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Metallurgical, manufacturing and surface finish requirements for high purity stainless steel system components.

The stainless steel piping systems that distribute water for injection (WFI) and other critical fluids in pharmaceutical and biotechnology plants will be the subject of this paper. We will confine our focus to the two major components of such systems--tubing and fittings. It should be noted that the discussions here can certainly be applied in the selection of other components such as valves, filter housings, pumps, and tanks used in these industries. The purpose of this paper will be to guide user choices with regard to raw material selection, surface preparation, and surface analysis within the context of system requirements. A suggested material specification for stainless steel tubing and fittings will also be presented.

Drug Industry↗

Urine chromium as an estimator of air exposure to stainless steel welding fumes.

Welding stainless steel with covered electrodes, also called manual metal arc welding, generates hexavalent airborne chromium. Chromium concentrations in air and post-shift urine samples, collected the same arbitrarily chosen working day, showed a linear relationship. Since post-shift urine samples reflect chromium concentrations of both current and previous stainless steel welding fume exposure, individual urine measurements are suggested as approximate although not exact estimators of current exposure. This study evaluates the practical importance of such measurements by means of confidence limits and tests of validity.

Adult↗

Variation in sessile microflora during biofilm formation on AISI-304 stainless steel coupons.

Coupons of stainless steel type AISI-304 were exposed to the industrial cooling system of a petrochemical plant fed by seawater from the Guanabara Bay, Rio de Janeiro, Brazil, in order to study the in situ formation of biofilms. Bacteria, microalgae and fungi were detected on the coupons as soon as 48 h after exposure. Their respective numbers were determined at times 48, 96 and 192 h and over the following 8 weeks. Aerobic, anaerobic and sulfate-reducing bacteria were quantified according to the technique of the most probable number, and fungi by the pour plate technique. The number of microorganisms present in the forming biofilm varied over the experimental period, reaching maximal levels of 14 x 10(11) cells cm-2, 30 x 10(13) cells cm-2, 38 x 10(11) cells cm-2 and 63 x 10(5) cells cm-2, respectively, for aerobic bacteria, anaerobic bacteria, sulfate-reducing bacteria and fungi, and the dynamics of this variation depended on the group of microorganisms. Bacillus sp, Escherichia coli, Serratia sp and Pseudomonas putrefaciens were identified among the aerobic bacteria isolated. Additionally, microalgae and bacteria of the genus Gallionella were also detected. Nonetheless, no evidence of corrosion was found on the stainless steel type AISI-304 coupons over the experimental period.

Bacteria, Aerobic↗

Kinetics of Pseudomonas aeruginosa adhesion to 304 and 316-L stainless steel: role of cell surface hydrophobicity.

Fifteen different isolates of Pseudomonas aeruginosa were used to study the kinetics of adhesion to 304 and 316-L stainless steel. Stainless steel plates were incubated with approximately 1.5 X 10(7) CFU/ml in 0.01 M phosphate-buffered saline (pH 7.4). After the plates were rinsed with the buffer, the number of adhering bacteria was determined by a bioluminescence assay. Measurable adhesion, even to the electropolished surfaces, occurred within 30 s. Bacterial cell surface hydrophobicity, as determined by the bacterial adherence to hydrocarbons test and the contact angle measurement test, was the major parameter influencing the adhesion rate constant for the first 30 min of adhesion. A parabolic relationship between the CAM values and the logarithm of the adhesion rate constants (In k) was established. No correlation between either the salt aggregation or the improved salt aggregation values and the bacterial adhesion rate constants could be found. Since there was no significant correlation between the bacterial electrophoretic mobilities and the In k values, the bacterial cell surface charge seemed of minor importance in the process of adhesion of P. aeruginosa to 304 and 316-L stainless steel.

Bacterial Adhesion↗

[Evaluation of correlation between radioactivity and exposure rate of irradiated concrete and stainless steel].

