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PubMed2004

Increased bone turnover as reflected by biochemical markers in patients with potentially unstable fixation of the tibial component.

INTRODUCTION: Whether biochemical markers of bone metabolism can be used in assessing the conditions of implant fixation is unknown. In this study, the serum levels of three bone markers were measured prospectively in patients undergoing total knee arthroplasty (TKA) to determine if patients with different fixation conditions of the tibial component showed any differences in the levels of the markers. MATERIALS AND METHODS: The fixation of the tibial component in 40 knees (40 patients, 14 male and 26 female, average age 71 years) was assessed by radiostereometric analysis (RSA), and based upon the pattern of migration, implants with stable fixation ( n=25) and potentially unstable fixation ( n=15) were identified. Serum levels of carboxyterminal propeptide of type I procollagen (PICP), osteocalcin (OC) and cross-linked carboxyterminal telopeptide of type I collagen (ICTP) were assessed and compared between the two fixation groups. Blood samples were obtained preoperatively (baseline) and repeated postoperatively at 1 week, 3, 6, 12, and 24 months. RESULTS: The baseline levels of the markers were statistically the same ( p>0.05) between the two fixation groups. Postoperatively, ICTP levels in the unstable group were significantly higher than in the stable group from 6 to 24 months ( p=0.02). Levels of OC in the unstable group were higher at 12 and 24 months compared with the stable group, reaching statistical significance only at 12 months ( p=0.03). No difference in the levels of PICP was found between the two groups. CONCLUSION: The findings indicate a more active bone turnover probably at the bone-cement/implant interface in knees with potentially unstable fixation. It reveals the potential value for biochemical markers in monitoring implant fixation and aseptic loosening and suggests a possibility for improving implant fixation by drugs which inhibit osteolysis.

Aged↗
PubMed2004

Carriage of Staphylococcus aureus among injection drug users: lower prevalence in an injection heroin maintenance program than in an oral methadone program.

OBJECTIVES: To compare the prevalence of Staphylococcus aureus and methicillin-resistant S. aureus (MRSA) carriage among injection drug users (IDUs) treated in an injection heroin maintenance program with that among IDUs treated in an oral methadone program, and to determine predictors of S. aureus carriage. DESIGN: Survey. SETTING: Two opiate maintenance programs at a psychiatric university clinic. PARTICIPANTS: A volunteer sample consisting of 94 (74%) of 127 IDUs treated in an injection opiate maintenance program with at least twice daily injections of heroin, and 70 (56%) of 125 IDUs treated in an oral methadone program. RESULTS: Addicts treated in the intravenous heroin substitution program had a significantly lower overall rate of S. aureus carriage (37 of 94 [39.4%] vs 42 of 70 [60%]; P = .009) and a significantly lower rate of nasal carriage (21 of 94 [22.3%] vs 30 of 70 [42.9%]; P = .005) than did addicts treated in the oral methadone program. Being treated in the oral methadone program was the only independent predictor of S. aureus carriage (odds ratio, 2.27; 95% confidence interval, 1.19-4.31; P = .012). All S. aureus isolates were susceptible to oxacillin. CONCLUSIONS: The regular use of needles under aseptic conditions did not increase the rate of S. aureus carriage among IDUs. Further studies are necessary to investigate whether the lower rate of S. aureus carriage among IDUs treated with intravenous heroin leads to a lower incidence of S. aureus infections in these patients.

Administration, Oral↗
PubMed2003

Stability of multidose, preserved formulation epoetin alfa in syringes for three and six weeks.

