Exclusive interview with Michael Creese, Senior Consultant, Smithers Rapra

28 October 2011

Michael Creese, Senior Consultant at Smithers Rapra provides his insight into key issues surrounding extractables and leachables

 

What are the main issues that your clients seek consultancy on?

As a consultancy and testing company we are lucky enough to work on a wide range of products from many different organisations with a variety of issues. Our consultancy group offers services associated with materials selection, design reviews to avoid failure, as well as extractables and leachables (E&L) testing. For extractables and leachables testing the main issues are associated with organisations moving into new packaging or new products and seeking support on how to understand the regulatory requirements, best practices and guidelines that are available and how best to fulfil those requirements. Typically we will assist with the interpretation of their requirements, help the customer develop the best testing strategies, and perform the extractables and leachables testing they require.

Has there been a trend towards a particular type of consultation?

Interestingly we have also seen an increasing number of container and closure manufacturers requesting extractables testing to support their pharmaceutical customers. Typically this is being driven by their own pharmaceutical customers who are increasingly aware of their E&L requirements and seek support from their suppliers. Also the container and closure manufacturers are proactively seeking a market advantage over their competitors and offer extractable data to their customers to build trust and win business.

We have seen an increasing number of projects from manufacturers who have had products on the market since before the resent best practices guidelines were published by the PQRI on E&L testing for Orally, Inhaled and Nasal Drug Products (OINDP) and the impending release of the best practices for Parenterals and Ophthalmic Drug Products (PODP). These customers now require E&L testing either due to moving the manufacturing site or changing the packaging. Because previously they may have only included a minimal assessment of E&L, that would now no longer be accepted, they now require the best practice to be followed and more detailed E&L testing to be conducted. We have also seen an increasing number of novel delivery systems and packaging that require customised testing strategies.

In your experience what is the most common reason for polymeric products to fail to meet technical and regulatory requirements?

Product failures can come in many different forms, but normally the root causes are associated with incorrect materials being selected and the design not considering all usages or environmental/ storage conditions. The root cause is often, in its simplest form, related to a poor specification being developed at the outset (something that should be considered during development using Quality by Design (QbD)). Poor material selection can lead to lengthy repeat testing, and costly delays to the product release. This is especially so if the failure is only detected during stability studies due to unacceptable leachables, the product failing to contain the product (leakage) or the packaging not sufficiently protecting the product. Failures can also be associated with creep (i.e. components under constant load such as spring loaded devices) and also fatigue (i.e. components that are exposed to repeated load and relaxation). This data is typically not published on material supplier sheets and therefore some assessment of creep and fatigue during the initial design stages can avoid delays later in the project.

What is the biggest change that you have seen in the industry in the past 5 years?

There seems to be some big changes in the packaging of some pharmaceutical products. One of the more simple examples is prefilled syringes but there are also more complex examples such as auto-injector "pens", DPI inhalers and other more novel technologies that have required some thought as to how to apply industry best practices. Another change is related to the increasing use of disposal systems used during drug manufacturing that incorporate a variety of plastic components such as bags, tubing, filters, and connectors; all of which can generate E&L species to varying degrees. It is interesting to see how regulators are increasingly focusing on these materials and how industry groups, such as the Bio-Process Systems Alliance (BPSA) are discussing best practices for assessing E&L.

What are you most looking forward to about Extractables and Leachables 2011?

As always I look forward to updates from the various industry work groups and listening to how different organisations assess their products. But I mostly look forward to many discussions on how different organisations approach E&L testing and how the results are interpreted.

As well as co-chairing, Michael Creese will be presenting at E&L 2011 on the parallels and differences between food, medical and pharmaceutical regulations.

Find out more on his presentation and other topics being discussed at E&L 2011 from the full agenda.

Further details on speakers at the conference can be found here.