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Over the years, medical device cleanrooms have become more cost effective in both initial cost and operating cost due to advances in technology and methods.
My first experience with cleanrooms was in 1967 with the first laminar flow room built for Honeywell's Solid State Electronics Center in Plymouth, Minnesota. That room has been in constant use for 39 years. There were no filter changes in those 39 years. The system was upgraded with ULPA (ultra low penetration air) filters in 2004 even though the HEPA(high efficiency particulate air) filters were not loaded.
Then in the early 1970s, Medtronic built their headquarter campus on the north side of the Twin Cities. Manufacturing was moved from St. Anthony to the new campus and a new cleanroom. This room was the first cleanroom for medical device manufacturing in the area. It was a "unidirectional" cross flow design. It has been in continuous use since it was constructed. In the beginning, a cross flow design was selected because all the manufacturing was done in one room, with the dirtier operations in the return end and the final assembly, cleaning and packaging near the supply wall.
Throughout the next 15 years or so, medical device cleanrooms used ducted modular HEPA filter systems and walls constructed of gypsum and coated with epoxy paint. The Class 10,000 room was the norm for medical device manufacturing. The filtration system began to change in the 1980s with the introduction in 1983 of the fan-filter unit by Envirco, Inc. in Albuquerque, NM. At first, it was thought this system would be too noisy for most operations, but over time this objection disappeared as the new unit proved to be very quiet. Today, over 90% of medical device cleanrooms use the fan-filter system. The reasons are straightforward:
- Lower first cost.
- Lower energy consumption.
- Easier to add or subtract HEPA filtered airflow to any space.
- Easier to take the investment in filtration to a new location.
Fan-filter units today have two basic motor-drive systems: a) permanent split capacitor motor and b) DC motor with built-in rectification from AC supply voltage. The DC motor option lowers energy consumption while maintaining airflow throughout the life of the HEPA filters. The motor automatically adjusts rpm to deliver constant flow through the HEPA filter. One change in medical device cleanrooms that we are beginning to see in our market area is the use of a low cost control system that offers unoccupied set-back of the system airflow. For systems with 40 hours per week peak flow usage, this system pays back the investment quickly. The system also identifies units that are not working and allows for setting individual fan speed from the control console.
Another change we have seen in the past eight years in medical device cleanrooms is the use of modular wall systems. Typically, a large manufacturing area is defined by occupancy separation walls with interior walls being constructed of a cleanroom panel system. This technique is being used because the device manufacturer can't afford down time for changes to the wall systems. One large manufacturer of implantable devices modifies their wall systems about 20 times per year. Walls are added, moved, and removed all while the cleanroom maintains the cleanliness rating. Technicians are gowned up appropriately and all materials and tools cleaned outside the room before the wall modification begins. By using a modular wall system, the cost of the walls disappears when compared to shutting down a large manufacturing operation for a day or so due to dust created by gypsum walls and painting.
The class 10,000 room has be the standard for medical device manufacturing for the past 30 years or so. But this too may be changing. About four years ago, Medtronic asked Gerbig Engineering to develop and manufacture a clean workstation specifically for medical device assembly. After a couple of prototypes were constructed the design was finalized. The new workstation offered many new ideas in device assembly.
- Double sided airflow with two fans and two HEPA filters. More assembly area per dollar invested.
- Smaller HEPA filter area; only the first few inches above the work surface has HEPA filtered airflow. This reduces heat gain and total energy, but still offers contamination protection superior to conventional assembly stations.
- Putting the airflow at the work surface means fewer HEPA units in the ceiling. In our prototype test, particle counts below 3000 were recorded in an office environment. Less than 100 particles were measured in a Class 10,000 room. Using the clean workstation approach, the room could be designed as a Class 100,000 or unclassified with HEPA filters in the air handling system, while the work area itself can be class 10,000 or better.
- The assembly workstation has quick connects for compressed air and electrical circuits to pass from station to station eliminating drops from the ceiling.
- Using a shorter HEPA filter allows for storage or monitors to be mounted at a more usable height.
Today, with the advances in clean room construction and controls, a manufacturer needs to make sure that they are considering all options before investing in a clean room. A little time researching and using an expert system designer work out the specifications, one could realize thousands of dollars in startup as well as on going costs,.
