There are numerous standards to help life science companies manufacture and ship products safely. Today, we’re talking two common ISTA standards which may be updated soon—Standard 20 and 7E. For background:
- Standard 20 (STD-0020) is a design and qualification process that provides the structure and path to design, test, and verify a specific Insulated Shipping Container (ISC) for use. “It's really intended to set a minimum requirement for qualifying insulated shippers in a standardized way,” explained AJ Gruber, ISTA president and CEO, at the recent Pharma Committee Technical Exchange in February.
- Standard 7E (STD-7E) is a testing standard for thermal transport packaging used in parcel delivery system shipments. It includes hot and cold profiles developed from data gathered in real-world transport in North America through a parcel carrier. It’s intended to address the issue of gauging ISC performance for designs across manufacturers by offering a standard profile for performance testing. “I think nuance that gets lost in the discussion sometimes is that it was really intended to be a standardized profile that companies can use to get an apples-to-apples comparison of ISC performance when you compare them head-to-head,” noted Gruber.
At the Exchange, Gruber also provided context behind different types of certified labs. “We have two different kinds of lab certifications: one for a transport lab and one for a thermal lab. A transport testing laboratory certification assures that the laboratory is properly equipped to conduct our pre-transit package performance testing for parameters like shock and vibration that a package incurs when it's being shipped through your distribution environment,” he explained. “The thermal testing lab certification is ensuring that the lab is capable and compliant with ISTA Standard 20.”
A certified lab that utilizes that process, in conjunction with the ISTA 7E profiles, can qualify packaging solutions as certified to ISTA Standard 20.
There are a few additional requirements for a lab to become certified as a thermal lab—there's a requirement for training and certification of the lab personnel themselves, and there's an in-person audit requirement for the initial certification and for re-certification. These two aspects are unique to the thermal lab certification process and aren't required for the transport lab certification.
Scroll below for a preview of the 2023 ISTA Forum TempPack and pre-Forum training sessions, taking place in Houston, TX, May 1-3, 2023.
The future of standard 20 and 7E
ISTA is looking into ways of ensuring that these standards are up to date and providing as much value to the industry as possible.
“One of the things we've identified is that it might need a bit of a reorganization and the key areas that we've identified for future improvement and wider adoption is the accessibility, flexibility, and relevance and intent,” said Bill Mayer, director of research and development, Peli BioThermal. Mayer shared some of the topics that came up in feedback from pharma end users:
- The availability for review for packaging end users came up as an area for improvement. Also on the accessibility front, the documentation package is time-consuming and quite large, which makes it tough to share easily.
- The large and ongoing investment for the packaging solution providers and independent labs can be a hurdle.
- Regarding flexibility, some respondents wished for flexible levels of participation in the standard based on their particular organization's maturity level and cost-benefit analysis. The second issue around flexibility was being able to choose the amount of value that an organization wants and allow those levels to change, based on individual company growth and industry need as they change over time.
- Relevance and intent: The intent is to provide a document and standard that is relevant to the industry. “We can drive that and increase the relevance by driving the flexibility and the accessibility and encouraging a technical standards review committee that reviews the technical data of the standard, where all stakeholders are allowed a voice,” said Mayer.
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 what is being put in front of them. 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 if they don't know.”
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.
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.
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 for the ISTA certification mark to be used 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.