Advancements in internationally accepted standards for radiation processing

Three subcommittees of the American Society for Testing and Materials (ASTM) are developing standards on various aspects of radiation processing. Subcommittee E10.01 “Dosimetry for Radiation Processing” has published 9 standards on how to select and calibrate dosimeters, where to put them, how many to use, and how to use individual types of dosimeter systems. The group is also developing standards on how to use gamma, electron beam, and x-ray facilities for radiation processing, and a standard on how to treat dose uncertainties. Efforts are underway to promote inclusion of these standards into procedures now being developed by government agencies and by international groups such as the United Nations' International Consultative Group on Food Irradiation (ICGFI) in order to harmonize regulations and help avoid trade barriers.

Subcommittee F10.10 “Food Processing and Packaging” has completed standards on good irradiation practices for meat and poultry and for fresh fruits, and is developing similar standards for the irradiation of seafood and spices. These food-related standards are based on practices previously published by ICGFI.

Subcommittee E10.07 on “Radiation Dosimetry for Radiation Effects on Materials and Devices” principally develops standards for determining doses for radiation hardness testing of electronics. Some, including their standards on the Fricke and TLD dosimetry systems are equally useful in other radiation processing applications.     

Provisional regulation of metrological supervision and management for radiation processing in China

In order to implement the “Law of metrology of the People's Republic of China” for guaranteeing the product quality of radiation processing, safeguarding State's interest and people's health, promoting the progress of radiation processing techniques, SBTS and SCST have jointly issued “the Provisional Regulation of Metrological Supervision and Management for Radiation Processing”, according to present situation of ionizing radiation measurement in radiation precessing plants. This is an administrative rule, which provides the regulation of radiation measurement licence for radiation precessing plants. SBTS has decided to establish the State Office of Technical Examination for Measurement Licence of Radiation Processing, which is attached to the National Institute of Metrology (NIM). Its main tasks include establishment of examination plans for radiation processing licence, organization of technical examination and other works related to the measurement regulation and performance of measurement supervision and regulation inradiation processing fields.     

Detection of prior irradiation of dried fruits by electron spin resonance (ESR)

Dried almonds, raisins, dates and pistachio were irradiated using either gamma radiation or electron beam, at an average absorbed dose of 5 kGy. To detect the previous irradiation different parts of the dried fruits were analyzed by ESR spectroscopy: almonds: skin; raisins: dried pulp; dates: dried pulp and stone; pistachio: nutshell. Analyses were carried out 2–3 months and 6 months after irradiation. A series of signals tentatively described as “cellulose-like”, “sugar-like” and “complex” radical were observed, and some slight differences between spectra from samples irradiated with gamma rays and electrons were evident.     

ISO radiation sterilization standards

This presentation provides an overview of the current status of the ISO radiation sterilization standards. The ISO standards are voluntary standards which detail both the validation and routine control of the sterilization process. ISO 11137 was approved in 1994 and published in 1995. When reviewing the standard you will note that less than 20% of the standard is devoted to requirements and the remainder is guidance on how to comply with the requirements.

Future standards developments in radiation sterilization are being focused on providing additional guidance. The guidance that is currently provided in informative annexes of ISO 11137 includes: device/packaging materials, dose setting methods, and dosimeters and dose measurement, currently, there are four Technical Reports being developed to provide additional guidance:

1. 1. AAMI Draft TIR, “Radiation Sterilization Material Qualification”

2. 2. ISO TR 13409-1996, “Sterilization of health care products — Radiation sterilization — Substantiation of 25 kGy as a sterilization dose for small or infrequent production batches”

3. 3. ISO Draft TR, “Sterilization of health care products — Radiation sterilization Selection of a sterilization dose for a single production batch” li]4. ISO Draft TR, “Sterilization of health care products — Radiation sterilization-Product Families, Plans for Sampling and Frequency of Dose Audits.”

     

How gamma radiation processing systems are benefiting from the latest advances in information technology

This paper discusses how gamma irradiation plants are putting the latest advances in computer and information technology to use for better process control, cost savings, and strategic advantages.

Some irradiator operations are gaining significant benefits by integrating computer technology and robotics with real-time information processing, multi-user databases, and communication networks. The paper reports on several irradiation facilities that are making good use of client/server LANs, user-friendly graphics interfaces, supervisory control and data acquisition (SCADA) systems, distributed I/O with real-time sensor devices, trending analysis, real-time product tracking, dynamic product scheduling, and automated dosimetry reading. These plants are lowering costs by fast and reliable reconciliation of dosimetry data, easier validation to GMP requirements, optimizing production flow, and faster release of sterilized products to market.

