Impact of pneumatic tube system transportation on product quality of therapeutic monoclonal antibody liquid drug products filled in vials and pre-filled syringes.

To describe current practice in pediatric cardiac ICUs (CICUs) regarding use of bolus epinephrine in pre-arrest clinical scenarios; focusing on "epinephrine dose-readiness," meaning having emergency medications available at a patients' bedside. Academic and clinical CICUs in the United States. Cross-sectional survey of medical directors from August to October 2024. None. Forty-eight of 71 medical directors (68%) responded to the survey request. Of the respondents, 41 of 48 reported the practice of having bolus doses of epinephrine ready at patients' bedsides. In 36 of 41 units, epinephrine doses were drawn up for high-risk patients only, whereas the other 5 of 41 units reported placing bolus doses of epinephrine at the bedside for all CICU patients, regardless of risk. Of these 5 units with bedside epinephrine for all patients, 4 units reported that this was done throughout the entirety of CICU admission. Most CICUs (33/41) with bedside epinephrine reported having patient-specific doses ready at bedside, whereas the other (8/41) CICUs with bedside epinephrine said that they had pre-filled epinephrine syringes that were not patient-specific. Regarding the dose of epinephrine boluses, 27 of 48 units reported having 1 µg/kg doses ready, which included 14 of 48 units that reported having both 10 µg/kg (cardiac arrest dose) and 1 µg/kg doses of epinephrine ready. On stratifying responses by CICU size (> 20 beds vs. those ≤ 20 beds) we identified a greater proportion reporting epinephrine dose-readiness for all patients throughout their CICU stay (31.6% vs. 4.8%; p = 0.025). In 48 U.S. CICUs in 2024, medical directors reported a range of practices in epinephrine dose-readiness for anticipation of patient clinical deterioration. Our findings expose a lack of standardization in practice, and there is a need to establish best practices with more research.

Investigation of sterile hydrogels as topical vehicles for APOSECTM, a stressed peripheral blood mononuclear cell secretome for the treatment of poorly healing wounds.

Background and objectives Medical devices are essential in hospitals for diagnosis and treatment but may also cause unintended adverse events. Materiovigilance plays a crucial role in detecting, reporting, and preventing such events to safeguard patients. This study aimed to monitor, assess, and report medical device-associated adverse events (MDAEs) in a tertiary care hospital and to identify the devices most frequently implicated. Methods A prospective observational study was conducted at a tertiary care hospital in Bengaluru, India, from May 2023 to January 2024. Daily ward rounds were carried out in collaboration with the biomedical team to identify device-related issues. Confirmed MDAEs were documented using the standard reporting forms of the Materiovigilance Programme of India (MvPI). Results Among 1,100 medical devices in use, 31 (2.81%) were associated with adverse events. Most affected patients were females, with an average age of 61 years. Frequently implicated devices included disposable syringes and intravenous (IV) cannulas. The common events included thrombophlebitis, blocked or damaged needles, and elevated serum creatinine following contrast use. Most adverse events involved Class B devices. Causality assessment classified the majority as probable or possible. Interpretation and conclusions The overall frequency medical device associated of adverse events associated was low. However, the findings underscore the importance of continuous device surveillance. Strengthening awareness and structured reporting under MvPI can improve early detection, timely intervention, and long-term patient safety in clinical practice.

Reimbursement reviews are comprehensive assessments of the clinical effectiveness and cost-effectiveness, as well as patient and clinician perspectives, of a drug or drug class. The assessments inform nonbinding recommendations that help guide the reimbursement decisions of Canada’s federal, provincial, and territorial governments, with the exception of Quebec. This review assesses Induction: Guselkumab (Tremfya) 200 mg/20 mL vial of sterile solution administered through IV infusion. Maintenance: Guselkumab (Tremfya) 100 mg/1 mL pre-filled syringe, 100 mg/1 mL patient-controlled injector, 200 mg/2 mL pre-filled syringe, and 200 mg/2 mL pre-filled pen administered by subcutaneous injection. Indication: For the treatment of adult patients with moderately to severely active ulcerative colitis.