The integrity and biological activity of multidose, preserved formulation epoetin alfa stored in syringes at 2-8 degrees C were studied. Three independent 1.0-mL hubless syringes of epoetin alfa 20,000 units/mL were aseptically prepared and refrigerated for three and six weeks (a total of six syringes). Protein integrity was assayed by SDS-polyacrylamide gel electrophoresis (SDS-PAGE), immunoblotting, and glycoprotein detection. Biological activity was determined through a cell-based proliferation assay. The presence or absence of microbial contamination was observed after a one-week culture. A multidose, preserved formulation of epoetin alfa that was opened only at the time of assay served as the reference standard. SDS-PAGE silver-stained gels and immunoblots demonstrated no evidence of erythropoietin degradation after three and six weeks of storage when compared with the reference standard. In addition, SDS-PAGE, immunoblotting, and direct glycoprotein detection found that protein glycosylation was unaffected by the storage. Student's t test detected no significant difference between stored samples and the reference standard in biological activity (p > 0.05). A culture of epoetin alfa in bacterial and eukaryotic cell growth media showed no evidence of contamination. The results suggest that epoetin alfa can be dispensed to patients in prefilled syringes every four to six weeks to coincide with their peritoneal dialysis schedule. The integrity and biological activity of 20,000 units/mL epoetin alfa in prefilled syringes remain intact after three and six weeks when stored at 2-8 degrees C.

Cell Division↗
PubMed2003

[Repair of segmental bone defects in rhesus monkeys' radius with allogeneic tissue engineered bones].

OBJECTIVE: To construct tissue engineering bone with bio-derived materials and bone marrow stromal cells (MSCs), and to investigate the effect of allogeneic engineering bone implants on healing of segmental bone defects. METHODS: MSCs being aspirated aseptically from tibial tuberosities of young rhesus monkeys were induced into osteoblasts in vitro and then were cultured and marked with 5-bromo-2-deoxyuridine (BrdU). Tissue engineering bones were constructed with these labeled osteoblasts being seeded onto bio-derived materials made from fresh human bones which were treated physically and chemically, Then the constructs were implanted in 15 allogeneic monkeys to bridge 2.5 cm segmental bone defects of left radius as experimental groups, bio-derived materials only were implanted to bridge same size defects of right radius as control group. and, 2.5 cm segmental bone defects of both sides of radius were left empty in two rhesus monkeys as blank group. Every 3 monkeys were sacrificed in the 1st, 2nd, 3rd, 6th and 12th weeks postoperatively and both sides of the implants samples were examined macroscopically, histologicaly, and immunohistochemicaly. The two monkeys in blank group were sacrificed in the 12th week postoperatively. RESULTS: Apparent inflammatory reactions were seen around both sides of the implants samples in the 1st, 2nd, 3rd weeks, but it weakened in the 6th week and disappeared at the 12th week. The labeled osteoblasts existed at the 6th week but disappeared at the 12th week. The bone defects in experimental group were repaired and the new bone formed in multipoint way, and osteoid tissue, cartilage, woven bone and lamellar bone occurred earlier when compared with control group in which the bone defects were repaired in 'creep substitution' way. The bone defects in blank group remained same size at the 12th week. CONCLUSIONS: Engineering bones constructed with bio-derived materials and MSCs were capable of repairing segmental bone defects in allogeneic monkeys beyond 'creep substitution' way and making it healed earlier. Bio-derived materials being constituted with allogeneic MSCs may be a good option in construction of bone tissue engineering.

Animals↗
PubMed2002

An outbreak of eosinophilic meningitis caused by Angiostrongylus cantonensis in travelers returning from the Caribbean.

BACKGROUND: Outbreaks of eosinophilic meningitis caused by the roundworm Angiostrongylus cantonensis are rarely reported, even in regions of endemic infection such as Southeast Asia and the Pacific Basin. We report an outbreak of A. cantonensis meningitis among travelers returning from the Caribbean. METHODS: We conducted a retrospective cohort study among 23 young adults who had traveled to Jamaica. We used a clinical definition of eosinophilic meningitis that included headache that began within 35 days after the trip plus at least one of the following: neck pain, nuchal rigidity, altered cutaneous sensations, photophobia, or visual disturbances. RESULTS: Twelve travelers met the case definition for eosinophilic meningitis. The symptoms began a median of 11 days (range, 6 to 31) after their return to the United States. Eosinophilia was eventually documented in all nine patients who were hospitalized, although on initial evaluation, it was present in the peripheral blood of only four of the nine (44 percent) and in the cerebrospinal fluid of five (56 percent). Repeated lumbar punctures and corticosteroid therapy led to improvement in symptoms in two of three patients with severe headache, and intracranial pressure decreased during corticosteroid therapy in all three. Consumption of one meal (P=0.001) and of a Caesar salad at that meal (P=0.007) were strongly associated with eosinophilic meningitis. Antibodies against an A. cantonensis--specific 31-kD antigen were detected in convalescent-phase serum samples from 11 patients. CONCLUSIONS: Among travelers at risk, the presence of headache, elevated intracranial pressure, and pleocytosis, with or without eosinophilia, particularly in association with paresthesias or hyperesthesias, should alert clinicians to the possibility of A. cantonensis infection.

