Influence of the glass packing on the contamination of pharmaceutical products by aluminium. Part I: salts, glucose, heparin and albumin.

The presence of aluminium (Al) in pharmaceutical products used parenterally as sodium and potassium chlorides, glucose, heparin and albumin were investigated with respect to their storage in glass containers. As glasses can have aluminium in their composition, the aluminium may be released from the glass into the solution. The action of the substances above mentioned were investigated storing their solutions in glass and plastic containers, and measuring the aluminium in solution at determined time intervals. The aluminium present in the commercial pharmaceutical products, stored in both plastic and glass containers were also measured. All glass containers were analysed to determine their aluminium content. The aluminium determinations were done by atomic absorption spectrometry. The resuLts showed that aluminium is present in all analysed glasses in a percentage of 0.6 to 3%. Although all substances already have a residual aluminium contamination, the major contribution comes from the glass containers in which their solutions were stored. The contamination arising from glass depends too much on the nature of the substance. While the salts extracted about 400 microg Al/l in 60 days, glucose extracted 150 microg Al/l, and albumin and heparin about 500 microg Al/l in the same time interval. Commercial solutions of glucose contain about 10 microg Al/l when stored in polyethylene and from 350 to 1,000 microg Al/l when in glass ampules. Considering all commercial products, solutions stored in plastic containers contained no more than 20 microg Al/l whereas in glass the aluminium contamination reached 1,000 microg/l, and in all of them the aluminium increases with the age of the product.     

Influence of the glass packing on the contamination of pharmaceutical products by aluminium. Part II: Amino acids for parenteral nutrition

The presence of aluminium in amino acids parenteral nutrition solutions can be related to the affinity of the amino acids for aluminium present in glass containers used for storage. For this study solutions of 19 amino acids used in parenteral nutrition were stored individually in glass flasks and the aluminium measured at determined time intervals. Solutions of complexing agents for aluminium, as ethylene-diaminetetraacetic acid, nitrilotriacetic acid, citrate, oxalate and fluoride ions were also stored in the same flasks and the aluminium measured during the same time interval. The measurements were made by electrothermal atomic absorption spectrometry. The aluminium content of the glass containers was also measured. The results showed that the glasses have from 0.6% to 0.8% Al. Only solutions of cysteine, cystine, aspartic acid and glutamic acid became contaminated by aluminium. As the same occurred with the complexing agents, aluminum can be released from glass due to an affinity of the substances for aluminium. Comparing the action of complexing agents and amino acids for which the stability constants of aluminium complex are known, it is possible to relate the magnitude of the stability constant with the aluminium leached from glass, the higher the stability constant, the higher the aluminium released. The analysis of commercial formulations with and without cysteine, cystine, glutamic acid or aspartic acid stored in glass containers confirms that the presence of these amino acids combined with the age of the soLution are, at least partially, responsible for the aluminium contamination. The resuLts demonstrated that the contamination is an ongoing process due to the presence of aluminium in glass combined with the affinity of some amino acids for this element.     

Influence of the glass packing on the contamination of pharmaceutical products by aluminum. Part I: Salts, glucose, heparin and albumin

The presence of aluminium (Al) in pharmaceutical products used parenterally as sodium and potassium chlorides, glucose, heparin and albumin were investigated with respect to their storage in glass containers. As glasses can have aluminium in their composition, the aluminium may be released from the glass into the solution. The action of the substances above mentioned were investigated storing their solutions in glass and plastic containers, and measuring the aluminium in solution at determined time intervals. The aluminium present in the commercial pharmaceutical products, stored in both plastic and glass containers were also measured. All glass containers were analysed to determine their aluminium content. The aluminium determinations were done by atomic absorption spectrometry. The results showed that aluminium is present in all analysed glasses in a percentage of 0.6 to 3%. Although all substances already have a residual aluminium contamination, the major contribution comes from the glass containers in which their solutions were stored. The contamination arising from glass depends too much on the nature of the substance. While the salts extracted about 400 μg Al/l in 60 days, glucose extracted 150 μg Al/l, and albumin and heparin about 500 μg Al/l in the same time interval. Commercial solutions of glucose contain about 10 μg Al/l when stored in polyethylene and from 350 to 1000 μg Al/l when in glass ampules. Considering all commercial products, solutions stored in plastic containers contained no more than 20 μg Al/l whereas in glass the aluminium contamination reached 1000 μg/l, and in all of them the aluminium increases with the age of the product.     

