Healthcare packaging news

Physical testing of Medical Packaging Copyright © 2012 MOCON Inc. This document and its entire content are the property of MOCON Inc. I n a world full of hungry microorganisms, it is critical that medical devices, designed to heal, do not inadvertently do the opposite by infecting the patient. To prevent infection, a device’s packaging or “sterile barrier system” must maintain sterility over the product’s entire shelf-life. In fact, packaging can be the weak link in the chain of steps designed to keep a product sterile from production to final use. Traditional Sterility Testing Responsibility for maintaining safety and sterility is shared by development engineers, packaging developers, packaging managers, product managers, and quality auditors. A traditional way of testing a package’s sterile barrier system at any point in its life has been to bathe it in a contaminated solution and then test by culturing the contents to be sure that microbes have not penetrated the package.  

 While workable, this microbial challenge testing has several drawbacks. First, because culturing is a growth process, it is invariably time consuming. Second, errors in handling the package or its contents in the testing process can lead to accidental contamination and hence, costly false positives. Finally, there is also a risk of false negatives if the microbes used in testing behave differently than expected.

Opening the Door to Integrity Testing For all these reasons, there has long been discussion of using package integrity testing instruments to support or replace traditional sterility tests. In 2008, the FDA finalized guidance regarding “container and closure system integrity testing...as a component of the stability protocol for sterile products.” The guidance states that physical testing can be used to verify that seals are leak free and continuous. In its guidance, the FDA lists four advantages of container and closure system integrity tests. These include:

• the ability to “detect a breach...prior to product contamination”
• the ability to “conserve samples that may be used for other stability tests”
• the fact that they “require less time than sterility test methods”
• the fact that “the potential for false positive results may be reduced” But integrity testing offers other benefits as well. Like traditional microbial challenge testing, it can be used during package development for periodic checks on production or when critical events occur. Unlike microbial challenge, however, integrity testing doesn’t incur the delay required for culturing, making it far more convenient and usable. Nor does it require highly trained specialists or incur the same risk of operator error. Ease of testing means packages can be tested more often over their anticipated lifecycle. This can be critical for packaging that is shipped, handled, and otherwise challenged in ways that may affect its ability to keep contents sterile.

 

 Package integrity testing using instrument methods can be more sensitive, repeatable, and reproducible and, therefore, more reliable. The FDA’s guidance notes specific limitations of traditional sterility testing including:

• the fact that they “will only detect viable microorganisms present at the time of the test”
• the fact that these organisms “can only be detected if they are capable of growth in the specified culture medium

Forecasting the healthcare packaging market from 2015-2025

Visiongain offers prospects for leading companies in over-the-counter and prescription pharmaceuticals, and medical equipment.

The global healthcare packaging market will reach a value of $101.3 billion in 2015 and will grow at a Compound Annual Growth Rate of 6.3% between now and 2025, says a new report from visiongain, a London-based business intelligence provider.

 

“Healthcare Packaging Market Forecast 2015-2025,” notes that strong growth in the healthcare sectors around the world and increasing functional requirements for healthcare packaging products are some of the key growth factors in the global healthcare packaging market. A global ageing population, changing lifestyles, and the increasing prevalence of chronic diseases will strengthen the demand for healthcare products and services, stimulating growth in the healthcare packaging market.

Other important drivers of growth include the increasing incomes and higher living standards in emerging markets such as China and India, where the healthcare packaging market has recently exhibited double-digit growth rates. Despite the rapid growth observed in the emerging economies, we forecast the U.S. will lead the healthcare packaging industry throughout the forecast period.

Materials, package type predictions

Plastics will hold the greatest market share in the materials healthcare packaging market, mainly due to their cost effectiveness and high adaptability. Visiongain expects this submarket to continue exhibiting fast growth throughout the forecast period. Glass as a healthcare packaging material will be gradually replaced by other substitutes like plastics

In the healthcare packaging market by type, the prefillable syringes submarket will see the strongest growth, predicts visiongain. Meanwhile, the parenteral vials and ampules submarket will continue to be the second-fastest growing market.

The booming biologics market, where injection is normally the delivery method of choice, is the main growth driver of these two markets.

Market restraints

The global healthcare packaging market does face many restraints, however. The widespread cost containment measures placed on healthcare expenditure by governments is placing an increasing cost pressure on the healthcare packaging market. Changing regulations in the healthcare sector can also have major effects on the way healthcare packaging manufacturers operate.

Furthermore, greater buyer power and more intense competition within the healthcare packaging industry have resulted from the healthcare industry consolidation.

Future forecasts

What is the future of the healthcare packaging market? Visiongain's 306-page analysis contains quantitative content that provides analysis and illustrates new opportunities and potential revenue streams that can companies gain a competitive edge. In addition to market forecasts from 2015 to 2025, the new study shows current market data, market shares, original critical analysis, and reveals insight into commercial developments. The report provides 224 tables, charts, and graphs, and provides two exclusive expert company interviews from Walter Berghahn, Executive Director of the Healthcare Compliance Packaging Council (HCPC), and President of SmartRmeds for Life, and from Dr. Laura Bix, Associate Professor at the School of Packaging at Michigan State University and adjunct associate at Clemson University.

The report also explores the factors affecting product developers, the value chain, and describes the forces influencing market dynamics. It observes the strengths, weaknesses, opportunities and threats (SWOT) affecting the industry and product advances. The report dives into the subjects of R&D strategy, technological issues and constraints, supply and demand dynamics, increasing specialization by leading players, advances in product quality, and demographic changes. It identifies companies in in the healthcare packaging business that it believes hold the greatest potential.