Quality Control: Lessons Learned from a Trimix Stability Study in a 503A Compounding Pharmacy.

Changes in California regulations regarding beyond-use dates of sterile preparations have prompted many compounders to consider stability studies for their formulas. Traditionally, 503A compounders have relied on published data and professional experience to determine stability. However, due to these new regulations, stability studies are now required for California resident and nonresident licensees to extend the beyond-use date of sterile preparations. Conducting studies for the first time can be costly and difficult for compounding pharmacists. This article shares several lessons learned from the author's experience performing stability studies on Trimix injection, a sterile preparation for erectile dysfunction. Avoiding easily made errors can save the compounder unnecessary time and expense.

An alternative parameter to characterize biogas materials: Available carbon-nitrogen ratio.

Available carbon-nitrogen ratio (AC/N) was proposed as an alternative parameter for evaluating the potential of biogas materials in this paper. In the calculation of AC/N ratio, only the carbon that could be effectively utilized in anaerobic digestion (AD) process is included. Compared with total C/N, AC/N is particularly more suitable for the characterization of biogas materials rich in recalcitrant components. Nine common biogas materials were selected and a series of semi-continuous tests for up to 110days were carried out to investigate the source of available carbon and the relationship between AC/N and the stability of AD process. The results showed that only the carbon existing in proteins, sugars, fat and hemicelluose should be considered as available carbon for anaerobic microbes. Besides, the optimal AC/N for semi-continuous AD process was preliminarily determined to be 11-15. Taken together, our results demonstrate that AC/N is more effective than total C/N in the evaluation of the potential performance of AD process.

Application of composite water quality identification index on the water quality evaluation in spatial and temporal variations: a case study in Honghu Lake, China.

Composite Water Quality Identification Index (CWQII) and multivariate statistical techniques were used to investigate the temporal and spatial variations of water quality in Honghu Lake. The aims are to explore the characteristics of water quality trends in annual, monthly, and site spatial distribution and to identify the main pollution factors. The results showed that the values of CWQII increased from 2.0 to 4.0 from the years 2001 to 2005, then decreased from 2006 and kept a balance between 2.0 and 3.0 from 2006 to 2011, indicating that the water quality of Honghu Lake deteriorated from 2001 to 2005 and has gradually improved since 2006, which were likely achieved after water protection measurements taken since 2004. The monthly change rules of water quality were influenced by a superposition of natural processes and human activities. In samples numbered 1-9 from upstream to downstream, the maximum values of CWQII often occurred in sample site 9 while the minimum ones often occurred in sample site 2, indicating that the water quality near the upstream tributary was the poorest and that in the core zone was the best. Incoming water from the trunk canal of the Sihu area upstream was the largest pollution source. The sensitive pollution nutrients were mainly caused by the total nitrogen, followed by the total phosphorus.

Seasonal baseline of nutrients and stable isotopes in a saline lake of Argentina: biogeochemical processes and river runoff effects.

The seasonal variability of inorganic and organic nutrients and stable isotopes and their relations with plankton and environmental conditions were monitored in Lake Chasicó. Principal component analysis evidenced the strong influence of the river runoff on several biogeochemical variables. Silicate concentrations were controlled by diatom biomass and river discharge. Higher values of nitrate and soluble reactive phosphorus (SRP) indicated agricultural uses in the river basin. Elevated pH values (∼ 9) inhibiting nitrification in the lake explained partially the dominance of ammonium: ∼ 83 % of dissolved inorganic nitrogen (DIN). The low DIN/SRP ratio inferred nitrogen limitation, although the hypotheses of iron and CO2 limitation are relevant in alkaline lakes. Particulate organic matter (POM) and dissolved organic matter (DOM) were mainly of autochthonous origin. The main allochthonous input was imported by the river as POM owning to the arid conditions. Dissolved organic carbon was likely top-down regulated by the bacterioplankton grazer Brachionus plicatilis. The δ(13)C signature was a good indicator of primary production and its values were influenced probably by CO2 limitation. The δ(15)N did not evidence nitrogen fixation and suggested the effects of anthropogenic activities. The preservation of a good water quality in the lake is crucial for resource management.

Development of freshwater sediment management standards for organic matters, nutrients, and metals in Korea.

