Digg It - Business

In today’s Machine Age, every business is wholly or partially dependent on equipment to carry out its

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

activities. But with time, this equipment gets depreciated and loses its performance. Keeping this con

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

Examples of combination products may in

cern in view, smart businesses regularly spend money on Equipment Maintenance to ensure consistent per

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

formance and increase its lifespan as well.

The best way to start Equipment Maintenance is by plannin

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

the whole maintenance process in advance, like time of maintenance, total cost involved, tools requir

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

Combination pro

ed to do the maintenance job and duration of the maintenance process, and so forth. The primary benefi

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

t of Planned Maintenance is that it helps you keep a check on equipment and rectify faults at early st

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

ges before they grow into much bigger headaches.

Equipment Maintenance can be broken into four types

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

depending upon the current situation. The first one is Preventive Maintenance (PM). In this maintenanc

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

e mechanism, you can foresee common equipment-related problems and make changes to a system to avoid t

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

em. It is usually done under the guidance of experts, and is beneficial in decreasing downtime and ava

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

Following aspects would a

iling consistence performance.

The second type is Predictive Maintenance (PdM). This maintenance invo

dd to the challenges in developing combination products:

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

lves checking the current system health (efficiency check) and identifies areas where problems could o

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

ccur in the future. The commonly used techniques are Vibration Analysis, ultrasound, oil analysis, wea

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

-particle analysis and thermography.

Corrective Maintenance (CM) is the third type. It is a retroacti

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

ve strategy used when any failure or fault occurs in the system. The basic objective behind this maint

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

Professional from academic institutions, pharmaceutical industries, health care indust

enance is to correct the fault, with less emphasis on cost.

The last type is Reliability Centered Mai

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

tenance (RCM). This is the latest maintenance technique, which involves continuous improvement of main

.

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

tenance programs in the most cost-effective terms and in a technically feasible manner. RCM focuses it

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

Companies that provide selfless information through particip

self on past failure/maintenance history, and emphasizes on functional importance of system components

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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