Search results for "Aseptic processing"
showing 7 items of 17 documents
Simple Solution for Single Final Vial Filling of Ga-68 Radiopharmaceuticals in One Hot Cell Isolator at Small-Scale Radiopharmacy Laboratories under …
2020
A simple solution for fulfilling biosafety and national drug agency demands of radiation and biosafety during Ga-68 radionuclide containing radiopharmaceutical production (RP) by small scale laboratories has been demonstrated based on a novel sterile seal concept of multi-layer bag system prototype. These mid-and inner enclosures of the prototype with vial inside were sterilized by 50 kGy of gamma radiation. The microbial safety validation based on two-week testing confirmed successful sterilization of the sealing bags with vails. The analysis of physicochemical properties, namely mechanical properties, gel fraction studies revealed that sterilization did not cause any undesired changes in …
Aseptic Production vs. Terminal Sterilization
2000
The safety of substance use in intraocular surgery ideally requires the absence of all biologically-active components capable of causing an inflammatory reaction. Substance purity is achieved with isolation and cleansing methods (e.g., of the polysaccharide), which remove any biological component with infective potential. The methods of production for polysaccharide isolation should remove biological agents, regardless of its origin. Hyaluronic acid is isolated either from rooster combs or biological fermentation. Use of this substance showed the development of postoperative intraocular inflammatory reactions resulting from contaminations from both sources. OVD should have low endotoxin val…
Mechanisms of Disease: molecular insights into aseptic loosening of orthopedic implants
2007
Despite the success of treating rheumatic disorders with biologic therapies, joint replacement surgery still remains the final treatment option in many cases. Approximately 1.5 million joint arthroplastic operations are performed annually worldwide. Implant failure due to massive bone loss and aseptic loosening of prostheses, however, is a major complication of joint replacement, which can lead to high socioeconomic burdens both for the individual patient and for health-care systems. To date, there is no approved drug therapy to prevent or inhibit periprosthetic osteolysis, and aseptic loosening of prostheses can only be overcome by surgical revision. Research during the past decade, howeve…
Experimental Evaluation of a New Thermal Process for Microorganisms Inactivation
2015
A new thermal process for the inactivation of microorganisms in beverages has been studied and is presented in this paper. The treatment, not yet studied in the scientific literature, mainly consists of a thermal shock characterized by temperature increases up to 30°C/s, with final temperatures up to 65°C. This study presents the first experimental results obtained by the application of the new thermal treatment, with different combinations of the process parameters (rate of temperature rise, final temperature and holding time), on separate suspensions of Pseudomonas aeruginosa, Escherichia coli, Staphylococcus aureus, Listeria innocua and Candida albicans. The required rapid temperature in…
Efficacy of four cleaning solutions for the decontamination of selected cytotoxic drugs on the different surfaces of an automated compounding system
2018
The automated aseptic preparation of ready-to-administer antineoplastic drug solutions with robotic systems reduces the risk of occupational exposure. However, the surfaces in the preparation area of the robot are to be cleaned by wiping with an appropriate cleaning solution. The aim of the study was to evaluate the cleaning efficacy of four cleaning solutions on four surface materials installed in the APOTECAchemo robot. Predefined amounts of cisplatin (Cis), 5-fluorouracil (5-FU), and cyclophosphamide (CP) were intentionally spread on test plates made of stainless steel, aluminium, polyoxymethylene, and polycarbonate just as installed in the robotic system APOTECAchemo. After drying, the …
Is the re-use of sterilized implant abutments safe enough? (Implant abutment safety)
2019
Background: The reuse of implant healing abutments is common in dental practice. Effective elimination of bacteria and viruses is accomplished by conventional sterilization. The aim of this work was to explore the eventual survival of microorganisms on sterilized healing abutments and to rule out the presence of transmissible organic material after standard procedures. Material and Methods: A total of 55 healing abutments previously used in patients will be washed and sterilized in a steam autoclave at 121oC for 15 min. Each healing abutment will be cultured in Brain Heart Infusion broth (BHI) under strict aseptic conditions. Besides, two control groups will be included: one of 3 unused hea…
Media-fill simulation tests in manual and robotic aseptic preparation of injection solutions in syringes
2014
Objective The purpose of this study was to evaluate the contamination rate of media-fill products either prepared automated with a robotic system (APOTECAchemo™) or prepared manually at cytotoxic workbenches in the same cleanroom environment and by experienced operators. Media fills were completed by microbiological environmental control in the critical zones and used to validate the cleaning and disinfection procedures of the robotic system. Methods The aseptic preparation of patient individual ready-to-use injection solutions was simulated by using double concentrated tryptic soy broth as growth medium, water for injection and plastic syringes as primary packaging materials. Media fills w…