Advice Pool - Computers and Technology

Screen printing also called silk screen print also called serigraph was invented in the Far East around 2000 years ago. No supplemented data on when or where exactly it originates, but originally used to

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

make the screen printer's screen. A paper stencil was stiched onto the screen to control the print area.

Around a hundred years ago screen printing was reinvented in the west and it has become a common

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

Examples of combination products may in

method of printing on textiles. Most common, the custom t-shirts. The screens used for screen printing custom t shirts, are made with a mono filament mesh. Photopolymer emulsion is used to make the stenc

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

l. Thus, silk screen is coated with the liquid emulsion, and allowed to dry and harden. The emulsion is light sensitive. The stencil is made in the "silk screen" by placing a positive of the print over 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

e coated silk screen then exposing the screen to light. The areas of the screen shielded from the light remain water soluble and can be washed out of the screen. The light affects the emulsion in that on

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

Combination pro

e the dried emulsion has been exposed to light, water will not dissolve it. Take a look at the photograph to the left. In this case the positive for the screen print is hand drawn.

The availability of t

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

e screen printing products can be purchased locally from screen printing process supply stores. An "emulsion cup" is used to coat the silk screens with emulsion. The emulsion cup is a trough like cup tha

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

t holds the liquid emulsion and allows it to be spread evenly across the screen. The screen is held vertically and the emulsion is spread from bottom to top with one smooth motion. After the silkscreen h

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

s been coated with emulsion it will be left to dry. Ambient or soft light can expose the screen but it would take hours or days. Even so care should be taken that the silk screen is kept in a dark place.

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 "burn" a screen, the positive must make tight contact with the screen. A four inch thick foam rubber pad is placed under the screen with the glass placed on top. Sunlight can now expose the silk scre

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

n. It can take anywhere from around two to fifteen minutes. After the screen has been exposed it is taken to a wash out area usually a metal bathtub like trough or large sink. The screen is set in the tr

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

Following aspects would a

ugh and sprayed with a garden hose. Rinsed with water, after a second the design will be visibly lighter in the emulsion. After a minute or so of rinsing the design area should be free of emulsion. Rinsi

dd to the challenges in developing combination products:

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

g is continued for another minute or so to wash away emulsion scum that if allowed staying in the screen and dry will clog printing areas. The washed out screen is then allowed to dry.

After it has drie

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

the screen must be taped off. This is usually done with masking tape. The areas around the edges not coated with emulsion are taped front and back. The screen printer applies tape liberally over the fra

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

me and screen areas. The screen is then "pin holed". Sometimes imperfections in the screen printing process cause tiny "pin holes" in the emulsion that’s why these must be taped over or blocked with emul

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

ion or block out fluid. This is done on the bottom of the screen.

The emulsion can be removed from the screens so that the screens can be reused. This is called "reclaiming" the screen. After the print

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

Professional from academic institutions, pharmaceutical industries, health care indust

un the ink is scraped out of the screen and mineral spirits or ink wash is used to clean the ink from the screen. All the masking tape is pulled off the screen and the screen is sprayed with “emulsion re

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

over.” This chemical is left on the screen for 2 or 3 minutes and a high pressure sprayer or even a garden hose can be used to wash away the emulsion. After the emulsion has been removed the screen must

.

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

e degreased. There are degreasing liquids available also ivory soap works well. The screen is scrubbed thoroughly on both sides and then rinsed. It can now be dried and if kept clean reused. The screens

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

Companies that provide selfless information through particip

ust always be clean and degreased and dry before they can be coated with emulsion.

These procedures may sound very difficult but the application is totally easy. See and try the screen printing yourself

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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Advice Pool - Screen Press Printing: Looking At The Process

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