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Most industrial plants in need of oil analysis services might begin their search on the web. While this is a common and effective place to begin the evaluation process, it definitely will not tell the whole story. Knowing the

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

right questions to ask after the initial search is completed is crucial in uncovering a superior provider from an average oil analysis provider.

While the discerning potential customer may ask questions regarding testing cap

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

Examples of combination products may in

bilities, process and protocol, and price there are other questions whose answers may mean the difference between a seamless interaction and a laborious one. It is these questions that are most commonly overlooked and most imp

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

ortant to understand.

With your time and money on the line, and so many oil analysis labs to pick from, how do you choose the right company? Here are five critical questions to ask when evaluating an oil analysis laboratory t

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

ensure a successful long term oil analysis program.

1. What is your normal turnaround?
Contrary to popular belief, there are oil analysis laboratories out there that have the capability to provide high quality re

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

Combination pro

ults and reporting in 24 hours. If the lab you’re working with doesn’t provide this, at least make sure expectations are defined up front. Know exactly what you’ll be receiving, and when. Do “days” include weekends? What about

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

business hours?

While sample turnaround varies, just asking this question up front can give you a good idea of the overall process efficiency. No matter what the turnaround time, there should always be notification systems i

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

place so that you know when your samples have been received and when your samples are finished. The samples you pull contain time sensitive information which should be conveyed to you in a prompt fashion. The sooner you get y

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

ur results the better your program runs.

2. Is there an open line of communication?
It’s important to know you won’t be left high and dry in the event you need answers or support immediately. Often times pressing

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

machine problems arise unexpectedly and your search for help may take you back to your oil analysis report. Do you get a human voice to talk to when you call? Is there any on line communication available? How quick does someon

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

get back to you? What sort of expertise do the lab personnel maintain? These questions are best asked directly.

3. Are Web-based management reporting tools available?
Web-based management tools make managing and

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

Following aspects would a

administering your oil analysis program much easier. With web based tools you can view reports, order supplies, print labels, monitor your sampling activity, import data, and many other functions. The time you’ll save and aggr

dd to the challenges in developing combination products:

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

avation you will avoid using a web-based interface makes the answer to this question critical in your decision-making process.

4. Does the lab automatically include analytical ferrography?
Ferrography is a techniq

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

e for analyzing the wear particles present in fluids that indicate mechanical wear. Performing ferrography enables the analyst to see the whole picture. It is important that your lab takes testing to the next step by performin

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

analytical ferrography on abnormal samples. Ask the lab if and when they perform ferrography and what they charge for the test. It’s important to determine whether a lab offers ferrography because there are some instances whe

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

re the standard tests uncover problems but may not be able to quantify the extent of the abnormality.

5. How are alarm levels compared?
In assessing machine condition, it is essential not only to look at the machi

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

Professional from academic institutions, pharmaceutical industries, health care indust

e’s current and past data, but also compare that particular machine with the “family” that the machine is a member. Families can be made up of machine types, manufacturers, models, and sump capacities depending on the level of

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

information provided by the user. Statistics are calculated by looking into the database and extracting previous test results of “family” data. Family alarming produces tight limits which provide great value to the oil analysi

.

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

s user.

Another alarming method is to use customer specific limits. When a customer has previous knowledge of machine fault levels, it is beneficial to provide these hard limits to the lab. They can be utilized at either the

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

Companies that provide selfless information through particip

achine or customer level to trigger appropriate alarms. If there is not enough information identifying a machine but there is historical information for the specific sampling point, alarms can be set by using linear regression

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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