Aldevra had been selling refrigerators and temperature monitoring systems to federal agencies such as the Department of Veteran Affairs (VA) and the Department of Defense for years, when customers presented a new challenge. Through Aldevra’s strong ties with these government agencies, they became aware of a need for a portable, enclosed solution to store sterile supplies and equipment that was sophisticated enough to meet stringent VA and Joint Commission requirements. The company didn’t yet sell such a system, so they started researching options.
An Unexpected Collaboration
Aldevra discovered a public bid notice site and learned that another VA employee was already working with a local, small business manufacturer to develop a prototype for a sterile storage cabinet. The manufacturer’s representative, Dynamic Product Solutions, invited Aldevra to join their team of qualified sales agents to help get the best solution out to VA hospitals and other facilities.
Air Innovations was chosen to redesign and manufacture the sterile storage cabinet based upon their production capabilities and engineering expertise, which would enable them to take the current design to the next level.
The varied expertise of Air Innovations, Aldevra, and Dynamic Product Solutions made it possible for the trio to design and manufacture a sterile storage cabinet that could precisely control temperature, humidity, pressure, and cleanliness to meet any industry standards.
“Aldevra’s longstanding connection to VA hospitals played an instrumental role in our partnership, as did the vast HVAC knowledge Dynamic Product Solutions sales engineers had,” said Mike Wetzel, President and CEO of Air Innovations. “This depth of experience combined with our decades spent creating pristine environmental conditions enabled our partnership to tackle the redesign.”
Up untilthis time, keeping a VA hospital equipped with sterile surgical instruments was an inefficient, labor-intensive process. In some cases, staff would have to walk to a faraway temperature-controlled room where medical instruments and supplies were housed. Or, they had to wait for the items to be delivered by a Sterile Process Services team. Staff would drive to a hospital to collect all of their surgical instruments and bring them back to a facility to sterilize each instrument before returning them. If an item went unused within 72 hours, it had to be returned to be cleaned again. This process was repeated every three days.
In addition, many facilities struggled to control an area’s temperature and humidity, especially in older locations and leased spaces. Some customers needed an affordable response to a regulatory citation for storing items in properly controlled environments, as budgets wouldn’t allow for building new cleanrooms or renovating HVAC systems, while others needed a temporary solution during hospital construction and renovation.
“It’s a powerful moment when we can listen to our customers’ needs, note their suggestions, connect directly with engineers, and circle back to show the customer how and where their feedback was incorporated in the redesign of the sterile storage cabinet. It was a unique, awesome experience and demonstrates the benefit and value of working with U.S. small businesses.”Maggie Bullard-Marshall, Vice President at Aldevra
Air Innovations sterile storage cabinets were designed to replicate cleanroom conditions. Temperature, humidity, pressure, and cleanliness are controlled with precision to prevent decay and to preserve the shelf life of medications, surgical instrumentation, and other stored medical goods. VA hospitals outfitted with these units are able to meet compliance regulations with confidence.
In addition, each unit is equipped with HEPA filtration, which creates a barrier between sterile medical items and any number of contaminants such as dust, bacteria, and viruses. As a result, the sterile storage cabinets exceed ISO 6 Cleanliness standards.
The units also feature a powder-coated, aluminum exterior and stainless-steel interior that is hospital grade and easy to clean. The cabinets are fitted with bottom casters and handles on the sides, making them portable, thus allowing VA staff to move the units from room to room as needed. And a digital display enhances ease of use so that truly any medical professional can operate the system.
“Being able to collaborate with Mike Wetzel and his team at Air Innovations on the features of the redesign was energizing,” said Mike DeGaetano, Sales Director, Dynamic Product Solutions. “The engineers at Air Innovations really listened to our customers and ended up coming back with a product that exceeded all of our expectations. It’s a win-win for everyone.”
Minimal Disruption To Patient Care
The team utilized basic refrigeration components and functionality—compressor, condenser, expansion valve, and evaporator—to measure and control temperature, humidity, and pressure. Since the units would be used in hospital settings where time is of the essence, Air Innovations designed the refrigeration system, sensors, and controls into a cassette so it could be easily removed and replaced within 30 minutes. Once the new cassette is in place, the previous one can be repaired on-site or off-site causing minimal disruption to patient care.
