaceutical-grade injection-molded materials, resulting in nearly zero material loss during manufacturing. In contrast, traditional iris valve components are milled, generating significant waste. Our new design enables users to easily replace the sleeve as it wears over time, avoiding the need to replace the entire valve or send it back to the manufacturer, as is often required with traditional models where the sleeve is glued in. And last but not least, the significantly reduced weight of the iris valve contributes to a lower carbon footprint in logistics.
Strict material requirements for the bio-pharma iris valve left only a few challenging options for the body and soft parts. Managing POM’s 1.5-2.5% shrinkage required multiple mold adjustments, even after implementing three injection points to minimize deformation. The TPE also presented issues, with an uneven wall thickness caused by flow irregularities, resulting in skin formation and bubbles on the surface. To ensure strong TPE adhesion, we ultimately chose high-temperature PP for the overmolding. And deformations around threaded inserts caused bolt jamming, requiring further refinements to achieve smooth assembly and reliable performance. A step-by-step optimization process carried out by ManGo in collaboration with our skilled network of manufacturers.
Traditional stainless steel iris valves in bio-pharma were bulky, required significant force to operate and often leaked due to incomplete closure. Their rubber sleeve was difficult to replace, posing contamination risks as it wore down. Development began with a focus on a lighter, easier-to-operate closing mechanism and the rest of the design evolved from there. The newly developed iris valve is much more compact, easy to handle, and simple to disinfect, with user-replaceable parts that prevent contamination from wear. Even with all these improvements, it’s available at a price 30% lower than the “old-fashioned” valves with improved overall margins for our client Romynox. Following its market introduction, the new iris valve was such a success that additional valve sizes were developed and added to the product line.
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