Friday, 22 September 2017

Key Factors for Producing Error Free Pharma Packaging


The pharmaceutical industry stands for one of the fastest growing and the most profitable industries in the world. An increase in sales and growth of the work amount, apart from the high profit, can bring some unwanted problems and challenges for the pharmaceutical manufacturers when it comes to packaging.

This is a guest post by John Alex.
Although in the last several years we have witnessed a great revolution of automation tools for packaging quality control, a great number of manufacturers are still not up to the task with the technological advancements which can help with packaging issues.

Specifics of the pharmaceutical industry

The pharmaceutical industry represents one of the most demanding industries in the world and as such has a developed set of packaging quality control rules and regulations under the authority of FDA.

The specific regulations relate to a whole range of necessary activities in the production, research, creation of the products, product protection, and market placement.

Because of the global nature of the pharmaceutical industry, companies have to deal with different regulations worldwide which have the consequence that companies need to be adept in interpreting the different requirements of local regulations.

Such a variety of numerous and special legal regulations are the culprit factor of production and packaging mistakes.

Pharmaceutical manufacturers on the global market are often under pressure to deliver safer superior packaging, more effective medications affordable in less time and at a lower cost.

“Markets and Markets” are estimating that the global pharmaceutical market will grow at a CAGR of 6.7% from 2013 to 2018, reaching a value of $78,8 billion.

This value includes medications delivery systems that are also considered to be product packaging. This sector of the packaging market is growing at an even faster CAGR of 9.1% due to increasing demand for delivery/packaging solutions as many medications come off-patent in the coming years. (1) The Rx medicine packaging and OTC medicine packaging

There are two types of products in the pharmaceutical industry that significantly determine a packaging process approach.

First are the medicines that are only given through physician prescription, so-called Rx medicines. The second are medicines that can be purchased in retail, so-called over the counter ie. OTC medication.

For a long time, Rx medicines products were not given much artwork packaging importance because these medicines are intended for a very narrow circle of professionals- pharmacist and doctors. Because of that, the packaging artwork of Rx products has been focused solely on the basic elements necessary for correct use of medical products.

This lack of packaging attractiveness, of course, does not exclude the importance of up-to-date and accurate information on the medication package. This includes information about ingredients, dosage, and mode of application.

A medication package should not be similar to any other form of packaging in order to avoid confusion with other types of products.

There is a general rule that non-pharmaceutical products should not be packed in packaging which resembles a blister pack (e.g. chewing gum) so that children do not get used to opening such packaging, which could endanger their safety.

The appearance of OTC medications is nowadays approached as a form of promotion by which the pharmaceutical industry has finally reached a mass media access point in advertising, thus more direct access to consumers without the intermediary of doctors.

The packaging of these products allows much greater freedom for creativity in creating attractive product packaging. But, this also leaves plenty of room for errors usually caused by human factor. That often leads to complete products recalls, which represents the worst-case scenario for the manufacturers.

According to Esko's market research, it is estimated that more than 50% of product recalls are related to the labeling or packaging artwork, and more than 60% of recalls are caused by human error. (2)

Factors determining the attractiveness of packaging include imaginative and innovative packaging artwork.

Since quality should not suffer due to packaging design, it is equally important to ensure that the product keeps its credibility as well as providing the sense of responsibility and security, to inform the consumer of the benefits of using the product and to provide the information on proper use and warnings in case of improper use.

Besides protecting the product from external influences, the packaging must make it easier to consume products, protect products, and prevent abuse while ensuring the entire process of delivering the product to the end user.

Smart and intelligent packaging labels as a response to the demanding modern market

Lately, there is an increasing demand for smart and intelligent packaging labels, with the goal of maximum product protection and achieving clearer communication with the consumers.

As smart packaging labels, we consider the packaging labels which contain the crucial data, information, and solutions regarding the product process, distribution, and sales.

A newer technology advancement is the use of packaging labels that observe temperature oscillations, possible growth of microorganisms, labels that have moisture-absorbing properties, indicators that show products freshness, light protection etc.

The greatest thing about smart packaging labels is the fact they can serve as a means for feedback from the product consumers themselves which manufacturers can find very [1] [2] useful.

