Storage In Syringes Research Articles

The movement of syringes and medication during anesthesiology delivery: An observational study in laparoscopic surgeries

The movements of syringes and medications during an anesthetic case have yet to be systematically documented. We examine how syringes and medication move through the anesthesia work area during a case. We conducted a video-based observational study of 14 laparoscopic surgeries. We defined 'syringe events' as when syringe was picked up and moved. Medications were administered to the patient in only 48 (23.6%) of the 203 medication or syringe events. On average, 14.5 syringe movements occurred in each case. We estimate approximately 4.2 syringe movements for each medication administration. When a medication was administered to the patient (either through the IV pump or the patient port), it was picked up from one of 8 locations in the work area. Our study suggests that the syringe storage locations vary and include irregular locations (e.g., patient bed or provider's pockets). Our study contributes to understanding the complexity in the anesthesia work practices.

Pharmaceutical compounding and storage of faricimab in a syringe for intravitreal injection do not impair stability and bi-specific binding properties

BackgroundIntravitreal injection (IVI) of antibody biologics is a key treatment approach in ophthalmology. Pharmaceutical compounding and storage of prefilled syringes for IVI must take place without impairing the structure and function of the biologics. This study investigated the effect of withdrawing and storing the therapeutic antibody faricimab (Vabysmo, Roche, Basel, Switzerland) in the Zero Residual silicone oil-free, 0.2-mL syringe (SJJ Solutions, The Hague, the Netherlands).MethodsTo assess the effect of syringe withdrawal on faricimab, we compared samples from syringes prepared at day 0 with samples taken directly from faricimab vials. To assess the effect of syringe storage on faricimab, we kept prefilled syringes in the dark at 4 oC for 7, 14, or 37 days and compared samples from these syringes with day 0. We measured protein concentration (with spectrophotometry), stability and integrity (with sodium dodecyl sulfate-polyacrylamide gel electrophoresis (SDS-PAGE), size-exclusion chromatography (SEC), and melting temperature (Tm)), as well as binding of faricimab to its cognate antigens: vascular endothelial growth factor A (VEGF-A) and angiopoietin-2 (Ang-2) (with enzyme-linked immunosorbent assay (ELISA)).ResultsFaricimab migrated in line with its expected molecular mass under both reducing and non-reducing conditions for all time points when analyzed with SDS-PAGE, without any sign of degradation products or aggregation. The SEC elution profiles were identical for all time points. There were slight variations in Tm for different time points compared to day 0 but without consistent relationship with storage time. ELISA did not detect differences in VEGF-A or Ang-2 binding between time points, and faricimab did not bind the neonatal Fc receptor.ConclusionsWithdrawal and storage of faricimab in syringes for up to day 37 did not impair the structure and bi-specific binding properties of the therapeutic antibody.

Analysing the In-Use Stability of mRNA-LNP COVID-19 Vaccines Comirnaty™ (Pfizer) and Spikevax™ (Moderna): A Comparative Study of the Particulate.

Comirnaty™ and Spikevax™ were the first vaccines approved for human use based on modified non-replicating mRNA lipophilic nanoparticle (mRNA-LNP) technology, with great success in the treatment of COVID-19. They have been used massively worldwide. One of the major inconveniences of these vaccines is related to pharmaceutical stability issues. Proper transportation, storage, and in-use handling before administration to patients are critical steps since failures can potentially reduce potency. In this research, the in-use stability of Comirnaty™ and Spikevax™ clinical samples was analysed and the results were compared. As changes in the size of the mRNA-LNPs are related to potency, these modifications were analysed by qualitative Dynamic Light Scattering (DLS) as a stability-indicating method for control and stressed vaccine samples. Strong stress factors (accelerated light irradiation, manual shaking, and vortex vibration) and conditions that mimic in-use handling (exposure to natural light and room temperature, repeated cycles of injections, and 24 h storage in syringes) were checked. The morphology of the mRNA-LNPs was analysed by Transmission Electron Microscopy (TEM) to better interpret and support the DLS results. Although the two vaccines are based on the same mRNA-LNP technology, the results demonstrate that they are characterised by very different particle size profiles and behaviours against different handling/stress conditions.

