PVC Bags Research Articles

Effect of chitosan and natural materials on properties of polyvinylchloride for blood bags applications

Abstract Polyvinyl chloride is the most common material used in the manufacture of blood bags, and chitosan and wheat extract were used to improve the biological, physical, mechanical and optical properties of the manufactured blood bag. Chitosan was added at three concentrations (1, 2, and 3%) to the PVC matrix sample, and the wheat extract was supplemented to the sample having the highest properties to study its effect. It was found that the addition of chitosan led to an increase in tensile strength, as well as a significant increase in inhibition against the bacterial activity of two types of bacteria (S. aureus and C. albicans), and the ability to absorb water, but the addition of wheat extract led to a very small decrease in absorbency. Also, the supplement of chitosan and wheat extract reduced the transparency of the manufactured blood bag. All samples were characterized as not having the ability to non-hemolytic in the hemolysis test. All the results of polymer blends and polymer composite were compared with the pure PVC and commercial blood bags as reference samples.

Evaluating the effects of hypoxic storage on platelet function and health using a novel storage system.

Thousands of units of whole blood (WB) and blood components are transfused daily to treat trauma patients. Improved methods for blood storage are critical to support trauma-related care. The Hemanext ONE® system offers a unique method for hypoxic storage of WB, with successfully demonstrated storage of clinically viable RBCs. This work evaluated the system for the storage of WB, focusing on platelet health and function. WB was collected from healthy donors and processed through the Hemanext ONE® system. Hemoglobin oxygen saturation (HbSO2) levels of WB were depleted to 10%, 20%, or 30% of total HbSO2 and then stored in PVC bags sealed in oxygen-impermeable bags (except for normoxic control) with samples collected on days 1, 7, and 14 post-processing. Flow cytometry assessed the activation and apoptosis of platelets. Clot dynamics were assessed based on aggregometry and thromboelastography assays, as well as thrombin generation using a calibrated-automated thrombogram method. Hypoxic storage conditions were maintained throughout the storage period. Hypoxia triggered increased lactate production, but pH changes were negligible compared to normoxic control. Storage at 10% HbSO2 had a significant impact on platelet function, resulting in increased activation and reduced clot formation and aggregation. These effects were less significant at 20% and 30% HbSO2. This study indicates that platelets are sensitive to hypoxic storage and suffer significant metabolic and functional deterioration when stored at or below 10% HbSO2.

Physicochemical stability of ready-to-administer mitomycin C solutions for intravesical instillation

ObjectiveThe aim of the study was to investigate the physicochemical stability of mitomycin-containing medicinal products for bladder instillation, formulated with urea as excipient (mito-medac®, Mitomycin medac). For comparison, the stability...

A deep 96-well plate RBC storage platform for high-throughput screening of novel storage solutions.

Background: Red blood cell (RBC) storage solutions, also known as additive solutions (ASs), first developed in the 1970s, enable extended storage of RBCs. Unfortunately, the advancements in this field have been limited, due to labor intensive and time-consuming serial in vitro and in vivo testing, coupled with very high commercialization hurdles. This study examines the utility of deep 96-well plates for preliminary screenings of novel ASs through comparison of RBC storage with the standard PVC bags in terms of hemolysis and ATP levels, under both normoxic (N) and hypoxic/hypocapnic (H) storage conditions. The necessity for the presence of DEHP, normally provided by PVC bags, is also examined. Materials and methods: A pool of 2 ABO compatible RBC units was split between a bag and a plate. Each plate well contained either 1, 2 or 0 PVC strips cut from standard storage bags to supply DEHP. The H bags and plates were processed in an anaerobic glovebox and stored in O2 barrier bags. Hemolysis and ATP were measured bi-weekly using standard methods. Results: Final ATP and hemolysis values for the plate-stored RBCs were comparable to the typical values observed for 6-week storage of leukoreduced AS-3 RBCs in PVC bags under both N and H conditions. Hemolysis was below FDA and EU benchmarks of 1% and 0.8%, respectively, and excluding DEHP from plates during storage, resulted in an inconsequential increase when compared to bag samples. Discussion: In combination with high-throughput metabolomics workflow, this platform provides a highly efficient preliminary screening platform to accelerate the initial testing and consequent development of novel RBC ASs.

