Aseptic Processing

Total hip replacement (THR) is normally done for the failure of hip joint caused by osteoarthritis. It is performed to relief pain and to improve functionality. Issues related to the study include method to reduce fixation failure, means to improve the longevity of the prosthesis, methods to reduce the factors contributing to probability of failure such as cement strength, implant interface strength, and loosening. The present work focused on failure related to stress related only. The main aim of this work is to study the inner failure stress for THR and to suggest recommended functional activities for patient whom undergoes THR. By knowing the stress for the inner bone, the failure mechanisms of THR for different dynamics loadings can be predicted more objectively. For this study, ANSYS Workbench version 11.0 was used for the Finite Element (FE) analysis. The values of stress and strain distributions in anterior (A), posterior (P), medial (M) and lateral (L) positions of the healthy femoral bone and THR were obtained. The stress and strain distributions of inner healthy femoral bone surface subjected to standing were studied. The effect of materials on the variations of stress and strain of the outer and inner surface of the

In the pharmaceutical and biotech industries, ensuring product safety, regulatory compliance, and operational efficiency is crucial. Advanced containment and aseptic solutions play a key role in maintaining these standards. Here's a look at the latest innovations in GMP washers, aseptic isolators, containment isolators, and powder transfer systems that are revolutionizing cleanroom operations.

Long bone fractures account for a vast majority
of trauma related emergency surgeries. Tibia is the most commonly fractured long bone with the incidence of tibial shaft fracture being16.9/100,000/year. intramedullary nailing is a common method
for treatment of tibial shaft fractures.’ Intramedullary rods are secured within the bone by screws both above and below the fracture

Objective. To evaluate how flexible learning via online video review affects the ability and confidence of first-year (P1) pharmacy students to accurately compound aseptic preparations. Design. Customary instructions and assignments for aseptic compounding were provided to students, who were given unlimited access to 5 short review videos in addition to customary instruction. Student self-confidence was assessed online, and faculty members evaluated students' aseptic technique at the conclusion of the semester. Assessment. No significant difference on final assessment scores was observed between those who viewed videos and those who did not. Student self-confidence scores increased significantly from baseline, but were not significantly higher for those who viewed videos than for those who did not. Conclusion. First-year students performed well on final aseptic compounding assessments, and those who viewed videos had a slight advantage. Student self-confidence improved over the ...

Joint replacements may fail due to infection, dislocation, peri-prosthetic fracture and loosening. Between 0.4 and 4% of joint replacements are known to be complicated by infection and aseptic loosening 2-18%. Differentiating between infection and aseptic loosening has an important bearing on the ongoing strategy for antimicrobial therapy and surgical intervention, but distinguishing one from the other can be difficult and will often require a battery of clinical and biochemical tests including the use of varying radiological modalities to accurately identify whether problematic joints are infected or aseptically loose. Prompt diagnosis is important due to the development of a biofilm on the surface of the infected prosthesis, which makes treatment difficult. There is no consensus among experts on the ideal imaging technique nor the methodology for image interpretation, but there is an increasing trend to apply hybrid imaging in the investigation of painful joint prosthesis and recent attempts have been made using PET-CT to identify aseptic loosening and infection with 18 F-fluorodeoxyglucose (FDG) and sodium fluoride 18 F-Na. The aim of this paper is to evaluate the role of 18 F-NaF sodium fluoride ( 18 F-NaF) positron emission tomography (PET) in distinguishing between septic and aseptic failure in hip and knee replacements, in addition to evaluating the feasibility of using multi-sequential 18 F-NaF PET-CT for the assessment of painful lower limb prostheses.

Purpose Short stems use has increased substantially despite variable results reported in the literature. The purpose of this study was to report the rate of complications using a short stem implanted through the direct anterior approach (DAA), and to evaluate mid-term clinical and radiological results focusing on femoral stem fixation. Methods Between April 2009 and November 2014, 698 elective total hip arthroplasties (THAs) were performed using a fully hydroxyapatite-coated short stem (AMIStem-H®). The mean age was 65.7 years (SD 12.6). Patients were invited for clinical and radiological evaluation, and to complete patient-reported outcomes questionnaires at two and five years after surgery. The mean follow-up was 6.2 years (range 2-9.73 years). Results During the study period, 59 (8.5%) patients died and 24 (3.4%) were lost to follow-up. There were six (0.9%) dislocations and 12 (1.7%) fractures, seven occurred intra-operatively. Twenty-nine (4.2%) THAs required revision surgery. Eleven THAs were revised for aseptic loosening of the stem at a mean 4.9 years (1.2-7.3 years). Five years after surgery, radiographs of 324 THAs (324/425 eligible = 76.2%) were available. Stem subsidence ≥ 2 mm was present in 42 cases (12.9%), proximal radiolucencies in 101 hips (31.5%), cortical thickening in 52 (16.0%), and a pedestal in 219 (67.6%). An Engh score between -10 and 0 was associated with lower HHS pain subscore (p = 0.005), a higher risk of stem revision for aseptic loosening (18.8% vs. 2.7%; p = 0.008), and was more frequent in younger patients with ASA score 1. Conclusion Patients presenting radiological alterations at five years had an increased risk of revision for aseptic stem loosening and also inferior clinical results. Our study warrants further continued scrutiny of mid-and long-term survivorship of the AMIStem-H®, with radiological results at five years indicating suboptimal fixation of the stem in younger and active patients.

