Microbiology. Clindamycin inhibits bacterial protein synthesis by binding to the 50S subunit of the ribosome. It has activity against Gram-positive aerobes and anaerobes as well as some Gram-negative anaerobes. Clindamycin is bacteriostatic. Cross-resistance between clindamycin and lincomycin is complete. Antagonism in vitro has been demonstrated between clindamycin and erythromycin. Clindamycin inducible resistance has been identified in macrolide-resistant staphylococci and beta-hemolytic streptococci. Macrolide-resistant isolates of these organisms should be screened for clindamycin inducible resistance using the D-zone test. Clindamycin has been shown to be active against most of the isolates of the following microorganisms, both in vitro and in clinical infections, as described in the INDICATIONS AND USAGE section. Gram-positive aerobes Staphylococcus aureus (methicillin-susceptible strains) Streptococcus pneumoniae (penicillin-susceptible strains) Streptococcus pyogenes Anaerobes Prevotella melaninogenica Fusobacterium necrophorum Fusobacterium nucleatum Peptostreptococcus anaerobius Clostridium perfringens At least 90% of the microorganisms listed below exhibit in vitro minimum inhibitory concentrations (MICs) less than or equal to the clindamycin susceptible MIC breakpoint for organisms of a similar type to those shown in Table 1. However, the efficacy of clindamycin in treating clinical infections due to these microorganisms has not been established in adequate and well-controlled clinical trials. Gram-positive aerobes Staphylococcus epidermidis (methicillin-susceptible strains) Streptococcus agalactiae Streptococcus anginosus Streptococcus oralis Streptococcus mitis Anaerobes Prevotella intermedia Prevotella bivia Propionibacterium acnes Micromonas (“Peptostreptococcus”) micros Finegoldia (“Peptostreptococcus”) magna Actinomyces israelii Clostridium clostridioforme Eubacterium lentum Susceptibility Testing Methods When available, the clinical microbiology laboratory should provide cumulative in vitro susceptibility test results for antimicrobial drugs used in local hospitals and practice areas to the physician as periodic reports that describe the susceptibility profile of nosocomial and community-acquired pathogens. These reports should aid the physician in selecting the most effective antimicrobial. Dilution Techniques Quantitative methods are used to determine antimicrobial minimum inhibitory concentrations (MICs). These MICs provide estimates of the suscep...
Microbiology. We tried to divide the Laboratories where the sampling processing and the analysis itself is carried out, in order to minimize the potential pollution sources or any other incompatibility among the different analytical procedures.
Microbiology. The Employer and the Union acknowledge that the nature of the work performed in Microbiology may necessitate weekend work. To accommodate regular scheduled Saturday work each employee in Microbiology will have one (1) week per month which will be assigned to employees on a rotating basis as follows: Tuesday to Saturday - 8:30 a.m. – 4:30 p.m. For a period of one (1) year after the date of ratification, Microbiology employees will be scheduled on a rotating basis to work Sundays. The process of determining the schedule will involve the affected employees. The necessity for Sunday work will be re-evaluated at the end of the one (1) year period and may be extended by mutual agreement. The re-evaluation will include all Microbiology-related work that the Employer requires to be performed on Sunday.
Microbiology. It is important to understand the environmental niche of where the organisms causing CLABSI are found, including colonization on skin, to put the question of which organism groups may be responsible for early or late infections into context. A list of organisms that are responsible for CLABSIs includes coagulase-negative staphylococci, Staphylococcus aureus, Enterococcus species, Candida species, and gram negative bacteria. Of these listed, coagulase-negative staphylococci and S. aureus account for 20.5% and 12.3% of reported CLABSIs in the NHSN data from 2009-2010 (34). Enterococcus and Candida species were also commonly attributed with 18.1% and 14.6% of infections (34). Gram-negative organisms were responsible for approximately 25% of infections (34). As previously stated, skin organisms are more likely to be responsible for extraluminal, early line infections. Of the organisms that commonly cause CLABSIs, the ones that commonly are found on the skin include coagulase-negative staphylococci, S. aureus, and less commonly Candida species (12). Coagulase negative staphylococci are found on the skin of all people (14) while S. aureus is found in nasal passages of adults with an estimate carriage of 20% to 40% and are shed to the skin from the nasal reservoir (12, 13). Candida species, or yeasts, are also found on the skin though less common (14, 15). Candida species are more likely on the skin in patients who have been receiving antibiotics, which includes many hospitalized patients. In contrast, those organisms responsible for later infections may be less likely to be skin organism, however, the extent to which catheter hub is colonized from skin organisms is unclear. Enterococci are commonly found in the intestine (16). Gram negative species are also uncommon in skin flora (14). Gram-negative organisms include Klebsiella, Acinetobacter, Pseudomonas and Escherichia coli (17). Comparing organisms commonly found on the skin versus those that are not will serve as way to determine if these groups are associated with the time that the CLABSI occurred after insertion of the line. Risk factors for CLABSI Risk factor analysis has been done on CLABSI and is important when determining what effects covariates may have on the predictor and outcome. A risk factor that has been found in studies involves insertion site of the line. One study investigated insertion site by randomly assigning catheters for ICU patients at either the subclavian or the femoral site (21). Th...
Microbiology. (a) NPD challenge testing;
Microbiology. The microbiology lab will verify the conditions for growth and the establishment of a viable seed bank to be used in the production of the product. This effort may be in part or wholly combined with Phase II -
Microbiology. A working seed bank and inoculum culture will be prepared in accordance to pre-approved master batch records.
Microbiology. Total: 10 staff
Microbiology. Patheon will perform validation of microbial recovery from pharmacopeial articles following USP <1227> guideline and USP Harmonized methods (USP<61> and <62>) on Methylpyrazole. A harmonized specification based on USP<1111> will - [*****] CONFIDENTIAL Patheon Proposal # BNU-FCO1-0401-1107-R0 be followed to meet USP/EP/JP acceptance criteria for pharmaceutical preparations and substances for pharmaceutical use. The validated methods will cover USP, EP and JP compendia for Microbiological Examination of Non-Sterile Products and Antimicrobial Effectiveness Testing (AET). The budget represents four trials for the validation and assumes only [*****] will be evaluated.
Microbiology. The cost allocated to this Service in the Budget Summary of Part B is the per sample price and will vary depending on the number of samples required for method validation. If a worst case scenario approach were taken, the cost would be based upon testing MLT and AET (if applicable) at two dilutions and/or the usage of the largest volume of diluent(s) based on specification. Testing will be done in compliance with the applicable Pharmacopeia (i.e. USP/NF, EP, JP etc.). Client will be billed based on the actual number of samples and replicates required in order to successfully validate the Product.