A comparative study of mouse embryo freeze-preservation including the examination of a thermoelectric freezing device

In Study 1 over 2000 4- to 8-cell mouse embryos were randomly pooled and assigned to 1 of 12 treatment groups. A 2 X 2 X 3 factorial design was used to analyze two types of cryoprotectant/post-thaw (PT) dilutions (dimethyl sulfoxide [Me2SO]/stepwise dilution versus glycerol/sucrose dilution), two storage containers (glass ampoules versus plastic straws), and three cooling treatments. Two commercial, controlled-rate freezing machines were examined, employing either nitrogen gas (Planer) or thermoelectric (Glacier) cooling. Embryos were cooled slowly (0.5 degrees C/min) to -35 or -80 degrees C and then cooled rapidly by transfer into liquid nitrogen (LN2). Thawed embryos were cultured for 24 hr after which developmental stage, post-thaw survival (PTS), embryo degeneration rate (EDR), quality grade (QG), and fluorescein diacetate viability grade (VG) were assessed. Overall, PTS and EDR were similar (P greater than 0.05) among the three freezing unit/plunge temperature treatments. Cumulative results of container and cryoprotectant/PT dilution treatments consistently demonstrated greater PTS, QG, and VG ratings and lower EDR values when embryos were frozen in ampoules using glycerol/sucrose dilution. Embryos treated with Me2SO/stepwise dilution were particularly sensitive to freezing damage when stored in plastic straws and plunged into LN2 at -35 degrees C. Study 2 was directed at determining whether Study 1 methods for diluting Me2SO-protected embryos markedly affected PTS rates. Post-thaw culture percentages were no different (P greater than 0.05) for four- to eight-cell Me2SO-treated embryos frozen in ampoules (using the forced-LN2 device), thawed, and diluted either conventionally in reduced concentrations of Me2SO or in the sucrose treatment normally accorded glycerolated embryos.(ABSTRACT TRUNCATED AT 250 WORDS)     

Effect of climate and type of storage container on aflatoxin production in corn and its associated risks to wildlife species

The effects of grain storage containers on aflatoxin production, and the relationship between the level of aflatoxin and the number and weight of fluorescing kernels were determined in corn (Zea maize) stored in controlled climate regimes. Two hundred and forty 100-g samples were held up to 3 mos using four types of storage containers placed in four climates. Storage containers included corn placed in metal cans, paper bags, plastic bags, and paper bags placed in plastic bags. Climates were constant during the duration of the project and included a combination of temperatures and humidities. Temperatures were 29-32 C and 14-18 C; relative humidities were 85-88% and 35-40%. In addition, corn was exposed to environmental conditions conductive for aflatoxin production and 100 g samples were randomly collected, examined under ultraviolet light for fluorescence, and then quantified for aflatoxin levels. Corn samples tested negative for aflatoxin at the beginning of the project. Main (i.e., container, climate, and month) and interactive effects were not observed. Mean levels of aflatoxin ranged from 0 to 151 microg/kg. Aflatoxin was produced regardless of type of storage container, time of storage, and climatic conditions; however, only 8% of the samples produced aflatoxin levels that exceeded 50 microg/kg. Fluorescing corn ranged from 0 to 19 kernels per sample, while aflatoxin levels ranged from 0 to 1,375 microg/kg for the same samples. No relationships were found between the number and weight of fluorescing kernels of corn and aflatoxin levels. The black light test yielded a false negative rate of 23% when in fact the aflatoxin concentrations exceeded 50 microg/kg. Therefore, quantifying fluorescing grain under UV light should not be considered a feasible alternative for aflatoxin testing of grain intended for wildlife.     