There is a trend in the manufacturing sector towards total automation using “predictive process control”. Real-time verification of process parameters “on-the-run” allows control parameters to be adjusted appropriately, before the process strays out of limits. Applying this technology to the gamma radiation process, control will be based on monitoring the key parameters such as time, and making adjustments during the process to optimize quality and throughput. Dosimetry results will be used as a quality control measurement rather than as a final monitor for the release of the product. Results are correlated with the irradiation process data to quickly and confidently reconcile variations. Ultimately, a parametric process control system utilizing responsive control, feedback and verification will not only increase productivity and process efficiency, but can also result in operating within tighter dose control set points.     

Application of egs4 computer code for determination of gamma ray spectrum and dose rate distribution in gammacell 220

The EGS4 a Monte Carlo electron-photon transport simulation package together with a locally developed computer program “GCELL” has been used to simulate the transport of the gamma rays in Gammacell 220. An additional lead attenuator has been inserted in the chamber, has been included for those cases where lower dose rates were required.

For three cases of 0, 1.35 and 4.0 cm thickness of added lead attenuators, the gamma spectrum, and dose rate distribution inside the chamber have been determined. For the case of no attenuator present, the main shield around the source cage has been included in the simulation program and its albedo effects have been investigated.

The calculated dose rate distribution in the Gammacell chamber has been compared against measurements carried out with Fricke, PMMA and Gafchromic film dosimeters.     

Improvement of plant parameters of the ROBO gamma irradiation facility due to design modification

Two industrial scale, “ROBO” type ⁶⁰Co gamma irradiation facilities have recently been put into operation in Syria and Peru, and the dosimetry commissioning of both plants have been carried out to determine dose distribution within products and to calculate plant parameters such as efficiency, dose uniformity ratio and throughput. There are some design modifications between the two plants in connection with the location of the carriers with respect to the source plaque and also to each other. The effect of these construction modifications on the plant parameters is discussed in the analysis of the dose distribution data measured in the carriers with depth and height among the four irradiation rows on both sides of the source plaque. The plant parameters were also calculated for different product densities using the technical data of the facilities, and the calculated and measured results were compared to each other.     

Dose distribution in polyethylene irradiated with A 10-MeV electron beam

Radiation modification of the gel content and the complex modulus of plastics was used to determine the depth-dose distribution in a solid polyethylene block irradiated with a 10 MeV electron beam, under typical radiation processing conditions. The results indicate that the accumulated charge has no significant effect on the shape of the dose profile. This suggests that, under certain circumstances, intrinsic “dosimeters” could be more appropriate than conventional thin film dosimeters placed inside the material for dose measurements in electrically non-conducting materials.     

Dosimetric application of lyoluminescence using some saccharides

A measurement system for lyoluminescence has been constructed using a photon-counting apparatus equipped with a highly sensitive photomultiplier and a microcomputer for a data acquisition and processing. For the lyoluminescent dosimetry, seven saccharide samples, including five monosaccharides (glucose, mannose, galactose, levulose and ribose) and two disaccharides (sucrose and trehalose), were irradiated with 60Co gamma rays. Effects on lyoluminescence were examined of the amounts of the sample, concentration of luminol phosphor in an aqueous solution, elapsed time after mixing the samples in the solution, variations of absorbed doses, annealing treatments and different radiation fields. The results revealed that relatively small amounts of sample, say 3 mg, is sufficient for reproducible routine analyses by using 125 mg luminol/l for 10 s data accumulation, and that the lyoluminescent dosimetry is useful for the significantly high dose regions of 1Gy-10kGy (the use of galactose and trehalose can extend the dose-region to higher levels). The comparison of sensitivity for samples with the same dose (215 Gy) showed the great luminescent changes over one order of magnitude between the highest value for galactose and lowest one for ribose, although there is no substantial difference in the structure. No meaningful radiation-quality effect was observed for monosaccharides irradiated with gamma-rays, X-rays, and neutrons.     

Radiation sterilization of enzyme hybrids with biodegradable polymers

Ionizing radiations, which have already been utilized for the sterilization of medical supplies as well as gas fumigation, should be the final candidate to decontaminate “hybrid” biomaterials containing bio-active materials including enzymes because irradiation induces neither heat nor substances affecting the quality of the materials and our health. In order to check the feasibility of ⁶⁰Co-gamma rays on these materials, we selected commercial proteases including papain and bromelain hybridized with commercial activated chitosan beads and demonstrated that these enzyme-hybrids suspended in water showed the significant radiation durability of more than twice as much as free enzyme solution at 25-kGy irradiation. Enhanced thermal and storage stability of the enzyme hybrids were not affected by the same dose level of irradiation, either, indicating that commercial irradiation sterilization method is applicable to enzyme hybrids without modification.     

