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We are living in a world of paper: we receive important information on paper, and share confidential information on paper: creating documents, letters and many sensitive issues. Therefore it's important to be sure that our confidentiality and privacy are pro

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

tected, and that waste paper is disposed of. In the past people used ways of destroying paper like burning and tearing, etc. Nowadays with huge volumes of paper all these methods are useless and we need something really powerful and reliable.

The first idea

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

Examples of combination products may in

of a bulk paper shredding machine was patented in 1908 by A.A. Low, and the first shredder was created in Germany in 1935 by Adolf Ehinger. Since then with the fast growth of business and industry, shredders have become an important item of office equipment

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

, for both company and home needs.

Nowadays each company creates, edits, and destroys tons of paper documents that may contain highly confidential information that is not intended for third-party viewing and usage. And the best way for the company to prote

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

t itself is to shred all documents and other important papers before throwing them away.

This guide will help you choose the right shredder for your company needs.

Before you go to the nearest office equipment store or logon to an online office supplies sh

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

Combination pro

op, you need to know answers to these 2 questions:

1. How often will the shredder be used?

The environment in which the shredder will be placed is usually the best guide to how much shredding a machine will have to undertake and if it is the right 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

ype of machine to best meet your needs.

Home Personal shredders are the best for single users who works from home. Such machines can utilize about 20 sheets per day and work in an economical way for home workers to shred confidential business and personal 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

formation.

Medium duty use (not continuous) machines usually utilize 50-100 sheets a day. This is normal for shared use in an office with 3 and more users.

Heavy-duty use machines are designed for large companies to withstand everyday continuous use and ca

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

n work as centralised machines for all office users.

2. How confidential is the information to be shredded?

The security provided by the shredder is determined by how small the paper is shredded. Levels of security rated by a DIN Security Level
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
b> are ranging from 1 to 5. DIN stands for "Deutsche Industrie Normierung" which means "German Industry Standard" and it is a registered association promoting standardization, quality assurance, safety, and environmental protection internationally.

The DIN
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
evel of each shredder model can be found in the machine specs.

The official levels range from 1 to 5 with 1 being the least secure and 5 being the most secure. Level 3 is an average one and usually enough for most requirements.

Each level depends on cut ty
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a
pes a shredder uses: strip cut or cross cut.

Cross cut shredder cuts paper into confetti-like pieces providing higher security and significantly reducing bulk waste.

Strip cut shredder cuts paper into spaghetti-like pieces the length of the p
dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod
aper providing everyday security.

- 1 Level is used for general paperwork and provides strip cut (10.5mm) and cross cut (10.5x40-80mm)
- 2 Level is to be used for everyday documents with strip cut (3.9mm).
- 3 Level is used f
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
or confidential documents with cross cut (3.9x30mm)
- 4 Level is intended for sensitive documents and uses cross cut (1.9x15mm)
- 5 Level provides the highest security and is used for secret documents with cross cut (0.78x11mm)

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

Each company is legally required to adequately dispose sensitive information. Accounting and Personnel departments produce highly sensitive information that is extremely useful to competitors. The following documents should always be shredde
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
d before disposal:

Financial reports

Marketing reports

Sales reports

Budget information

Salary information

Personal data

Internal correspondence

There is a wide range of
ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust
shredders that can shred A4 landscape, A3 and even CDs, and that feed automatically. The maximum width of paper, which can be shredded by each machine, is listed in the specifications table for individual models.

Number of paper sheets that be shredded at o
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
e time varies depending on the model. A standard office shredder can shred from 15 to 20 sheets at one time. A strip cut machine shreds more sheets of paper in one time than cross cut machines, which provide higher level of security shredding fewer sheets.

.

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
Shredders maintenance

Shredders usually require very little maintenance. The basics maintenance can be easily done inside the company without calling in a specialist: this is periodical clearance of the cutting heads of excess shredded paper and regu
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip
lar oiling of the shredder to ensure the proper movement of the cutting heads. These are 2 crucial steps towards efficient and long lasting operation of the shredder. The shredders usually have a 2 -years warranty with a 5-years warranty of the cutting heads

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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