Suitability of containers from different sources as breeding sites of Aedes aegypti (L.) in a cemetery of Buenos Aires City,Argentina

Cemeteries are ideal urban areas to study the importance of different types of containers as breeding sites of Aedes aegypti (L.). In the present study, the suitability of plastic, glass, ceramic and metal containers was evaluated in four patches within a cemetery of Buenos Aires City, Argentina. Between October 1998 and May 2000, we found 215 breeding sites of Ae. aegypti out of 13,022 water-filled containers examined. In two patches containing microenvironments sheltered from the sun, the use of the different types of containers was proportional to the offer (correlation coefficient = 0.99, P < 0.05 in both cases). In the remaining patches, plastic and metal containers were the most and less frequent breeding sites, respectively (P < 0.001 in both cases). The number of immatures per breeding site (median = 4.5) did not show significant differences among the four types of containers examined (H3, 215 = 1.216, P = 0.749). Differences found in patches from a same cemetery suggest that different microenvironmental conditions affect the suitability of each type of container for Ae. aegypti breeding. Plastic containers appeared as key breeding sites that should be removed to reduce the Ae. aegypti population in the study area.     

Capillary electrophoresis-single strand conformation polymorphism for the detection of multiple mutations leading to tuberculosis drug resistance

For rate determinations of anaerobic metabolism it is essential to maintain strictly anoxic conditions throughout the experiment. However, even if oxygen contamination can be avoided while preparing the incubation containers, it is still possible that the incubation containers themselves contaminate the samples by oxygen diffusing from or through their plastic or rubber components. In this study, we investigated the sources and extent of oxygen contamination during anoxic incubations, and present solutions to minimize oxygen contamination. In particular, we investigated oxygen contamination in Labco® Exetainers, glass vials with a butyl rubber septum in the screw cap, which are frequently used in microbiological experiments. Our results show that significant oxygen contamination occurred at different stages during the incubation. Contamination occurred when Exetainers were either filled or incubated for more than 16 h under oxic atmosphere, but also under an oxygen-free atmosphere due to diffusion of oxygen out of the butyl rubber septum. Therefore, to avoid oxygen contamination during incubations, we suggest (1) filling and incubating the incubation containers under anoxic atmosphere (glove bag) and (2) deoxygenating all elastomers in sample processing and incubation equipment. If initial oxygen contamination cannot be avoided, introduction of an anoxic headspace might help extract oxygen from the incubated sample and present a buffer against oxygen diffusing out of the septum. We modeled the amount of oxygen diffusing out of butyl rubber septa under different conditions, and results fitted well with the observed oxygen contamination. Thus, the model can be used to predict oxygen contamination under varying conditions and for differently sized septa.     

Material Flows and Energy Analysis of Glass Containers Discarded in New Jersey,USA

The use of glass cullet (crushed recycled glass containers) as aggregate in construction projects and landfills has increased rapidly even though the use of cullet as feedstock in new glass container and fiberglass production is energetically more sound. The effect of increased use of cullet as aggregate has not yet been thoroughly assessed. The objectives of this study were to model and quantify glass container flows across New Jersey and the associated life cycle energy consumption, and then compare life cycle energy consumption for two different recycling scenarios and three different end‐use/disposal scenarios. The results of a material flow analysis showed that in 2008 only about 11% of the glass containers consumed in New Jersey were used as glass container or fiberglass feedstock, while five times more were used as construction aggregate. However, a lower system energy requirement can be achieved by increased use of cullet as container feedstock compared to construction aggregate, even when the cullet is transported 1,600 miles to a glass container manufacturer. Based on the uncertainty analysis, there is about an 80% probability for the scenario with increased use as container feedstock to have a lower system energy requirement when compared with all other scenarios. To achieve increased use of cullet as glass container feedstock in New Jersey, the quality of the cullet must be improved.     

On the stability of salivary progesterone under various conditions of storage

The concentrations of progesterone in saliva of women exhibited significant decreases when the fluid was stored in plastic vials for 3 days at room temperature or 37 C. The addition of antibiotics or a variety of metabolic poisons to the saliva prior to storage did not prevent the progesterone decrement. However, the addition of albumin (2 g/dl) was protective, suggesting that the protein impeded adsorption of salivary progesterone by the plastic container. Saliva could be maintained at 37 C for 3 days in glass vials or at -20 C in plastic containers for indefinite periods without loss of progesterone titers. These data indicate that a patient under luteal function assessment may collect saliva samples in glass vials at regular intervals during the latter half of her cycle and store them in the freezer compartment of the refrigerator until shipment by mail to the laboratory for progesterone assay. With special care, plastic vials charged with albumin may also be used.     