The sterile storage cabinets were also engineered to control humidity across ambient conditions. The most effective way to control humidity is to set the temperature coming off the cooling coil to a dew point of 52℉. At this temperature, it becomes easier to keep the relative humidity under 60%. Moisture can be removed or added back depending upon the ambient air conditions. For instance, during winter some arid climates may require water to be added to the front of the cabinet via a built-in humidifier, whereas moisture needs to be removed from a discard pan under the unit during humid spells.
Given the sensitive nature of the items inside the cabinet, another design requirement was creating positive pressure. Positive pressure means the pressure is higher inside the cabinet than outside. As a result, contaminants and humidity cannot enter the space. Since the cassette is removable, the cabinet is not perfectly sealed. This was engineered to discharge very clean air versus drawing in humidity and airborne particles that originate in the room the cabinet is stationed in.
Today, Aldevra’s VA hospital clients have eliminated the need for Sterile Process Services to clean and transport surgical instruments every three days. Now, they simply sterilize the items and stock the sterile storage cabinets on an as-needed basis. These facilities have been able to save resources while maintaining the highest level of safety for their healthcare community.
“I credit the VA staff for being so forward-thinking in their search to find a cutting-edge solution,” added Bullard-Marshall. “We are all thrilled with the end result.”
A design engineering firm came to us to design a medical environmental control system (ECS) that could maintain <3% relative humidity (RH) and 75°F temperature ±2° for automated packaging of biotherapy reagents, some of which were highly sensitive to moisture and sensitive to heat. The desiccant humidity control and temperature regulation system would be located in an ISO 8 cleanroom space with ambient air from 65-77°F (18.3-25°C) and at 35-75% RH. In addition, some of the packaged items would include liquids that would introduce an evaporative load into the environment prior to the placement of heat seals. The heat sealing equipment would introduce 400W of heat to the environment. Finally, the machine would contain a stainless steel, pressurized dry-environment enclosure air-locked to minimize the introduction of ambient air.
In order to dehumidify the system to the required conditions, Air Innovations introduced a desiccant dryer with pre-filtered air into the design of this environmental control system. Re-circulated air is then returned to the acceptable ambient temperature and passed through HEPA filtration to maintain the cleanroom environment, while the hot exhaust is ducted away from the ECS. The system was designed to sit below floor level, though the end location was ultimately moved onto floor level. The air change rate was designed to ensure a recovery time of less than 30 minutes anytime after the doors opened.
- Relative Humidity controlled to ±0.5%, and set to <3% RH with 0.011 µg/min. continuous evaporation latent load plus moisture leakage loads.
- Temperature controlled to 75°F ±2°F
- ISO 8 cleanroom level HEPA filtration (99.97% to 0.3µ)
- Environmental Control System designed to fit in a 37.5” x 52” trench
- PID loop controls for temperature and humidity
- Stainless steel 304 exterior
- Airflow designed for 90 CFM – Max. external static pressure of 1”
- Hot-gas bypass refrigeration control
- 1kW electric reheater
The medical environmental control system controls humidity to desiccant levels and maintains a steady temperature in the ISO 8 cleanroom space. The system also employs HEPA filtration.
- Meets all key specifications
- Addresses humidity requirements through both creation of a vapor barrier and use of return air via a desiccant dryer to counteract internal evaporative loading.
- Meets UL standards
- Features stainless steel 304 exterior.
Additionally, we have whitepapers available covering the aerospace industry, the semiconductor industry, and our Micro Environments product line. The whitepaper page can be found here. If you would like to read case studies for other industries, view our general case studies page. If you are interested in viewing more case studies for the pharmaceutical industry, look at the items below.
Interested in explosion-proof HVAC in other industries? Read more
Air Innovations’ Cleanroom Systems division was asked to design a Class I, Div I Enclosure. This form of environmental control system (ECU) is used to control the process air needed for solvent-based coating of pharmaceutical tablets. The final environmental control solution needed to dehumidify the ambient air in a single pass (versus re-circulating air) – which is a critical parameter for the fluid-bed coating process – in an explosion-proof environment.