In Aotearoa New Zealand, prefilled syringes for patients receiving palliative care in the community can be prepared (compounded) by certain pharmacies. Currently, there is limited information regarding the scope of compounding these prefilled syringes. The study aimed to explore the range of subcutaneous bolus-dose medications and the compounding processes used in community pharmacies in Tāmaki Makaurau Auckland when preparing prefilled syringes used for anticipatory needs in patients receiving palliative care. A convenience sample of community pharmacies contracted to prepare prefilled syringes was invited to complete an online survey. Information was requested on the medications compounded for bolus-dose syringes over the previous 6-month period, including what medications and facilities were used, how expiration dates were determined, and the time spent preparing these syringes. Data were requested on compounding between 1 September 2022 and 28 February 2023 with complete responses received from 8 of the 40 pharmacies invited to participate. The top four medications compounded, in rank order, were midazolam, oxycodone, haloperidol, and morphine sulfate. All eight pharmacies compounded syringes in a still air box, and 'published guidance' was the most common source of expiration dates. Most respondents each reported spending 5-10h per week preparing the compounded products. Community pharmacies in Tāmaki Makaurau Auckland compounded a range of medications as bolus-dose prefilled syringes for patients receiving palliative care. These results will inform future planned studies on the stability and sterility of these syringes.

The rapid growth of biologic therapeutics has driven the need for advanced, patient-centric drug delivery systems that ensure safety, stability, and ease of administration. Prefilled syringes (PFS) have emerged as a preferred delivery format for biologics due to their ability to reduce dosing errors, enhance patient compliance, and streamline healthcare workflows. This review explores the current landscape of PFS in biologic drug delivery, highlighting key innovations in syringe design, material selection, and integration with self-injection devices such as autoinjectors. Particular attention is given to formulation and stability challenges unique to biologics, including protein aggregation, interactions with syringe components, and cold chain requirements. Advances such as silicone-free syringes, dual-chamber systems, and smart connected devices are discussed in the context of improving usability and safety. Regulatory considerations, including human factors, engineering and post-market surveillance, are examined to underscore the importance of risk mitigation in PFS development. Finally, the paper discusses market trends, accessibility challenges, and future directions aimed at optimizing the delivery of biologic drugs through prefilled syringe technologies. As biologics continue to dominate therapeutic pipelines, PFS innovations will play a critical role in supporting safe, effective, and patient-friendly drug administration.

Postoperative fluid accumulation within surgical wounds can lead to complications such as hematoma, seroma, surgical site infection, and delayed wound healing. Closed suction drainage systems are commonly used to prevent these complications by eliminating dead space and facilitating continuous evacuation of fluid collections; however, commercially available systems may not always be accessible in resource-limited settings. This prospective observational case series was conducted at B. D. Pandey District Hospital, Nainital, India, from January 2024 to June 2025, including 24 patients undergoing minor surgical procedures with anticipated dead space formation. A syringe-based closed suction drainage system was assembled using a disposable syringe and infant feeding tube to generate negative pressure drainage. The mean age of patients was 28 years, with 16 males and 8 females. Indications included excision of soft tissue swellings, minor reconstructive procedures, and closure of wounds with potential dead space. Mean drainage volume was 25 ml on postoperative day 1, 12 ml on day 2, and 4 ml on day 3, with a mean drain duration of 3 days. No hematoma or seroma formation was observed, while two patients developed superficial surgical site infection managed conservatively. Syringe-based closed negative suction drainage is a simple, safe, and cost-effective alternative for small surgical wounds, particularly useful in low-resource healthcare settings.

Background Prefilled syringes (PFS) are commonly used for self-administered injectable drugs, particularly for chronic conditions. A critical design factor is the injection force needed to depress the plunger, which varies by drug viscosity and syringe mechanics. This is especially important for patients with potential strength limitations. Human factors studies help evaluate these physical demands to ensure PFS can be used safely and effectively across diverse users. Assessing both maximum force capabilities and endurance provides key insights for optimizing syringe design and minimizing patient discomfort.Objectives This study evaluated Chronic Obstructive Pulmonary Disease (COPD) patients' experience with PFS samples of varying injectability (injection force and duration) and measured pinch force endurance-an indicator for PFS physical demand. Those insights aimed to guide PFS design for users with strength limitations.Methods 42 COPD patients performed simulated injections using three PFS samples (28N, 38N, 47N force) and rated perceived demand. They also gripped a surrogate PFS device at 28N and maximum force to measure endurance. Data predicted the 5th percentile pinch force endurance for COPD patients.Results The estimated COPD patients' 5th percentile pinch force endurance at 28N was 16 seconds, while their maximum pinch force endurance was around 4.4 seconds. Males pinched and held 28N longer than females, but no gender difference was observed at the maximum force. Endurance decreased as required force approached maximum capacity (consistent with Rohmert's Curve).Conclusions PFS usage can be challenging for users with strength limitations. A 28N force was sustainable for 16 seconds for 95% of COPD patients. Developers should minimize injection force where possible and accommodate varied injection styles-lower forces improve endurance, aiding users with reduced strength. These findings support designing accessible PFS for diverse populations.