Standardised colour-coded compartmentalised syringe trays improve anaesthetic medication visual search and mitigate cognitive load

BackgroundAnaesthetic procedures are complex and subject to human error. Interventions to alleviate medication errors include organised syringe storage trays, but no standardised methods for drug storage have yet been widely implemented. MethodsWe used experimental psychology methods to explore the potential benefits of colour-coded compartmentalised trays compared with conventional trays in a visual search task. We hypothesised that colour-coded compartmentalised trays would reduce search time and improve error detection for both behavioural and eye-movement responses. We recruited 40 volunteers to identify syringe errors presented in pre-loaded trays for 16 trials in total: 12 error present and four error absent, with eight trials presented for each tray type. ResultsErrors were detected faster when presented in the colour-coded compartmentalised trays than in conventional trays (11.1 s vs 13.0 s, respectively; P=0.026). This finding was replicated for correct responses for error-absent trays (13.3 s vs 17.4 s, respectively; P=0.001) and in the verification time of error-absent trays (13.1 s vs 17.2 s, respectively; P=0.001). On error trials, eye-tracking measures revealed more fixations on the drug error for colour-coded compartmentalised trays (5.3 vs 4.3, respectively; P<0.001), whilst more fixations on the drug lists for conventional trays (8.3 vs 7.1, respectively; P=0.010). On error-absent trials, participants spent longer fixating on the conventional trials (7.2 s vs 5.6 s, respectively; P=0.002). ConclusionsColour-coded compartmentalisation enhanced visual search efficacy of pre-loaded trays. Reduced fixations and fixation times for the loaded tray were shown for colour-coded compartmentalised trays, indicating a reduction in cognitive load. Overall, colour-coded compartmentalised trays were associated with significant performance improvements when compared with conventional trays.

The Impact of Syringe Age Prior to Filling on Migration of Subvisible Silicone-Oil Particles into Drug Product

Silicone oil is often applied to the inner surface of glass syringes and cartridges to reduce friction between the glass surface and elastomeric plunger stopper. This oil can appear as intrinsic and non-proteinaceous particles in the ejected fluid or drug product. Limited data is available to understand the impact of age (time between syringe manufacture and filling) on silicone oil migration into the drug product. This study compares subvisible particle count and extrusion force of siliconized syringes from two different manufacturers stored at ambient condition for 2-3 (fresh syringes) and 13-14 (aged syringes) months then filled and placed at 40°C for an additional three months. The fresh syringes exhibit a 2.5-fold increase in subvisible particle count compared to those aged ones. Moreover, the fresh syringes exhibit up to a 2-fold increase in extrusion force. These findings suggest the degree and amount of silicone oil migration is influenced by the time in storage of the glass syringe prior to filling. This rapid communication highlights syringe storage time prior to filling as a factor to be considered during development.

Stability of 4 Intravenous Drug Formulations in Prefilled Syringes Stored Frozen for Up to 60 Days.

Purpose: Prefilled drug syringe use may reduce the cost of routine antibiotic drug delivery. Storage of prefilled syringes frozen (-20°C) or refrigerated (4°C-5°C), can optimize the use of robotic syringe filling systems if acceptable stability data is gathered per USP 797 standards. Methods: Four intravenous (IV) drug formulations were prepared from bulk standard solutions and filled into 10 mL syringes using an Intellifill© IV Robot. Formulations were Piperacillin (2.0 g) and Tazobactam (0.25 g) as 2.25 g in 10 mL; Piperacillin (3.0 g) and Tazobactam (0.375 g) as 3.375 g in 10 mL; Cefuroxime as 1.5 g in 11 mL; and Vancomycin as 1.0 g in 10 mL. Concentrations were assayed at "zero time," and after 21, 45, and 60 days frozen. Syringes were warmed to room temperature (RT) by gently rolling in hands. Three syringes of each formulation were assayed by stability-indicating HPLC per USP procedures. Assay results are the average of 5 injections of samples from each syringe upon return to RT and repeated for 3 separate syringes maintained at RT for 24 hours. Results: All formulations were stable out to 60 days frozen. Both of the piperacillin/tazobactam formulations were also stable when kept at refrigerated temperature for 9 days. Conclusion: Piperacillin/Tazobactam formulations can be stored frozen (-20°C) for up to 60 days with no appreciable loss. Cefuroxime and Vancomycin formulations can be stored frozen for up to 60 days. Both Piperacillin/Tazobactam formulations can be refrigerated for up to 9 days. Implementation of larger batch compounding coupled with frozen syringe storage and delivery could result in enhanced uniformity of composition and significant manpower savings.