First Report of Fusarium verticillioides Causing Fusariosis on Triticale Grain in Serbia.

Triticale (Triticosecale Wittmack) is a cereal crop species developed to combine positive traits of wheat and rye into a single plant (Arendt and Zannini, 2013). Due to its high protein content, favourable amino acid composition and nutritional values higher than maize, triticale is an excellent component for preparing feed for domestic animals (Đekić et al. 2019). In May 2017, discoloured spikes of triticale were observed in a field in Zemun Polje, Serbia, with a disease incidence between 15 and 20%. A total of 400 kernels obtained from discoloured spikes were surface sterilised with 1% sodium hypochlorite solution for 3 minutes and then rinsed 3 times with sterilized water and plated on potato dextrose agar (PDA) at 25°C incubated in the dark for 7 days. A total of 15 isolates of genus Fusarium on PDA formed cottony white to greyish purple colony with dark yellow to purple grey reverse and average colony. Obtained isolates were transferred to carnation leaf agar (CLA) and synthetic nutrition agar (SNA), for 7-day incubation in the dark at 25°C. Ten isolates formed "rabbit ear" monophialides which is the main characteristic of Fusarium verticillioides (Sacc.) Nirenberg. Microconidia are formed from monophialids in long chains. Their shape is oval with a flattened base, without septa (4.0-18.0 x 1.5-4.5 µm). Shape of macroconidia is slightly falcate to almost straight, (3.5-4.5 x 31-58 µm). Chlamydospores are not produced (Leslie and Summerell, 2006). The genomic DNA from one F. verticillioides isolate was extracted using the DNeasy Plant Mini kit (Qiagen, Hilden) according to the manufacturer's protocol. Molecular identification was confirmed by sequencing the internal transcribed spacer (ITS), translation elongation factor-1 alpha (EF-1α) and RPB2 (O'Donell, 2000). Sequence was deposited in GenBank as MZ664391, MZ666958 and MZ666957. This sequence was compared with the sequences of F. verticillioides strains registered in the GenBank database based on nucleotide similarity. It showed 100% identity to the sequences MT180471.1 (ITS), MN861767.1 (EF-1 α) and MT264836.1 (RPB2). Pathogenicity of all isolates was tested on 20 randomly selected triticale spikes in four replicates (Mesterházy et al. 1999). Inoculation was performed when half of the plants reached the flowering stage, by spraying with 20 ml of spore suspension (1 × 106 spores/ml from 7-day-old cultures on PDA). F. verticillioides RBG 1603 Q27 was used as a positive control. Inoculated spikes were covered with PVC bags for 48h. Discoloured spikes were observed after 3 week incubation in a greenhouse at 20°C with a 16h light/8h dark photoperiod. All inoculated spikes showed symptoms, similar to those from field infections. Control spikes were symptomless. The fungus was reisolated and was morphologically identical to the original isolates, thus completing Koch's postulates. Based on morphological, molecular and pathogenic features the isolated fungus was identified as F. verticillioides. Fusarium species infect crop plants worldwide resulting in yield loss and reduced grain quality due to mycotoxin contamination (Asam et al, 2017). In Serbia F. verticillioides was isolated from wheat and barley grains (Stanković et al., 2012) and to the best of our knowledge, this is the first report of F. verticillioides on triticale grain in Serbia.

INFUSION THERAPY: HISTORY, MODERNITY, PROSPECTS

The article describes the historical aspects of the formation and development of infusion therapy since the. V century BC to the present day. After William Harvey created the theory of the circulatory system, attempts were made to inject various substances intravenously.
 Interesting data on the evolution of the syringe as a device for the introduction of various substances, from primitive, simple - to reusable and disposable. The history of the latter began in 1949, when the American Arthur Smith received the first US patent for a disposable glass syringe. Seven years later, in 1956, New Zealand veterinarian and pharmacist Colin Murdoch invented and patented a plastic disposable syringe.
 However, these developments are not very suitable for intravenous injections into productive animals, especially in livestock facilities. Some exceptions were only modifications of the syringe Jeanne. It was developed by the French physician Pierre-Marie Felix Jeanne in 1934 for a variety of medical procedures. Its initial volume was 150 ml. Over time, for veterinary purposes, this model began to be produced in volumes of 250 and 500 ml.
 Describes our own new experience in installing a technological line for the manufacture of solutions for veterinary medicine with their packaging in PVC bags in volumes of different formats (200, 250, 500, 750 and 1000 ml). It is possible to make solutions in packages of smaller (50, 100 ml) or larger volume (2 and 5 liters). Industrial production of 11 types of solutions is registered and mastered at the enterprise.
 Adhering to modern requirements for the quality of drugs, the material for the packages we have chosen a multilayer film based on polypropylene called SIFLEX PACK® Italian production. Tactical to the infusion procedure for animals, SIFLEX PACK® film packs are easy to use. They are an ideal alternative to glass or plastic containers and significantly reduce the cost of production of solutions and prevent contamination of medicinal solutions with indoor air microflora.