The objective of the present work was to develop an alternative propagation procedure with in vitro germination and axillary shoot propagation for Nepeta nuda subsp. albiflora (Boiss.) Gams (Lamiaceae) has potential importance as medicinal plant. The seeds were surface sterilized and transferred to different in vitro media. At the end of the experiments, maximum germination percentage was obtained 85% in distilled water medium solidifed with agar. Germinated seeds were transferred onto Murashige and Skoog and White media for further seedling development. MS medium was found to be a superior medium than White medium as seedling growth medium. The obtained shoots were transferred onto MS media containing Benzyladenine, Kinetin and Thiduazuron (0.1, 0.5 and 1 mgL) for axillary shoot propagation. MS medium without plant regulator was used as a control. The highest shoot number per explant and maximum shoot lenght were obtained on MS medium supplemented with 0.1 mgLKin.

Most of periapical lesions usually result from microbial infection with oral microorganisms originating from the degenerated pulp tissue. These lesions are commonly painless and incidentally found on routine radiographic examinations. Treating these cases using non-surgical root canal is the fruit of the innovative techniques, tools and root medicaments as well as the tendency toward minimally invasive treatment. The healing process of the infected area is conditioned by a proper diagnosis, a treatment that follows good clinical practice under aseptic environment including cleaning, shaping and root filing. The aim of the present clinical case report was to report non-surgical healing of a periapical lesion of endodontic origin associated with maxillary left central incisor, observed over a period of 2 years.

Background: The study was conducted to evaluate the wound healing potential of nano-based curcumin-chitosan-aloe vera, an indigenously prepared healing agent, for treatment of aseptic surgical wounds in clinical canine cases presented to the Department of Veterinary Surgery and Radiology, College of Veterinary Science and Animal Husbandry, Odisha University of Agriculture and Technology, Bhubaneswar. Methods: The wounds were assigned into two therapeutic regimens, application of nano-based healing agent and mupirocin to the test and control group respectively as topical therapy along with parenteral antibiotics as per standard operative procedure (SOP). Results were statistically analyzed, using analysis of variance (ANOVA), paired t-test (parametric) and kruskal-wallis one way ANOVA test (non parametric). Result: Chitosan-curcumin-aloevera based healing agent resulted in early reduction of wound exudates and cast formation than control group. Time of appearance and filling of wound...

Aseptic technique includes the use of sterile surgical gloves for survival surgeries in rodents to minimize the incidence of infections. Exam gloves are much less expensive than are surgical gloves and may represent a cost-effective, readily available option for use in rodent surgery. This study examined the effectiveness of surface disinfection of exam gloves with 70% isopropyl alcohol or a solution of hydrogen peroxide and peracetic acid (HP-PA) in reducing bacterial contamination. Performance levels for asepsis were met when gloves were negative for bacterial contamination after surface disinfection and sham 'exertion' activity. According to these criteria, 94% of HP-PA-disinfected gloves passed, compared with 47% of alcohol-disinfected gloves. In addition, the effect of autoclaving on the integrity of exam gloves was examined, given that autoclaving is another readily available option for aseptic preparation. Performance criteria for glove integrity after autoclaving con...

To evaluate the safety and efficacy of locking plate combined with bone grafting in the treatment of aseptic nonunion following intramedullary nailing fixation of fractures of the long bones. Thirty-eight consecutive patients treated in our hospital between January 2004 and December 2006 were included in this retrospective study. The nonunions included 20 femurs, 15 tibias, and 3 humeri. The duration of non-union ranged from 6 to 84 months and 21 (55.3%) of them were located around the metaphysis of the affected long bones. There were 12 women and 26 men with a mean age of 39.2 years (range, 9-70 years). Locking plate combined with bone grafting was the procedure chosen to treat every case of nonunion in this series. The clinical outcomes were evaluated. All patients were followed up for 6-20 months (average 11.6 months). After locking plate fixation combined with bone grafting, union was achieved in all cases, the average healing time being 5.3 months (range, 4-8 months). Infection...

Nonunions of the tibia, particularly those located in the distal third of the bone, are relatively common in clinical practice. There is no gold standard for the treatment of nonunions of the tibia. The purpose of our study was to assess the results of treatment with the Ilizarov method in patients with aseptic nonunions of the tibia, depending on the employed treatment strategies and surgical techniques. A total of 75 patients with Ilizarov treatment of aseptic nonunions of the tibia were evaluated in the study. The patients's mean age at the beginning of treatment was 46 years. The mean follow-up period was 10 years and 11 months. The evaluated patients underwent either closed technique or open technique. The operators used one of two treatment strategies: neutral fixation without compression or continued compression. The following were assessed: rates of union, ASAMI bone scores, ASAMI functional scores, treatment time, complications, duration of hospital stay. Bone union was achieved in all of the 75 evaluated patients. The results of most analyses showed no significant differences in the assessed variables, except for the ASAMI functional scores, which were higher in the group of patients who underwent closed surgery (Me = 6.00 vs. Me = 4.00). We observed better ASAMI functional score outcomes in the patients who underwent closed fixation than in the open fixation group. The different surgical techniques and treatment strategies had no effect on the number of complications, rates of bone union, length of hospital stay, duration of Ilizarov treatment, or ASAMI bone scores. For managing nonunions of the tibia we recommend the technique of closed fixation without continued compression. The Ilizarov method in the treatment of nonunions of the tibia gives good outcomes. Nonunions of the tibia, particularly those located in the distal third of the bone, are relatively common in clinical practice . Despite of this, they pose a serious therapeutic challenge for orthopedic surgeons . Nonunions of the tibia may be associated with: low-density bone tissue, bone loss, adjacent soft-tissue damage, limb shortening, limb deformities, and joint contractures (Fig. ). All of these adversely affect the course of treatment and increase the risk of treatment failure . In nonunions of the tibia, the Ilizarov method helps achieve bone union, eliminate possible infections, equalize limb length, and correct any deformities that may have developed over the course of treatment . Various strategies and surgical techniques employing the Ilizarov method have been reported for treating nonunions of the tibia . The specific strategies or techniques are selected based on bone tissue density and vitality, limb shortening and deformity, the shape of bone fragments, condition of soft tissues, presence of infection, and operator's preferences . There is no gold standard for the treatment of nonunions of the tibia. Moreover, there are not many studies comparing the different tactics of surgical management . Some authors claim that bone transport combined with the use of external fixators carries a higher risk of complications and yields worse outcomes in comparison with other methods of tibial nonunions treatment . Most of the available analyses concern infected nonunions of the tibia , whereas few reports discuss the treatment of tibia nonunion that is uncomplicated by infection .