Korean water quality managers are required to promptly develop national assessment standards for freshwater sediment quality due to the Four Major River Restoration Project in Korea in 2009. We conducted this study to develop sediment management standards (SMSs), determining obviously and severely polluted sediment, which could have adverse impacts on water quality and aquatic ecosystem. The SMSs values were derived from the 95th percentile of concentration distribution for organic matter and nutrients in sediment quality database. For the SMSs of metals, foreign sediment quality guidelines (SQGs) were adopted. As a result, 13% for loss on ignition (LOI), 1,600 mg/kg for total phosphorus (TP), and 5,600 mg/kg for total nitrogen (TN) were set as the SMSs for freshwater sediment in Korea. These values were higher than the range of heavily polluted sediment from USEPA Region 5 guideline derived by the similar approaches for the Great Lakes harbor sediments, and similar or lower than the severe effect level (SEL) from provincial sediment quality guideline (PSQG) of Ontario, Canada by screening level concentration (SLC) approach. However, SMSs in the present study are appropriate considering the concentration ranges and the Korean SMSs' definition for freshwater sediments in Korea. The Puget Sound marine sediment cleanup screening level (CSL) in Washington State, USA were adopted as the Korean SMSs for As (93 mg/kg), Cd (6.7 mg/kg), Cr (270 mg/kg), Cu (390 mg/kg), Pb (530 mg/kg), and Zn (960 mg/kg) in freshwater sediments. Hg concentration (0.59 mg/kg) of CSL was too low to determine the polluted freshwater sediments in Korea, and the SEL of Ontario, Canada for mercury concentration (2 mg/kg) was selected as the SMS for Hg. These values were found reasonable through the assessment of applicability with the datasets from locations directly affected by obvious point sources. These results indicate that SMSs for organic matter, nutrient, and metals derived within the present study can successfully determine obviously and severely polluted sediment in Korea. However, the SMSs have limits to specifically determine the effects of polluted sediment on water quality and aquatic ecosystem in Korea. Thus, we will revise and specify SMSs considering those effects and further sediment quality assessment framework in the near future.

Recreational technical diving part 1: an introduction to technical diving methods and activities.

Technical divers use gases other than air and advanced equipment configurations to conduct dives that are deeper and/or longer than typical recreational air dives. The use of oxygen-nitrogen (nitrox) mixes with oxygen fractions higher than air results in longer no-decompression limits for shallow diving, and faster decompression from deeper dives. For depths beyond the air-diving range, technical divers mix helium, a light non-narcotic gas, with nitrogen and oxygen to produce 'trimix'. These blends are tailored to the depth of intended use with a fraction of oxygen calculated to produce an inspired oxygen partial pressure unlikely to cause cerebral oxygen toxicity and a nitrogen fraction calculated to produce a tolerable degree of nitrogen narcosis. A typical deep technical dive will involve the use of trimix at the target depth with changes to gases containing more oxygen and less inert gas during the decompression. Open-circuit scuba may be used to carry and utilise such gases, but this is very wasteful of expensive helium. There is increasing use of closed-circuit 'rebreather' devices. These recycle expired gas and potentially limit gas consumption to a small amount of inert gas to maintain the volume of the breathing circuit during descent and the amount of oxygen metabolised by the diver. This paper reviews the basic approach to planning and execution of dives using these methods to better inform physicians of the physical demands and risks.

Broad-scale patterns of tissue-δ15N and tissue-N indices in frondose Ulva spp.; developing a national baseline indicator of nitrogen-loading for coastal New Zealand.

A survey of tissue-δ(15)N and tissue-N values in the green macroalga, Ulva, was conducted around the coast of New Zealand to determine if these indices could be used as indicators of anthropogenic nutrient loading in coastal waters. In addition, data from four case studies showed temporal and spatial responses of tissue-δ(15)N and tissue-N in Ulva to significant terrestrial nutrient inputs. Tissue-δ(15)N in Ulva from 'natural' exposed coastal sites showed a relatively narrow baseline range of values (6.6±0.1-8.8±0.1‰) in both summer and winter that was consistent throughout New Zealand. Departures in Ulva tissue-δ(15)N ratios outside this range, particularly when coupled with high (>3.1%) tissue-N values, indicate significant contributions of terrestrially-derived nitrogen to coastal seawater. We note that tissue-N content is also affected by exposure, light and season; however provided such factors are taken into account Ulva can be a cost-effective indicator of relative changes in both source and amount of nitrogen-loading.

Estimating reference nutrient criteria for Maryland ecoregions.