Influence of Concentration and Temperature on Stability of Imipenem Focused on Solutions for Extended Infusion.

BackgroundImipenem remains active against most Gram-positive and Gram-negative organisms. This study aimed to evaluate chemical stability of imipenem in 2 commonly used concentrations when stored in 3 various temperatures.MethodsImipenem injection powder was used to prepare 5 mL and 10 mg/mL of imipenem in .9% sodium chloride solution. Prepared solutions in PVC bags were stored at 25°C, 30°C, and 40°C. The solutions were investigated over 0, 1, 2, 3, 4, and 6 hours using HPLC analysis. The association between drug stability, temperature, and concentration was determined.ResultsThe 5 mg/mL solutions of brand A and B imipenem mL were stable for 6 hours at 25°C, 30°C, and 40°C, respectively. For 10 mg/mL, the solution of brand A was stable for 3 hours and brand B was stable for 6 hours at 25°C. Also, brand A and B imipenem solutions at the concentration of 10 mg/mL were stable for less than 1 hour at 30°C and 40°C.ConclusionThe stability of imipenem injection solution was affected by temperature and concentration. Increasing in temperature and drug concentration resulted in decreased stability of imipenem. Suitable temperature and drug concentration should be concerned when this drug is given by extended infusion.

Specification and Evaluation of Plasticizer Migration Simulants for Human Blood Products: A Delphi Study.

Potentially toxic plasticizers are commonly added to polyvinyl chloride medical devices for transfusion in order to improve their flexibility and workability. As the plasticizers are not chemically bonded to the PVC, they can be released into labile blood products (LBPs) during storage. Ideally, LBPs would be used in laboratory studies of plasticizer migration from the medical device. However, short supply (i.e., limited stocks of human blood in collection centres) has prompted the development of specific simulants for each type of LBP in the evaluation of new transfusion devices. We performed a Delphi study with a multidisciplinary panel of 24 experts. In the first (qualitative) phase, the panel developed consensus definitions of the specification criteria to be met by each migration simulant. Next, we reviewed the literature on techniques for simulating the migration of plasticizers into LBPs. A questionnaire was elaborated and sent out to the experts, and the replies were synthesized in order to obtain a consensus. The qualitative study established specifications for each biological matrix (whole blood, red blood cell concentrate, plasma, and platelet concentrate) and defined the criteria required for a suitable LBP simulant. Ten criteria were suggested: physical and chemical characteristics, opacity, form, stability, composition, ability to mimic a particular clinical situation, ease and safety of use, a simulant–plastic interaction correlated with blood, and compatibility with analytical methods. The questionnaire data revealed a consensus on the use of natural products (such as pig’s blood) to mimic the four LBPs. Opinions diverged with regard to synthetic products. However, an isotonic solution and a rheological property modifier were considered to be of value in the design of synthetic simulants. Consensus reached by the Delphi group could be used as a database for the development of simulants used to assess the migration of plasticizers from PVC bags into LBPs.

Stability of Aprepitant Injectable Emulsion in Alternate Infusion Bags, in Refrigerated Storage, and Admixed with Dexamethasone and Palonosetron.