The Effect of Expiration Date on Mechanical Properties of Resin Composites.

Objective:The aim of this in vitro study is to evaluate the effect of expiration date on some mechanical properties of resin composites after controlled storage of syringes and compules in a refrigerator at 4°C.Materials and Methods:Specimens were tested at 7 days after storage in distilled water at room temperature. The investigated properties are the static modulus of elasticity, the flexural strength, and the Vickers microhardness. Same batches of restorative materials were examined at baseline (at least 1 year before their expiration date) and 1 year after they expired.Results:Paired t-test is used to compare the results between the two groups using StatView software (version 5.0) SAS Campus Drive Cary, North Carolina, USA. Except for the flexural strength, no statistical differences were found between the mechanical properties of the expired and the unexpired group.Conclusion:The 1-year expiry date did not seem to affect the investigated mechanical properties.

Chemical stability of morphine and methadone, and of methadone in combination with acepromazine, medetomidine or xylazine, during prolonged storage in syringes.

To assess the chemical and physical stability of morphine and methadone stored in syringes for 12 months and of methadone when mixed with acepromazine, medetomidine or xylazine. A high-performance liquid chromatography (HPLC) technique was developed and validated for the analysis of morphine and methadone. Morphine and methadone were dispensed into syringes and stored at 25°C/60% relative humidity (RH) and 40°C/75% RH. Solutions containing mixtures of methadone combined with acepromazine, medetomidine or xylazine were stored in syringes at 25°C/60%RH. At initiation, after 1 week and then 1, 3, 6, 9 and 12 months, samples were analysed by HPLC for the quantification of the morphine or methadone. Measured concentrations were assessed as a function of storage time and temperature using linear regression statistics to calculate stability. When stored at 40°C/75%RH as pre-dispensed syringes, severe physical and chemical changes were observed after the third month for both morphine and methadone. In contrast, at 25°C/60%RH both drugs remained chemically stable for 12 months, with concentration variations not exceeding a 5% change from initiation as stipulated in VICH stability guidelines. When in combination with acepromazine or xylazine, methadone also remained chemically stable, but the combination with medetomidine failed stability criteria prior to 6 months. Precipitation compromised the physical stability of methadone in all unsealed syringes prior to 9 months' storage. Pre-dispensing morphine or methadone into unsealed syringes compromises the drugs' physical stability. Mixing of methadone with other drugs can degrade its chemical stability.

Stability of daptomycin 5 mg/mL and heparin sodium 100 units/mL combined in lactated Ringer's injection and stored in polypropylene syringes at 4 and -20°C.

The stability of an admixture containing reconstituted daptomycin and heparin in lactated Ringer's injection was evaluated. Two samples of the admixture of daptomycin 5 mg/mL and heparin sodium 100 USP units/mL diluted in lactated Ringer's injection were prepared and divided into 5-mL portions for storage in syringes at 4 and -20 °C for 14 days. The percentage of the initial concentration of the drugs remaining in the syringes was assessed using a high-performance liquid chromatographic (HPLC) method with diode-array detection previously validated as stability indicating for both drugs. Forced degradation studies were performed independently with each drug diluted in lactated Ringer's injection. One sample from each stored syringe was analyzed in triplicate on days 0, 1, 2, 3, 4, 7, and 14; quality-control samples of each concentration tested were used throughout the analysis. The admixture samples were visually inspected for color, clarity, and the formation of particulate matter. The HPLC analysis indicated no significant reduction (loss of ≤5%) in the concentration of daptomycin and heparin diluted in lactated Ringer's injection stored in syringes refrigerated at 4 °C and frozen at -20 °C. None of the chromatographic peaks observed in samples subjected to forced degradation were detected in any sample during the 14-day study. All of the syringe-stored samples remained clear and colorless on visual inspection for the duration of the study. The admixture of daptomycin 5 mg/mL and heparin sodium 100 USP units/mL was stable when stored in polypropylene syringes for up to 14 days at 4 and -20 °C.