Dosimetry characteristics of the nitro blue tetrazolium-polyvinylalcohol film for high dose applications

The dosimetry characteristics of a polyvinylalcohol based radiochromic dye film containing the ditetrazolium salt nitro blue tetrazolium chloride were studied with respect to the potential use of the films for routine dosimetry in radiation processing. The useful dose range for the dosimeter film for gamma and electron irradiation is 5–50 kGy depending on the concentration of the dye. The effects of irradiation temperature and humidity, as well as the stability of the response of the film before and after irradiation, were investigated and determined. Formulations for preparation of the films with different concentrations of the dye and with different pH were tested. The films were also tested in industrial gamma irradiation facilities for process control purposes by comparing their performance with transfer standard dosimeters.     

CCRI supplementary comparison of standards for absorbed dose to water in 60Co gamma radiation at radiation processing dose levels

Six national standards for absorbed dose to water in ⁶⁰Co gamma radiation at the dose levels used in radiation processing have been compared over the range from 5 to 30 kGy using the alanine dosimeters of the NIST and the NPL as the transfer dosimeters. The standards are in agreement at the level of around 0.5%, which is significantly smaller than the stated standard uncertainties.     

A novel approach towards development of real time chemical dosimetry using pulsating sensor-based instrumentation

The paper presents an innovative approach towards development of real time dosimetry using a chemical dosimeter for measurement of absorbed radiation dose in the range between 1 and 400 Gy. Saturated chloroform solution in water, a well known chemical dosimeter, is used to demonstrate the concept of online measurement of radiation dose. The measurement approach involves online monitoring of increase in conductivity of saturated chloroform solution due to progressive build up of traces of highly conducting HCl during exposure to gamma irradiation. A high performance pulsating sensor-based conductivity monitoring instrument has been used to monitor such real time change in conductivity of solution. A relation between conductivity shift and radiation dose has been established using radiochemical yield value (G value) of HCl. The G value of HCl in saturated chloroform dosimeter has been determined using laboratory developed pulsating sensor-based devices. In this connection dose rate of Co-60 gamma chamber was determined using Fricke dosimeter following a simple potentiometric measurement approach developed in-house besides conventional spectrophotometry. Results obtained from both measurement approaches agreed well. Complete instrumentation package has also been developed to measure real time radiation dose. The proposed real time radiation dosimeter is successfully tested in several measurement campaigns in order to assure its performance prior to its deployment in field.     

Sterilization of Bacillus spores by converted X rays

Relative sensitivities of endospores of Bacillus pumilus E601, B. subtilis IAM1069, B. megaterium S31 and B. brevis S5 to gamma rays, converted X rays (bremsstrahlung) and electron beams were examined in order to estimate the conditions in which converted X rays kill Bacillus spores. The radiation sensitivities to gamma rays and electron beams of each strain dried on glass fiber filter without additives were found to be almost equivalent, and D values were obtained as follows: 1.5–1.6 kGy for B. pumilus, 1.4–1.5 kGy for B. subtilis, 1.9–2.0 kGy for B. megaterium and 1.6–2.0 kGy for B. brevis. The radiation sensitivities of endospores of each strain to electron beams were slightly lower than those to gamma rays in the dry condition with additives of 2% peptone + 1 % glycerin on glass fiber filters. The increase of radiation resistance in the presence of additives was also observed with X rays, and it was on an intermediate level between those with gamma rays and electron beams. In the dry condition using cellulose filter paper, only the radiation resistances of B. megaterium and B. brevis in the presence of additives B. megaterium and B. brevis in the presence of additives were increased.     

Preparation of alpha-elastin nanoparticles by gamma irradiation

Nanoparticles were prepared by utilizing the thermosensitive aggregation of alpha-elastin and gamma ray crosslinking. Three different heating process, “Slow heating”, “Fast heating”, and “Heat shock”, were applied for the aggregation of the alpha-elastin and examined to yield nanoparticles by gamma rays crosslinking. As a result, only “Slow heating” process yielded nanoparticles with diameters of about ca. 300 nm above cloud point (CP) and about ca. 100 nm below CP, and a narrow size distribution above 1.0 mg/ml concentration (exclude 1.0 mg/ml).     