PurposeThe stability of aprepitant injectable emulsion is evaluated in various admixture bags and solutions, under different storage conditions, and when combined with other antiemetics.MethodsA volume of 18 mL aprepitant injectable emulsion was added to infusion bags (either non-di-(2-ethylhexyl) phthalate [DEHP], polyvinyl chloride [PVC]-containing bags or non-DEHP, non-PVC bags) containing 100, 130, or 250 mL of 0.9% normal saline solution (NSS) or 5% dextrose in water (D5W). Bags were stored at controlled room temperature (20–25°C) for up to 12 hours or refrigerated (2–8°C) for up to 72 hours. Compatibility/stability was also assessed in admixtures combined with either dexamethasone or palonosetron. At specified time points, bags were tested for appearance, pH, assay for aprepitant (ie, percent label claim of aprepitant) and aprepitant-related substances, Z-average particle size, globule size distribution, particulate matter, and DEHP content (PVC bags). In separate analyses to assess microbial burden, bags containing aprepitant were inoculated with seven different organisms and assessed for microbial growth.ResultsThere was no detectable impact on the physicochemical properties or potential to promote microbial growth of aprepitant when diluted with various amounts of either NSS or D5W and when admixed with either dexamethasone or palonosetron at room temperature for at least 6 hours or during refrigeration for up to 72 hours in either PVC- or non-PVC-containing bags.ConclusionAprepitant-containing admixtures are stable under these conditions, a finding that may improve patient and provider convenience and reduce medication wastage.

Qualidade pós-colheita de tubérculos de batata ‘Ágata’ embalados armazenados em diferentes condições

The adequate storage of raw materials is fundamental to obtain a quality final product. The objective of this study was to evaluate the effect of different plastic packages on the maintenance of post-harvest quality of ‘Agata’ potato tubers stored under refrigeration and room temperature. Two experiments were conducted, both with a completely randomized design, arranged in a 3 x 4 factorial scheme (three types of packages – unpacked, with polyvinyl chloride film – PVC (21 cm x 40 cm and 12 μm thick) and with plastic bag (30 cm x 40 cm and 30 μm thick) and four evaluation times), with three replicates of one tuber each. In one experiment the samples were maintained under ambient conditions (25 ± 2°C and 60% ± 5% RH), with evaluations performed at 0, 7, 14 and 21 days, and another under refrigeration (8 ± 2ºC 75% ± 2% RH) and 0, 25, 50 and 75 days. The evaluated characteristics were: firmness, pH, soluble solids, total titratable acidity, vitamin C and the appearance of shoots. Tubers can only be stored under ambient conditions for seven days, and during this period the PVC packaging is the most suitable for storage. Tuber firmness was reduced and the vitamin C content of the last evaluation was higher than the initial content in both storage conditions. The refrigerated storage extended the shelf life of tubers for up to 50 days, period during which the PVC and plastic bags did not influence the conservation of the ‘Agata’ potato tubers.

Antibacterial cationic poly(vinyl chloride) as an approach for in situ pathogen-inactivation by surface contact with biomedical materials

Bacteremia is a serious problem of public health that is caused by bacteria in the blood and their components, in this way, total asepsis is a critic aspect in the different stages of transfusion medicine and in the use of biomedical devices in contact with tissues and blood. The aim of this study is to advance in the development of a new pathogen-inactivation technique by surface-contact based on the making of plasticized PVC bags with antibacterial properties. For that, films of PVC were chemically modified by nucleophilic substitution and quaternization of amino groups using dimethylamine and 1-bromoethane, respectively. Films were characterized by infrared spectroscopy, nuclear magnetic resonance, thermogravimetric analysis and elemental analysis; in addition, antibacterial properties against Gram-positive and Gram-negative bacteria (S. aureus and E. coli, respectively), hemolytic activity and surface adsorption of blood-components were evaluated. Results shown that cationic PVC, with ∼15% of quaternary ammonium groups, has antibacterial activity and hemolytic properties (hemolysis ∼7%), but also, affinity of blood-components with the surface was increased in comparison with PVC. Our results evidenced that cationic PVC can be obtained by the procedure performed, being a promissory alternative for the making of biomedical surface with capacity of pathogen-inactivation by in situ surface-contact.

Determination of the selected heavy metal and metalloid contents in various types of plastic bags.

