15/16 February 2022
Temperature excursions during pharmaceutical product storage and distribution may present a real risk to product quality.
A publication in the Pharmacopeial Forum 38/6 (Stimuli to the Revision Process "An Assessment of the Impact on Pharmaceutical Product Quality Resulting from Humidity Exposure") examines the question of risks possibly associated with relative humidity excursions encountered during storage and distribution.
The article describes the different protective properties provided by various types of primary packaging using a validated moisture-vapour transfer model. The information presented should help revising the General USP Chapters <1079> and <1118>.
The document begins with the definition of the following terms: absolute humidity, relative humidity, and water activity.
All types of pharmaceutical packaging materials are addressed, among others those for finished drug products, APIs, intermediates, etc. Refrigerated and frozen materials are excluded from the scope of the document.
As a conclusion the risk of lower product quality due to humidity is considered to be minimal compared to that caused by temperature variations. Changes in environmental humidity result in much slower changes in the moisture exposure of the drug product because of the protection afforded by packaging material. Yet, PVC blister packaging materials are excluded from this statement because they do not provide good moisture protection.
Humidity excursions of 7 days maximum are unlikely to result in loss of product quality. Therefore, humidity monitoring during transportation isn't considered as necessary, whereas it is indispensable in long-term storage facilities. There, appropriate humidity control must be monitored.
The European Compliance Academy has developed a new course on barrier properties of different packaging materials and on the "Container Closure Integrity" to address the measures necessary for proper storage and transportation of medicinal products. During the ECA Education Course Barrier Packaging - Basic Principles - Measuring Methods - Systems on 26-27 February 2013 you will get a comprehensive overview.
The aim of this course is to provide up-to-date knowledge about Barrier Packaging. Which physical fundamentals are relevant? Which measuring procedures and methods do exist? Which drying agent systems are used? By means of specific packaging types and dosage forms (blister, oral, parenteral), all these questions will be answered and practical case studies will be presented.
More details can be found in the online edition of the PF.