Nonunions of the tibia, particularly those located in the distal third of the bone, are relatively common in clinical practice. There is no gold standard for the treatment of nonunions of the tibia. The purpose of our study was to assess the results of treatment with the Ilizarov method in patients with aseptic nonunions of the tibia, depending on the employed treatment strategies and surgical techniques. A total of 75 patients with Ilizarov treatment of aseptic nonunions of the tibia were evaluated in the study. The patients’s mean age at the beginning of treatment was 46 years. The mean follow-up period was 10 years and 11 months. The evaluated patients underwent either closed technique or open technique. The operators used one of two treatment strategies: neutral fixation without compression or continued compression. The following were assessed: rates of union, ASAMI bone scores, ASAMI functional scores, treatment time, complications, duration of hospital stay. Bone union was ach...

Background Aseptic loosening of the femoral stem remains a significant reason for revision in total hip arthroplasty (THA). Although stem fixation methods have changed over time, there is relatively little evidence supporting cemented or uncemented stems as more durable constructs. Questions/purposes We examined whether there was a difference in survival to revision between cemented and uncemented THA stems (1) for any reason; (2) for aseptic loosening or loosening related to wear/osteolysis; (3) based on patient age groupings (as a proxy for patient activity level); and (4) based on procedural timeframe groupings between cemented and uncemented stems. Methods A total of 6498 primary cemented and uncemented THAs were registered in our community total joint replacement registry between 1991 and 2011. Analysis was performed to compare age, sex, procedural timeframe, and diagnosis for both groups. Our primary outcome was revision of the stem component for aseptic loosening or loosening secondary to wear/osteolysis. Analyses were done using Wilcoxon rank sum tests, Pearson's chi-square tests, Kaplan Meier methods, and Cox regression. Results After adjusting for age, sex, primary diagnosis, and procedural timeframe as confounders, cemented femoral stem components were 1.63 times as likely as uncemented stems to be revised for any reason (p = 0.02) and 3.76 times as likely as uncemented stems to be revised for aseptic loosening or loosening related to wear/osteolysis (p \ 0.001). When grouped by age, specifically in regard to revisions for aseptic loosening or loosening related to wear/osteolysis, uncemented stems had lower cumulative revision rates in patients aged \ 70 years (p \ 0.001) compared with cemented stems. There was a trend away from cemented fixation in our registry, which shifted from over 80% cemented stem use in 1996 to 3% in 2011. Each author certifies that he or she, or a member of his or her immediate family, has no funding or commercial associations (eg, consultancies, stock ownership, equity interest, patent/licensing arrangements, etc) that might pose a conflict of interest in connection with the submitted article. All ICMJE Conflict of Interest Forms for authors and Clinical Orthopaedics and Related Research editors and board members are on file with the publication and can be viewed on request. Clinical Orthopaedics and Related Research neither advocates nor endorses the use of any treatment, drug, or device. Readers are encouraged to always seek additional information, including FDA-approval status, of any drug or device prior to clinical use. Each author certifies that his or her institution approved the human protocol for this investigation, that all investigations were conducted in conformity with ethical principles of research, and that informed consent for participation in the study was obtained.

Daily oral endodontic and surgical care requires careful management of infection risks to prevent both patient and medical staff from nosocomial infection by cross-contamination. The purpose of this study is to review the sterilization process of endodontic and surgical equipment at the Municipal Center of Oral Health (CMSBD) of Ouagadougou. This is a cross-sectional study carried out during January 2016. Data were collected from the staff responsible for the sterilization of endodontic and surgical equipment and the head of the aseptic chain. Various steps of the aseptic chain at CMSBD were generally complied with. However, weaknesses in the system include packaging and sterilization of rotary equipment. Though, sterilization rules at CMSBD were satisfactory, they should be further strengthened. Quality checkups are necessary regarding the importance of the field.

Daily oral endodontic and surgical care requires careful management of infection risks to  prevent both patient and medical staff from nosocomial infection by cross-contamination. The purpose of this study is to review the sterilization process of endodontic and surgical equipment at the Municipal Center of Oral Health (CMSBD) of Ouagadougou. This is a cross-sectional study carried out during January 2016. Data were collected from the staff responsible for the sterilization of endodontic and surgical equipment and the head of the aseptic chain. Various steps of the aseptic chain at CMSBD were generally complied with. However, weaknesses in the system include packaging and sterilization of rotary equipment. Though, sterilization rules at CMSBD were satisfactory, they should be further strengthened. Quality check- ups are necessary regarding the importance of the field. Key words: Hygiene, sterilization, endodontic, surgical equipment.