The immense plastic bags (PBs) consumption is the potential threat for environment and public health due to discharging toxic pollutants (i.e., metals and metalloids) throughout its entire life cycle. The purpose of the study was to investigate the heavy metal (HM) contents in PE, HDPE, LDPE and PVC bags with several colors and applications. The HM contents in the PB were analyzed by ICP-OES after acid digestion. Results demonstrated that the HM contents in PB notably disagreed based on the used polymer types, colors and applications. The highest contents of Pb, Cr, Cd, As, Cu and Zn were 66, 75, 16, 28, 96 and 154 in mg/kg unit, respectively in PE bags; 71, 74, 34, 39, 430 and 212 in mg/kg unit, respectively in HDPE bags; 12, 74, 23, 43, 158 and 54 in mg/kg unit, respectively in LDPE bags; and 16, 23, 474, 12, 45 and 90 in mg/kg unit, respectively in PVC bags. Furthermore, 12 out of 36PB samples were noticed to violate the standards (ISO 8124-3) in terms of Pb, Cr, Cd and As contents. So there is the potentiality of HM and metalloid pollution from discarded PB during treatment, recycling and disposal.

Variations in the number of genital setae in Raphignathus hecmatanensis species (Acari: Raphignathidae)

Aim of study: In this study, in 32 females species of the Raphignathus hecmatanaensis Khanjani and Ueckermann, 2003, were found from the samples collected from different of the same date and localities, variations in genital setae numbers were determined in 10 species.Area of study: This study was conducted at the Zoology Research Laboratory, Department of Biology Faculty of Arts and Sciences, Manisa Celal Bayar University. The soil and litter samples were found from Emirdağları, 1300 m a.s.l., Büyükkarabağ village, Bolvadin district, Afyonkarahisar, Turkey.Material and Methods: Soil samples and litter taken from under Crataegus sp., Astragalus sp., Euphorbia sp., Rosacanina sp. in research area were brought to the laboratory in PVC bags and extracted in Berlese funnels for 7 days. Mites accumulating in collection bottles with 70% alcohol, were selected from the samples under a stereomicroscope, left to clear into lactophenol and then embedded in Hoyer's solution. 32 females species of the R. hecmatanaensis were determined and examined.Main results: In Turkish (Afyonkarahisar) specimens, R. hecmatanaensis in 32 females, while 22 females have 6 genital setae (3 pairs), 9 females have abnormal 7 genital setae and one female have abnormal 5 genital setae.Research highlights: It is very interesting, about one-third of the R. hecmatanaensis species have been found to have an abnormal number of genital setae. In this case, genital setae number used for key to the species of Raphignathus is debate.

Migration of plasticizers from poly(vinyl chloride) and multilayer infusion bags using selective extraction and GC–MS

Flexible poly(vinyl chloride) (PVC) is widely used in the pharmaceutical industry for the manufacture of medical devices (tubes, probes, bags, primary packaging, etc.). The objective of the present study was to develop a procedure to evaluate the migration potential of nine plastic additives in aqueous infusion bags (NaCl 0.9% and glucose 5%): five phthalates, one adipate, two alkylphenols, and benzophenone. Two types of materials were analyzed: (i) new and outdated plasticized PVC (containing 40% of diethylhexyl phthalate DEHP); and (ii) tri-laminate polyethylene-polyamide-polypropylene, a multilayer material presumably exempt from DEHP. In addition, we evaluated the migration of plasticizers from PVC raw materials (film and grain) under controlled conditions to compare the migration levels according to Regulation 2011/10. Solid phase extraction and liquid-liquid extraction with gas-chromatography coupled to mass spectrometry were used in all tests. The migration of DEHP in PVC grain exceeded the maximum regulated level of 5000 μg/kg, whereas the levels were much lower in films. In new PVC bags, DEHP was the only compound detected at 4.31 ± 0.5 μg/L in NaCl 0.9% and 4.29 ± 0.25 μg/L in glucose 5% serums, whereas the levels increased 10 times in three-year shelf-life bags. In multilayer bags, DEHP was not found but instead, two plasticizers were detected namely dibuthylphthalate (DBP) and diethylphthalate (DEP) at 0.7 ± 0.1 μg/L and 4.14 ± 0.6 μg/L, respectively. These plasticizers are not mentioned as additives allowed in materials intended for parenteral use (European Pharmacopoeia 8.0, 3.1.5. and 3.1.6.). Caprolactam was tentatively identified and could have stemmed from the polyamide of the multilayer composite. The levels of phthalates remained low but not negligible and might constitute a risk to public health in the case of reiterative infusions.