Fred T. Gerbig, PE, has been involved with both the cleanroom industry and HVAC systems for the past 33 years. In 1985, Fred started Gerbig Engineering Company specializing in contamination control. The Company designs, builds, and certifies cleanrooms. In addition, the company performs validation work for GMP facilities and designs high purity gas and water systems. Mr. Gerbig has a Bachelor of Science in Mechanical Engineering and Bachelor of Science in Electrical Engineering, both from Iowa State University (1964).
As an active member of the Institute of Environmental Sciences (IES), he was the secretary of subcommittee RP-50 for updating Federal Standard 209B to 209D and was the Secretary for IES subcommittee RP-006 to standardize the testing of cleanrooms. Mr. Gerbig was awarded the 1986 "James R. Mildon Award" for outstanding contributions to the Institute of Environmental Sciences Contamination Control Division. He holds a patent in the field of air filtration.
Flight News On Modernizing Used Business Jets As Stratos Heads For"Tunnel" & Superjet International Nets Mexican Order For The SSJ100
Modernizing Used Business Jets
Of course, not all executive jets are purchased as factory fresh, brand new machines. Some companies need to exercise fiscal prudence and seek better deals in the pre-owned arena and then modify or refurbish the aircraft to suit both application and budget.
A new paint job is a quick and effective improvement and specialized companies offer distinctive corporate identity solutions, while modern paint techniques and booths reduce rework and produce a very high quality product at a competitive price.
Internal refurbishment typically covers custom-designed cabinets, including galley, storage vanity and entertainment units.
LED lighting systems are increasingly popular together with high quality music and entertainment centres.Thermal insulation and soundproofing packages are common and provide a much more relaxing environment both for work and rest enroute.
Then there is the cockpit where state-of-the-art "glass cockpit" avionic suites are now being used in increasing numbers to replace out-of-date,"steam-driven "technology.
As a demonstration of being totally up to date in the technology stakes, US-based Duncan Aviation recently integrated an iPad application for wireless control of the cabin systems in a Falcon 900.
This installation uses an iPad app,an Aircell CTR Wi-Fi source and an interface unit to communicate instructions to the Honeywell MH cabin management system.
This is the first of many iPad control systems that Duncan Aviation plans to deliver in the near future. Now the company is exploring the possibility of integrating iPad control with other cabin systems in other aircraft models.
A major attraction for the executive traveler is in-flight connectivity and the ability to work in much the same way as in an office on the ground. This has already become established on larger aircraft, but technology is ever-evolving and Wi-Fi is now on offer in the smaller executive jet.
Thrane &Thrane has developed the Aviator 200, the company's latest and smallest Switch Broadband solution. Through using a combination of proven avionics and antenna technologies the Aviator 200 offers reliable and affordable connectivity within an exceptionally compact and lightweight package, ensuring the systems suitability for the broadest range of aircraft possible. Aviator 200 simultaneously provides data speeds up to 200 kbps and a single AMBE two channel for voice calls, offering users aboard smaller aircraft a complete communications service where this was previously not achievable .Data and voice services can be accessed via wired or wireless connections built into the Aviator 200, alleviating the need for external wired and wireless routers.
"For the first time, small business aircraft will be able to stay connected via an extensive range of services including voice, Internet and email," according to Kim Gram ,vice president, Aeronautical Business Unit, Thrane & Thrane ."At a time when passengers are demanding more from in-flight communications, the Aviator 200 enables the broadest range of aircraft possible to offer Swift Broadband, allowing passengers with their own Wi-Fi enabled PDA devices such as Blackberry's and iPhones to use their own handsets aboard."
The Aviator 200 has received a Supplemental Type Certificate (STC) for the systems installation aboard the Cessna Citation family of aircraft. The STC follows the successful installation and testing of the Aviator 200, which was carried out by Thrane & Thrane partner Banyan Air Service.
The technology offers considerable promise by purchasing an older pre-owned airframe and then upgrading it at a competitive price.
A simple case of "you pay your money and you make your choice."
Stratos Heads For "The Tunnel"
Having received part of its external funding,Stratos Aircraft will conduct wind tunnel testing of the Stratos 714 very light personal jet market,durig April and May.
