The IQ Consortium Physicochemical
In-Use Stability Testing Working Group Issues a Call for a Volunteer with Expertise in Polymer Chemistry
** Responses due by 15 July 2025 **
Background and Rationale
The biologics physicochemical in-use stability testing working group is focused on industry-wide topics regarding in-use compatibility studies. The working group consists of biopharmaceutical experts in the field from many different companies. The objective of this working group is to establish best practices for designing, performing and presenting these in-use stability studies. The group also identifies applicable regional regulatory requirements and provides guidance where no specific regulations exist. Using scientific rationale and expert knowledge, the group is developing key perspectives to address these issues.
Project Details
The working group is discussing potential challenges around materials of construction of medical consumables. Besides stainless steel, the main component of these consumables are various types of pharmaceutically accepted polymers.
Since polymer manufacturing processes, raw materials, and processing aids vary across manufacturers – and only limited information is accessible to scientists – the pharmaceutical industry often assesses in-use compatibility based on general polymer categories rather than specific items. For instance, in the case of polypropylene bags, the focus is on evaluating polymer types instead of each manufacturer’s product individually.
The pharmaceutical company may also assess the material compatibility of certain medical consumables suggested by individual sites upon request. This approach ensures compliance with the pharmacy manual specifying the allowed materials for construction of the medical devices.
However, most recently, a risk-based assessment has been considered to mitigate the potential delays in testing and assist with the FTE time and cost of testing.
In this context of either testing and / or risk assessment, the trial sponsor needs to have sufficient data of the material for construction available, which is provided by the medical device manufacturer to make an assessment. Unfortunately, this data is usually not publicly available for all components or at least not to the detail required for this assessment.
The working group is attempting to gather information about the composition of the various polymers used for ancillary items to provide some guidance on how it can be assessed for compatibility testing based on a risk-based approach or, is there a significant difference between, e.g. a polypropylene bag of manufacturer A or B, to warrant individual testing.
Qualifications for the Candidate (all are required)
Note: Qualifications below must be based on specific scientific or technical expertise.
- Work in the area of medical device manufacturing for the administration of parenteral drugs such as IV bags, infusion lines, etc. (no autoinjectors, no pens and related devices)
- Fundamental knowledge in polymer chemistry (required)
- Knowledge on production, process parameters and variances
- Knowledge on relevant quality standards
- Knowledge on labeling for the material construction of the medical device and its directions for use
- Knowledge on regulatory requirements for medical devices and change notifications as above
Objectives and Boundaries of Engagement
The ideal candidate will be responsible for providing insights in the topic of polymer chemistry and related topics of medical devices and is willing to answer questions and join discussions with the team ad hoc.
The shared information might be used to publish a white paper and/or be presented in the scientific conferences. The candidate may be mentioned in the acknowledgement section of a white paper. No proprietary information should be shared by the candidate.
Respondents, please note this is a temporary volunteer role. When this project is completed, membership with this IQ working group ends.
Submission Deadline
Respondents must submit their statements of interest (SoI) and current CV by 15 July 2025.
