Back to Basics: ISTA Standards 20 and 7E

Voices of the industry

Attendees at the Exchange offered varying perspectives on Standard 20 as it currently stands.

Packaging suppliers noted that the standard is valuable to the industry as a whole, offering best practices and procedures they use and providing standardization on running packaging qualifications so that the end users understand. They also noted that it could benefit from a refresh in how it’s applied and structured.

From the auditor perspective, Carolyn Williamson, president at Parenteral Supply Chain, said, “I really like the structure that it provides. Also, for some of the test labs using this, it really helps them if they're just starting off because some of them are small. It’s a good foundation for what they need from all the perspectives like quality systems, training, etc. There are places we can work on, I think. Working with these test labs, they sometimes find the training a little cumbersome and we can probably work on that… I'd be very open to helping to improve the system, but I find tons of value in it. If the lab goes to this trouble, there’s a lot of value to that, and I think it’s important for end users to understand that.”

Bryan Cardis, sr. consultant engineer, Eli Lilly and Company, noted that when you have the ability to use a certified lab, it strengthens the position of the company to know that you're getting validated results. “Then compound with that, you have a strong position when you're going to an auditor that (1) you have validated results and (2) you have a certified lab and it generally appeases auditor concerns about what kind of data you have and what kind of facilities you're using,” he added.

From a supplier perspective, demand among pharma manufacturers is a key issue. One president of an independent test lab noted that while they are already ISTA-accredited, they’re not Standard 20 accredited and they haven’t yet seen the value in incurring the extra costs associated. Another independent lab president echoed those concerns, explaining that it’s a “chicken and egg” issue for them to invest the time and work to get accredited. “We need to have our customers ask for it. That hasn't hit a critical mass yet for the investment. But that's also why I'm on these calls to feel out if we're at a tipping point and if we should start the process,” she explained.

Reorganizing standards

ISTA is looking at reorganizing the standards to offer a tiered approach. At this point, a direction is not set in stone, but the group is focused on improving the accessibility, investment level, and flexibility based on how companies want to apply it and the maturity level of the organization.

While a direction is not set in stone, the group is considering a tiered approach to improve the accessibility, investment level, and flexibility of standards for the industry. (Credit: ISTA)At base of the pyramid are Standard 20 and 7E. “What's being proposed is to be able to give broader access in making that available to all ISTA members with their annual dues and for minimal purchase cost for non-members. Very much like buying any other standards, like 3A for example. Maybe there's an abstract that can be available to everyone. But the bottom line was making the base standard widely available and reviewable by all those that might have interest in it,” Mayer said.

Then stepping up the pyramid, access to the templates and the appendices may be added, which would be the minimum level that a company would need to execute the standard and document it properly. Mayer explained, “That would assume that you already have an existing quality system. So, something like ISO 17025 and a training program in place that is adequate for developing it and conducting these tests.”

For the next level on the pyramid, there is discussion of adding access for Standard 20 to the recently developed ISTA digital platform, PackSight, to help with the documentation process. “Since some of the issues around Standard 20 had to do with the documentation level, this could certainly help fill some of those documents out,” Mayer said. “We could have some of those pre-filled, we could have it as a sharing site, for documentation sharing benefits.”

The next layer would feature levels that add value to the companies that might not have a certification for their lab or a certification for personnel. “If you already have an existing lab accreditation and you want to add additional lab certification value, then that can be added, or if you don't have any lab certification value, you're new to the industry, then that can certainly be added as well. And then a lot those lines can be done with the personnel certification, too,” Mayer noted.

At the very top of the pyramid is package certification, allowing companies to use the ISTA certification mark on the package after ISTA review.

The idea is to allow for broad access to the standard base for minimal cost, and then create a technical review committee that's allowed to review this on a normal basis like any other standard and offer input.

One audience member noted that personnel certification might be beneficial before the lab certification part of the pyramid. Another attendee asked if they wanted to purchase the lab certification, would they also need to purchase the digital platform access, or would the pyramid levels be a la carte?

Gruber explained, “This is just a concept at this point, and we're looking for feedback on the approach. The concept, though, is that it’s an a la carte type of pyramid. But in order to get to the top of the pyramid, you would need the pieces to fill in underneath as well.”

This approach could allow companies to step up based upon the value proposition and the maturity level of their organization, being able to switch between those levels as they progress over time.