Cylindrical concrete and stainless steel blocks were irradiated one week by the cyclotron of Institute for Nuclear Study of University of Tokyo. Their gamma-ray activities were measured by a high-purity Ge( HPGe ) detector and simultaneously the residual exposure rates were measured by the GM survey-meter. Radionuclides and their gamma-ray activities were obtained by dividing the peak counts of the measured pulse height spectra by the peak efficiencies. For this purpose, the HPGe detector having known sensitive region in good accuracy was used, and its peak efficiency to these cylindrical sources was calculated by the PEAK Monte Carlo code including the self-absorption correction. The residual exposure rates were obtained from the simple analytical calculation by using these gamma-ray activities uniformly distributed in the concrete and stainless steel blocks. The calculated exposure rates showed very good agreement with those measured by the GM survey-meter. From this comparison, the relationship between gamma-ray activities and residual exposure rates were evaluated in good accuracy for these volume samples.

Gamma Rays↗

Corrosion characteristics of ferric and austenitic stainless steels for dental magnetic attachment.

The corrosion behaviors of four ferric stainless steels and two austenitic stainless steels were examined in a simulated physiological environment (0.9% NaCl solution) to obtain basic data for evaluating the appropriate composition of stainless steels for dental magnetic attachments. The corrosion resistance was evaluated by electrochemical techniques and the analysis of released metal ions by atomic absorption spectrophotometry. The surface of the stainless steels was analyzed by X-ray photoelectron spectroscopy (XPS). The breakdown potential of ferric stainless steels increased and the total amount of released metal ions decreased linearly with increases in the sum of the Cr and Mo contents. The corrosion rate of the ferric stainless steels increased 2 to 6 times when they were galvanically coupled with noble metal alloys but decreased when coupled with commercially pure Ti. For austenitic stainless steels, the breakdown potential of high N-bearing stainless steel was approximately 500 mV higher than that of SUS316L, which is currently used as a component in dental magnetic attachments. The enriched nitrogen at the alloy/passive film interface may be effective in improving the localized corrosion resistance.

Carbon↗

The quality of clinical fit of stainless steel bands used in endodontics.

Stainless steel bands are commonly advocated to protect posterior teeth against fracture during endodontic treatment and before final restoration. A poorly fitting band, however, may lead to a compromised coronal seal and gingival irritation. This radiographic study assessed the quality of fit and marginal adaptation in the proximal area of stainless steel bands placed during routine endodontic treatment. Clinical radiographs of 120 maxillary and mandibular premolars and molars were evaluated. All radiographs were taken during routine clinical endodontic treatment and randomly selected from cases completed by ten operators. Approximately one-half of cases did not meet the criteria of adequate marginal seal (mesial: 65/120; distal: 49/120). Only 11 teeth were found to have adequate fit of the band on both mesial and distal aspects of the tooth. The most common reason for inadequacy of fit was lack of band adaptation to the tooth contour in the cervical region. Stainless steel bands have a high possibility of poor marginal fit and should be used with the awareness that they may produce other clinical problems.

Bicuspid↗

[Clinical evaluation of gingival tissue restored with stainless steel crown].

The use of stainless steel crown for the restoration of primary molars is widely accepted in pediatric dentistry. There has been a concern regarding their effect on the health of the gingival tissue. It is a possibility that the preformed crown may be a contributing cause of gingivitis. This study evaluated one hundred and thirty-seven crowns in forty-five patients who had received pedodontic treatment at Chang Gung Memorial Hospital. The results indicated that the majority of stainless steel crowns had one or more defects, with crown crimping being the most common error. According to what the paired t-test showed, non-ideal crowns indicated that the gingival index was significantly higher than the entire mouth and control teeth. However the supragingival plaque accumulation of these teeth was significant lower than the entire mouth and control teeth. There was only a moderate positive correlation between supragingival plaque and gingivitis. The operator is necessary to adapt the stainless steel crown margin as closely as possible to the tooth and to avoid the mechanical defect of a crown. It minimizes the irritation of gingival tissue and diminishes the bacterial adherence of subgingival plaque, therefore preserving the health of gingival tissue.