Prefilled syringes are valuable drug delivery systems, offering convenience and precision dosing. Among the critical factors influencing their performance is the stability of the silicone oil layer, which acts as a lubricant, guaranteeing the gliding properties of the plunger. The silicone oil, if it comes in contact with therapeutic formulations, can be subject to drug–container interactions, potentially leading to silicone oil release into the solution, thereby altering the gliding properties of the syringe and leading to unwanted particle formation, compromising drug efficacy and safety. Different measurement techniques, such as visual inspection, dynamic light scattering and spectroscopic analysis, are used to assess silicone oil layer stability in prefilled syringes. However, a quantitative, rapid and low-volume screening method to rapidly evaluate container compatibility for therapeutic formulations is not available. Here, we present a multi-well-based screening protocol allowing users to quantify, through fluorescence, the silicone oil released into a solution upon contact with liquid formulations. Fluorescently labeled uniform silicone oil layers of the desired thickness are deposited in glass-bottom wells and exposed to typical formulations, containing surfactants and monoclonal antibodies. The release of silicon oil as a function of contact time is quantified using fluorescence calibration. Beyond its use as a screening tool to evaluate drug–container compatibility, our protocol can contribute to the fundamental understanding of the factors and mechanisms influencing silicone oil layer stability and, furthermore, to the optimization of drug delivery systems.

IntroductionTo report 1.5-year real-world outcomes on the incidence of sterile intraocular inflammation (IOI) following intravitreal aflibercept 8 mg injections, with emphasis on differences between vial and pre-filled syringe (PFS) use.MethodsThis retrospective multicenter study reviewed the electronic medical records of all patients who received aflibercept 8 mg injections at Vista Augenklinik sites between March 1, 2024, and November 30, 2025. The primary outcome was the incidence of IOI per injection. Secondary analyses included stratification by treatment indication and by vial versus PFS administration.ResultsA total of 2631 injections were administered to 453 eyes of 398 patients. IOI was documented in 41 eyes (37 patients), corresponding to an incidence of 1.56% per injection (95% confidence interval [CI], 1.21–2.41), 9.05% per eye (95% CI, 7.13–13.0), and 9.30% per patient (95% CI, 7.0–13.32). Mean time to presentation was 7.3 days (range 2–31) after a mean of 4.7 injections. All cases presented with anterior chamber and/or vitreous inflammation without posterior involvement. No retinal vasculitis or infiltrates were observed. Inflammation resolved with topical corticosteroids and/or nonsteroidal anti-inflammatory drugs (NSAIDs), with no significant change in best-corrected visual acuity (VA) compared to pre-event VA (20/32 versus 20/35 Snellen equivalent, p = 0.62). The incidence differed significantly between formulations: 2.26% per injection with the vial versus 0.21% per injection with the PFS (p = 0.010).ConclusionIn a real-world setting, aflibercept 8 mg was associated with a higher incidence of IOI than reported in pivotal trials, particularly when administered from vials. Conversion to the PFS markedly reduced the incidence, suggesting a formulation- or preparation-related effect. All cases were mild, anterior, and reversible under topical therapy without long-term visual impact.

Reimbursement reviews are comprehensive assessments of the clinical effectiveness and cost-effectiveness, as well as patient and clinician perspectives, of a drug or drug class. The assessments inform nonbinding recommendations that help guide the reimbursement decisions of Canada’s federal, provincial, and territorial governments, with the exception of Quebec. This review assesses efgartigimod alfa injection (Vyvgart SC), 1,000 mg/5 mL (200 mg/mL) solution in single-dose prefilled syringe for SC use. Indication: As a monotherapy for adult patients with active chronic inflammatory demyelinating polyneuropathy.