Management of stream nutrients is becoming increasingly important in order to protect both water quality and aquatic resources throughout the USA. Using an extensive water quality database from the long-term Maryland Biological Stream Survey (MBSS), we describe nutrient relationships to landscape characteristics as total nitrogen (TN) and total phosphorus (TP) of small-order, non-tidal streams in USEPA L2 and L3 ecoregions in Maryland and by MBSS stream order at the L2 and L3 ecoregion levels. To protect stream ecosystem integrity, preliminary reference nutrient estimates (TN and TP) as percentiles (25th of all stream reaches and 75th of stream reference reaches) for the six Maryland L3 ecoregions are: Blue Ridge TN 0.29 and 0.64 mg/L, TP 0.0065 and 0.0090 mg/L; Central Appalachians TN 0.40 and 1.0 mg/L, TP 0.0060 and 0.015 mg/L; Middle Atlantic Coastal Plains TN 0.93 and 2.5 mg/L, TP 0.094 and 0.065 mg/L; Northern Piedmont TN 1.6 and 1.8 mg/L, TP 0.010 and 0.015 mg/L; Ridge and Valley TN 0.40 and 0.98 mg/L, TP 0.0063 and 0.012 mg/L; and Southeastern Plains TN 0.33 and 0.82 mg/L, TP 0.016 and 0.042 mg/L. High levels of both TN and TP are present in many streams found in non-tidal watersheds associated with all Maryland ecoregions, but are especially elevated in the Northern Piedmont and Middle Atlantic Coastal Plain ecoregions, with the latter second-order streams (average TN > 2.9 mg/L) significantly higher than all other ecoregion-order combinations. Across all six ecoregions, mean nutrient loading for both TN and TP was generally equivalent in first-order streams to nutrient concentrations seen in both second- and third-order streams, indicating a definite need to increase efforts in preventing nutrients from entering first-order streams. Small-order stream nutrient levels are the drivers for subsequent TN and TP inputs into the upper freshwater tidal reaches of the Chesapeake Bay, resulting in a potential risk for altered estuarine ecosystems.

An integrated risk management model for source water protection areas.

Watersheds are recognized as the most effective management unit for the protection of water resources. For surface water supplies that use water from upstream watersheds, evaluating threats to water quality and implementing a watershed management plan are crucial for the maintenance of drinking water safe for humans. The aim of this article is to establish a risk assessment model that provides basic information for identifying critical pollutants and areas at high risk for degraded water quality. In this study, a quantitative risk model that uses hazard quotients for each water quality parameter was combined with a qualitative risk model that uses the relative risk level of potential pollution events in order to characterize the current condition and potential risk of watersheds providing drinking water. In a case study of Taipei Source Water Area in northern Taiwan, total coliforms and total phosphorus were the top two pollutants of concern. Intensive tea-growing and recreational activities around the riparian zone may contribute the greatest pollution to the watershed. Our risk assessment tool may be enhanced by developing, recording, and updating information on pollution sources in the water supply watersheds. Moreover, management authorities could use the resultant information to create watershed risk management plans.

Towards ecologically relevant targets for river pollutant loads to the Great Barrier Reef.

Degradation of coastal ecosystems in the Great Barrier Reef (GBR), Australia, has been linked with a decline in water quality from land-based runoff. This paper examines the reduction in current end-of-catchment loads required for total suspended solids (TSS) and dissolved inorganic nitrogen (DIN) to achieve GBR water quality guidelines. Based on first-order estimates of sustainable pollutant loads, current TSS and DIN loads would need to be reduced by approximately 7000ktons/y (41%) and 6000tons/y (38%), respectively. Next, these estimated reductions for TSS and DIN are compared with Reef Plan targets for anthropogenic sediment (-20% by 2020) and nitrogen (-50% by 2013) loads. If successful, these targets will accomplish approximately 40% of TSS and 92% of DIN load reductions required to achieve sustainable loads to the GBR lagoon. These first-order estimates elucidate the need to establish ecologically relevant targets for river pollutant loads to the GBR for management and policy.

Rationale for control of anthropogenic nitrogen and phosphorus to reduce eutrophication of inland waters.

Concentrations of phosphorus and nitrogen in surface waters are being regulated in the United States and European Union. Human activity has raised the concentrations of these nutrients, leading to eutrophication of inland waters, which causes nuisance growth of algae and other aquatic plants. Control of phosphorus often has had the highest priority because of its presumed leading role in limiting development of aquatic plant biomass. Experimental evidence shows, however, that nitrogen is equally likely to limit growth of algae and aquatic plants in inland waters, and that additions of both nutrients cause substantially more algal growth than either added alone. A dual control strategy for N and P will reduce transport of anthropogenic nitrogen through drainage networks to aquatic ecosystems that may be nitrogen limited. Control of total phosphorus in effluents is feasible and is increasingly being required by regulations. The control strategy for nitrogen in effluents is more difficult, but could be made more feasible by recognition that a substantial portion of dissolved organic nitrogen is not bioavailable; regulation should focus on bioavailable N (nitrate, ammonium, and some dissolved organic nitrogen) rather than total N. Regulation of both N and P also is essential for nonpoint sources.

