Advice You - Business

All possible plastic film defects ought to be detected and eliminated by the extruder operator before the roll gets shipped to the customer. But in practice, through oversight and inatten

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

tion to detail defects can slip by that may be all too easily spotted by the customer or the customer's customer. I have found a variety of unrelated faults that fit into this category.

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

Examples of combination products may in

irst is the appearance and a good looking finished plastic roll of film this aspect can be half of the battle. Keep in mind is that first impression what you see is what you get! A superf

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

cially ugly looking roll which may convert on the filling machine or bag machine can have the operator looking at the roll much closer for the entire lot for real or imaginary defects.

A

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

roll that has a machine cylinder look means no scuff marks, damaged edges, and fuzzy ends, protruding or buried core ends, or crushed cores. The solutions to these problems are self evide

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

Combination pro

t. There are other finer detailed defects that can be buried in the roll, and may be if the production line is never approached by the operator except during a roll change. There is no ex

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

use for the customer being the first to see these.

I have a couple of areas for helping prevent roll defects:

How to Tackle Blocking of the Plastic Film - a common reason for blocking 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

too much winding tension. This maybe over looked unless tension is so great as to crush the core as the film is being wound on the roll. This makes it impossible for the operator to remo

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

e the roll from the winder shaft. With a case of crushed cores, the rolls may be hard to get off of the shaft, only to have the customer find them impossible to remount on a un-wind stand

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

Just as bad of a problem can arise if the winding tension is too light, no blocking but the film may telescope from one end of the roll, making it impossible to convert into finished p

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

oduct. Hot weather can bring its share of blocking problems. Plastic Film is insufficiently cooled and the inner surface blocks as they pass through the nip rolls. For a cure you must re

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

Following aspects would a

duce the output, raise the tower height or nip rolls, or use refrigerated air or other means of improving cooling efficiency. It also can be an inefficient air ring. An entirely differen

dd to the challenges in developing combination products:

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

cause of blocking can be using a resin to produce 1 mil film that has a slip and anti-block additive level designed for heavier gauges like 4 mil. There just isn't enough additive to do

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

he proper job. Over-treatment and or high gloss can aggravate if not cause blocking with any of the above conditions.

Tendency to Split - Plastic Film with splits tendencies can also be

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

verlooked unless samples are taken to examine, or actually tested. Insufficient cooling, a high frost line or to low of a blow up ratio, separately or a combination can accentuate the mac

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

ine direction or orientation of the film causing the film to become splits. Also your nips in the tower maybe to tight particularly with an old and hardening nip roll which can deform the

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

Professional from academic institutions, pharmaceutical industries, health care indust

plastic film in the edge crease and make it splits. Die lines or another name is weld lines from the extrusion die make splits film as can scratches from the collapsing frame in the extru

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

ion tower or a bur that has developed if using wooden collapsing frames. But not so readily detected are the fine weld lines caused by degraded particles of resin or dirt lodged under or

.

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

n the die lips that make the film extremely split at the weld.

Good operator observations to equipment maintenance, quality testing of roll samples and putting the proper procedures in p

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

Companies that provide selfless information through particip

ace will help in building customer loyalty.

http://www.prflexbag.com

dbanig@prflexbag.com

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 You - Plastic Film and Roll Defects

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