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As a predictive maintenance tool, oil analysis is used to uncover, isolate and offer solutions for abnormal lubricant and machine conditions. These abnormalities, if left unchecked,

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

usually result in extensive, sometimes catastrophic damage causing lost production, extensive repair costs, and even operator accidents.

The goal of a world-class oil analysis progr

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

Examples of combination products may in

am is to increase the reliability and availability of your machinery, while minimizing maintenance costs associated with oil changeouts, labor, repairs and downtime. Accomplishing yo

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

r goal takes time, training and patience. However, the results are dramatic and the documented savings in cost avoidance are significant.

What are Lubricants
Industrial

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

oils are specifically designed fluids composed of a base oil and a compliment of additives. The base oil performs these functions, including forms a fluid film between moving parts i

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

Combination pro

order to reduce friction and wear; carries away contaminants to the filter; and removes heat generated within the machine. Additives are chemical components added to the base oil to

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

significantly enhance the performance characteristics of the lubricating oil. Typical enhanced properties include oxidation stability, wear protection, and corrosion inhibition.

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

Why Analyze Used Lubricants
There are three aspects of oil analysis, contaminants, lubricant conditions and machine wear. Ingressed contaminants from the surrounding environ

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

ment in the form of air, dirt, water and process contamination are the leading cause of machine degradation and failure. Increased contamination alerts you to take action in order to

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

save the oil and avoid unnecessary machine wear.

The assessment of the lubricant condition reveals whether the system fluid is healthy and fit for further service, or is ready for a

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

change. Lastly, an unhealthy machine generates wear particles at an exponential rate. The detection and analysis of these particles assist in making critical maintenance decisions.

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

Following aspects would a

Machine failure due to worn out components can be avoided. Remember, healthy and clean oil lead to the minimization of machine wear.

How Lube Oils Fail
Typically lubrica

dd to the challenges in developing combination products:

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

t oils fail as a result of contamination, oil degradation and additive depletion. Contamination is usually caused by external sources like dirt, water, and process related liquids or

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

materials or internal sources like machine wear and degradation by-products. Lubricant oils also fail because of oil degradation, or oxidation. It is where atmospheric oxygen combin

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

s with hydrocarbon molecules. The hotter the oil and the greater exposure to air, the faster oxidation proceeds. The initial by-products of oxidation are sludges and varnishes. Howev

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

er, further oxidation converts these by-products into carboxylic acids. These acids then aggressively attack and corrode many machine component surfaces. In addition, lube oils fail

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

Professional from academic institutions, pharmaceutical industries, health care indust

ecause of additive depletion, which are consumed or chemically changed while performing their function. The performance characteristics of the lubricant are altered and the enhanced

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

properties are wiped out.

What Oil Analysis Measures
Oil analysis measures the physical and chemical properties of the oil, contamination and mechanical wear. You can un

.

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

over contamination or degradation by trending rates of change in selected lube properties, such as viscosity, acid number, particle counting, fourier transform infrared (FT-IR) and K

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

Companies that provide selfless information through particip

arl Fischer water. Oil analysis also measures mechanical wear, which uncovers machine related problems using ICP spectroscopy, wear particle concentration, and analytical ferrography

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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