Controlled liquid exchange is a fundamental requirement for numerous biological and chemical experimental protocols. However, achieving constant-volume exchange often requires electronic syringe pumps that are cost-prohibitive and time-consuming to set up in a push-pull configuration. To address these limitations, we developed the Push2Pull syringe holder, a simple 3D-printed device that mechanically synchronizes two syringes to simultaneously add and extract equal fluid volumes. This device is compatible with standard disposable syringes from 1 to 60 mL in size and operates without electricity or additional hardware, making it ideal for both laboratory and field settings. Validation experiments demonstrate an exchange accuracy within across the whole travel range, while fluid exchange efficiency was calculated for various use cases using CFD simulations. The Push2Pull syringe holder offers an accessible, open-source solution for precise fluid handling, for a material cost of less than $10.

Introduction Anaesthetic emergency drugs are essential for safe practice; however, when prepared from ampoules, they are frequently wasted when unused. Prefilled syringes (PFS) may reduce waste as they can be opened at the point of use. Additional benefits may include reducing medication errors and saving clinician time, although higher initial purchasing costs have been a barrier to universal adoption across the NHS. We undertook two quality improvement cycles to quantify the use and waste of anaesthetic emergency drugs before and after transitioning fromampoules to PFS for metaraminol, ephedrine, and atropine, measuring cost, waste generated, andenvironmental impact. Methods This was a prospective, observational study conducted across nine operating theatres at Queen Elizabeth the Queen Mother Hospital, Margate, United Kingdom, quantifying the use and waste of anaesthetic emergency drugs. Surveys were distributed to each theatre and completed by anaesthetic teams through February 2024 for cycle 1 and February 2025 for cycle 2. Cycle 1 collected baseline data on emergency drug use and waste for metaraminol, ephedrine, atropine, propofol, and glycopyrrolate. We repeated this for cycle 2 after transitioning to PFS for metaraminol, ephedrine, and atropine. Annual use and waste of emergency drugs were estimated with costs of ampoules, PFS, and equipment, including syringes, sharps bin disposal, and waste incineration provided by hospital pharmacyand facilities teams. Kilograms of carbon dioxide equivalent (kgCO2e) were estimated using emission and conversion factors based on NHS financial expenditure and incineration of the generated waste weight according to the Sustainability in Quality Improvement guidelines. Results Cycle 1 returned 28 surveys describing 87 surgical cases. Of 208 emergency drugs prepared from glass ampoules, 100 (48.1%) were wasted, costing an estimated £23,348 a year, equivalent to £2,594/theatre/year and producing196.8 kg of waste. This corresponded to an annual production of an estimated 3,372 kgCO2e, equivalent to 52 flights from London to Paris. Cycle 2 returned 87 surveys comprising 270 surgical cases. Wasted drugs reduced to 15/159 (9.4%), with the cost of waste falling by 91.1% to £231/theatre/year. Waste weight reduced by 93.0% to 13.8 kg, with associated emissions falling by 91.3% to 294 kgCO2e. Replacing metaraminol, ephedrine, and atropine ampoules with PFS yielded an estimated annual cost saving of £14,042 (31.6%), equivalent to £1,560/theatre/year. Conclusions Replacing metaraminol, ephedrine, and atropine ampoules with PFS was associated with substantial reductions in anaesthetic emergency drug costs, medication waste, and the environmental impact associated with pharmaceutical disposal. These reductions were accompanied by changes in drug preparation practices in the theatre. Limitations include self-reported survey data, the use of NHS-specific conversion factors for kgCO2e estimation, and not assessing the financial or human costs of potential medication errors. Generalisability may be limited by the single-centre study design. PFS may represent a useful strategy to reduce waste, costs, and environmental impact while supporting medication safety in anaesthetic practice.