We evaluated the use of a stemmed acetabular component in the treatment of severe acetabular deficiency during revision and complex primary total hip arthroplasty. There were 31 hips of which 24 were revisions (20 for aseptic loosening, four for infection) and the remainder were complex primary arthroplasties. At a mean follow-up of 10.7 years (6 to 12.8), no component had been revised for aseptic loosening; one patient had undergone a revision of the polyethylene liner for wear. There was one failure because of infection. At the latest follow-up, the cumulative survival rate for aseptic loosening, with revision being the end-point, was 100%; for radiographic loosening it was 92% and for infection and radiographic loosening it was 88%. These results justify the continued use of this stemmed component for the reconstruction of severe acetabular deficiency. The management of severe acetabular deficiency at revision or complex primary total hip arthroplasty remains a complex problem. 1,2 Cementless, hemispherical ingrowth acetabular components are considered the gold standard by most arthroplasty surgeons in these difficult cases. 3,4 The results of cemented or uncemented acetabular components for contained defects has a success of 90% at ten years in several series. 5,6 However, the treatment of uncontained defects remains a dilemma. The various treatment options range from the use of uncemented, hemispherical ingrowth acetabular components, or cemented components, to complex reconstructions with bulk allograft or antiprotrusio rings, or cages, all with equivalent results. 3,7,8 We describe our experience using a stemmed acetabular component with non-structural allograft in patients with major acetabular bone loss.

We evaluated the use of a stemmed acetabular cup with morcellized allograft in the treatment of severe acetabular deficiency requiring reconstruction at arthroplasty. There were 29 hips, of which 22 were revision operations (18 aseptic, 4 postinfective) and 7 were complex primary hip replacements. All patients had severe acetabular deficiency as classified by the American Academy of Orthopaedic Surgeons: type lIB, 3; type IIIa, 18; type IIIB, 8. The patients had a mean follow-up of 46 months (range, 14-74 months). The hip center of rotation improved from a mean preoperative, side-to-side difference of 11.5 mm to 2.5 trim postoperatively (P < .001). The medial bone stock improved from a mean preoperative value of 1.5 mm to 11 mm postoperatively (P< .001). The Harris Hip Score improved from a mean preoperative score of 42 points to a postoperative score of 84 points (P < .001). There was 1 case of failure resulting from sepsis. The early results with this method of reconstruction of severe acetabular deficiency show encouraging restoration of bone stock, with no cases of aseptic loosening until the last follow-up.

We evaluated the use of a stemmed acetabular component in the treatment of severe acetabular deficiency during revision and complex primary total hip arthroplasty. There were 31 hips of which 24 were revisions (20 for aseptic loosening, four for infection) and the remainder were complex primary arthroplasties. At a mean follow-up of 10.7 years (6 to 12.8), no component had been revised for aseptic loosening; one patient had undergone a revision of the polyethylene liner for wear. There was one failure because of infection. At the latest follow-up, the cumulative survival rate for aseptic loosening, with revision being the end-point, was 100%; for radiographic loosening it was 92% and for infection and radiographic loosening it was 88%. These results justify the continued use of this stemmed component for the reconstruction of severe acetabular deficiency.

We evaluated the use of a stemmed acetabular cup with morcellized allograft in the treatment of severe acetabular deficiency requiring reconstruction at arthroplasty. There were 29 hips, of which 22 were revision operations (18 aseptic, 4 postinfective) and 7 were complex primary hip replacements. All patients had severe acetabular deficiency as classified by the American Academy of Orthopaedic Surgeons: type lIB, 3; type IIIa, 18; type IIIB, 8. The patients had a mean follow-up of 46 months (range, 14-74 months). The hip center of rotation improved from a mean preoperative, side-to-side difference of 11.5 mm to 2.5 trim postoperatively (P < .001). The medial bone stock improved from a mean preoperative value of 1.5 mm to 11 mm postoperatively (P< .001). The Harris Hip Score improved from a mean preoperative score of 42 points to a postoperative score of 84 points (P < .001). There was 1 case of failure resulting from sepsis. The early results with this method of reconstruction of severe acetabular deficiency show encouraging restoration of bone stock, with no cases of aseptic loosening until the last follow-up.

Actualización en técnica aséptica y uso de antibióticos profilácticos en procedimientos quirúrgicos ambulatorios que comprometan piel y mucosas Marcela concha-rogazy, catalina andrighetti-Ferrada a , MaxiMiliano curi-tuMa a Aseptic techniques for minor surgical procedures. An update Aseptic techniques are those practices designed to reduce the risk of surgical site infection (SSI), defined as such, all those that occur within the first 30 days of the procedure. While the patient's risk of developing an SSI in dermatologic surgery is low since many of the procedures are considered sterile, there are different factors associated with an increased or decreased risk of developing SSI. The characteristics of the surgical wound (such as involving infected or inflamed tissue or when breaks in the aseptic technique occur), patient characteristics (such as age, comorbidities, medication use and smoking) and procedure factors (such as setting, surgical technique, type of procedure, duration and body region involved). In this article we discuss the management of potential sources of infections such as personnel (hand washing, dressing), preparation of the patient, maintenance of a clean surgical environment, sterilization and the use of antiseptic solutions. Similarly, the current indications for prophylactic antibiotics for these procedures are considered.

This study is a 5-to 11-year retrospective followup of 40 hips in 33 patients with cementless acetabular revision for aseptic failure of a cemented total hip arthroplasty. A porous coated, Harris-Galante acetabular component was used in all revisions. Thirty-eight of the 40 hips received acetabular bone grafting at revision. The mean Harris Hip Score improved from 51 points just before the index cementless revision to 87 points at the most recent followup. Twenty-nine of 40 (73%) hips were classified as having a good or excellent result. Radiolucencies were observed in seven of the 40 (18%) hips at the most recent followup, but none of these radiolucencies were complete or progressive. Five of the 40 (13%) hips were rated as failures and required repeat revision. Two (5%) of these failures were caused by From the

This study is a 5-to 11-year retrospective followup of 40 hips in 33 patients with cementless acetabular revision for aseptic failure of a cemented total hip arthroplasty. A porous coated, Harris-Galante acetabular component was used in all revisions. Thirty-eight of the 40 hips received acetabular bone grafting at revision. The mean Harris Hip Score improved from 51 points just before the index cementless revision to 87 points at the most recent followup. Twenty-nine of 40 (73%) hips were classified as having a good or excellent result. Radiolucencies were observed in seven of the 40 (18%) hips at the most recent followup, but none of these radiolucencies were complete or progressive. Five of the 40 (13%) hips were rated as failures and required repeat revision. Two (5%) of these failures were caused by From the