Development of ready-to-use cefuroxime syringes for use in ophthalmology

ObjectivesTo improve the safety of the preparation and its availability in ophthalmology, a ready-to-use cefuroxime syringe prepared under aseptic conditions according to good manufacturing practice was developed by the hospital...

Stability of dexmedetomidine 4 μg/mL in polypropylene syringes

The results of a study to determine the long-term (up to 14 days) stability of diluted dexmedetomidine kept in polypropylene syringes under typical pharmacy storage conditions are presented. Four samples of dexmedetomidine injection diluted to 4 μg/mL in 0.9% sodium chloride were prepared and divided into 25-mL portions for storage in syringes at ambient room temperature (20-25 °C) with light exposure or under refrigeration (5 °C) in darkness. At 24 and 48 hours, the percentage of the initial dexmedetomidine concentration remaining in all samples was assessed via high-performance liquid chromatography with diode-array detection; further stability testing of the refrigerated samples was performed on days 7 and 14. At each time point, the test samples were visually inspected for color, clarity, and signs of formation of particulate matter. As determined by chromatographic analyses, the samples of diluted dexmedetomidine stored in syringes at room temperature exhibited a loss of drug concentration of <10% over 48 hours; the refrigerated samples exhibited a loss of drug concentration of <5% over 14 days. All of the syringe-stored samples remained clear and colorless on visual inspection for the duration of the study. Dexmedetomidine diluted to 4 μg/mL in 0.9% sodium chloride injection was stable for at least 48 hours at 20-25 °C and 14 days at 5 °C when stored in polypropylene syringes.

Patient self‐injection of methotrexate for inflammatory arthritis: A study evaluating the introduction of a new type of syringe and exploring patients' sense of empowerment

To evaluate the introduction of a new type of syringe for patients on a self-injection of methotrexate (MTX) programme and explore patients' sense of empowerment relating to the self-injection of MTX. Data were collected using a postal questionnaire, which yielded quantitative and qualitative data. The questionnaire was sent to all eligible patients in the primary care setting who self-injected MTX (n=24). The response rate was 88% (n=21). Patients' responses illustrated numerous disadvantages of using the syringe, particularly difficulties with the syringe stopper, syringe handling and leakage potential of the mildly cytotoxic drug MTX. The advantages included the ease of syringe storage and longer use by date. Difficulties in using the syringe, and the amount of support and training from hospital staff were among the factors affecting patients' sense of empowerment. Although a small study, this work indicates that there may be benefits in a collaboration between hospital staff and the syringe manufacturer, to modify the new syringe to address the problems noted. The potential of cytotoxic MTX spillage being minimized is recognized, making the new syringe more suitable for use by patients with inflammatory arthritis. Patient training may help to alleviate difficulties in using a new syringe, which, in turn, may also increase patients' sense of empowerment.

Latex allergen levels of injectable collagen stored in syringes with rubber plungers

Objectives To assess the latex allergen content of glutaraldehyde cross-linked injectable bovine collagen stored in rubber plunger syringes. Methods Extracts of syringe plungers and collagen solutions before and after storage in syringes with natural rubber latex plungers were tested for latex protein allergens. Thirty-nine patients known to be allergic to latex underwent skin prick testing with extracts of the latex plungers, collagen solutions before and after storage in syringes, standard latex skin test reagents, four extracts from commercially available gloves, and positive (histamine) and negative (diluent) control solutions. Thirty-one control patients not known to be latex allergic were similarly tested. Results No latex proteins were detected using in vitro immunochemical techniques. Only 1 of 39 (2.5%) latex allergic patients reacted to the syringe extract and the collagen stored in the syringe. No reactions were recorded to collagen that had no contact with latex. Conclusions The level of latex antigens in injectable collagen is very low. The low prevalence of skin test reactivity in these highly latex allergic individuals suggests that type 1 hypersensitivity reactions as a result of latex contamination would be unlikely.