In vitro quality of apheresis platelets divided into paediatric-sized units and stored in PVC bags plasticised with TOTM, BTHC or DINCH.

Two of the predictive factors of the quality of small volumes of platelets suitable for paediatric use are bag size and material. This study evaluated the storage properties of paediatric platelet aliquots in TOTM-, BTHC- or DINCH-PVC bags. (i) Three apheresis platelet concentrates (PC) were pooled and split into three units. One was retained as an adult unit (control; polyolefin bag). The second and third units were split into four MacoPharma TOTM-PVC and BTHC-PVC paediatric bags, respectively. (ii) Two apheresis PC were pooled and split into two units. One PC was retained as an adult unit, and the other was split into four Fresenius DINCH-PVC paediatric bags. Testing was performed on storage for pH, blood gases, hypotonic shock response, soluble CD62P, LDH, glucose and lactate, ATP, CD62P, CD63, platelet-derived microparticles and annexin V. The volumes, platelet yields and pH of all paediatric units met local specifications. The TOTM-PVC bag showed no worse quality than the adult bag up to day 7 for all parameters studied, and it maintained pH higher than BTHC-PVC and DINCH-PVC over storage. The BTHC-PVC bag was shown to be the most gas permeable; however, it had the highest glucose consumption rates and the highest platelet activation. All bags showed an acceptable in vitro quality. Overall, the TOTM-PVC paediatric bag showed better platelet quality compared to the other storage bags, whereas storage in the BTHC-PVC bag resulted in poorer platelet quality.

Characteristics of plastic bags and their potential environmental hazards

The main environmental and health concerns for plastic bag (PB) consumption are the release of heavy metal (HM) and chlorine (Cl) during its service life and disposal. The objective of the investigation was to characterize different PBs made of commonly used polymers and colors. The elemental compositions, heating values and total metal contents of the samples were measured by an elemental analyzer, a sulphur/halogen analyzer, a bomb calorimeter, and an ICP–OES, respectively; leaching behaviours of metals by stimulants (distilled water, HCl, acetic acid) and temperature (cooling, sunlight, heating); and thermal decomposition rate by treating in tube furnace at different temperatures with air flow. Results demonstrated that PVC bags contain 40%–56% of Cl while others 70%–90% of C followed by H and insignificant quantity of N and S. All samples showed the lowest moisture content (˂1%) and higher LCV (18–47 MJ/kg). 5 out of 33 PB samples exhibited Cr and Cd contents exceeded standards (ASTM F963); i.e., Cr in black HDPE (63 mg/kg), multi–color LDPE (78 mg/kg) and black LDPE (67 mg/kg), while Cd in purple PVC (334 mg/kg) and black PVC (135 mg/kg). A noteworthy quantity of Pb, Cr and Cd leaching was noticed in all samples where HCl and heating treatment demonstrated the highest amount of metals leaching, and most of the samples crossed EPA standards. Furthermore, different polymers exhibited different mass reduction ratios (85%–99%) during thermal treatment at 850 °C and 950 °C.

Heavy metals dispersion during thermal treatment of plastic bags and its recovery

One of the main worries for thermal treatment of plastic bag (PB) is the air pollution resulting from heavy metal (HM) evaporation and emission. The quest of the study was to investigate their fate during thermal treatment varying with temperature and atmosphere to explore the appropriate treatment technology. Four commonly consumed polymer bags such as PE, HDPE, LDPE and PVC were selected for the analysis. The elemental compositions, heating values and total metal contents of the samples were measured by an elemental analyzer, a sulphur/halogen analyzer, a bomb calorimeter and an ICP–OES, respectively. Thermal treatments of the samples were conducted in a tube furnace at 350, 550, 650, 750, and 850 °C with 1 L/min air or N2 gas flow, respectively. 5% HNO3/10% H2O2 solution was used for absorbing metals from gas phase, and then HM distributions both in flue gas and bottom ash were determined. Results revealed that the lower heating values of HDPE, LDPE, PVC and PE bags were 33.32, 34.28, 24.82 and 36.7 MJ/kg, respectively indicating energy recovery potential. Thermal treatment showed the maximum mass reduction (>90%) of PB at 850 °C. The higher percentage of metals was distributed in ash at initial temperature that promoted to gas with rise of temperature. The used absorption solution exhibited tremendous quantity of metals recovery. However, there was no significant difference between using air and N2 gas flow during treatment of PB.