Electrothermal atomic absorption spectrometry determination of aluminium in parenteral nutrition and its components

Aluminium concentration in samples of total parenteral nutrition solutions and samples of their individual components were analysed to know the exposure to this element. The median aluminium content obtained for the total parenteral nutrition solutions was 105.7 μg/L; for their individual components, 10% calcium gluconat and 1 M monopotasic phosphate were the most contaminated, as well as the 1 M sodium bicarbonate. The great variability found in the aluminium content of solutions suggests that contamination occurs during the manufacturing process.     

Ion-exchange and potentiometric characterization of Al–cystine and Al–cysteine complexes

The interaction between aluminium and cysteine and cystine was evaluated by means of ion-exchange experiments and potentiometry. Ion-exchange experiments included other ligands with affinity for aluminium and two kinds of resins, either a Na⁺-form or an Al³⁺-form exchanger. The ability of the ligands to keep aluminium in solution in the presence of the Na⁺ exchanger or to withdraw it from the Al³⁺-form resin was evaluated. Aluminium quantification was carried out by either graphite-furnace or flame atomic absorption spectrometry. Aluminium extraction isotherms were linearised using the Scatchard plot, and stability constants were obtained from the curves’ slopes. The experiments showed that the ability of the ligands to withdraw aluminium from the Al³⁺-form resin increased following the order cysteine < oxalate < citrate = cystine < nitrilotriacetic acid < ethylenediaminetetraacetic acid. Potentiometric titrations, carried out in aqueous solution with constant ionic strength and temperature, showed that the predominant species in solution have a metal–ligand proportion of 1:1 for both amino acids. The main species are Al(OH)₃L, with log K of 6.2 for cysteine, and AlL and Al(OH)L, with log K of 10.3 and 1.7, respectively, for cystine. Stability constants obtained from the Scatchard plots showed a linear correlation with the stability constants obtained by potentiometry for cystine and cysteine in this work and those collected from the literature for the other ligands. These results show that cysteine and cystine extract and maintain aluminium in solution, which may explain elevated concentrations of aluminium in parenteral nutrition solutions containing these amino acids.Electronic Supplementary Material Supplementary material is available to authorised users in the online version of this article at .     

Improved method of studying the blood for sterility

The technique used for the inoculation and subculturing of blood samples in testing them for sterility is described. This technique eliminates the possibility of contaminating the culture medium and the blood sample under test with extraneous bacterial flora. Blood samples were inoculated without opening the containers with the culture medium. Inoculation was made with the syringe and the needle used for taking the blood sample through the punctured rubber stopper closing the container. Subculturing on solid culture media was also carried out without opening the containers: the rubber stopper was punctured and the contents of the container withdrawn with a pipette needle. The use of this new technique made it possible to detect bacteremia in 12.8% of cases, only in persons with purulent and septic diseases, whereas by using the existing technique bacteremia was detected both in sick and healthy persons, in 38.6% and 26.6% of cases, respectively.     

Environmental Sustainability of Fluid Milk Delivery Systems in the United States

Beverage producers in the United States choose packaging based on cost and consumer preference. Monolayer high‐density polyethylene (HDPE) and gable‐top carton containers have long dominated the U.S. fluid milk market, but pressure for more sustainable packaging is increasing. We present a broad discussion on environmental sustainability of 18 fluid milk containers through life cycle assessment. Because different container types require unique milk processing, distribution, and disposal and incur or avoid milk losses, fluid milk delivery systems (FMDSs) are evaluated, rather than containers in isolation. By assessing FMDSs, a complete measure of containers’ environmental sustainability was obtained. Despite conservative assumptions about milk losses, differences in container size, milk processing, distribution, and container recycling, pair‐wise cradle‐to‐grave comparisons of FMDSs show there are no superior FMDSs. But, 500‐ to 1,000‐milliliter FMDSs are potentially superior to ≥half gallon if they prevent milk losses. Thus, the future of FMDSs in the United States depends on the industry's ability to prevent distribution (12%) and consumption milk losses (20% to 35%). Farm‐gate‐to‐grave comparisons showed that chilled HDPE FMDSs are superior to other plastic and chilled paperboard FMDSs for climate‐change impact, but the result is inconclusive for chilled HDPE to ambient (unrefrigerated) paperboard or plastic pouch FMDS comparisons. Plastic pouch FMDSs show potential to reduce nonrenewable fossil energy, but need to be recyclable. Ambient FMDSs are superior to chilled FMDSs for water depletion. Eight‐ounce paperboard FMDSs are superior to 8‐ounce plastic FMDSs. Thus, alternative FMDSs may improve environmental sustainability of the U.S. postfarm fluid milk supply chain.     

