Advice You - Business

Control panels are used to identify switches and controls on equipment. May cover membrane switches, and have holes for switches or screws, clear areas for indicator lights, etc.

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 printed on Lexan pr Lexsaver. Because control panels are often subject to physical contact - whether due to use of membrane switches, or due to proximity to connectors and

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

Examples of combination products may in

control knobs--the most durable materials are usually used in their construction. For practical purposes, this generally means one of three types of material compositions: Lexan&

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

reg; 10 mil, LexSaver™ or Polyester 2 mil - Gloss White or Clear.

Lexan® 10 mil UL RECOGNIZED: This is the most common construction for electronic control panels. 10 mi

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

l clear Lexan® (polycarbonate) with a velvet finish on the top surface is subsurface printed (printed with mirror image) on the back side. A 2 mil or 5 mil adhesive (usually c

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

Combination pro

rystal clear adhesive; we use 3M 467MP or 468MP) is laminated over the printed back, and the control panel and its internal cutouts are cut from the Lexan. The printing is protect

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

ed by the 10 mils of Lexan, and the velvet surface masks minor surface scratches keeping the control panel looking like new for years. Clear (non printed) windows can be designed

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

in for display panels, or LEDs. Adhesive free areas ("patterned adhesive") can be designated if necessary under certain switches or display window areas.

LexSaver&trade

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

; UL RECOGNIZED: In the LexSaver™ process, a substrate material (usually 2 mil white or clear polyester), which has a preapplied pressure sensitive adhesive (PSA) on a relea

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

se liner, is printed and then overlaminated with a 5 mil velvet surface Lexan overlaminate. The outer shape of the control panel and the interior cuts are then "kiss cut"

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

; (cut through just to the release liner). The excess material is stripped away leaving the control panels in place on the roll of release liner.

The LexSaver™ process can

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

Following aspects would a

be less expensive than subsurface printing 10 mil Lexan®, especially if there are a large number of internal cutouts on each control panel. It can also save money if a white s

dd to the challenges in developing combination products:

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

ubstrate material can be used, since white will not have to be printed. (If the control panel requires clear or translucent areas, then a clear substrate material would be require

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

d.)

A LexSaver™ control panel has the additional advantage of being more flexible, and less prone to minor cracking that can occur when the control panel is used over membr

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

ane or microswitches. There have been tests on the Polyester/Lexan® combination and was found it particularly be well suited to membrane switch applications. In addition, if p

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

olyester is used as the substrate, all components of the control panel are UL recognized materials.

For special applications, other substrate materials can be used in place of po

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

Professional from academic institutions, pharmaceutical industries, health care indust

lyester. Reverse printing black on Glow-in-the-Dark vinyl will produce a control panel with text or graphics which can be seen in the dark. Reflective Vinyl, Fluorescent Vinyl, or

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

Removable Vinyl might also be used.

Polyester 2 mil - Gloss White or Clear UL RECOGNIZED: For less demanding applications, white polyester can be a durable, low cost alternative

.

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

to the two Lexan® constructions above. Since it is less rigid, it is slightly more difficult to align and apply, so is best suited for smaller control panels. Can be used on

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

Companies that provide selfless information through particip

areas of equipment that are not likely to be seen as much, such as behind panel doors. For additional protection, or a high gloss or matte finish, use the appropriate overlaminate

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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