ASTM Charts Its Course

An industry veteran shares her thoughts on the significance of global standards.


Julie A. Clifford,
ASTM Board of Directors

To say Julie A. Clifford is active in industry is probably an understatement. Throughout most of her career, she has been involved in ASTM International (West Conshohocken, PA), an organization that develops global consensus standards for materials, products, systems, and services. A 16-year member of ASTM's Committee D10 on Packaging, she currently serves as chairman of D10's Division III on Consumer Products. Clifford is a former D10 Division III vice chairman and former secretary of D10.34 on Identification of Pharmaceutical Drug Product Containers (now D10.32 on Consumer, Pharmaceutical, and Medical Packaging). She is also a member of Committee F02 on Flexible Barrier Materials. In her current position at Alcon Laboratories (Fort Worth, TX), Julie manages packaging for the company's ophthalmic products.

Recently elected to ASTM's board of directors, Julie Clifford spoke with managing editor Kassandra Kania about the organization's role, membership benefits, and future goals.

How did you first become involved in ASTM?

Clifford: When I was first out of school from Michigan State, my first job was at General Mills in Minneapolis, and I worked in a shock and vibration lab where they evaluated distribution testing. General Mills at the time was a market leader in this area of testing. The staff frequently conducted tours of the facilities, and a few of those tours included foreign dignitaries interested in establishing a national testing lab in their country. At the time, it was the only complete lab with equipment to evaluate both rail and truck distribution. So, it was one of the locations where testing was being done to support the development of D4169, which is the cornerstone standard for the D10 Packaging Committee. I got involved with ASTM very early in my career. 

What are the primary benefits of working with ASTM?

Clifford: The key benefit of being a member of ASTM is that you have an avenue to standardize on a method that is important to your business. If there's a method, for instance, that my company prefers to use to evaluate a specific characteristic, we can take that [method] to ASTM and present it as a standard to be developed and evaluated. Because ASTM is a consensus body, the standard undergoes a full review at all levels. Once it is approved by ASTM, it is a very solid standard, and it can be used in regulatory documents.

What short-term goals do you have for ASTM's Committee D10 on Packaging?

Clifford: Currently we are working on supporting the PACPAC change tables with testing standards. (For more information about these standards, see the news story, "ASTM Supports PACPAC," p. 12.) These tables were developed by a committee, which had representation from industry, government, and academia, and they denote what testing is required for a specific component change. ASTM is defining what standards currently exist and what standards need to be developed or improved to meet the pharmaceutical industry needs. There are five new standards just released for the first time at the last committee meeting in April. The task group has just begun to review these standards and provide comments.

What about long-term goals?

Clifford: One of our long-term goals is to address what the strategic future of our committee looks like. We've done some significant work in the past, and I think right now the committee, especially in consumer packaging, is looking at developing a strategic plan to address packaging globally. We need to look at what the future is going to be for packaging and try to assess what standards are going to be necessary to support the future. In order to do that, we need to envision how our industry is evolving and take a look at regulations that are in place around the world. How are those regulations im-pacting packaging and forcing the business to change? 

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