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We configured the explosion-proof air conditioner to provide once-thru air to a single LDCS-PRO coater. The explosion-proof HVAC system was designed for near continuous operation to ensure a non-condensing environment and to provide thermal stability. The electrical panel, humidifier, and compressor are encased inside the pressurized cavity of the ECU to protect against sparks, to keep out volatile gases, and to remain isolated from other compartments.
- Ambient inlet conditions range from 21°C to 24°C temperature and from -12°C to 16.7° C dew point
- Design output conditions maintained at 22°C ±2°C temperature and at 10°C ±1°C dew point
- Ambient change rates over a 1-hour period are no more than 1°C temperature and no more than 5% RH
- Electrical and mechanical sections are pressurized with purge gas via a Cyclops system, with max external static pressure 0.5”
- System airflow 750-1000 CFM
- Fan is an explosion-proof direct-drive impeller wheel
- The heater is a 5.0kW electric reheater, Class 1 Division 1, Groups C&D, T2D (max 215⁰C)
- UL approved
- All design specifications and parameters were met, incl. Class 1, Division 1 requirements (for the fluid-bed coating applications)
- The explosion-proof air conditioners were designed for near continuous operation, as outlined.
- All controls were mounted behind a viewing pane.
- Stainless-steel construction
- First piece delivered in 5 months (within quoted lead time).
We have whitepapers available covering the aerospace industry, the semiconductor industry, and our Micro Environments product line in addition to our case studies. The whitepaper page can be found here. If you would like to see case studies for other industries, view our general case studies page. If you are interested in reading more case studies for the pharmaceutical industry, look at the items below.
Proper technology is needed to control close-tolerance cold and dry environments in order to protect on-board process reagents. The company brought an initial concept for a custom chemical process control system to Air Innovations. Our task was to refine the design to meet the customer’s performance, serviceability and space specifications, and to prototype, test and ramp up the unit for manufacturing.
Developing the right chemical process control solution for this client required us to overcome a number of challenges. Since the client sells these FDA approved units to a worldwide customer base, we had to design a system that could hold temperature and humidity levels across a broad range of differing environmental conditions while operating 24/7 year-round.
Air Innovations designed a chemical process control solution that relies upon two independent cooling coils and process fans operating on an alternating basis managed by software and various sensor inputs to determine switchover intervals. This ensured the cooling coils continued to operate without defrost interruptions well below the point of freezing, while fitting into the required space equivalent of a small microwave.
1. All designed specifications were met by Air Innovations.
2. An environmental control system with two independent cooling coils and process fans was designed, prototyped and manufactured.
3. The system controls close-tolerance cold and dry environments, protects onboard process reagents, and meets all performance, serviceability and space specifications, while holding temperature and humidity levels 24/7.
If you’re ready for a custom solution from Air Innovations, contact us by submitting a quick Project Inquiry today.
We also have whitepapers available in addition to our case studies. These whitepapers cover the aerospace industry, the semiconductor industry, and our Micro Environments product line, and can be found here. If you would like to read case studies for other industries, view our general case studies page. If you are interested in viewing more case studies for the pharmaceutical industry, look at the items below.
Two separate pharmaceutical packaging firms required unique air conditioning technology. In one case, a returning customer requested precisely controlled conditions to provide an exact level of uniform drying for fluid bed dryers used by the manufacturer to coat capsules, pills and caplets. The second pharmaceutical company required a single packaged system containing humidification and a cooling system, plus a desiccant dryer, for a blister pack packaging machine. The company requested broad flexibility in environmental control in anticipation of future requirements in the industry.
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For the first company, Air Innovations delivered a precision pharmaceutical process control unit supplying air to the process tools with the ability to add or remove humidity and maintain a 50°F dew point level. For the second company we developed a multiple device pharmaceutical HVAC system designed to provide either a very dry or a very humid environment on demand.
1. All design specifications were met in both pharmaceutical HVAC systems.
2. For the first company an environmental control system supplying air to the process tools that could add or remove humidity and maintain 50°F dew point level was designed.
3. For the second company Air Innovations developed a multiple device system that could provide either a very dry or very humid environment — on demand.
In addition to case studies, we have whitepapers available covering the aerospace industry, the semiconductor industry, and our Micro Environments product line. The whitepaper page can be found here. If you would like to view case studies for other industries, see our general case studies page. If you are interested in seeing more case studies for the pharmaceutical industry, look at the items below.