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Prototype evaluation, research & development testing, production testing, accelerated stress testing, reliability testing, failure analysis,

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

etc. these are some of the types of testing where climatic test chambers are used. In fact, a climatic test chamber can be used for any such

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

Examples of combination products may in

application that requires the simulation of a particular climate.

Climatic Test Chamber: Climatic Simulation

Temperature, humidity, altitud

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

, vibration, solar, wind & rain, dust, etc. climatic test chambers can simulate virtually any kind of climatic condition. You can find these

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

test chambers with interior workspace for 1.2 cubic feet. For cold chambers, the temperature capabilities can start down to -300 degree F, an

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

Combination pro

for the extreme high temperature conditions, it can even go up to +1000 degree F. The interiors of these chambers are made of stainless stee

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

l with powder coated finishing.

Next we'll take a look at a few of the more common types of climatic test chambers available on the market.

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

Highly Accelerated Life Test

This test chamber is used to locate a product weakness and assess its life. It performs such functions with a c

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

mbination of temperature, shock and vibration.

Highly Accelerated Stress Screening

This climatic test chamber is used for production units.

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

It performs its function by fast temperature cycling.

Temperature chambers

These test chambers tests the effects on a product over a range

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

f temperature conditions by simulating temperature. It combines climatic conditions, such as humidity, altitude, and vibration, etc in order

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

Following aspects would a

to perform its functions.

Humidity Chambers

Humidity chambers are used to simulate humidity and consequently tests the effects on the produ

dd to the challenges in developing combination products:

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

t over different humidity conditions. This test chamber can perform its function either with or without temperature.

Bench up Test Chambers

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

These test chambers require very little floor space in comparison to other test chambers. They are specially designed to test small products.

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

Thermal Shock Chambers

In this climatic test chamber, the temperature rapidly changes from extreme cold to extreme hot climate. This way, i

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

performs its function by shocking and stressing the product thermally.

Liquid-to-liquid Thermal Shock Chambers

In this test chamber, the p

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

Professional from academic institutions, pharmaceutical industries, health care indust

roduct is transferred through the hot and cold liquid without any contamination and the test is performed by immersing a part or assembly in

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

ot and cold liquid.

Air-to-air thermal Shock Chambers

This climatic test chamber works by transferring the product from a hot chamber to a

.

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

old chamber, and they are available in various configurations, including two zone, three zone, and double duty.

In fact, there is a long lis

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

Companies that provide selfless information through particip

of climatic test chambers, which may include altitude chambers, climatic stress screening chambers, walk-in chambers, drive in chambers, etc

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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