Aseptic fi lling process can contribute to extend the shelf-life of pasteurized milk. However, this technology is not still commercially practiced in Brazil for this product. The aim of this study was to evaluate the effect of the pasteurization temperature and aseptic fi lling on the stability of milk packaged in high density polyethylene bottle (HDPE). Three batches of one hundred bottles each were processed at 72, 83, and 94ºC/15s, followed by aseptic packaging and storage at 9ºC, simulating a defi cient cold chain scenario as found in the Brazilian market. Microbiological stability evaluation was based on mesophilic and psychrotrophic counts. Sensory shelf-life was estimated according to the ratings assigned to the attributes appearance, aroma, fl avor and overall appreciation of milk samples. The pasteurization temperature, in the range investigated, did not affect the shelf-life of milk, which lasted up to 11 days for the three processed batches. The aseptic fi lling, associated to the employed thermal treatments, did not extend the shelf-life of milk stored under the abuse condition of 9°C, considering that the commercial product shelf-life in Brazil is of about 10 days.

Processou-se uma mistura isotônica com pH 3,4; objetivando-se a produção de uma bebida microbiologicamente estável, prescindindo de refrigeração. A bebida isotônica foi pasteurizada a 85°C/5s em trocador de calor a placas e acondicionada em garrafas de polietileno tereftalato (PET) sanificadas por aspersão com solução de ácido peracético 0,3% durante 5s, a 30°C. Foram processados 1 lote com 50mg/L de sorbato de potássio, 1 lote com 100mg/L e 1 lote sem sorbato. Os 3 lotes foram mantidos a 25°C durante 26 semanas, sendo realizadas determinações de pH, sólidos solúveis, acidez total titulável, ácido ascórbico, testes de aceitação sensorial e contagens de microrganismos mesófilos aeróbios totais, bolores e leveduras durante a estocagem. Verificou-se diferença significativa (p<0,05) entre as médias das determinações de ácido ascórbico, no início e fim do período de estocagem, para os três lotes processados. As contagens de bolores e leveduras e mesófilos aeróbios totais foram <10 UFC/mL e 5,7 UFC/mL, respectivamente, para os três lotes analisados durante as 26 semanas. As médias das notas atribuídas nos testes de aceitação sensorial não diferiram entre si (p<0,05) ao longo da estocagem. Os resultados obtidos evidenciaram a possibilidade de produção de uma bebida isotônica em garrafa de PET sem adição de conservadores químicos; visto que, o lote processado sem sorbato apresentou resultados microbiológicos confiáveis, aliados a sua satisfatória aceitação sensorial e estabilidade físico-química. bebida isotônica; estabilidade; garrafa plástica.

Thermal processing technology has been widely applied for the preservation of food. Initially used for canned foods, thermal processes have since been extended to a large range of foods. Ready-to-eat products processed at Ultra-High Temperature (UHT) and aseptically filled are extensively consumed because of their convenience. Sterilization and aseptic filling are critical steps, and food business operators have to verify their efficacy by demonstrating commercial sterility. Methods commonly used to demonstrate commercial sterility also originate from the canning industry and are both cumbersome and time consuming. Several alternative methods are available, but they do not have official validation status since standard validation protocols, such as ISO 16140-2 and AOAC guidelines cannot be applied due to differences in the testing procedure. We propose a validation protocol based on inclusivity and limit of detection LOD 95 as performance criteria. The traditional direct streaking and six alternative methods were assessed to demonstrate the relevance of the protocol; three methods were based on cellular metabolism during microbial growth (CO 2 production, O 2 consumption), one was based on cell count by flow cytometer and two methods were based on cellular ATP activity. Nine food items including challenging matrices (high pH, high fat contents) were tested with sporeforming and non-sporeforming microorganims. Inclusivity results show that all the methods could detect a large range of microorganisms provided appropriate culture ACCEPTED MANUSCRIPT media were used. The LOD results indicated that methods based on cellular metabolisms were very sensitive (LOD 95 < 1 log 10 CFU/ mL) compared to cells counts and ATP-based methods (LOD 95 > 3 log 10 CFU/ mL). This is the first study proposing relevant performance criteria to validate alternative commercial sterility methods. The outcomes allow the end user to select a right method according to their requirements.

The host defense mechanisms are not well developed in neonates. The aim of this study was to evaluate the dynamics of microbial colonization of the oral cavity in newborns. Eighty-one samples of the oral microbiota were obtained from 51 healthy newborns 10 min to 53 h after birth by gently rubbing sterile swabs onto the surface of the tongue, cheek mucosa, alveolar process and palate. After microbiological processing, counting of the colony forming units of streptococci, staphylococci and Gram-negative aerobic bacilli was performed. Between 10 min and 8 h, Staphylococcus epidermidis was detected in 30.7% of the samples; between 8 and 16 h, S. epidermidis was detected in 69.5% of the samples and streptococci in 56.5% of the samples; between 16 and 24 h, S. epidermidis, streptococci and S. aureus were detected in 77.78%, 85.18% and 37.03% of the samples, respectively. Between 24 and 53 h, S. epidermidis was detected in 88.89%, streptococci in 94.4% and S. aureus in 33.3% of the sample...