The effect of container porosity on root environment and plant growth

Summary The effect of container porosity on water relations in the substrate and on plant growth was examined. With clay containers the proportional effect of the wall on water loss varied with season, being responsible for 42 per cent of the total loss in winter and 25 per cent in summer. Water loss from plastic containers was 55 per cent of that from clay containers in winter, and 66 per cent in summer. Wall porosity also had a significant effect on water distribution within the container under high radiation conditions. Tomato plants grown under three water regimes showed no effect of matric stress in winter, but growth was significantly reduced for each increase in stress in summer. There was no interaction between container type and water stress. Non-porous containers gave a higher water-use efficiency and had a lower irrigation requirement than porous ones, their greatest advantage being under conditions of low transpirational loss and high evaporative loss.     

Comparison of 12 different containers for dispensing anti-inflammatory drugs.

Twelve containers manufactured by 10 pharmaceutical companies for dispensing anti-inflammatory drugs, 10 of which are currently in use in the United Kingdom, have been compared in 99 patients with arthritis of the hands. Patients were given the containers in random order and were asked to open them, extract the tablets, and close them. Patients were questioned on ease of handling at each stage and were then timed on reopening and closing each container. Finally, the patients were asked which container was the best and which was the worst. There was a wide variation in popularity of containers. One was judged outstanding on almost every attribute, and four were preferred over the others on most attributes. A successful container for arthritic hands is likely to have a sharply angulated or "wing" cap placed on a tall slim base that is also angulated. Flip off tops, tops with long threads requiring many turns, very small containers, and glass were regarded as unfavourable. Manufacturers should take note of these findings and, where necessary, consider redesigning the containers.     

Environmental evaluation of aluminium cans for beverages in the German context

Background

In the years 2000 and 2002, the German Environment Agency in Berlin (UBA) published the results of a comprehensive LCA study on beverage containers comprising aluminium cans with volumes of 330 ml and 500 ml. Starting with the aluminium can scenarios and the respective results obtained during the UBA study, additional analyses were performed by IFEU in 2003, a German consultant having been a member of the project team working on the UBA study. The objective was to examine the influence of selected parameters on the LCA profile of carbonated soft drink containers. Data and method were in complete analogy with the LCI and LCA part of the UBA study.

Materials

In 2006, the aluminium industry commissioned a study on further influential factors that help determine the sale of certain types of beer, studying the effects of two selected parameter settings on the comparative results of the aluminium can against the refillable glass bottle. In this scenario, special attention was given to two influential factors, the distribution distance—distinguished by regional and nationwide distribution—and trippage rate.

Results and discussion

The results of the initial LCA from the years 2000 and 2002 showed, for the examined parameters container weight, rate of post-consumer recovery of used containers, degree of recycled content and quality of the recycling routes, that each had a considerable influence on the environmental impact profile of the aluminium can within the given framework. Can weight and recycling rate were sensitive factors in the impact categories of climate change, fossil resources, summer smog (POCP), acidification and terrestrial eutrophication. Can volume affected virtually all impact categories examined.

Conclusions

By now, individual improvement options have already been put into practice in Germany. The environmental profile of the average 330 ml aluminium can on the German market can be expected to be ahead of that of the aluminium can at the time of the UBA study. The introduction of a 500-ml can on the market denotes a fundamental step forward in improving LCA results of the aluminium can as a container for beverages.

