Pharmaceutical Technology Europe - November 2010 - (Page 13)

Leak detection of pharma packaging Product integrity issues in the global pharma market are a hot topic at the moment and many companies are reviewing and increasing their quality control procedures. Good leak detection procedures are a critical element of cGMP and provide the manufacturer with confidence over the integrity of their packs, as well as ensuring product stability and overall shelf life. In our experience, leaks in pharmaceutical packaging are relatively uncommon on a well set-up and maintained pharmaceutical line. Assuming that the material itself is correctly specified, installed and not out of date, when a leak does occur it tends to be the result of problems with packing machine setup or material issues. Less commonly, leaks may occur when packaging line tooling gets damaged or when foreign bodies, such as cleaning materials, are introduced to the line. For leak testing, the most common method is the destructive methylene blue test. However, many pharma companies are improving their quality control systems by turning towards a new generation of non-destructive leak detection systems. Such technologies include lasers, ultrasonics, gas sniffers and load cell technologies to monitor physical changes in packaging under vacuum conditions. All of these are driven by software that enables objective results to be captured without damaging the product. The capture and integration of these detailed and specific results, such as what pocket in a blister pack is leaking, for example, helps production to identify reoccurring problem areas and implement appropriate solutions. Also, by being non-destructive, new generation testing technologies enable manufacturers to recover product environmental impact. Consequently, manufacturers of leak detection technology are being challenged by the pharma industry to provide: • products that are flexible across a range of production lines and package types • products that increase the accuracy and objectivity of testing • products that enable valuable drugs to be recovered rather than destroyed • products that have software that will integrate into their quality control systems. PTE Based on a contribution by Paul Kelly, Marketing Manager at Sepha. To read the full version of this article, go to www.pharmtech.com/kelly www.sepha.com Paul Kelly that would otherwise be destroyed, which is a major cost saving. This also offers environmental benefits, as there are many issues relating to the disposal of drugs, packaging and methylene blue dye. The changing market The pharmaceutical packaging market is increasingly global, with a dual focus on improving efficiencies and increasing quality levels by improving package integrity, lowering production costs and lowering 1 CONTENTS 12 ENVIRONMENTAL IMPACT 3 EMERGING MARKETS 13 LEAK DETECTION 7 ANTI-COUNTERFEITING 14 ROBOTICS 11 INNOVATION 15 TOP TECHNOLOGIES http://www.pharmtech.com/kelly http://www.sepha.com

Table of Contents for the Digital Edition of Pharmaceutical Technology Europe - November 2010

Pharmaceutical Technology Europe - November 2010
Table of Contents
Pharmaceutical Technology Europe Poll Assesses the Most Important Feature of Pharmaceutical Secondary Packaging
Emerging Markets
Counterfeiting
Green Packaging and Processes
Innovation
Is Pharma Doing Enough to Reduce the Environmental Impact of Packaging?
Leak Detection of Pharma Packaging
Should Your Implement Robotics in Your Packaging Operations?
Twelve Latest Technologies Showcased

Pharmaceutical Technology Europe - November 2010