Compounding sterile preparation, especially for hospitalized pediatric patients, needs more concern due to dose adjustment. Things to be concerned about are compounding personnel, utilization of aseptic technique, and facilitation that affects the quality of sterile preparations. The aims of this study were to observe compounding process and to quality the sterile preparations for hospitalized pediatric patients in “X” Hospital, Semarang City, Indonesia. This research is an observational analitic with incidentally sampling research. Subject in this research was personnel who performed sterile preparations for hospitalized pediatric patients. Results from 114 sterile preparations which were observed in pediatric ward showed that compounding personnel (100%), facilities & infrastuctures, and sterile preparations procedure were not suitable with the Mixing Guideline for injectable drug and cytostatic (2009), hence it could impact the quality of sterile preparations. In addition, even a...

Aim: Diagnosis of periprosthetic joint infection (PJI) is not easy and it is made by presenting of combined findings rather than a single finding. The aim of this study is to investigate the role of blood parameters in diagnosing PJI. Material and Method: Revisions of total knee replacement and total hip replacement operated by the same surgeon between 2008 and 2018 were included in this study. Preoperative blood parameters of the patients were recorded. 69 primary arthroplasty patients with similar demographic characteristics to the patients were also included as the control group. Results: 214 arthroplasty patients, 79.0% of whom were female (n=169), were included in this study. The patients were divided into 3 groups; 32.2% were primary arthroplasty, 36.9% were aseptic revision arthroplasty, and 30.8% were septic revision arthroplasty. There was no difference between the three groups in terms of demographic characteristics. In pairwise comparisons, preoperative erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), lymphocyte, and platelet-tolymphocyte rate (PLR) parameters were found to be significantly different in the septic group when compared to both the aseptic group and the primary arthroplasty group. Further analyzes were performed to evaluate the diagnostic performances of ESR, CRP, lymphocyte, and PLR in PJI relative to aseptic patients by plotting to receive operating characteristic curves. Conclusion: Lymphocyte, PLR, ESR, and CRP may have diagnostic value in predicting PJI. Therefore, these parameters may be helpful in deciding on revision arthroplasty for PJI.

Aim: Diagnosis of periprosthetic joint infection (PJI) is not easy and it is made by presenting of combined findings rather than a single finding. The aim of this study is to investigate the role of blood parameters in diagnosing PJI. Material and Method: Revisions of total knee replacement and total hip replacement operated by the same surgeon between 2008 and 2018 were included in this study. Preoperative blood parameters of the patients were recorded. 69 primary arthroplasty patients with similar demographic characteristics to the patients were also included as the control group. Results: 214 arthroplasty patients, 79.0% of whom were female (n=169), were included in this study. The patients were divided into 3 groups; 32.2% were primary arthroplasty, 36.9% were aseptic revision arthroplasty, and 30.8% were septic revision arthroplasty. There was no difference between the three groups in terms of demographic characteristics. In pairwise comparisons, preoperative erythrocyte sedime...

This study aims to investigate the properties of the proteolytic enzyme protepsin and its impact on beef meat raw materials. The methods include histological studies to assess the effect of protepsin on meat, potentiometric measurement of pH, determination of water-binding capacity using the Grau-Hamm method. The independent parameters were pH level of 1.5; pH level of 2.2; temperature range for thermal action from 30°C to 50°C; hydrolysis time of 30 minutes. It was installed that the protepsin, an enzyme preparation, is active within a narrow pH range, optimizing its activity around pH 2.2. The study indicates that protepsin can increase the water-binding capacity to 69.73% compared to 64.37% without the enzyme, correlating with optimal pH levels (differences at p ≤ .05 were considered statistically significant). These findings support the use of protepsin in sausage production, where it can improve the overall quality of the final product.

INTRODUCTION “Quality assurance” is a wide ranging concept covering all matters that individually or collectively influence the quality of a product. It is the totality of the arrangements made with the object of ensuring that pharmaceutical products are of the quality required for their intended use. Quality assurance therefore incorporates GMP and other factors, including those outside the scope of this guide such as product design and development. [1] The principal objective of dosage form design is to achieve a predictable therapeutic response to a drug included in a formulation which is capable of large scale manufacture with reproducible product quality. To ensure product quality numerous features are required, like chemical and physical stability, suitable preservation against microbial contamination if appropriate, uniformity of dose of drug, acceptability to users including prescriber and patient, as well as suitable packing, labeling and validation. [2] Validation has beco...

Background: Aseptic nonunion of the distal femur presents a significant challenge in orthopedic surgery, affecting patient outcomes and healthcare systems. Traditional treatments include locked reamed intramedullary nailing (LRIN) and K-nail with augmented plating, with varied reported efficacies. Objective: The study aimed to compare the outcomes of LRIN versus K-nail plus augmented plating in the treatment of aseptic nonunion of the distal femur, focusing on union rates, operative time, complications, and functional recovery. Methods: In this prospective comparative study, 50 patients with aseptic nonunion of the distal femur were randomly assigned to undergo either LRIN (Group A) or K-nail plus augmented plating (Group B). The primary outcome measures included the modified Radiographic Union Score for Tibial fractures (mRUST) and rates of implant failure and infection. Secondary outcomes considered operative time and intraoperative blood loss. Statistical analysis was performed using SPSS version 25, with a p-value of less than 0.05 deemed significant. Results: Group A exhibited higher mRUST scores at 12 weeks (4.84 vs. 4.16, p=0.010), 24 weeks (6.40 vs. 5.48, p<0.001), and 36 weeks (8.12 vs. 7.00, p<0.001). Nonunion rates at 36 weeks were lower in Group A (12% vs. 36%, p=0.047), with no significant differences in infection rates. Operative time was significantly longer for Group A (159.40±5.82 minutes) compared to Group B (123.96±6.20 minutes, p<0.001), but there was no significant difference in blood loss between the groups. Conclusion: LRIN outperformed K-nail plus augmented plating in promoting bone union in aseptic nonunion of the distal femur, with a lower nonunion rate and higher mRUST scores, despite a longer operative time.