Recent incident reaffirms importance of action plan for gas-related emergencies.

Contaminated gas supplies present a risk to clinical staff and patients, with serious and possibly even fatal consequences. Hospitals should have policies in place so that staff can react quickly in the event of gas contamination or other gas-related emergencies.

Reliability analysis of wastewater treatment plants.

This article presents a reliability analysis of 166 full-scale wastewater treatment plants operating in Brazil. Six different processes have been investigated, comprising septic tank+anaerobic filter, facultative pond, anaerobic pond+facultative pond, activated sludge, upflow anaerobic sludge blanket (UASB) reactors alone and UASB reactors followed by post-treatment. A methodology developed by Niku et al. [1979. Performance of activated sludge process and reliability-based design. J. Water Pollut. Control Assoc., 51(12), 2841-2857] is used for determining the coefficients of reliability (COR), in terms of the compliance of effluent biochemical oxygen demand (BOD), chemical oxygen demand (COD), total suspended solids (TSS), total nitrogen (TN), total phosphorus (TP) and fecal or thermotolerant coliforms (FC) with discharge standards. The design concentrations necessary to meet the prevailing discharge standards and the expected compliance percentages have been calculated from the COR obtained. The results showed that few plants, under the observed operating conditions, would be able to present reliable performances considering the compliance with the analyzed standards. The article also discusses the importance of understanding the lognormal behavior of the data in setting up discharge standards, in interpreting monitoring results and compliance with the legislation.

Evaluating farm performance using agri-environmental indicators: recent experiences for nitrogen management in The Netherlands.

Intensive agriculture, characterized by high inputs, has serious implications on the environment. Monitoring and evaluation of projects aiming at designing, testing and applying more sustainable practices require instruments to asses agronomic as well as environmental performance. Guidelines for Good Agricultural Practice (GAP) or Good Farming Practice (GFP) define sustainable practices but give limited insight into their environmental performance. Agri-environmental indicators (AEIs) provide information on environmental as well as agronomic performance, which allows them to serve as analytical instruments in research and provide thresholds for legislation purposes. Effective AEIs are quantifiable and scientifically sound, relevant, acceptable to target groups, easy to interpret and cost-effective. This paper discusses application of four AEIs for nitrogen (N) management in three Dutch research projects: 'De Marke', 'Cows and Opportunities' and 'Farming with a future'. 'De Marke' applied Nitrogen Surplus and Groundwater Nitrate Concentration in the design and testing of environmentally sound dairy systems. 'Cows and Opportunities', testing and disseminating dairy systems designed at 'De Marke', mainly applied Nitrogen Surplus, while 'Farming with a future' used Nitrogen Surplus, Groundwater Nitrate Concentration and Residual Mineral Soil Nitrogen to support arable farmers in complying with Dutch legislation (MINAS). Nitrogen Surplus is quantifiable, appealing and easy to interpret, but lacks scientific soundness or a good relationship with groundwater quality. Nitrogen Use Efficiency is sensitive to changes in management, while Residual Mineral Soil Nitrogen is appealing and cheap, but has difficulties in scaling. Groundwater Nitrate Concentration lacks clear rules for sampling, is labor consuming, expensive and mainly used in combination with other indicators. AEIs enhanced improvements in N management by facilitating (i) definition of project goals, (ii) design of desired systems, (iii) evaluation of applied systems and (iv) improving effective communication. AEI applications in other countries show a similar pattern as found in The Netherlands. Limitations to AEI application relate to inconsistencies between different indicators, heterogeneity of soil characteristics and linkages of N, carbon and water management. AEIs should be applied in an integrated evaluation, at a scale that reflects the farm's spatial variability. Simple AEIs like Nitrogen Surplus should be supported by other indicators and/or model calculations. The paper concludes that AEIs proved their value in design, implementation and testing of farming systems, but they should be used with care, always keeping in mind that indicators are simplifications of complex and variable processes.

Potential phosphorus recovery in a WWTP with the BCFS process: interactions with the biological process.

