4 minute read
MATERIAL DEVELOPMENTS
all. Bryan Cardis, Sr. Consultant Engineer at Eli Lilly and Company, said, “I think it’s always nice to have a standard profile as a starting point, especially when you have limited data or new lanes. Then over time, optimize it to those lanes.” As companies collect data they can begin to understand whether the standard profile was efficient or too robust, needing modification.
One attendee remarked that having a standard profile leads to better leveraging of vendor data, explaining, “If the manufacturer and vendor had the same profile, it would be very easy to adopt a shipping system, because right now they’re writing 12-page justification letters as to why vendor data is applicable.”
Smaller companies should be aware though that a standard profile—while generally helpful—will not always be a perfect fit. Williamson said, “Some of these companies have far less money to spend on shipping, both for the actual package and for transportation costs. A standard profile may lead them to have a more expensive box, which increases their costs.”
From the vendor perspective, Anthony (TJ) Rizzo, Chief Commercial Officer at Cold Chain Technologies, Inc., noted that having the same profile would make things a bit more straightforward. “One of the challenges is navigating the maze of ambient profiles. Some people use 7D, some people use 7E, some are using their own qualifications and they can be significantly different. So I think there is an appetite from both sides to try to adopt the same standard when we’re qualifying,” he explained. “I think that the challenge is how do you do that and meet the different risk tolerances of different organizations, and weigh that against the cost. Obviously the more severe a profile, usually the more costly the solution is. Some companies have stability data, some don’t, some are a little bit more open to risk due the cost of their other products. Personally, I think it leads to something of a good/better/best type of approach, where you could have different levels and different solutions at different performance and cost levels as a result. But it’s definitely something that we are interested in taking on as a group.”
Stay tuned for more as the ISTA Pharma Committee reevaluates Standard 20 and ISTA 7E. Said Rizzo, “We want to engage as many people from the industry as possible in those discussions from different parts of the table: end users, testing facilities, packaging providers, and any professional service providers within the industry.”
The 2022 ISTA Forum, including TempPack, takes place in-person from April 11 to 13 in San Diego, CA. Topics will include sustainability case studies in re-use vs. single-use, COVID-19 lessons, and more.
all. Bryan Cardis, Sr. Consultant Engineer at Eli Lilly and Company, said, “I think it’s always nice to have a standard profile as a starting point, especially when you have limited data or new lanes. Then over time, optimize it to those lanes.” As companies collect data they can begin to understand whether the standard profile was efficient or too robust, needing modification.
One attendee remarked that having a standard profile leads to better leveraging of vendor data, explaining, “If the manufacturer and vendor had the same profile, it would be very easy to adopt a shipping system, because right now they’re writing 12-page justification letters as to why vendor data is applicable.”
Smaller companies should be aware though that a standard profile—while generally helpful—will not always be a perfect fit. Williamson said, “Some of these companies have far less money to spend on shipping, both for the actual package and for transportation costs. A standard profile may lead them to have a more expensive box, which increases their costs.”
From the vendor perspective, Anthony (TJ) Rizzo, Chief Commercial Officer at Cold Chain Technologies, Inc., noted that having the same profile would make things a bit more straightforward. “One of the challenges is navigating the maze of ambient profiles. Some people use 7D, some people use 7E, some are using their own qualifications and they can be significantly different. So I think there is an appetite from both sides to try to adopt the same standard when we’re qualifying,” he explained. “I think that the challenge is how do you do that and meet the different risk tolerances of different organizations, and weigh that against the cost. Obviously the more severe a profile, usually the more costly the solution is. Some companies have stability data, some don’t, some are a little bit more open to risk due the cost of their other products. Personally, I think it leads to something of a good/better/best type of approach, where you could have different levels and different solutions at different performance and cost levels as a result. But it’s definitely something that we are interested in taking on as a group.”
Stay tuned for more as the ISTA Pharma Committee reevaluates Standard 20 and ISTA 7E. Said Rizzo, “We want to engage as many people from the industry as possible in those discussions from different parts of the table: end users, testing facilities, packaging providers, and any professional service providers within the industry.”
The 2022 ISTA Forum, including TempPack, takes place in-person from April 11 to 13 in San Diego, CA. Topics will include sustainability case studies in re-use vs. single-use, COVID-19 lessons, and more.