An Interview with... Kevin McLean Quality and Technical Director – Americas SGD Pharma Packaging

In general, what are some industry issues biopharmaceutical manufacturers are encountering with their parenteral packaging requirements?

We hear three repeating themes from our glass packaging customers.

1. Product-Package interaction: This goes beyond container chemical durability. Customers are seeking support regarding elemental impurities and leachable/extractable characteristics.
2. Container-Closure integrity (CCI): There are existing CCI evaluation methods to test filled products, but SGD Pharma is working with our customers to develop standards and methods of evaluating the empty container’s “finish quality”. The “finish” is the part that mates with the closure.
3. Total Cost of Ownership (TCO): A relatively new way many customers’ look at cost. Filled products frequently are extraordinarily expensive, and highly scrutinized from a production cost and final quality cost perspective. These customers are factoring in costs of lost time and product, so they look at the TCO of a container, vs its simple acquisition cost.

As the pharmaceutical industry becomes more global in nature, are there issues pharma companies are encountering with respect to glass packaging? Specifically, are there supply chain, quality or other issues your company is trying to address.

Kevin McLean Quality and Technical Director – Americas SGD Pharma Packaging

We pursue the goal of “think globally and act locally”. Customers absolutely need local, or at least regional, technical support, yet at the same time there are global harmonization goals for customers and at regulatory levels. For example, we operate five modern plants in France (2), Germany, China & India. All five plants are ISO 15378 certified, but more than that, they operate under the same global quality management system, which makes multi-plant qualification easier. This helps customers optimize supply lines and mitigate supply chain risk. (ISO 15378 combines ISO 9001 and GMP specific to pharma packaging).

However, we don’t want harmonization to constrain continuous improvement, so we mandate that plant quality and technical services managers, from around the world, meet in-person at least 3 times per year, at rotating plant sites. They conduct extensive local site reviews and take agreed-to best practices back to their sites.

This firsthand experience with specific best practices pays strong dividends in spreading the practice and achieving continuous improvement on a global basis.

A key aspect of our quality and service commitment are our regional Technical Service and Support teams. Members are recognized Pharma Glass SME’s (subject matter experts), and they provide local support for time-sensitive product issues, as well as coordinating development projects. Around the world, team members routinely volunteer time on industry advisory and standards development groups, in support of advancing and harmonizing the industry.

Can you tell us what the various stakeholders (patients, FDA, industry) expect regarding pharmaceutical glass packaging?

It starts with Patient Safety. Beyond technical requirements, it is crucial that glass suppliers have a “pharma mindset” in all they do. Patient Safety and Pharma Mindset should be central elements of their vision, mission and quality statements. The container is considered part of the drug product, and customers expect suppliers to have robust Quality, R&D and Technical Service infrastructures to support their needs.

From the technical perspective, glass remains the packaging material of choice due to its broad product compatibility, its global regulatory acceptance and its long history of proven performance. Still, moreand-more attention to long term product-package interaction is required. Our industry wants a stronger understanding of product package interaction risk, and better methods of predicting and mitigating the risk. Multiple pharma glass suppliers are active with programs to characterize and benchmark glass vials.

Another technical issue is advancement of quality standards and practices. In areas such as internal particle risk and the previously mentioned CCI concerns, suppliers must work on internal continuous improvement, as well as partnering with equipment suppliers to advance process and inspection capabilities of the empty container. Supplier advances there provide positive impact for customers wanting to reduce risk in their process and products.

Finally, looking ahead, what developing industry trends do you see that will affect the glass segment of biopharmaceutical packaging, and what products, technologies and expertise will your company offer users?

As described earlier, the concept of reducing primary packaging TCO will drive many new products and services. I can mention three, pertinent to this segment.

1. Traditionally tubular glass vials are used for lyophilized products, but we heard from customers that in-process breakage is a challenge. We developed a range of molded glass vials specifically designed for the lyo process, which can be very harsh on glass. Branded EasyLyo™ vials, they combine a tubular glass footprint with the strength of molded glass vials. Studies show they are 2 to 5 times more break resistant, and only 5-10% less heat transfer efficient than traditional lyo vials. Customers are also using them to reduce glass delamination risk for challenging liquid fill products.
2. Clareo™ premium, Type II molded vials were developed to improve visual inspection characteristics for empty and filled vials, and to reduce process breakage due to increased mechanical durability. Type II glass is used in Europe and other parts of the world more than in the U.S., and SGD Pharma is the leader in Type II glass, especially for blood derivative products.
3. Perhaps the most interesting new product comes through a partnership with the developers of the EZ-Fill® platform (Nuova Ompi, S.r.l.). This platform enables us to deliver GMP compliant, sterile and depyrogenated molded vials, ready for customers to fill. The platform is more than just sterile packaging. It incorporates a special tray design which interfaces with a range of existing filling equipment. The EZ-Fill platform is already approved and in use at many top tier pharmaceutical companies, who can now focus on their core competencies of developing and filling drug/biotech products, and be faster to market.