Stability of 2 mg/mL Adenosine Solution in Polyvinyl Chloride and Polyolefin Infusion Bags.

Adenosine is a potent endogenous mediator of vasodilation. Compounded sterile solutions of adenosine are used in cardiac catheterization lab to perform stress tests on the heart. These tests are used to determine the fractional flow reserve (FFR) and are commonly used in the management and diagnosis of cardiovascular conditions. The purpose of this study was to assess the physical and chemical stability of 2 mg/mL adenosine in 0.9% Sodium Chloride Injection, USP in polyvinyl chloride [PVC]) and polyolefin infusion bags stored at room temperature (20°C-25°C) and under refrigeration (2°C-8°C). The compounding and analytical methods used in this study were very similar to those described in the prior publications from the authors' laboratory. To ensure a uniform starting concentration of all stability samples, a batch of 2 mg/mL adenosine solution was prepared and then packaged into empty PVC and polyolefin infusion bags. These stability samples were prepared in triplicate for each bag type and storage temperature (a total of 12 samples). The infusion bag samples were assessed for stability immediately after preparation and after 1 day, 3 days, 7 days, and 14 days. At each time point, the infusion bags were first visually inspected against a light background for color change, clarity, and particulates. Aliquots were drawn from each sample at each time point for pH analysis and high-performance liquid chromatography (HPLC) analysis. Over 14 days of storage at room temperature or refrigeration, no considerable change in visual appearance or pH was observed in any bags. All samples retained 90% to 110% of the initial drug concentration. No significant degradation peaks were observed in the HPLC chromatograms.

Determination of di(2-ethylhexyl) phthalate in plastic medical devices

The presence of DEHP in dialysis and infusion sets for peritoneal dialysis and parenteral nutrition, which are made of PVC and other plastic polymeric materials, were investigated. Phthalate determination was carried out by gas chromatography - mass spectrometry method (GC-MS). The results showed that the peritoneal dialysis set (bag and tubing) made of PVC contains DEHP in significant amount, about 31 - 34%. Solution for peritoneal dialysis which was stored in the investigated PVC bag, contains low amount of DEHP, about 3.72 ?g dm-3. Infusion bottles which are made of LDPE, also contain DEHP but in lower amount than PVC bags. LDPE bottle for packaging physiological saline solution (0.9% NaCl) showed higher amount of DEHP than LDPE bottle for packaging Ringer?s solution. In contrast, solution stored in bottle with lower DEHP level, i.e. Ringer?s solution contained about three times higher concentration of DEHP than physiological saline solution stored in bottle with higher DEHP level. Concentrations of DEHP in Ringer?s solution and physiological saline solution are 17.30 and 5.83 ?g dm-3, respectively. The obtained values are under estimated upper-bound dose of DEHP received by adult patients undergoing procedures of peritoneal dialysis and parenteral nutrition.

Non-invasive spectroscopy of transfusable red blood cells stored inside sealed plastic blood-bags.

After being separated from (donated) whole blood, red blood cells are suspended in specially formulated additive solutions and stored (at 4 °C) in polyvinyl chloride (PVC) blood-bags until they are needed for transfusion. With time, the prepared red cell concentrate (RCC) is known to undergo biochemical changes that lower effectiveness of the transfusion, and thus regulations are in place that limit the storage period to 42 days. At present, RCC is not subjected to analytical testing prior to transfusion. In this study, we use Spatially Offset Raman Spectroscopy (SORS) to probe, non-invasively, the biochemistry of RCC inside sealed blood-bags. The retrieved spectra compare well with conventional Raman spectra (of sampled aliquots) and are dominated by features associated with hemoglobin. In addition to the analytical demonstration that SORS can be used to retrieve RCC spectra from standard clinical blood-bags without breaking the sterility of the system, the data reveal interesting detail about the oxygenation-state of the stored cells themselves, namely that some blood-bags unexpectedly contain measurable amounts of deoxygenated hemoglobin after weeks of storage. The demonstration that chemical information can be obtained non-invasively using spectroscopy will enable new studies of RCC degeneration, and points the way to a Raman-based instrument for quality-control in a blood-bank or hospital setting.