Adrenal Cortex Hormones↗
PubMed2002

Reduction of eggshell aerobic plate counts by ultraviolet irradiation.

The effects of 254 nm ultraviolet light (UV) radiation on aerobic plate count (APC) of egg shells were investigated. In the first experiment, eggs were exposed to UV treatment (7.35 mW/cm2) for 0, 15, 30, and 60 s. Three eggs from each treatment were aseptically collected and placed into sterile plastic bags containing 50 mL of sterile phosphate-buffered solution. Serial dilutions of the phosphate-buffered solution were plated on aerobic plate count agar and incubated at 37 C for 48 h. Exposure of eggshells to 30 and 60 s UV significantly reduced aerobic plate counts compared to untreated eggs. Exposure to 60 s of UV resulted in a 2 to 3 log10 cfu/egg APC reduction and reduced counts below detectable levels. In the second experiment, UV lights were placed in a chamber equipped with a commercial-style egg conveyor. A UV treatment of 7.5 mW/cm2 and time intervals of 0, 12, 36, and 48 s were used. Three eggs were placed consecutively on the conveyor and passed through the chamber. The center egg was selected for APC evaluation. Sample size, dilution, plating, and incubation procedures were used as described for the first experiment. A significant 1 to 2 log10 reduction in colony-forming units per egg between the eggs treated 48 s to the untreated eggs was detected. The results of these studies show that UV light treatment at high intensities and low time intervals has the potential to reduce aerobic plate counts of eggshells.

Animals↗
PubMed2005

An outbreak of hepatitis C virus infections among outpatients at a hematology/oncology clinic.

BACKGROUND: Approximately 2.7 million persons in the United States have chronic hepatitis C virus (HCV) infection. Health care-associated HCV transmission can occur if aseptic technique is not followed. The authors suspected a health care-associated HCV outbreak after the report of 4 HCV infections among patients at the same hematology/oncology clinic. OBJECTIVE: To determine the extent and mechanism of HCV transmission among clinic patients. DESIGN: Epidemiologic analysis through a cohort study. SETTING: Hematology/oncology clinic in eastern Nebraska. PARTICIPANTS: Patients who visited the clinic from March 2000 through December 2001. MEASUREMENTS: HCV infection status, relevant medical history, and clinic-associated exposures. Bivariate analysis and logistic regression were used to identify risk factors for HCV infection. RESULTS: Of 613 clinic patients contacted, 494 (81%) underwent HCV testing. The authors documented infection in 99 patients who lacked previous evidence of HCV infection; all had begun treatment at the clinic before July 2001. Hepatitis C virus genotype 3a was present in all 95 genotyped samples and presumably originated from a patient with chronic hepatitis C who began treatment in March 2000. Infection with HCV was statistically significantly associated with receipt of saline flushes (P < 0.001). Shared saline bags were probably contaminated when syringes used to draw blood from venous catheters were reused to withdraw saline solution. The clinic corrected this procedure in July 2001. LIMITATION: The delay between outbreak and investigation (>1 year) may have contributed to an underestimate of cases. CONCLUSIONS: This large health care-associated HCV outbreak was related to shared saline bags contaminated through syringe reuse. Effective infection-control programs are needed to ensure high standards of care in outpatient care facilities, such as hematology/oncology clinics.

Adult↗
PubMed2004

Molecular evaluation of residual endodontic microorganisms after instrumentation, irrigation and medication with either calcium hydroxide or Septomixine.

