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Preventive and Predictive Maintenance Predictive maintenance aims to predict the occurrence of problems so that action can be taken to avert downtime. The most common usage of predictive maintenance is with wear parts. Variatio

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

ns in the key dimensions of wear parts are measured and when they go below a predefined level, the part is replaced. In this way downtime and poor machine performance is averted.

There are two stages to predictive maintenance: first i

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

Examples of combination products may in

entify a characteristic that varies as a component nears its end-of-life and second, define the level at which action should be taken. For example when a bulb is nearing its end of life it may gradually reduce its operating temperature

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

before complete failure. By understanding the failure mechanism and the characteristic associated with its failure, the breakdown can be predicted. The temperature of the bulb at a defined distance is measured at regular intervals and

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

ogged. And temperature variations associated with failure are noted. A procedure is set up such that any recurrence of these temperature variations with future bulbs results in the earliest possible replacement of the bulb.

There are

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

Combination pro

5 steps to effective predictive maintenance:

Step 1: List the significant functions that constitute the machine: For example;

• The loading section

• The machine transportation system

• The Labelling system

• The tooling section

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

• The unloading section

Step2: Define the acceptable performance criteria for these functions: For the transportation system, the product must move at a linear speed and no jerky motion is acceptable (it is currently not possible to

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

uantify acceptable tolerances).

Step 3: List the consequences of the function failure: Are there safety or economic implications or hidden elements where the consequence of failure may not be immediately detected? For example failure

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

of the transportation system leads to product being scrapped resulting in economic loss.

Step 4: List the causes of each functional failure: Elongation of any or the drive belts, wear out within the gear boxes or bearings may cause d

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

eterioration in the performance of the transportation system.

Step 5: Identify what can be done to prevent failure

For the drive chains:

• Weekly lubrication extends their life

• Weekly inspection of chains for tight spots

• Repla

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

e drive chains every 6 months For the gear box

• Inspect the quality of the lubrication oil every month

• Inspect gear box for smooth action

• Change the oil at least every 3 months

• Replace the gearbox every 2 years

• Etc.

For

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

Following aspects would a

the bearings

• Replace bearings when there is evidence of damage.

Depending on the answers to the analysis at least one of the following four options is taken

1. On-condition task maintenance

2. Scheduled restoration

3. Scheduled

dd to the challenges in developing combination products:

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

iscard

4. Default task

On condition maintenance means inspecting the equipment components at regular intervals to find and correct potential faults. In the example, on-condition tasks include inspecting the drive chains and the gear

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

box

Scheduled restoration involves reworking the equipment components at specified intervals to reduce the potential for failure. The example refers to applying lubrication to the chains and changing the oil in the gearbox at defined

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

ntervals.

Scheduled discard involves replacing the components at regular intervals in anticipation of failure. Returning to the earlier example, the chains are to be replaced every 6 months and the gearbox, every two years.

Default t

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

sks involve either redesigning the machine function if none of the previous tasks can suitably control exposure to failure or alternatively not performing any scheduled maintenance where the cost of preventive maintenance is higher tha

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

Professional from academic institutions, pharmaceutical industries, health care indust

the cost of rectifying the failure and its consequences. In the above example, bearing are only replaced when there is evidence that they are not working correctly.

In each case, the team considers the failure mechanism and the asso

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

ciated reliability data before deciding on appropriate preventive measures. Historical records of machine performance, advice from vendors and feedback from technical staff are recommended to determine the appropriateness of each preve

.

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

tive maintenance task. Predictive and preventive maintenance means intensive analysis of equipment to establish the tasks that will minimise breakdowns.

Initially designing preventive maintenance systems is time consuming. The www

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

Companies that provide selfless information through particip

passtechnique.com website may help to speed up the process by providing the maintenance team with tools for solving problems. The www.managemaintenance.com website discuses ways of implementing preventive maintenance plans

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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