Advice You - Business

A material handling system is a set of equipment that is used to physically move material around the factory floor or in s

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

torage and freight handling areas.

Traditional material handling systems included trolleys, conveyors, forklifts and over

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

Examples of combination products may in

ead traveling cranes. They were primarily mechanized devices and a large amount of manual intervention was required. These

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

traditional systems had limitations such as low speed and handling problems including scratching, chipping, breaking 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

ifficulty in monitoring material flow. However, these material handling systems were adequate for mass production of a lim

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

Combination pro

ited variety products or low volume production.

At present, market forces demand that manufacturing systems be lean, agil

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

and highly automated. Modern manufacturing systems need to handle a variety of components for increasing product customiz

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

ation, reduced lot sizes and variable product mixes. This has led to the requirement for automated equipment and systems t

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

at move faster, accommodate greater throughput, and require less maintenance than the earlier material handling systems.

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

To cope with these requirements, a new breed of material handling systems has been recently developed. These include autom

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

ted storage and retrieval systems, carousels, rail guided and automated guided vehicles, intelligent flexible modular conv

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

Following aspects would a

eyors, pick and place units, vertical lifts and high density storage systems. Gripper or holding devices are also availabl

dd to the challenges in developing combination products:

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

for fragile, delicate and super finished components.

Usually material handling takes place along all the links of the su

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

pply chain, including production, distribution, storage and retail functions. Minimizing the complexity and number of hand

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

ing operations can increase productivity. Most material movements need to be automated and simple. A detailed analysis nee

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

ds to be carried out to track the flow of material, before installing the material handling equipment.

It is important to

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

Professional from academic institutions, pharmaceutical industries, health care indust

note that there is an increasing demand for real-time information at all stages of the distribution and supply chains. Mat

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

erial handling systems need to be connected to sensing devices that provide essential information for handling, such as th

.

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

location or status of the material. This requirement is basic and is usually met with, but the importance of connecting h

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

Companies that provide selfless information through particip

andling equipment to a broader network and the plant management system has not yet been fully recognized by some companies

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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