BACKGROUND AND OBJECTIVE: The correct choice of antimicrobial agents as inter-appointment medicaments is as important as the instrumentation and irrigation to remove pathogens from infected root canals. Calcium hydroxide [Ca(OH)2] and framycetin sulfate (Septomixine) are common endodontic medicaments. Therefore, we evaluated the efficacy of either calcium hydroxide or Septomixine in eliminating residual intra-canal bacteria, particularly Actinomyces spp., during inter-appointment interval in endodontic therapy using molecular methods. METHODS: A total of 31 single-rooted teeth with primary root canal infections were studied immediately after opening the canals and subsequently after instrumentation, irrigation with sterile saline and 1-week medication with either Ca(OH)2 (n = 25) or Septomixine (n = 6). Whole bacterial genomic DNA was isolated directly from samples and PCR with universal primers performed to detect total intra-canal bacteria. The variable regions of 16S rDNA of bacteria were amplified and labeled with digoxigenin for further hybridization to detect Actinomyces spp. A total of seven oligonucleotide probes specific for A. bovis, A. gerencseriae, A. israelii, A. meyeri, catalase-negative A. naeslundii (genospecies 1 and 2), catalase-positive A. naeslundii genospecies 2 and A. odontolyticus were used to detect Actinomyces spp. in 22 of 31 medicated root canals [Ca(OH)2: n = 17; Septomixine: n = 5]. RESULTS: The PCR results showed that 25 of 31 examined canals were positively detected with residual microorganisms after instrumentation, irrigation with sterile saline and 1-week medication with either Ca(OH)2 (n = 20) or Septomixine (n = 5). Thus, only six canals [Ca(OH)2: n = 5, Septomixine: n = 1] were aseptic after treatment. Hybridization results showed higher detection frequency of both A. odontolyticus and A. gerencseriae after treatment. Significant correlation was found between exposed pulp before treatment and positive detection of Actinomyces spp., particularly A. odontolyticus on the second visit (P < 0.05). CONCLUSION: The conventional, 1-week medication of either Ca(OH)2 or Septomixine in endodontic therapy may not effectively inhibit residual bacterial growth in all root canals during inter-appointment intervals. Further investigations using, for instance quantitative real-time PCR analyses, are required to substantiate the present findings.

Actinomycosis↗
PubMedDate not supplied

Analysis of blood clotting factor activities in canine Legg-Calvé-Perthes' disease.

Legg-Calve-Perthes' (LCP) disease is a noninflammatory aseptic necrosis of the femoral head and neck in small-breed dogs. The etiology of the disease is not known, but ischemia resulting from vascular compression or occlusion has been proposed. A latent ischemic phase during development of the femoral epiphysis seems to be responsible for the onset of the typical clinical features of LCP disease. Ischemia might result from insufficient oxygen supply either caused by a reduced number of afferent arterial vessels or an occlusion of the efferent venous vessels by thrombosis. In humans, LCP disease has been linked to hypercoagulability and hypofibrinolysis caused by deficiencies of protein C, protein S, or resistance to activated protein C. To determine whether canine LCP disease is caused by similar deficiencies, we determined protein C, protein S, activated protein C, factor II, factor V, factor VIII:C, and AT III activities in plasma samples of 18 dogs with clinically and histopathologically verified LCP disease. All dogs had normal plasma activities of these factors, indicating that in these dogs LCP disease was not caused by deficiencies of the analyzed blood clotting factors.

Animals↗
PubMed2005

Postoperative ascites associated with intraperitoneal antiseptic lavage.

BACKGROUND: Peritonitis is the established term for infective inflammation of the peritoneum, whereas serositis generally refers to aseptic inflammation of a serous cavity, including the peritoneum. Serositis may be metabolic, viral, autoimmune, drug induced, genetic, allergic or granulomatous, or due to chemical antiseptics. CASES: In our gynecological department, 4 patients had peritonitis and ascites after laparotomy. CONCLUSION: Based on the investigation, we think that the solution used for peritoneal lavage (0.1% octenidine dihydrochloride and 2% phenoxyethanol) played a role in the tissue toxicity that caused chemical serositis with effusion.