Child↗

Evaluation of the effect of three surface treatments on the biocompatibility of 316L stainless steel using human differentiated cells.

AISI 316L stainless steel (SS) is widely used in orthopaedic implantology, although biological complications may result from its insufficient mechanical and tribological properties. In order to improve the wear and corrosion resistance as well as the hardness of 316L SS, three surface treatments, derived from those applied in mechanical engineering industries, were investigated: (1) glow discharge nitrogen implantation, (2) carbon-doped stainless steel coating sputtering and (3) low temperature plasma nitriding. Surface characterization according to the different heat treatments showed that corrosion and wear resistance were strongly improved, especially by ion implantation or carbon-doped SS coating sputtering. In the same way, microhardness was significantly increased after the three treatments. The effect of such treatments on the biocompatibility of 316L SS was studied with human osteoblast and fibroblast cultures. Basic and specific features of the cells showed that ion-implanted and carbon-doped stainless steels were biocompatible, whereas dramatic cellular reactions were noted when contacted with nitrided stainless steel. A hypothesis is given to explain this observation but further experiments are needed to optimize the nitriding process. Nitrogen implantation and carbon-doped layer deposition could be efficient means for improving the physical properties of stainless steel without affecting its biocompatibility. Such surface treatments may have relevance for increasing the life time of 316L biomedical devices.

Alkaline Phosphatase↗

An experimental model of saphenous vein-to-coronary artery anastomosis with the St. Jude Medical stainless steel connector.

BACKGROUND: A new stainless steel anastomosis device developed by St. Jude Medical Cardiovascular Group was studied in a canine model. METHODS: In 12 dogs, coronary saphenous vein grafts were made to the left anterior descending coronary artery and to the circumflex coronary artery; one anastomosis was completed with the St. Jude Medical stainless steel connector device, and the other with conventional suturing. A 30-day coronary angiogram was performed in surviving animals, and, after sacrifice, anastomoses were measured, examined grossly, and submitted for histologic study. RESULTS: All 12 animals survived the procedure, and 9 survived to sacrifice at 30 days. Comparing the connector grafts and sutured grafts, no significant differences were found between vessel diameters, intraoperative graft flows, graft patency, and histology. The average loading time for the connector was 8.5 minutes (range 4 to 16 minutes). Mean time for the 12 connector anastomoses was 3 minutes (range 2 to 5 minutes) compared with 8.4 minutes for suture (range 4 to 13 minutes). CONCLUSIONS: The side-to-side stainless steel connector anastomotic device produces a secure anastomosis with minimal variability; compared with suture methods, it is expeditious and has comparable 30-day histology and angiographic results. It promises to be an important addition to the surgical armamentarium for the treatment of coronary artery disease.

Anastomosis, Surgical↗

Occupational asthma due to manual metal-arc welding of special stainless steels.

Occupational asthma (OA) can be induced by fumes of manual metal-arc welding on stainless steel. In recent years, the use of special stainless steels (SSS) with high chromium content has increased. This study presents two cases of OA caused by manual metal-arc welding on SSS. In both cases, the diagnosis of OA was based on respiratory symptoms, occupational exposure and positive findings in the specific challenge tests. In the first case, a 46-yr-old welder had experienced severe dyspnoea while welding SSS (SMO steel), but not in other situations. Challenge tests with both mild steel and stainless steel using a common electrode were negative. Welding SSS with a special electrode caused a delayed 37% drop in forced expiratory volume in one second (FEV1). In the second case, a 34-yr-old male had started to experience dyspnoea during the past few years, while welding especially SSS (Duplex steel). The workplace peak expiratory flow monitoring was suggestive of OA. Challenge tests with both mild steel and stainless steel using a common electrode did not cause bronchial obstruction. Welding SSS with a special electrode caused a delayed 31% drop in FEV1. In conclusion, exposure to manual metal-arc welding fumes of special stainless steel should be considered as a new cause of occupational asthma.