Background: Viral meningitis is an inflammation of the leptomeninges as a manifestation of central nervous system (CNS) infection. More than 85% of viral meningitis cases are caused by non-polio enteroviruses. This is the first study on the description of the enteroviruses and the related serotypes involved in viral meningitis in Iran. Objectives: This project was conducted to improve our knowledge about the role of enteroviruses and their circulating serotypes in viral meningitis in Iran. Patients and Methods: Cerebrospinal fluids from 118 children under 13 years old with primary clinical diagnosis of aseptic meningitis were collected in Children Medical Center in Tehran and sent to Department of Virology of Pasteur Institute of Iran. To investigate the enteroviruses, 5`-noncoding regions were amplified by Real-Time PCR method using Pan-EV primers and a specific probe. Serotype identification in enterovirus positive samples was conducted by RT-PCR. Results: Enterovirus detection rate in all 118 Cerebrospinal fluid specimens was 10.16%. Most patients were 0-2 years old (40.67%). Serotyping was achieved from 6 specimens with two polio viruses type 1 (vaccine type), two echoviruses 14, one echovirus 5 and one echovirus 30. Conclusions: Enteroviruses should be considered as the main cause of viral meningitis in Iran. Molecular detections of 5-'NCR and VP1-2A RT-PCR with sequence analysis were found to be better than the conventional methods, for direct diagnosis and EVs typing that may lead to decrease of the unnecessary hospitalizations.

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The aseptic loosening rate of the Mayo hip prosthesis femoral stem was determined in a 44 patient (52 hips) series, by comparing preoperative and postoperative clinical and radiographic parameters, over a minimal 5-year postoperative period. Loosening was obvious before five years in four hips (7.6%), while the stem was considered stable in the remaining 48 hips over a mean 6.1 year period, therefore accounting for a 92.3% Kaplan-Meier survival rate. We conclude that the aseptic loosening rate is too high for the Mayo hip prosthesis femoral stem, as compared to literature data concerning the non-conservative stems.

Background Aseptic loosening is a leading cause of revision following total hip and knee arthroplasty which is caused by chronic inflammation around the prosthesis. Diabetes mellitus causes systemic inflammatory changes which could increase the risk of aseptic loosening. This study investigated the association between diabetes mellitus and aseptic loosening around hip and knee arthroplasty. Methods A case-control study was conducted at a single arthroplasty centre over the seven-year period of January 2015 to December 2021. Cases were defined as any adult patient undergoing revision hip or knee arthroplasty for aseptic loosening. Controls were randomly selected patients undergoing primary total hip or knee arthroplasty during the same period at a 1:4 ratio. Risk factors were compared between the two groups. Results A total of 440 patients were included in our study-88 in the aseptic loosening group and 352 patients in the control group. The odds of having diabetes mellitus in the aseptic loosening group was 2.78 (95%CI 1.31-5.92, P = 0.01). Other risk factors were not significantly different between the two groups. Conclusions The incidence of diabetes mellitus is significantly greater in patients undergoing revision arthroplasty for aseptic loosening. Further research is required to explore whether this association is indeed causative.

Antibacterial activity of crude extracts of pisang kepok kuning plants (Musa paradisiaca Linn.) were tested against Staphylococcus aureus and Escherichia coli. Roots, corms, pseudoterms, flowers, and ripe fruits of pisang kepok kuning cultivar were macerated with ethanol 96% and evaporated in a rotary evaporator at 50 0 C. All of crude extracts were screened for its antibacterial activity by using Agar Well Diffusion Method with concentration based on 200 grams of fresh weight. This research used Completed Randomized Design (CRD) with nested pattern, four replications, and consist of two factors. First factor was bacteria and the second factor was crude extracts of pisang kepok kuning such as roots, corms, pseudoterms, flowers, and ripe fruits. The results showed that all of crude extracts have significant antibacterial activity against S. aureus and E. coli. Crude extract of the corm has highest antibacterial activity against S. aureus with diameter of inhibition area was 20,391 mm with inhibition zone type isirradical and diameter inhibition area 18,962 mm for E. coli that has radical zone.

Revision total knee arthroplasty (TKA) is a complex procedure which carries both a greater risk for patients and greater cost for the treating hospital than does a primary TKA. As well as the increased cost of peri-operative investigations, blood transfusions, surgical instrumentation, implants and operating time, there is a well-documented increased length of stay which accounts for most of the actual costs associated with surgery. We compared revision surgery for infection with revision for other causes (pain, instability, aseptic loosening and fracture). Complete clinical, demographic and economic data were obtained for 168 consecutive revision TKAs performed at a tertiary referral centre between 2005 and 2012. Revision surgery for infection was associated with a mean length of stay more than double that of aseptic cases (21.5 vs 9.5 days, p < 0.0001). The mean cost of a revision for infection was more than three times that of an aseptic revision (£30 011 (SD 4514) vs £9655 (SD 599.7), p < 0.0001). Current NHS tariffs do not fully reimburse the increased costs of providing a revision knee surgery service. Moreover, especially as greater costs are incurred for infected cases. These losses may adversely affect the provision of revision surgery in the NHS.

OBJECTIVE: To determine the postoperative infection result after use of a single and simple antibiotics for prophylaxis in open elective cholecystectomy. STUDY DESIGN: Descriptive (quasi-experimental) study. PLACE AND DURATION OF STUDY: This study was ...

Objective: To identify compatibility, types and frequency of errors in preparation and administration of intravenous drugs. Methods: A cross-sectional and descriptive study performed at the emergency department of a university hospital in the city of São Paulo (SP). The sample consisted of 303 observations of the preparation and administration of intravenous drugs by nursing aides, nursing technicians and registered nurses, using a systematized script, similar to a checklist. The following variables were collected: errors related to dispensing, omission, schedule, unauthorized administration, dosage, formulation, incompatibility, preparation and administration. Results: In the preparation stage, the following errors were identified: no hand hygiene (70.29%), and no use of aseptic technique (80.85%). Upon administration, no hand hygiene (81.18%), and no use of aseptic technique (84.81%). In 31.35% of observations, there was more than one medication at the same time for the same patie...

