HEALTHiiaR: iia Collaboration Community

HEALTHiiaR is a collaborative community operating under the International Irradiation Association (iia) focused on advancing the use of radiation technologies in the Pharmaceutical and Biopharmaceutical sectors. Guided by a steering committee of industry leaders, the community is open to all stakeholders, including regulators, standards bodies, academia, and industry partners.

The steering committee includes representatives from Johnson & Johnson, GSK, Pfizer, AbbVie, Abbott, Genentech, Roche, Cytiva, Sterigenics, Meissner, ValSource Inc. and STERIS.

The community is organised into topical groups, each focused on the identified work streams listed below.

Safety Assurance

The historical paradigm used for radiation processing application in the healthcare industry is a Sterility Assurance Level (SAL) where SAL is a probability of a microorganism surviving the radiation processing event. In the pharmaceutical/biopharmaceutical industry, the term Probability of a Non-Sterile Unit (PNSU) is used to establish the acceptance criteria for highly controlled manufacturing processes. The objective of this workstream is to incorporate the best practices associated with determining an SAL with those for evaluating a PNSU in establishing a mechanism for determining the safety assurance level for the sterility of a product.

Adjunct Processing Plus (AP+)

The acceptance criteria for using radiation to reduce/mitigate bioburden should be based on the engineering controls and overall microbiological quality output of the manufacturing process and end-product specifications and not an arbitrary radiation dose based on a overkill approach for a resistant population (e.g.25 kGy). The objective of the AP+ workstream is to better define the requirements and acceptance criteria for using radiation processing applications as a bioburden reduction manufacturing step.

Radiopharmaceuticals

The emergence of radiopharmaceutical therapies creates an opportunity to evaluate and implement alternative methods for determine product quality and acceptance. Traditional methods for testing and verifying the quality and acceptance have limitations and present challenges from a material handling and safety perspective. The objective of this workstream is to connect diverse communities (the international irradiation community and the pharmaceutical & biopharmaceutical industries) to enable the crossover of expertise and to establish fit for purpose best practices for the manufacturing, handling, testing and shipping of radiopharmaceutical products.

Annex 12

As a requirement in the European regulations for using radiation in the Manufacture of Medicinal Products, manufacturers who use radiation are required to follow and be in compliance with this Annex. The scope of this workstream will be to review and provided recommended updates to this Annex to incorporate additional practices and methods that have been introduced over the years.

Joining HEALTHiiaR

If you would like to join one of the HEALTHiiaR work streams, please send an expression of interest by email to Arthur Dumba at adumba@iiaglobal.com, including the following details: