Radiation‐induced migration of additives in PVC‐based biomedical disposable devices. Part 1. Surface morphology by AFM and SEM/XEDS

Two different types of plasticized poly(vinyl chloride) (PVC) used for biomedical disposable devices—extruded and injection moulded—were studied in the non‐sterilized condition and after 25 and 50 kGy of beta irradiation. The polymer surfaces were analysed by scanning electron microscopy (SEM) equipped with an x‐ray energy‐dispersive spectroscopy (XEDS) and by atomic force microscopy (AFM). The inner surface of two parts of a venous line showed a different morphology according to their original formulation (for extrusion or injection moulding process) and reacted differently on sterilization with beta irradiation. Moulded parts were affected only slightly by the radiation step, whereas the variations were bigger for the extruded parts. In order to gain the best performances for the medical devices studied, the utmost care must be taken in the sterilization step, which should be optimized as well as the other steps of the manufacturing process. Copyright © 2003 John Wiley & Sons, Ltd.     

Current R & D activities at TRCRE in polymer processing by EB

The current status of the R & D activities is presented on electron beam processing of polymers being carried out at TRCRE. Topics included are sterilization of medical products, graft polymers for selective separation or absorbents and curing of liquid prepolymer-monomer systems.     

Development of honey hydrogel dressing for enhanced wound healing

Radiation at 25 and 50 kGy showed no effect on the acidic pH of the local honey, Gelam, and its antimicrobial property against Staphylococcus aureus but significantly reduced the viscosity. Honey stored up to 2 years at room temperature retained all the properties studied. Radiation sterilized Gelam honey significantly stimulated the rate of burn wound healing in Sprague-Dawley rats as demonstrated by the increased rate of wound contraction and gross appearance. Gelam honey attenuates wound inflammation; and re-epithelialization was well advanced compared to the treatment using silver sulphadiazine (SSD) cream. To enhance further the use of honey in wound treatment and for easy handling, Gelam honey was incorporated into our hydrogel dressing formulation, which was then cross-linked and sterilized using electron beam at 25 kGy. Hydrogel with 6% of honey was selected based on the physical appearance.     

Photocatalytic activity and biodegradation of polyhydroxybutyrate films containing titanium dioxide

This study aims to evaluate the photocatalytic activity and biodegradation of polyhydroxybutyrate (PHB) films containing titanium dioxide (TiO₂). Nanosized TiO₂ photocatalysts were immobilized onto PHB film to overcome the difficulty of the recovery process. PHB is a suitable base material as it is naturally biodegradable and is produced from renewable resources. The photocatalytic degradation of organic compounds, photocatalytic sterilization activity and biodegradation rate in garden soil of PHB-TiO₂ composite films were investigated. After an hour under solar illumination, 96% of methylene blue solution was decolorized. The antibacterial activity against Escherichia coli (E. coli) using PHB-TiO₂ composite film exhibited enhanced photocatalytic sterilization activity over time. As for the ability to biodegrade, PHB-TiO₂ composite films placed on soil surface with no direct solar illumination showed slower degradation rate compared to those receiving direct solar illumination. Interestingly, the latter composite films showed faster degradation rates compared to pure PHB films indicating that the degradation is mainly due to photocatalytic activity. PHB-TiO₂ composite films buried in soil generally showed slower degradation rates compared to pure PHB films and were dependent on the soil microbial activity.     

Studies on the disposable obstetrical dressings sterilized by radiation and the effect of its application

In order to attain an optimum sterilization treatment to obstetric dressings, a new product made by us, with ⁶⁰Coγ-ray, the effects of radiation on standard bacteria pseudomonas aeruginosa ATcc27853, Escherichia coli ATcc25922, Staphylococcus aureus ATcc25923, Clostridium PB6KA, short Bacillus E60163202 and HBSAg were studied. Results showed that at the absorbed dose of 10 kGy, all the bacteria, bacillus and HBSAg were killed off, and sterilized with the dose, the dressings can completely accord with the demands of hygiene, which was further confirmed by microbiological and poisonous tests and the effects of clinical application. In Nov. 1988, the dressings was awarded the excellent prize in the 1st international exhibition of patent, new technique and new equipment in Guangzhou; its effective application is also reported in the paper.     