In the modern day’s Oral and Maxillofacial surgical practice, complex surgical and aesthetical procedures are being carried out associated with an increased risk of infectious complications. Therefore, to ensure better outcomes of the surgical procedures, it is absolutely necessary that appropriate measures must be taken to decrease the incidence of associated infections. The practices to be carried out for infection control include proper scrubbing procedures for both patient and the operator, specific protocols to be followed by the operating personnel at the time of procedures, proper handling of the instruments and maintaining an aseptic environment throughout the procedure. The main aim of this chapter is to provide information on the preoperative, operative and post-operative protocols that should be adhered to improve the safety of the patients undergoing surgical procedures.

Background Invasive procedures such as epidural anesthesia carry risks for complications such as erroneous placement arising from inadequate manual skills and infection secondary to breaches in aseptic technique. Although it is assumed that improvement in aseptic technique parallels improved dexterity, this assertion remains unproven. The aim of this study was to determine whether increased proficiency in the manual skills for epidural anesthesia is associated with improved aseptic technique. Methods Second-year anesthesia residents were repeatedly videotaped performing epidural anesthesia over 6-month periods. Three independent examiners blinded to the level of training of the residents evaluated the procedures for manual skills and aseptic technique. Each procedure was graded using a manual skills checklist, a global rating scale, and an aseptic technique checklist. The main outcome measures were the scores for these three tools. Results Thirty-five sessions were videotaped over 1...

Introduction: Distal femur fractures represent 4-6% of all the femoral fractures and they occur within the 9terminal centimeters. Most supracondylar fractures are the result of a severe axial load with a varus, valgus or rotational force. Though various treatment options are available for the management of these injuries with their own advantages and disadvantages, experience with use of locking compression plate which combines fixed-angle locking screw technology with the option for conventional screw utilization is still very limited. Locked plating (LP) of distal femoral fractures has become very popular. In this study we study the result of these fractures treated with locking plates and the outcome of these management in terms of regaining early mobility and ability to go to routine activity of daily living. Aim of the study: The aim of the study the efficacy, technical requirements, functional results, radiological results, pitfalls, complications, union rate and Time of Mobilization of locking plate method.

Methods: With prior ethical clearance study was conducted on prospectively 30 Patients, with distal femur fractures (AO classification type A, C) who were treated with distal femur locking compression plate (DF- LCP) at Department of Orthopaedics, SMIMER, Surat with minimum period of follow up with 6 months and with average period of follow up of 9 months. The study sample was 30 patients and all these patients were included with predefined inclusion and exclusion criteria in this study.

Results: We studied different parameters like age of the patients, mode ofinjury, type of injury according to AO classification, duration of hospitalization, movement of knee after operation, Neer's score results, union or non-union and compared our studies with other studies we find satisfactory results in our study in outcome of the patient.

Conclusion: From our study we concluded that DF-LCP, the “internal fixator” was a safe and reliable implant although careful preoperative planning and case selection were important factors which determine the final outcome.

The aim of this study was to examine the results of the acetabular distraction technique in achieving implantation of a stable construct, obtaining biological fixation, and producing healing of chronic pelvic discontinuity at revision total hip arthroplasty. We identified 32 patients treated between 2006 and 2013 who underwent acetabular revision for a chronic pelvic discontinuity using acetabular distraction, and who were radiographically evaluated at a mean of 62 months (25 to 160). Of these patients, 28 (87.5%) were female. The mean age at the time of revision was 67 years (44 to 86). The patients represented a continuous series drawn from two institutions that adhered to an identical operative technique. Of the 32 patients, one patient required a revision for aseptic loosening, two patients had evidence of radiographic loosening but were not revised, and three patients had migration of the acetabular component into a more stable configuration. Radiographically, 22 (69%) of the cohort demonstrated healing of the discontinuity. The Kaplan-Meier construct survivorship was 83.3% when using revision for aseptic acetabular loosening as an endpoint. At the time when one patient failed due to aseptic loosening (at 7.4 years), there were a total of seven patients with a follow-up of seven years or longer who were at risk of failure. The acetabular distraction technique demonstrates encouraging radiographic outcomes, with healing of the discontinuity in over two-thirds of our series. This surgical technique permits biological fixation and intraoperative customization of the construct to be implanted based on the pattern of the bone loss identified following component removal.

Monitoring of heterogeneous flows in aseptic processing is necessary to ensure safety of the resulting products.  Particles in a liquid carrier are a very complex system which needs to be developed, tested, and validated.

Over more than two decades of collaborative research, development, innovations, pilot and industrial process validation projects, the co-authors have worked as team members and contributors to the establishment of a set of scientific principles, sensors, instruments and methods of process design, process monitoring software and data analyses.
Recent renewal of interest in particulate products by aseptic processing and packaging motivated the pursuit of the following objectives of this presentation:
• Review the established, experimentally confirmed principles and methods of particle property determination, adjustment, construction and use in process validation
• Examine and highlight the myths, and persistent misconceptions that jeopardize safety
• Note examples of implemented, evolving and pending recent developments methods using established principles for construction of “cold spot carrier” particles
i.e. the “fastest moving” and “slowest heating” characteristics under conventional and advanced (ohmic and continuous flow microwave) thermal processing have been developed and implemented.
• Reported results will highlight the successful validation cases in U.S. and Europe and recent progress: 3D printing of particles, sensing network upgrades and significance of these cumulative developments to the appropriate statistical models and analyses.