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oxygen transmission rate #212

Open timbrisc opened 2 years ago

timbrisc commented 2 years ago

Issue migrated from trac ticket # 5814

component: organization | priority: minor | keywords: cc/m².24h

2022-06-07 20:09:41: william.hess@fda.hhs.gov created the issue

UCUM already has "signal transmission rate" so the UCUM Board should also consider adding "oxygen transmission rate". It is defined in wiki (https://en.wikipedia.org/wiki/Oxygen_transmission_rate) as "The measurement of the amount of oxygen gas that passes through a substance over a given period. It is mostly carried out on non-porous materials, where the mode of transport is diffusion, but there are a growing number of applications where the transmission rate also depends on flow through apertures of some description. It relates to the permeation of oxygen through packaging to sensitive foods and pharmaceuticals."

This new concept is needed to support the U.S. Food and Drug Administration Pharmaceutical Quality Chemistry Manufacturing and Control (PQ/CMC) initiative. Please see https://www.regulations.gov/document/FDA-2022-N-0297-0001, which in part, states:

"PQ/CMC is a term used to describe manufacturing and testing data of pharmaceutical products. PQ/CMC encompasses topics such as drug stability, quality specification, batch formula, and batch analysis, which are important aspects of drug development. PQ/CMC plays an integral part in the regulatory review process and life cycle management of pharmaceutical products. The development of a structured format for PQ/CMC data will enable consistency in the content and format of PQ/CMC data submitted, thus providing a harmonized language for submission content, allowing reviewers to query the data, and, in general, contributing to a more efficient and effective regulatory decision-making process by creating a standardized data dictionary.

The impetus for this standardization effort was the provisions from the 2012 Food and Drug Administration Safety and Innovation Act (Pub. L. 112-144), which authorized the Agency to require certain submissions to be submitted in a specified electronic format. PQ/CMC standardization supports FDA's regulatory needs in receiving structured and standardized data in pharmaceutical quality and includes two objectives: (1) To standardize the pharmaceutical quality data that is currently received by FDA in eCTD Module 3 from the sponsoring organizations, and (2) to use these structured elements and develop a FHIR data exchange solution."

colin-e-hscic commented 1 year ago

This request appears to be lacking a lot of necessary detail. Is the Oxygen permeability assumed to be fixed per unit area of the substance but inversely proportional to the thickness? Is permeation driven by a pressure gradient or a concentration gradient (or both?)

This appears to be something that should be defined by a well-specified test procedure with a result in standard SI units.