Effects of Radiation sterilization Dose on the Molecular Weight and Gelling Properties of Commercial Alginate Samples

To estimate the molecular weight (Mw) and gelling properties, a total of 26 alginate samples consisting of control (n = 13) and 15 kGy γ-irradiated (n = 13) samples were characterized through viscometric and gel permeation chromatography (GPC-MALLS) methods. Based on the observations, a remarkable decrease in the intrinsic viscosity of all samples of alginates was evident due to the effects of radiation, with a linear relationship between viscosity and concentration in 0.01 M NaCl solution. The correlation among the Mw, percentage mass recovery, radii of gyration (Rz/Rg), and percentage reduction of Mw assessed by GPC was significant. The Mw decreased dramatically (from 3.1 × 105 to 0.49 × 105 mole/g in sample no. 12) by the effect of radiation with momentous relation to the % reduction of the molecular weight. The highest molecular weight reduction (84%), which is the most sensitive to γ-radiation, and the average reduction rate was ≥50%. The mass recovery was 100% obtained from samples no. 1,3,4,5,7,12, and 13, while the rest of the samples’ recovery rate was significantly higher. The reduction rate of mass molecular weight (Mw) is higher than the average molecular weight (Mv), but they showed a sensitivity towards radiation, consequently their performance are different from each other. The stability test was performed as a critical behaviour in the control, recurrently same as in the irradiated samples. Thus, the sterilization dose of 15 kGy for the Mw distribution, and subsequently for the characterization, was significantly effective.

Radiation Dose Audit Failures: Truth and Consequences

The validation of a radiation sterilization dose involves an initial sterilization dose determination as well as maintenance of that sterilization dose. The procedures for maintenance of the sterilization dose typically include the periodic use of two types of tests: bioburden and dose audits. The details for the procedures are outlined in the ISO radiation sterilization standards. These documents also provide guidelines for recommended actions in response to the results of the two tests. The results for the dose audit are based on the number of positive tests of sterility (TOS) for products that have been irradiated at a verification or experimental dose. When the dose audit yields TOS positives, it is often thought that they indicate a sterilization failure and nonsterile product. The belief that any TOS positive is a failure is an incorrect assumption because of the statistical basis used for the determination of the sterilization dose. This article will outline the truth of what dose audit TOS positives mean in terms of the sterility assurance of product, as well as the consequences of TOS positives.

TO EVALUATE THE QUALITY OF CRYOPRESERVED GAMMA-STERILIZED DOG SKULL AT TISSUE CRYOPRESERVATION UNIT - HUE UNIVERSITY OF MEDICINE AND PHARMACY HOSPITAL

Objective: To evaluate the effect of gamma sterilization and the changes in the durability and the histological structure of cryopreserved gamma-sterilized dog skull. Subjects and methods: 50 dog skull fragments had the same size (4 x 4 cm), which were taken at parieto-frontal region, symmetrically through the midline of the skull were divided into two lots. Evident lot consisting of 50 fragments were just cryopreserved, not irradiated by gamma rays. Experimental lot which composed of 50 fragments were cryopreserved and exposed to 25 kGy of gamma radiation. Afterwards, evaluating the changes in the durability, microscopic structure and the effectiveness of sterilization on the dog skull after being cryopreserved at -85 0C in 3 months and exposed a gamma sterilization. Results: The durability was decreased of 8.28% compared with the lot of dog skull just cryopreserved at -85 0C and not exposed a gamma sterilization. On histological structure, no difference was found between the two lots and there was no structural change in the irradiated dog skull. All gamma-sterilized dog skull fragments were negative with bacteria culture test. The gamma ray had the ability to kill bacteria completely in the type of bacteria commonly infected tissue. Conclusion: After being cryopreserved at -85 0C in 3 months and exposed a gamma sterilization dose of 25 KGy, the durability of dog skull was insignificantly decreased and the microscopic structure was not changed. All irradiated dog skull fragments were negative with bacteria culture test. Key words: dog skull, gamma, durability, irradiated

Identification of Radiodegradation Products of Acebutolol and Alprenolol by HPLC/MS/MS

Two therapeutically active compounds from the group of β-blockers, acebutolol (AC) and alprenolol (AL), in solid form were subjected to ionizing radiation emitted by a beam of high energy electrons from an accelerator with a standard sterilization dose of 25 kGy and in higher doses of 50–400 kGy. The effects of irradiation were detected by chromatographic methods (TLC, HPLC) and a hyphenated method (HPLC/MS/MS). No significant changes in the physicochemical properties of both compounds studied irradiated with 25 kGy were noted, but upon irradiation with the highest dose (400 kGy) the loss of AC and AL content determined by HPLC was 2.79 and 9.12%, respectively. The product of AC decomposition and the two products of AL decomposition were separated and identified by HPLC/MS/MS. It has been established that radiodegradation of AC and AL takes place by oxidation, leading to formation of the products of radiolysis, most probably alcohol derivatives of the β-blockers studied. The additional product that appears on radiodegradation of AL is probably formed as a result of two simultaneous reactions: oxidation and CH2 group elimination.