Ascites↗
PubMed2006

In vitro effects of non-steroidal anti-inflammatory drugs on cytokine, prostanoid and matrix metalloproteinase production by interface membranes from loose hip or knee endoprostheses.

OBJECTIVE: To study the effects of the non-steroidal anti-inflammatory drugs (NSAIDs) aceclofenac, piroxicam, tenoxicam and indomethacin on cytokine, matrix metalloproteinases (MMPs), tissue inhibitors of metalloproteinases (TIMPs) and prostaglandin E2 (PGE2) production, by interface membranes (IFT), obtained at revision surgery for aseptic loosening of total joint arthroplasty. Involvement of these soluble factors is well documented and probably, a pharmaceutically induced inhibition of them might retard loosening. METHODS: IFTs from 10 patients with a loose hip or knee endoprosthesis were collected. The possibility of septic loosening was thoroughly excluded by histopathologic and microbiologic evaluation. IFTs were cultured in the absence or presence of the tested drugs and the levels of the soluble mediators were determined, using electrophoretic and enzyme-linked immunosorbent assay techniques. Paracetamol was used as neutral drug. RESULTS: All NSAIDs exhibited a pronounced inhibitory effect upon the production of interleukin-6 (IL-6) and tumour necrosis factor-alpha (TNF-alpha). This specific effect on IL-6 is reported in the literature for the first time. The majority of NSAIDs also induced the production of IL-1beta in an adequate portion of samples. These drugs did not have a clear effect on MMP synthesis, but they had a stimulatory tendency on TIMP-1 production. Paracetamol, significantly decreased the synthesis of TNF-alpha and that of the gelatinases. CONCLUSION: Our in vitro results are encouraging, since it appears that the action of NSAIDs, globally considered, may be beneficial upon the loosening process. The inhibitory effect of paracetamol upon TNF-alpha and gelatinases is intriguing. Our data, if supported by similar observations, probably justify performance of long-term clinical trials.

Aged↗
PubMed1987

Infection potential of nondisposable pressure transducers prepared prior to use.

This study was designed to examine whether pressure transducer systems prepared hours or days before actual use represent an infection potential. Twenty-one nondisposable transducers assembled with sterile plastic disposable domes and extension tubing were utilized. The systems were prefilled with heparinized flush solution (2 U sodium heparin per ml normal saline). Flush solution samples were cultured from the distal end of the equipment immediately after set-up (time 0) and 24, 48, and 72 h after set-up in all 21 transducers. In 11 of 21 transducers, cultures were also taken at 168 h (1 wk) and 336 h (2 wk) after set-up. Out of the total 106 cultures, only two showed growth, both of which proved to be external skin or mouth contaminants. Binomial distribution testing indicated that if a .05 probability level was used, the chance was 1.3% that one or more transducers in 100 could become contaminated by 72 h. Using the same statistical analyses for the 66 cultures involving the 11 transducers cultured for 2 wk, the chance of contamination in 100 cultures is 2.7% at 2 wk. We conclude from these data that nondisposable transducer systems, when preassembled using standard aseptic precautions and sterile disposable plastics, show no evidence of significant contamination when allowed to stand in readiness after assembly but not connected to a patient. We feel it is safe to preassemble transducers for at least a 72-h period before use. Longer intervals from set-up to use may also be justified.

Equipment Contamination↗
PubMed1984

Semiautomated technique for identification of subgingival isolates.