     

Protection of histones isolated from elastase-treated mouse epidermis

Small glass shell vials (12 × 35 mm minivials), containing 2.0 ml of a dioxane-based scintillation solution plus a ¹⁴C-labeled sample, were placed in a conventional glass, 20-ml count vial and assayed in a scintillation spectrometer. Statistical comparison of counts recorded from ¹⁴C samples prepared both in the minivial system and conventional 20-ml count vials indicated that the two systems were equivalent with sample volumes of 10 and 100 μliters (1600-cpm solution) and 10 μliters (60-cpm solution). Conventional 20-ml glass or plastic count vials were both acceptable as containers for the minivials.There were no significant differences in the counts from samples in minivials placed on-center and off-center in the container vial. Cost per sample was reduced from 24.8 cents (conventional glass vials) to 4.7 cents (minivial system).     

Effect of sub-lethal concentrations of aluminium on the filtration activity of the freshwater mussel Anodonta cygnea L. at neutral pH

Significant amounts of aluminium (Al) are commonly present in rivers and lakes, largely in particulate form in neutral waters. Freshwater bivalves, as filter feeders are therefore exposed to both particulate and dissolved metal and are potentially vulnerable to Al. The effect of Al on filtering behaviour of the freshwater mussel Anodonta cygnea L. was investigated during short (1 hour) and long-term (15 days) exposure to environmentally relevant concentrations (250 and 500 microg l(-1)) at neutral pH. Water flow through the outflow siphon was monitored as an indicator of pumping capacity. Short-term (1 hour) exposure to 500 microg l(-1) added Al produced an irreversible decrease in the duration of filtering periods, presumably as an avoidance response to the toxicant. One-hour exposure 250 microg l(-1) Al had no detectable effect. When mussels were exposed to 250 or 500 microg l(-1) added Al for 15 days, siphon activity measured in days 11-15 of exposure was inhibited by 50% and 65%, respectively, compared to pre-exposure levels. Recovery occurred following transfer of mussels to uncontaminated water. Interaction between Al and freshwater bivalves at neutral pH may affect both the performance of the mussels and the chemical speciation of the metal in the natural environment.     

Prognostic significance of low serum levels of Clara cell phospholipid-binding protein in occupational aluminium neurotoxicity

The relationship between respiratory and neurological effects of exposure to aluminium (Al) was investigated in a group of foundry workers exposed to Al at concentrations below the threshold limit value (TLV) binding in Poland (2.0 mg Al2O3 m(-3)). Neurological and neurophysiological parameters indicated subclinical effects of Al exposure on the nervous system. The measurement of serum anti-inflammatory Clara cell protein (CC16) was employed as a peripheral marker of the lung epithelium function. There was a strong inverse relationship between serum Al (Al-S) and CC16 concentrations (p = 0.006). The lowest CC16 concentrations were found in serum of workers characterised by subjective symptoms of the central nervous system (CNS) and abnormal results of neurophysiological examinations (EEG and VEP). Low serum CC16 concentrations and enhanced Al and iron (Fe) levels were also observed in the younger age group of workers with the subjective CNS symptoms and abnormal VEP results, which suggests that Fe is implicated in strengthening of the neurotoxic Al potential. The results of our study support the hypothesis that subclinical neurological symptoms (especially abnormal VEP) are most likely associated with internalisation of Al ions with lipid fractions of the lung epithelium, which in turn may help Al ions overcome the blood-brain barrier. Low serum CC16 concentrations (<10 microg L(-1)) were noted in workers with the abnormal results of neurological (CNS) and neurophysiological (EEG and VEP) examinations as well as with Al body burden manifested by urinary excretion (Al-U) below 60 microg L(-1) and Al-S concentration of 2 microg L(-1). This concentration may be considered as a threshold allowable biological concentration of aluminium.     

A problem encountered in a study of the effects of lanthanide ions on enzyme-catalyzed reactions.

Investigations have been made of the time-dependent loss of the ability of dilute lanthanide solutions to inhibit creatine kinase. Using [¹⁵²Eu]Cl₃, it has been demonstrated that the loss is due to the reduction in concentration that occurs because of the adsorption of lanthanide ions onto walls of containers. Further, it has been shown that the adsorption varies with pH and the composition of the container. The results also indicate that dilute solutions of EuCl₃ do not undergo concentration changes when stored in Pyrex glass vessels either under slightly acidic conditions or in buffered solution at pH 8.0.