Adult↗

Decomposition of energetic chemicals contaminated with iron or stainless steel.

Contamination of chemicals or reaction mixtures with iron or stainless steel is likely to take place during chemical processing. If energetic and thermally unstable chemicals are involved in a manufacturing process, contamination with iron or stainless steel can impact the decomposition characteristics of these chemicals and, subsequently, the safety of the processes, and should be investigated. The goal of this project was to undertake a systematic approach to study the impact of iron or stainless steel contamination on the decomposition characteristics of different chemical classes. Differential scanning calorimetry (DSC) was used to study the decomposition reaction by testing each chemical pure, and in mixtures with iron and stainless steel. The following classes of energetic chemicals were investigated: nitrobenzenes, tetrazoles, hydrazines, hydroxylamines and oximes, sulfonic acid derivatives and monomers. The following non-energetic groups were investigated for contributing effects: halogens, hydroxyls, amines, amides, nitriles, sulfonic acid esters, carbonyl halides and salts of hydrochloric acid. Based on the results obtained, conclusions were drawn regarding the sensitivity of the decomposition reaction to contamination with iron and stainless steel for the chemical classes listed above. It was demonstrated that the most sensitive classes are hydrazines and hydroxylamines/oximes. Contamination of these chemicals with iron or stainless steel not only destabilizes them, leading to decomposition at significantly lower temperatures, but also sometimes causes increased severity of the decomposition. The sensitivity of nitrobenzenes to contamination with iron or stainless steel depended upon the presence of other contributing groups: the presence of such groups as acid chlorides or chlorine/fluorine significantly increased the effect of contamination on decomposition characteristics of nitrobenzenes. The decomposition of sulfonic acid derivatives and tetrazoles was not impacted by presence of iron or stainless steel.

Calorimetry↗

Respiratory status of stainless steel and mild steel welders.

Eighty-three full-time stainless steel and 29 mild steel welders from one shipyard were examined clinically, and their lung function was measured. The stainless steel welders had used both tungsten inert-gas (low-fume concentration) and manual metal-arc (MMA) (high-fume concentration) welding methods. The individual exposure of the welders was estimated based on the time spent doing MMA welding, the amount of retained contaminants in the lungs (magnetopulmography), and urinary chromium excretion. The results suggest that there is a greater prevalence of small airway disease among shipyard mild steel MMA welders than among stainless steel welders. Among the stainless steel welders the impairment of lung function parameters was associated with the MMA welding method. The type of welding, then, is important when the health hazards of welders are studied, and welders cannot be regarded as a single, homogeneous group.

Adult↗

Use of stainless steel implants in facial bone reconstruction.

Stainless steel has adequate strength, flexibility, ductility, and bio-compatibility for most maxillofacial implant applications. In addition, it is relatively cheap and easy to manufacture. Stainless steel may be effectively used in the maxillofacial region in the form of wires, pins, and plates. This article presents a technique for using a transmalar Steinmann pin to secure a midface prosthesis in cases of bilateral midfacial, bilateral maxillectomy, and total rhinectomy defects. The stainless steel pin may serve as a stable long-term anchoring if used for retention rather than load bearing. This method offers the potential for single-stage reconstruction and allows for prosthesis removal to inspect the surgical defect for early evidence of recurrence.

Face↗

Photocatalytic activity, antibacterial effect, and photoinduced hydrophilicity of TiO2 films coated on a stainless steel substrate.

Transparent TiO2 films on stainless steel prepared by dip coating in a nonionic microemulsions solution have been shown to have much higher photocatalytic activity than those coatings on glass. Fe3+ and Fe2+ ions, diffusing from stainless steel substrate into TiO2 films during high-temperature calcination, behave as dopants to significantly affect the films' photocatalytic activity. An optimum calcination condition, under which the amount of diffused Fe3+ and the ratio of Fe3+ to Fe2+ ions favor the film's photocatalytic reaction, was obtained. In addition, this TiO2 films also exhibits excellent photoinduced hydrophilicity and antibacterial effect for the sterilization of Bacillus pumilus. As stainless steel is a very common material, practical systems for pollution treatment and disinfection may be designed based on this enhanced coating.

