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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 Electroni

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

cs 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 lo

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

ded.

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 “un

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

directional” 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 packagin

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

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 medi

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

al 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 disappeare

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

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.

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

li>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 consumpt

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

on 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 syste

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

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.

Ano

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

her 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

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

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 rat

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

ng. 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

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

o dust created by gypsum walls and painting.

The Clean Workstation

The class 10,000 room has be the standard for medical device manufacturing for the past 30 years or so. But this too may b

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

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

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

ssembly.

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

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

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 measure

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

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 f

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

r 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

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

ontrols, 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,

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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