In vitro characteristics of white cell‐reduced single‐unit platelet concentrates stored in syringes

Platelet concentrates (PCs) for premature infants may be subjected to filtration, centrifugation, and various storage conditions before transfusion. As there are few data on the cumulative effect of these procedures on PCs, platelet properties (including biochemical and functional in vitro assays) were evaluated after the processing of single units of PCs through a 1-unit-capacity high-efficiency white cell (WBC)-reduction filter followed by syringe storage at either 22 or 37 degrees C for 6 hours. Two- and 5-day-old PCs, volume-reduced PCs, and prestorage WBC-reduced PCs were evaluated. WBC filtration consistently resulted in a 3 to 4 log10 reduction in WBCs, with less than 15-percent platelet loss. No adverse effects of platelet function or evidence of increased platelet activation as determined by the percentage of P-selectin positivity were noted. A decrease in pH associated with increased lactate production and consumption of glucose was observed following syringe storage under all conditions tested. Such changes were most pronounced, however, with volume-reduced PCs stored at 37 degrees C (pH 6.31 +/- 0.15, lactate 23.0 +/- 3.06 mmol/L). All pH levels at the end of storage were above the minimum Food and Drug Administration requirement (pH 6.0). The in vitro data suggest that single units of PCs can undergo WBC filtration followed by syringe storage for up to 6 hours and still maintain acceptable storage characteristics. The practice of maintaining volume-reduced PCs in syringes for 6 hours at 37 degrees C in isolettes during transfusion should, however, be avoided.

The stability of mesna in beverages and syrup for oral administration

We evaluated the stability of the aqueous formulation of mesna during storage in syringes and after dilution in beverages and syrups. Measurements of the concentrations of mesna showed that the undiluted formulation was stable for at least 9 days in standard polypropylene syringes at 5 degrees, 24 degrees, and 35 degrees C. There was no detectable oxidation of mesna to dimesna over the course of at least 1 week when mesna was diluted 1:2 and 1:5 in syrups and incubated at 24 degrees C in capped tubes. Concentration changes were clinically negligible for 1:2, 1:10, and 1:100 dilutions of mesna in six carbonated drinks, two juices, and milk after incubation for 24 h at 5 degrees C. Thus, the aqueous mesna formulation is stable when diluted and stored in a variety of beverages and syrups under conditions suitable for oral administration.

In vitro characteristics of volume‐reduced platelet concentrate stored in syringes

For convenience, small volumes of platelet concentrate (PC) intended for neonatal patients are often dispensed in syringes. The PC, however, may remain in the syringe for up to several hours before the actual transfusion. As there are few data on the effect of such syringe storage on PCs, the in vitro syringe storage properties of small volumes of 1- and 5-day-old units, and volume-reduced units of PC were evaluated. In four separate experiments, PCs were stored in syringes in volumes of 10, 15, or 30 mL for up to 6 hours at 20 to 24 degrees C without agitation. Platelets were evaluated for pH, platelet count, and a variety of biochemical and in vitro functional assays. Results showed that even with the equivalent of a full unit of platelets stored in the syringe for up to 6 hours, the pH did not fall below 6.0. Although there was an increase in lactate production and consumption of glucose, which paralleled the decline in pH, the changes were not greater than those seen in platelets stored up to 5 days in gas-permeable blood bags. Similar results were seen for PCs stored in syringes for 6 hours at 37 degrees C. All of the pH levels recorded at the end of 6 hours of syringe storage were above the minimum required level of pH 6.0. Data from in vitro platelet assays imply that at any time during their shelf life, PCs can be stored in gas-impermeable polypropylene syringes for up to 6 hours and can maintain acceptable storage characteristics; in vivo data are needed to confirm these observations.

Stability of carbenicillin and oxacillin frozen in syringes

The stability of carbenicillin disodium and oxacillin sodium following storage in syringes for three months at -20 C was studied. Employing a spectrophotometric assay, it was found that carbenicillin (2500 mg/ml) and oxacillin (200 mg/ml) remained stable in both glass and plastic syringes for three months when frozen at -20 C. Stability was not altered by storage in either glass or plastic, nor by the size of the syringe used. Although the results were favorable, additional evidence is necessary before the practice of freezing reconstituted carbenicillin and oxacillin in syringes is advocated.

Sterilization and storage of syringes, dressings and instruments

Sterilization and storage of syringes, dressings and instruments