Acetone↗

Self-expanding stainless steel biliary stents.

Self-expanding stainless steel stents of a modified Gianturco design were used to relieve biliary obstruction in 31 patients. Fifteen patients had benign strictures, and 16 patients had malignant obstructions. The median age was 62 years. The stents were placed through a 10-F sheath, and in most cases multiple stents were used. Complex malignant obstructions involving multiple systems were successfully treated with stainless steel stents in order to reconstruct the biliary tree. Stents have been in place for more than 6 months in 20 of the 31 patients; occlusions have occurred in 10% of the 31 patients. Patients with benign postoperative strictures have done very well, with one patient free of symptoms at 14 months. The initial results are encouraging. Further studies will determine the role of stainless steel stents in the treatment patients with benign postoperative strictures and malignant obstructions with involvement of multiple systems.

Bile Duct Neoplasms↗

Evaluation of friction of stainless steel and esthetic self-ligating brackets in various bracket-archwire combinations.

This study measured and compared the level of frictional resistance generated between stainless steel self-ligating brackets (Damon SL II, SDS Ormco, Glendora, Calif), polycarbonate self-ligating brackets (Oyster, Gestenco International, Göthenburg, Sweden), and conventional stainless steel brackets (Victory Series, 3M Unitek, Monrovia, Calif), and 3 different orthodontic wire alloys: stainless steel (Stainless Steel, SDS Ormco), nickel-titanium (Ni-Ti, SDS Ormco), and beta-titanium (TMA, SDS Ormco). All brackets had a.022-in slot, whereas the orthodontic wire alloys were tested in 3 different sections:.016,.017 x.025, and.019 x 0.025 in. Each of the 27 bracket and archwire combinations was tested 10 times, and each test was performed with a new bracket-wire sample. Both static and kinetic friction were measured on a custom-designed apparatus. All data were statistically analyzed (Kruskal-Wallis and Mann Whitney U tests). Stainless steel self-ligating brackets generated significantly lower static and kinetic frictional forces than both conventional stainless steel and polycarbonate self-ligating brackets, which showed no significant differences between them. Beta-titanium archwires had higher frictional resistances than stainless steel and nickel-titanium archwires. No significant differences were found between stainless steel and nickel-titanium archwires. All brackets showed higher static and kinetic frictional forces as the wire size increased.

Dental Alloys↗

Comparison of the thrombogenicity of stainless steel and tantalum coronary stents.

This study was designed to compare the thrombogenicity of stainless steel and tantalum coronary stents of the same design. Stainless steel and tantalum coronary stents are being evaluated for their utility in treating acute closure and restenosis. A major disadvantage of stainless steel stents is radiolucency. To determine whether radioopaque tantalum stents may be safely substituted for stainless steel stents, we compared the relative thrombogenicity of these materials in stents of identical design. Total platelet and fibrin deposition on the stents were determined from measurements of indium 111-labeled platelet and iodine 125-labeled fibrinogen accumulation after deployment into exteriorized chronic arteriovenous shunts in seven untreated baboons. In another series of experiments, 111In-platelet deposition was compared 2 hours after stent implantation in coronary arteries of pigs. In baboons, platelet thrombus formation on stainless steel and tantalum stents was equivalent and plateaued at approximately 2.5 x 10(9) platelets after 1 hour (p > 0.05). Fibrin deposition averaged approximately 1 mg/stent and did not differ between the stainless steel and tantalum stents (p > 0.05). In the porcine coronary model there was no significant difference in 111In-labeled platelet deposition between the stainless steel and tantalum stents (p > 0.05). This result was confirmed by scanning electron microscopic analysis of the coronary stents. Based on these two models, we conclude that there is no significant difference in the thrombogenicity of stainless steel and tantalum wire coil stents.

Animals↗