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Coordinated research project on radiation sterilization and decontamination of pharmaceuticals and pharmaceutical raw materials. CRP report

Abstract

Radiation processing is a very convenient tool for imparting desirable effects in materials and it has been an area of enormous interest in the last few decades. Radiation processing of synthetic and natural polymers for improving their characteristics is largely used in laboratory and industrial scale. Radiation sterilization is a well developed and established technology for many products. It is especially useful for the treatment of pharmaceuticals due to flexibility of radiation processing to be carried out at any desired temperature, sterilizability of mixed products in kits, offering simultaneous sterilization and modification of polymer based formulations. The success of radiation technology for processing of synthetic and natural polymers and treatment of pharmaceuticals has been based, to a large extent, on empirical knowledge. But now, the applications of natural polymers are being sought in knowledge-demanding areas such as pharmacy and biotechnology. Reliable analytical methods are being developed for controlling of degradation effects of radiation on polymers. Procedures and chemical formulations are being investigated enhancing or preventing degradation effects depending on the desired application of the process. The Coordinated Research Project (CRP) on the use of radiation processing for sterilization or decontamination of pharmaceuticals and pharmaceutical raw materials has been completed in  More>>
Authors:
"NONE"
Publication Date:
Jul 01, 2005
Product Type:
Technical Report
Report Number:
INIS-XA-823
Resource Relation:
Other Information: Refs, figs, tabs
Subject:
60 APPLIED LIFE SCIENCES; AQUEOUS SOLUTIONS; BIOTECHNOLOGY; COORDINATED RESEARCH PROGRAMS; DECONTAMINATION; DRUGS; HERBS; LEADING ABSTRACT; MEDICINE; POLYMERS; POLYSACCHARIDES; RADIOLYSIS; RADIOSTERILIZATION; RAW MATERIALS
OSTI ID:
20693050
Research Organizations:
International Atomic Energy Agency, Division of Physical and Chemical Sciences, Vienna (Austria)
Country of Origin:
IAEA
Language:
English
Other Identifying Numbers:
TRN: XA0502755009874
Availability:
Available from INIS in electronic form
Submitting Site:
INIS
Size:
126 pages
Announcement Date:
Mar 22, 2006

Citation Formats

Coordinated research project on radiation sterilization and decontamination of pharmaceuticals and pharmaceutical raw materials. CRP report. IAEA: N. p., 2005. Web.
Coordinated research project on radiation sterilization and decontamination of pharmaceuticals and pharmaceutical raw materials. CRP report. IAEA.
2005. "Coordinated research project on radiation sterilization and decontamination of pharmaceuticals and pharmaceutical raw materials. CRP report." IAEA.
@misc{etde_20693050,
title = {Coordinated research project on radiation sterilization and decontamination of pharmaceuticals and pharmaceutical raw materials. CRP report}
abstractNote = {Radiation processing is a very convenient tool for imparting desirable effects in materials and it has been an area of enormous interest in the last few decades. Radiation processing of synthetic and natural polymers for improving their characteristics is largely used in laboratory and industrial scale. Radiation sterilization is a well developed and established technology for many products. It is especially useful for the treatment of pharmaceuticals due to flexibility of radiation processing to be carried out at any desired temperature, sterilizability of mixed products in kits, offering simultaneous sterilization and modification of polymer based formulations. The success of radiation technology for processing of synthetic and natural polymers and treatment of pharmaceuticals has been based, to a large extent, on empirical knowledge. But now, the applications of natural polymers are being sought in knowledge-demanding areas such as pharmacy and biotechnology. Reliable analytical methods are being developed for controlling of degradation effects of radiation on polymers. Procedures and chemical formulations are being investigated enhancing or preventing degradation effects depending on the desired application of the process. The Coordinated Research Project (CRP) on the use of radiation processing for sterilization or decontamination of pharmaceuticals and pharmaceutical raw materials has been completed in 2002. The overall objective of the CRP was to coordinate the research and development programmes carried out in different countries in use of radiation processing for sterilization or decontamination of pharmaceuticals and pharmaceutic raw materials. It has been concluded that in addition to well known advantages of radiation sterilization being a well developed and established technology requiring the control of only one parameter, dose, to achieve sterilization; it is especially useful for the treatment of pharmaceuticals due to flexibility of radiation processing to be carried out at any desired temperature, sterilizability of mixed products in kits, offering simultaneous sterilization and modification of polymer based formulations. Radiation sterilization has already demonstrated its advantages over conventional (chemical) methods, with the scale of its application rising. The results of the CRP demonstrated new fields of applications and roles of the process in the decontamination of natural medical herbs, which finds increasing usage worldwide. The process application for synthetic pharmaceuticals sterilization has also been demonstrated. The analytical and processing procedures were elaborated for selected materials. The radiation effects on drugs of different types and on traditional herbal medicine components (e.g.Traditional Chinese Medicines) were investigated, in particular the identification of the products of radiolysis was achieved and evaluation of their role in changing of biological activity of radiation sterilized pharmaceuticals was performed. Some of the methods were introduced to the manufacturer practice. New TC projects in the field were initiated. Despite all these apparent advantages, radiation sterilization of pharmaceuticals has to be addressed on a case by case basis. It has been concluded that radiation sterilization of aqueous solutions and suspensions of most organic substances is difficult if not impossible. The trends and opportunities of using radiation processing for sterilization and decontamination of pharmaceutical raw materials and herbs have been evaluated. Proteins and polysaccharides and their formulations and new biotechnology products are currently being considered for radiation sterilization.}
place = {IAEA}
year = {2005}
month = {Jul}
}