The BCFS process was developed to optimize the activity of denitrifying and P-removing bacteria. In this technology in combination with optimal operating conditions for biological nitrogen removal, chemical precipitation of phosphorus is used to ensure compliance with effluent standards regarding phosphorus. This work addresses the potential of the BCFS technology for phosphorus recovery and the interactions with the biological process. The TUD model calibrated for the Hardenberg WWTP was used. Nitrification was the biological process most influenced by the P stripper operation; however, further research is needed into the effect of limiting phosphate concentrations. Phosphate removal in the anaerobic reactor causes a decrease in the sludge poly-P content. The evaluation of the process operation under dynamic conditions showed that the P stripper use for phosphate recovery does not imply complicated control strategies. The use of the BCFS for phosphate recovery implies a change in the design philosophy not only to achieve the effluent requirements but also to maximize the anaerobic phosphate release and thereby recovery.

Concentration determination of a recombinant vaccine antigen adsorbed onto an alum adjuvant by chemiluminescent nitrogen detection.

PURPOSE: A chemiluminescent nitrogen detector (CLND) has been evaluated for determining the concentration of an aluminum-adsorbed recombinant vaccine antigen. METHODS: Quantification of the antigen was based upon several nitrogen-containing compounds used to calibrate the CLND. All calibrants (6.75-400 microg/ml) generated linear standard curves, with slopes being directly proportional to the % nitrogen. The limit of quantification (LOQ) was determined to be 6.75 microg/ml based on the performance of the antigen standard curve, and the limit of detection (LOD) was defined by setting the CLND minimum peak area to 40,000 U. The CLND was capable of analyzing antigen-adjuvant suspensions (adsorbed + unbound antigen) without any sample pretreatment. To measure unbound antigen, the suspension was centrifuged and an aliquot of supernatant removed for analysis; the difference between these two measurements was the amount of adsorbed antigen. RESULTS: The adjuvant exhibited no significant matrix effect. Samples were analyzed in triplicate with observed relative standard deviation values ranging from 0.065% to 10.0%. The most accurate concentrations of the antigen were recovered relative to the antigen itself and to glycine as standards. CONCLUSION: This methodology provides a direct measurement of the concentration of a vaccine antigen adsorbed onto an aluminum adjuvant.

Evaluation of microbiological and physicochemical indicators for wastewater treatment.

The quality control of wastewater treatments was monitored using selected novel and classical physicochemical and microbiological indicators, and the associations of the treatments with the effluents was analyzed. The microbiological indicators monitored were heterotrophic plate count (HPC), total coliforms (TC), fecal coliforms (FC), fecal streptococci (FS), sulfite-reducing clostridia (SRC), Pseudomonas aeruginosa, and Salmonella spp. The stages of wastewater treatment also were evaluated through determination of ammonia; biological oxygen demand (BOD(5)); chemical oxygen demand (COD); chloride; conductivity; suspended dissolved and total solids; fats; nitrate, nitrite, and total nitrogen; pH; phosphate and total phosphorus. Additional indicators included the Escherichia coli growth inhibition (IGEC) bioassay for assessing whole effluent toxicity, spectral determinations between wavelengths (lambda) 190-650 nm, and total (TP) and soluble (SP) protein contents. Of the more common physicochemical parameters, only BOD(5), COD, suspended and total solids, and fats showed a statistically significant reduction between raw water and effluent; for the microbiological indicators, significant reduction was seen only for HPC, FC, and Ps. aeruginosa. We suggest that determinations of Ps. aeruginosa be commonly used as an indicator of wastewater quality. Spectral analysis--most notably the values of absorbance at 225, 255, and 295 nm-revealed a statistically significant correlation with several physicochemical parameters. Statistical analysis of SP and TP values showed them to be good indicators of contamination. The quantitative study of Salmonella spp. and the results of the IGEC bioassay show the need for close control of infectious and toxic risks in wastewater and effluents.

Refinement of the pressure assay for milk urea nitrogen.

We report improvements in the application of a pressure-based assay for urea. The assay involved the enzymatic hydrolysis of urea and subsequent measurement of CO2 partial pressure. Effects of the preservative bronopol on the assay and their implications for laboratory applications are discussed. A method of remediating these effects with cysteine is described. A method is also described wherein these additives can be used to prepare standards of known urea concentration in milk. The improved assay can be used to measure urea N in unadulterated milk or in bronopol preserved milk with an accuracy of +/-0.7 mg/dl (0.25 mM) in the range from 0 to 30 mg/dl (0 to 10.7 mM).