October 27, 2017

ASTM Standards Meeting Update

ASTM held its semi annual meeting in New Orleans beginning October 8, 2017.  PCL attended! We were particularly keen on committee D10, which includes standards such as conditioning and transportation simulation.  What an experience!  It was a great opportunity for PCL to make valuable contributions to discussions about several key packaging standards and also understand potential changes coming down the pipeline.  Here are a few takeaways affecting medical packaging:

  • ASTM D4169 was up for revision with changes focused on pre-conditioning expectations. There were three negative votes on the ballot and the proposed changes are now being re-worked with the revision being pushed to 2018.  In a nutshell, the goal is to better clarify how samples should be preconditioned to simulate the stresses that climate imposes on packaging during distribution.  Users should expect to see differentiated guidance on shipments that are short term (air or 2 day ground) vs. shipments that are longer in duration; key differences being the length of time that samples are exposed to climate extremes in the lab.  ASTM D4169, D4332, and F2825 are being aligned for language consistency that will allow the three standards to better support each other.
  • ASTM D4169 will also see future updates to Schedule J (concentrated impact) and Schedule G (rail switching). Regarding Schedule J, there has been a lot of pushback from the industry about how representative this schedule is compared to real world distribution, and will likely see this schedule eliminated all together. For Schedule G, there will be proposed updates to the technique to better align with other industry practices for railcar simulation.
  • We also spent time discussing the 2016 update to ASTM D4169 which affected Schedule E (vehicle vibration) profile and some of the data and background that went into the updated approach. Turns out the ‘background’ on this goes way back to the 70’s.  It has been a long and interesting ride (pun intended)!
  • A new working group is being considered with the goal of creating a standard for pharmaceutical cold chain testing. The current standard on this is ASTM D3103 but it is very high level. The ASTM committee would like to see more prescriptive guidance on what temperatures to use (such as ISTA 7D, 7E) and also to create consistency on technique, such as how many thermocouples, where to place the thermocouples, etc.
  • We also heard from Geoff Pavey (Oliver Healthcare Packaging) on updates to a new work item regarding guidance on establishing minimum seal strength. The idea is to throw the old “1 lb minimum” out the window (there are several issues with this rule of thumb) in favor of better aligning seal strength specifications to practical applications.  The goal will be to use data from Operational Qualification (OQ) and transit testing to develop a minimum value.  For example, if samples are subject to transit simulation after being built at OQ-Low conditions, then statistics can be applied to seal strengths produced by OQ-Low (e.g. one-sided tolerance limit calculation) in order to determine an appropriate value; this value is backed up by passing transit results at that limit.

We also thought it was very cool that ASTM is improving student outreach by exploring a relationship with Michigan State University.  While this program still needs to be put together, the idea is to develop a way for students to become involved in the conversation and support the development of new standards.  PCL will be supporting this outreach program since many team members here are MSU graduates, and we are only located about an hour away from the university.

The next ASTM semi-annual meeting will be held in April 2018.  The PCL team will stay ahead of evolving standards to keep you in the loop on any big changes.