Developing a low-cost depyrogenation process is vital in extending medical applicability of polymers that can be used in medicine. We present an overview of the plasma-based depyrogenation literature and address the need to develop a non-thermal plasma-based depyrogenation process for delicate materials such as chitosan. We present a low-cost plasma apparatus to treat chitosan powder in hermetically sealed bags. We decouple the experiments into two; depyrogenation experiments for dried standard endotoxin on glass slides, and chitosan modifications analysis through FTIR spectroscopy. We demonstrate depyrogenation efficacy with up to a 4-log reduction in endotoxin levels and discuss minor changes observed in plasma-treated chitosan.
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http://dx.doi.org/10.1002/ppap.202100089 | DOI Listing |
PDA J Pharm Sci Technol
November 2024
Schott AG.
This paper is the result of a round robin activity run by the Technical Committee TC12, Pharma Packaging, of the International Commission on Glass (ICG). The study was motivated by a concern about the risk that the depyrogenation treatment of glass vials, when performed in an abnormal way that deviates from the usual procedure, may have a negative impact on the hydrolytic resistance of the container inner surface. The study was executed by using 10 ml clear type I Borosilicate glass vials representing four different compositions.
View Article and Find Full Text PDFEur J Hosp Pharm
December 2024
Service Pharmaceutique, Plateforme FRIPHARM, Groupement Hospitalier Centre, Hôpital Edouard Herriot, Place d'Arsonval, Hospices Civils de Lyon, Lyon, Auvergne-Rhône-Alpes, France
Introduction: The COVID-19 pandemic has led to unforeseen and novel manifestations, as illustrated by the management of drug shortages through the development of hospital production of sterile pharmaceutical preparations (P2S). Visual inspection of P2S is a release control whose methods are described in monographs of the European Pharmacopoeia (2.9.
View Article and Find Full Text PDFAnn Biomed Eng
May 2024
Center for Innovation, Technology and Education - CITÉ, Parque de Inovação Tecnológica de São José dos Campos, São José dos Campos, SP, 12247-016, Brazil.
Human amniotic membrane (hAM) is an important biomaterial for Tissue Engineering, due to its great regenerative properties and potential use as a scaffold. The most used procedure to sterilize biomaterials is gamma-irradiation, but this method can affect several properties, causing damage to the structure and reducing the growth factors. The present work evaluated the efficiency of a new method based on ozonated dynamic water for hAM sterilization.
View Article and Find Full Text PDFJ Pharm Sci
April 2023
Pfizer, Inc Global Supply, 1776 Centennial Dr., McPherson, KS 67460, USA.
Vial breakage during lyophilization reduces yield and can lead to product contamination with glass particulates, personnel interventions during manufacturing and damage to equipment. We present case studies of full-scale commercial lyophilization operations and small-scale laboratory lyophilization studies to understand and mitigate the sources of vial breakage for sterile injectable products. In the first case study, changes to the lyophilization cycle caused the breakage of 11% of the vials.
View Article and Find Full Text PDFJ Pharm Sci
December 2022
Process Development, Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA 91320, United States.
A new type of lamellae-like particles was observed in protein based liquid therapeutic protein drug product (DP) packaged in standard (STD) and delamination controlled (DC) Type IB glass vials stored at 2-8°C as early as two weeks after manufacture. These particles were determined to be remarkably different from lamellae in not only in their chemical composition, but in the mechanism by which these are formed. The lamellae-like particles were an ultra-thin (< 200 nm) film, appeared curled, sheet-like, folded with no defined edges identified as lamellar silica composed of silica and polysorbate 80 (PS 80).
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