Packaging against counterfeiting

The pharmaceutical industry permanently continues to face challenges with an increased number of counterfeit medicines and medical products.

One of the reasons for this is certainly high medication prices but also an opportunity for the black market to take up the part of pharmaceutical “market cake”. The challenge of protecting pharmaceuticals from counterfeiting continues to be one of the greatest issues in less developed countries.

The pharmaceutical industry is very sensitive to any kind of counterfeiting and misuse of the product. This is because every counterfeiting means a direct threat to the health and life of consumers. The riskiest group being children and elderly.

Taking into account the fact that as many as 10% of the worldwide medicines are falsified, it is easy to conclude why the pharmaceutical industry invests so much effort and money into the contemporary forms of protecting its products.

One of the possible ways to combat medicines counterfeit is packaging with protective elements. Among these elements is Braille text. Most legitimate pharmaceutical manufacturers take care of special user categories, so most of the pharmaceutical packaging also contains Braille.
Implementation of Braille to the medication product packaging is a sensitive and technically demanding process. Important information has to translate to Braille clearly and accurately.

Braille text itself, is not a great protection. But, its presence on the packaging in combination with other protection elements makes it much more difficult to counterfeit the original medication's packaging.

Another way of counterfeit protection is the amendment to the Falsified Medicines Directive (FMD), among which are serialization and the tamper seal.

Manual VS Automation packaging process

The use of automation technology for both, primary and secondary pharmaceutical packaging can help manufacturers save time, minimise errors, reduce costs and ensure an aseptic manufacturing process.

Primary packaging includes aseptic fill-finish and capping equipment, non-aseptic fill-finishing and capping equipment, unit dose fill-seal, blow/fill/seal, inspection systems, containment solutions, and product assembly lines.

Secondary packaging includes cartooning equipment, overwrappers and stretches banners, bulk packaging equipment, check weighers, serialization equipment, tamper-evident solutions and end packaging. (3)

It is evident that such a complex manufacturing process requires strict and efficient control in order to protect consumers themselves as well as manufacturers.

Since packaging of pharmaceuticals often contains small and complex details, much of the product information is often printed in small dots, barcodes, and graphics.

Because of its technical nature, manual inspection of these products is highly inadvisable, so packaging printing inspection automation technology should be introduced into the production process.

A good packaging quality control software platform should adhere to the rules and regulations of the pharmaceutical quality control standards.

Beside the individual packaging quality control segments which can be automated - Braille text, spelling, artwork label, text inspection, data integrity, pixel proof, graphics inspection, packaging print, discount, quality control inspection, preprint and print; it is possible to integrate an all in one quality control platform into the workflow and producing process.(4)

A packaging quality control platform which offers an all in one solution and is also integrable with other systems and hardware encompasses most pharmaceutical packaging challenges and provides the best value of ROI which is also an important business segment and goal of every manufacturer.

References:

1.(Markets and Markets. Pharmaceutical packaging market by packaging type (plastic bottles, blister packs, caps & closures, ampoules, vials and others) raw material (plastics, paper & paperboard, glass, aluminum foils), and drug delivery type–global trends & forecast to 2018.

http://www.marketsandmarkets.com/Market-Reports/pharmaceutical-packaging-market-890.html.

2. Philippe Adam, Global Marketing, Esko Best Practices:- How to Avoid the Five Common Pharma Packaging and Labelling Artwork Hurdles

http://www.pharmtech.com/best-practices-how-avoid-five-common-pharma-packaging-and-labelling-artwork-hurdles

3. KshitiJ (TJ) Ladage, Market Research Manager, Nice Insight, Nice Insight Pharmaceutical Equipment 2016 Annual Study

https://www.pharmasalmanac.com/articles/q2-ni-nice-insight-pharmaceutical-equipment-2016-annual-study

4. Mike Spooner, Integrating Quality Control Tools Into Print Workflow Automation Solutions

http://www.globalvisioninc.com/blog/saas/integrating-qc-tools-into-print-workflow-automation-solutions/

Author Bio: John Alex is a freelance writer, experienced blogger, and a professional social media coach. Currently, He’s working with globalvisioninc.com. Furthermore, John assists in the business creation and control social media content planning.