Medical device manufacturing takes place in cleanroom environments with strict requirements for atmospheric control. Depending on the production processes being undertaken, it can be the case that standard heating, ventilating and air conditioning equipment cannot provide the precise conditions necessary to turn a product design into a manufacturing reality.

JS Humidifiers has extensive experience in controlling the humidity and temperature in this type of cleanroom manufacturing environment. By researching different environmental conditions and then maintaining them consistently at the optimum level during manufacturing JS has helped medical device manufacturers improve yields on products such as stents, sutures, blood glucose sensors and medical dressings.

Humidity is controlled in these environments for several reasons. It can be because the materials being processed are moisture sensitive and any change in their moisture content intrinsically changes their composition. This can be a dimensional change, a chemical imbalance or simply a drying of an aqueous based element.

Humidifiers are also used to eliminate static from medical device production environments. By maintaining humidity at 55% relative humidity (%rH) static electricity is naturally dissipated and won’t discharge as a spark or cause materials to become attracted to each other. This level of humidity also helps suppress dust and airborne particles.

Humidification can also be used as an activating agent. For instance, ethylene oxide can be used as a sterilising agent but only becomes active at 70%rH or above.

JS offers a range of humidifiers suitable for cleanroom environments. The Condair Mk5 resistive steam humidifier fed with RO water can provide ±1%rH. Alternatively the JetSpray compressed air and water humidifier offers almost as close control but with a fraction of the energy consumption and the additional benefit of evaporative cooling.

For applications where close temperature control is required as well as humidity, the Mobile Environment Control System (MECS) can provide up to 200 litres of air per second at any temperature from 15°C to 45°C (±0.1°C) and humidity from 30% to 98%rH (±1%rH) consistently over any period. This system can control the atmosphere in a whole cleanroom or in an individual micro-environment, like a glovebox, for environmental conditions that would cause human discomfort.

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