Uncertainties of gas chromatographic measurement of troublesome pesticide residues in apples employing conventional and mass spectrometric detectors

In recent years the declaration of estimated uncertainty of measurement has become an integral part of analytical results. This study presents the assessment of results generated within the analysis of selected pesticides represented by carbamates, pyrethroides and azoles, residues of which may be found in treated apples. Multiresidue method used for analysis of spiked samples (residues at levels 0.040–0.163 mg/kg) consisted of (i) ethyl acetate extraction, (ii) GPC clean-up and (iii) identification/quantification of residues by GC. Procedures utilizing either conventional (electron-capture, nitrogen–phosphorus) or mass-selective detectors (quadrupole and ion trap analyzer) were evaluated. The results generated through alternative strategies of uncertainty estimation (“bottom-up”, “top-down”) were compared.

Using the “bottom-up” approach uncertainty of extraction which comprises two components—(i) repeatability of extraction and (ii) uncertainty of extraction recovery was shown to represent the main source of combined standard uncertainty (values of uncertainty of extraction for tested pesticides ranged from 4.6% to 21.6%). On the other hand, uncertainties associated with the GC calibration (uncertainties of weighing and diluting standards, uncertainties of purity of standards) were not so important (most of them did not exceed 2%). Combined standard uncertainties associated with the described analytical method ranged for individual compounds from 9.3% to 24.3%. Similar values of combined standard uncertainties were obtained using the alternative “top-down” approach.     

The radiation resistance of the bioburden from medical devices

An extensive study of the radiation resistance of microbial species constituting the bioburden of a number of different medical devices obtained from Japanese medical device manufacturers has been carried out. A standard protocol for determining radiation resistance was used and validated at the fourteen centres involved in the study. Individual microbial isolates from the bioburden obtained from seven different devices manufactured in these centres were studied. A total of 3742 unselected isolates were obtained, of which 197 failed to survive long enough for subsequent radiation resistance studies. The remainder were subjected to an initial screen test to identify those organisms that were sensitive to the lethal effects of radiation with a D₁₀ of < 1.5kGy. The 465 isolates that survived the screen doses were then tested for survival in an incremental series of radiation doses using methods similar to those of Whitby (1979) and Yan and Tallentire(1995). The isolates from “dry” devices were more resistant than those obtained from the one water filled (“wet”) device studied. The overall distribution of radiation resistance among the isolates was considered to be similar to that forming the “Standard Distribution of Resistance” (SDR) included in the ISO International Standard 11137 “Sterilization of Health Care Products — Requirements for validation and routine control — Radiation sterilization”.     

Dosimetry for radiation processing in Malaysia

The development of accurate and precise radiation dosimetry to control radiation-processing activity in Malaysia is discussed. Various procedures required to establish thorough dosimetry control for radiation processing in Malaysia is highlighted. The validity of the measurement process is guaranteed through regular quality control including standardization, calibration and intercomparison against other international institutes.     

Zur nomenklatur der phane—II

The new term “Phanes” has been clearly defined and a nomenclature system tentatively developed. This system is comprehensible and of general application and at the same time relatively simple. The notations “nucleus”, “bridge”, “number of bridge members” and “number of ring members” are defined. In order to get a definite characterisation of the phanes which contain a carbocyclic nucleus, a carbocyclic and heterocyclic bridge the following terms: “carbophanes”, “carba-phanes” and “hetera-phanes” have been newly introduced. The prefix “hetera-” has been proposed as a general expression and as a representative term for the syllables “aza-”, “oxa-”, “thia-” and so on. The so called “a-nomenclature” is clearly called “hetera-nomenclature”. The new expressions “heteralogous” and “substitulogous” are explained. As the various examples will show, the “Phane-Nomenclature” can also be applied to the naming of complicated metallocenophanes.     

Consumer attitudes to radiation and irradiated potatoes at “radiation fair” in Osaka, Japan

“Radiation Fair” has been held in summer vacation season in August for more than 10 years in Osaka, the largest city of western Japan, for the purpose of public education and information transfer of radiation and radiation-related technology. We distributed questionnaires to the visitors for recent 3 years to inquire their status toward radiation and irradiated products including irradiated potatoes as well as impression toward the displays. According to the survey results, more than 60% of the kids visitors were satisfied with this exhibition as informative, more than half of the older visitors (16 years old and upward) indicated that they recognized the word of “radiation” when they were at elementary school and the most significant sources of this information were school lessons and the mass media. Consumer's image toward radiation seems to shift to more “positive” when correct knowledge about radiation is given. More than half of consumers did not know “irradiated potatoes” but the percentage indicating that irradiated potatoes was definitely hazardous was less than 10%.