A semiautomated approach for the characterization of subgingival bacterial isolates which economizes in media preparation, inoculation, reading, recording, and interpretation of results was tested. Test ingredients were added to a basal medium consisting of Mycoplasma broth supplemented with 5 micrograms of hemin, 0.5 mg of NaHCO3, and 0.5 mg of L-cysteine per ml. Sterile test media were aseptically dispensed into wells of sterile microtiter plates with a MIC 2000 dispenser. Inocula were grown in broth or scraped from agar plates, dispersed, and inoculated with a MIC 2000 inoculator. After 2 to 4 days of incubation, the optical density of growth was determined with an Artek 210 vertical beam reader at 580 nm and stored on a floppy disk. Reagents were added to each well, and the changes in optical density were determined. Thresholds for positive reactions were determined after extensive preliminary studies for each test. The tests were run in duplicate on each plate and interpreted with an Artek vertical beam reader. Tests that were run in this system included: fermentation of carbohydrates, decarboxylase reactions, reduction of nitrate and nitrite, ammonia production, hydrolysis of esculin, growth in the presence of inhibitory or stimulatory substances, and indole production. Approximately 80% of all isolates from subgingival samples could be characterized by this technique. Comparisons were made between the semiautomated and conventional identification techniques. Overall reproducibility of 2,980 strains by the semiautomated and conventional techniques were 95 and 90%, respectively. There was an 86% similarity of results by the semiautomated and conventional methods. The semiautomated technique was more rapid, less expensive, and as reproducible as the conventional method of identification.

Bacteria↗
PubMed2004

[Long-term results of alumina-on-alumina total hip arthroplasty].

PURPOSE OF THE STUDY: Mechanical failure in total hip arthroplasty is usually related to aseptic loosening itself related to wear particles as seen with polyethylene bearings. Alumina has bee proposed to avoid wear problems. In vitro and mid-term clinical studies have shown tribological advantages but early acetabular fixation remains an issue. Since alumina-on-alumina bearings are currently used with new fixation techniques, updated evaluations of older series are informative regarding the long-term tolerance of alumina in vivo. MATERIAL AND METHODS: We investigated 104 consecutive alumin-on-alumina cemented total hip arthroplasties (Cervaer-Osteal, Roissy, France) implanted 20 years ago in 81 patients (from 1979 to 1983). A32-mm alumina femoral head was used. The alumina acetabular socket and the titanium femoral stem were cemented. The Postel-Merle-d'Aubigne score was used for clinical evaluation. Radiological wear and development of osteolysis or loosening were noted for establishing actuarial curves. When accessible, histological samples from revision procedures were analyze. RESULTS: Six infected cases were not taken into account for data analysis. The average follow-up was 11 years, reaching 18 years in 38 cases. Twenty-three hips were revised for changing 23 acetabular sockets, 12 femoral heads, and one femoral stem. We noted one femoral head fracture, 24 definite acetabular loosenings, 12 probable acetabular loosenings, and 3 definite femoral loosenings. Radiological acetabular osteolysis was present in 4 cases, always limited to De Lee zone 1, and associated with loosening. Radiological wear was below eye detection. Periprosthetic tissue showed non-specific histological reactions to cement particles. Survival rate at 20 years was 62.8% [49.3-76.2%], in terms of revision 57.1% [42.5-71.7%] and 95.2% [89.9-100%] in terms of definite acetabular and femoral loosening. DISCUSSION: Besides the high rate of cemented fixation failure of the socket, loosened and non-loosened cases showed an excellent long-term tolerance of the alumina-on-alumina bearing with normal wear and osteolysis. This may also have protected the femoral component from complications. This study confirms in vivo the long-term tribological benefit of the alumina-on-alumina bearing in total hip arthroplasty and suggests that acetabular fixation should be improved to achieve full benefit.

Aged↗
PubMedDate not supplied

Aseptic efficacy of prefilled syringes in a polluted environment.

INTRODUCTION: To evaluate the aseptic efficacy of prefilled syringes compared with ampules when used in a polluted environment similar to that at a disaster site. METHODS: The researchers tested epinephrine, 0.1%, atropine sulfate, 0.05%, and lidocaine hydrochloride solutions, 2% (Group A) as well as lidocaine hydrochloride, 10%, sodium bicarbonate, 8.4%, and glucose solutions, 50% (Group B), that frequently are used for intravenous injection and intravenous infusion respectively in Disaster Medicine. Each of these solutions in 10 prefilled syringes (PFSs) and 10 ampules was placed in a box of contaminated soil along with needles and empty syringes for ampules. In the box, each was taken out of its package, all syringes were connected with a needle, and empty syringes were filled with a solution. After this procedure, all syringes were taken out of the box to check their contents for bacterial contamination. RESULTS: No bacterium was observed in any of the 10 PFS samples of Group A and B solutions. In contrast, out of 10 ampule samples, six of the 10 samples containing epinephrine, nine of the 10 containing atropine sulfate, all 10 samples containing lidocaine hydrochloride, 2%, and all of the ampule samples containing Group B solutions tested positive for bacteria. A statistically significant difference was observed between the PFS and ampule samples in all six solutions. CONCLUSION: Results indicate that, in environments with airborne contaminants, the use of prefilled syringes may be useful for preventing bacterial contamination of the medicine inside.