Design and construction of the wind tunnel 1/8 –scale model has begun and tests will be conducted over a five to ten day period.
The purpose of the programme is to verify that extensive computational fluid dynamics (CFD) studies confirm aircraft performance projections.
Extensive engineering has defined the Stratos 714 as capable of carrying four/five people to FL 410 with cruise speeds of over 400 knots and having a range of 1500 nautical miles with NBAA reserves.
The 714 feature side-stick controls, a state –of –the –art glass cockpit, and fully integrated autopilot designed to lighten the pilot's workload. Landing speeds and distances are considerably less than competing twin jets, making many more airports accessible.
Stratos Aircraft is now accepting $ 10000 deposits on 714 delivery positions.
Super Jet International Nets Mexican Order For The SSJ100
Interjet, the second –largest airline in the Mexican market, has signed a contract to the value of US$ 650-million for the purchase of 15 long-range Sukhoi Superjet 100s, as well as an additional five options.
The aircraft are scheduled to be delivered in the second half of 2012.Along with the order, SuperJet International (SJI) , a joint venture between Alenia Aeronautical and Sukhoi Holding, revealed that interjet had signed a "Supercare" agreement, whereby SJI, will provide after-sales support for 10 years, from the date of entry into-service of the aircraft.
When addressing the media, the chief executive officer of Interjet, Jose Luis Garza, explained that the aircraft was selected after careful evaluation of every regional jet on the market. He added that the SSJ100 incorporated the best of western aeronautical technology.
On its part, Superjet International is confident the Interjet order will lead to others being inked, especially once EASA certification has been achieved in the near future.
ItAli Airlines which was supposed to have been the launch customer of the SSJ100 in the Western world, has found itself in huge financial difficulties after its owner, Giuseppe Spadaccini, was arrested and held in custody pending investigation into a tax evasion scheme, whereby money was invested, without ever being declared to the Italian Financial Police, affectionately known as "Fiamme Gialle".
Press reports alleged that Spadacini had invested about 90-million Euros in banks in Portugal.
Late last year, rumours were rife that Alitalia was going to order the SSJ100. SJI released information that had initially indicated 20 super jets being ordered by Alitalia, but this information proved to be totally untrue, as the Italian flag carrier opted to put its weight instead behind the Embraer E-Jet series.
Reshuffles
Since the beginning of this year, Superjet International has been through some major reshuffles at management level. Chief executive, Alessandro Franzoni, was replaced by Carlo Logli.
Rumour has it that another European customer may be signed in the not too distant future. An undisclosed customer for 20 SSJ100s is expected .All indications point towards Icelandair, although, Superjet is tight-lipped as o who the customer is.
With this new contract in hand, the Sukhoi Superjet 100 will have garnered 170 firm orders. Carlo Logli is fully aware, that as things stand, the lions share of orders has come from lessors.He is determined to change this, and wants to make sure, the airlines are on board, too.
A stretched version of the SSJ100 that could seat between 115 and 120 passengers is currently on the drawing board. Various sources within SJI have confirmed the studies, but technical details are sketchy.
It is hoped more will emerge on the stretched version, once the certification process is completed.
Type Certification
In late news just released, IAC AR, the Russian certification authority, has granted Type Certification to the Sukhoi Superjet 100. The certificate is a result of an unprecedented vast certification campaign performed by ICA AR, Certification Centres, Sukhoi Civil Aircraft as the aircraft developer, and Alenia Aeronautica, which was involved in noise and HIRF testing.
The Type Certificate confirms the compliance of the aircraft with the IAC certification norms and airworthiness directives thus opening the way to start commercial operation.
Simultaneously the IAC AR, based on the audiut of the aircraft development quality system and Sukhoi Civil Aircraft performance, has taken the decision to grant Design Organization Approval certificate to Sukhoi Civil Aircraft Company.
About the Author
Anthony Juma is the Editor and Senior Aviation Director at Wings Over Africa Aviation.
This is an Air Charter Company that specializes on Private Business Jet Charter Flights In Kenya,Uganda,Rwanda,Tanzania,Burundi ,Eastern &Central Africa & Within Africa. The website has guided thousands of travelers to achieve their dream holiday. For more information and guidance, visit the site at http:// / www.wingsoverafrica-aviation.com/index.php/services/charter-flights.html
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