The effect of composition of parenteral solution on the thermal resistance of Bacillus stearothermophilus and Bacillus subtilis spores

Large-volume parenteral solutions were submitted to heat treatments after being inoculated with Bacillus stearothermophilus ATCC 7953 (T _r =121°C) and Bacillus subtilis ATCC 9372 (T _r =104.5°C) spores. The average decimal reduction time for B. stearothermophilus ranged from a D _121°C value of 1.31 to 3.14 min, in glucophysiologic and Ringer’s solutions respectively. For B. subtilis, D _104.5°C value increased from 0.69 to 1.37 min, in Ringer’s (pH=5.91) and 50% glucose (pH 3.05) solutions respectively. The z value ranged from 7.95°C (20% mannitol solution) to 13.14°C (50% glucose solution), corresponding to an activation energy (Ea) of 81.48 and 49.30 kcal/mol, respectively.     

Field evaluations of the VDmax approach for substantiation of a 25 kGy sterilization dose and its application to other preselected doses

The International and European standards for radiation sterilization require evidence of the effectiveness of a minimum sterilization dose of 25 kGy but do not provide detailed guidance on how this evidence can be generated. An approach, designated VD_max, has recently been described and computer evaluated to provide safe and unambiguous substantiation of a 25 kGy sterilization dose. The approach has been further developed into a practical method, which has been subjected to field evaluations at three manufacturing facilities which produce different types of medical devices. The three facilities each used a different overall evaluation strategy: Facility A used VD_max for quarterly dose audits; Facility B compared VD_max and Method 1 in side-by-side parallel experiments; and Facility C, a new facility at start-up, used VD_max for initial substantiation of 25 kGy and subsequent quarterly dose audits. A common element at all three facilities was the use of 10 product units for irradiation in the verification dose experiment.

The field evaluations of the VD_max method were successful at all three facilities; they included many different types of medical devices/product families with a wide range of average bioburden and sample item portion values used in the verification dose experiments. Overall, around 500 verification dose experiments were performed and no failures were observed. In the side-by-side parallel experiments, the outcomes of the VD_max experiments were consistent with the outcomes observed with Method 1.

The VD_max approach has been extended to sterilization doses >25 and <25 kGy; verification doses have been derived for sterilization doses of 15, 20, 30, and 35 kGy. Widespread application of the VD_max method for doses other than 25 kGy must await controlled field evaluations and the development of appropriate specifications/standards.     

Effect of γ-radiation on ointment cold cream

In this paper, Co-60γ ray was used to irradiate the ointment cold cream at room temperature (25°C). We also used FTIR, GC and thin film chromatogram to analyse various irradiated samples. It was found that the ointment cold cream can be irradiated at dose of 5–35 kGy and at dose rate from 0.2 to 0.6 kGy/h at room temperature (25°C) without evident decomposition. At dose of 5–15 kGy, the number of bacteria can be reduced to hygienic standard value. The radiation sterilization is a safe method for killing the bacteria in the ointment cold cream.     

Effect of Topology on Photodynamic Sterilization of Porphyrinic Metal-Organic Frameworks

Porphyrinic metal-organic frameworks (MOFs) are promising photosensitizers due to the lack of self-aggregation of porphyrin in aqueous solution. However, how the topology of porphyrinic MOFs affects the generation of singlet oxygen (¹O₂) is unclear. Here, the effect of the topology of porphyrinic MOFs on their photodynamic performance is reported. Four porphyrinic zirconium MOFs (MOF-525, MOF-545, PCN-223 and PCN-224 with different topologies: ftw , csq , shp and she , respectively) were selected to study the influence of topology on the photodynamic antibacterial performance. The ¹O₂ generation and the photodynamic antibacterial performance followed an decreasing order of MOF-545>MOF-525>PCN-224>PCN-223. The results reveal that the pore size, the distance between porphyrin, and the number of porphyrin per Zr₆O₈ cluster in MOFs greatly affected ¹O₂ generation. This work provides guidance for designing new MOFs for efficient photodynamic sterilization.