Air Microbiology↗
PubMed2002

[Lymphocytic meningitis in Spain: a possible epidemic situation in 2000].

UNLABELLED: In order to clarify the unexpected increase in 2000 of lymphocyticmeningitis analyzed in the Centro Nacional de Microbiología,Instituto de Salud Carlos III, Madrid, here we present their microbiological features. PATIENTS AND METHOD: Samples of 732 patients were tested by virological and serological methods to detect infections by neurotrophic agents. RESULTS: Infections were identified in 375 (51%) cases. Nopolio enteroviruses were identified in 90% cases. Echovirus 30 and 13 were mainly characterized, the latter for the first time in Spain. CONCLUSIONS: The emergence of Echovirus 13 may explain the past epidemic situation.

Adolescent↗
PubMedDate not supplied

A method for demonstrating appropriate environmental protection for capping aseptically filled and plugged vials.

Conventional aseptic filling of drug product into vials ultimately includes a step that requires time and travel from the stoppering stage to the capping/crimping stage. Lyophilized product necessarily includes a partial stoppering step and, therefore, Grade A conditions. The level of environmental control that is required to protect the contents of fully stoppered, but uncapped, vials of sterile product from microbial contamination hasn't been formally defined. There is considerable range of opinion regarding this topic. This is the result of the lack of data that indicates the level of protection afforded by vials that are closed with a stopper, but that have not yet been capped. In order to provide some insight into the level of environmental control that is appropriate for vials at this stage of production, studies were conducted that consisted of exposing stoppered, uncapped vials containing sterile microbiological media to an aerosolized microbial challenge. The test samples were selected and assembled in such a way that a range of container/closure presentations was simulated. Furthermore, a microbial challenge was selected that was in excess of the environmental conditions to which product vials would be exposed. The results of this testing indicated a high level of confidence that stoppered, uncapped vials exposed to microbiologically challenging conditions would be expected to maintain the sterility of their contents.

Drug Contamination↗
PubMed1998

Quantification of the bone-related mRNAs at the bone/prosthetic interface.

Aseptic loosening is one of the major reasons for failure of joint prostheses. The periprosthetic tissue has previously been described microscopically; however, little work has been devoted towards quantitating genes expressed by cells at the materials/tissue interface. This study aims to characterize the phenotypic expression of osteoblasts and test the feasibility of quantifying the level of gene expression in periprosthetic tissue sections by combining in situ hybridization and image analysis techniques. There are many factors to consider when quantifying mRNA, in that comparing labeling between different cDNA probes, these should have comparable length and base comparison. The probes should be labeled with the same specific activity, that is the amount of probe to label added is the same, both between different probes and between batches of the same probe. Chromagen color reactions are variable in that the color development is not always linear and more likely follows a sigmoidal curve. Samples should only be compared when it is known that the reaction has been in the linear range. The image analysis of such staining introduces further factors which should be considered and controlled. Color analysis is a very complex problem with respect to reproducibly analyzing histological sections. The brightness component of the image should be independent of the colors within the image, in conventional RGB (red, green and blue) signalling mode this is not possible, while when using HSI (hue saturation and intensity) mode this becomes possible, and factors like staining intensity and brightness of the image become much more accountable and controllable. With these factors identified, we consider that the quantitative image analysis approach does allow comparison of patterns of bone-related mRNAs and demonstrates differences in expression in these osteogenic factors depending on distance from the prosthesis, tissue type, patient and device.

Journal Article↗