To compare and evaluate, across different agents, the risk of intraocular pressure (IOP) elevation after anti-VEGF therapy and the accuracy of prefilled syringes. Total of 175 eyes treated with anti-VEGF drugs were enrolled for this study. An accuracy evaluation of the prefilled syringes was conducted involving 25 participants, comprising 17 physicians and 8 nurses. The anti-VEGF agents including aflibercept 2 mg, aflibercept 8 mg, brolucizumab, faricimab, and ranibizumab-BS were assessed. IOP was measured before, and at 1 and 15minutes after intravitreal injection, and analyzed separately for each drug. Furthermore, prefilled syringes of aflibercept 2 mg, brolucizumab, and ranibizumab-BS, as well as 1-mL syringes filled with saline solution, were equipped with 30-gauge needles, followed by careful removal of air. The weight of the saline discharged according to the scale marking was measured using an electronic balance. At 1 min after intravitreal injection, the IOP was highest in the aflibercept 2 mg group, with a mean value of 52.8mmHg. A mild inverse correlation was observed between axial length and IOP elevation at 1 min post-injection, suggesting that eyes with longer axial length exhibited less pronounced IOP increases. In the syringe accuracy analysis, the prefilled syringe of aflibercept 2 mg expelled a significantly larger volume, with a mean of approximately 0.076 mL, compared to other prefilled syringes. Intravitreal injection using the aflibercept 2 mg prefilled syringe may deliver approximately 1.5 times the intended volume into the eye. This may raise safety concerns, such as the risk of transient vision loss due to marked immediate IOP elevation, and may also affect clinical outcomes and the validity of clinical trials.

Control strategy for subvisible particulates of therapeutic protein injections in pre-filled syringes using flow imaging.

Protein stability and viscosity in molecularly crowded high-concentration biologics.

Sustainable injectable drug delivery devices, such as prefilled syringes, multi-chamber syringes, and reusable systems, are gaining attention due to their potential to decrease resource use and waste. Despite these considerations, the integration of sustainability metrics into healthcare systems and pharmaceutical manufacturing is inconsistent, necessitating a systematic review of existing practices and outcomes. To address this gap, a systematic literature review (SLR) was conducted in June 2024, utilizing the databases of PubMed/MEDLINE and Embase. The studies were examined for sustainability outcomes related to environmental impact, economic efficiency, and public health benefits of injectable drug delivery systems. Cost adjustments were standardized to their respective 2024 currency along with U.S. dollars using price indices for the United States, United Kingdom, Netherlands, and Italy. The literature search returned 2384 unique articles, with 24 studies meeting the inclusion criteria. The reviewed studies highlighted some of the potential benefits of sustainable injectable drug delivery devices. Environmental assessments reported reductions in waste and CO2 emissions, with examples from hospital implementations of prefilled syringes cutting waste by 26% to 86%, and modular insulin pumps showing a 44% increase in recycling efficiency compared to conventional systems. Economic evaluations revealed potential cost reductions of up to 26% of total drug expenditures, attributed to inefficient drug preparation processes and unused medications. Public health outcomes ranged from identified challenges in disposal practices to safer sustainable strategies, including a 57% reduction in hazardous waste that enhanced safety in a resource-limited setting. While the included studies varied in methodological rigor, most were rated as fair quality, with 2 studies rated as poor - indicating a need for more robust evidence to strengthen future evaluations. This review suggests that sustainable injectable drug delivery devices can reduce environmental impact, improve economic efficiency, and contribute to public health. By limiting waste, reducing carbon emissions, and supporting safety, these devices can offer measurable contributions for advancing sustainability in healthcare. However, the lack of clear sustainability standards and guidance from health systems and governments remains a key barrier to broader adoption.

The Australian Commission released the 'Management of Peripheral Intravenous Catheters (PIVC): Clinical Care Standard' in 2021. In response, a nationwide private health service reviewed current practice to ensure alignment with evidence-based PIVC insertion and management and aim to reduce associated Staphylococcus aureus bloodstream infections (SABSI). A quality improvement project to develop and implement an evidence-based PIVC bundle was conducted across 38 private hospitals Australia-wide during 2022-2023. A complete review of existing policies and practices was undertaken, followed by implementation of a bundle consisting of a service-wide PIVC policy, nursing documentation, I-DECIDED® tool, audit tool, and risk reporting; prefilled saline flush syringes; and updated consumer information. Measures included monitoring infection and complication data; ongoing audits of bundle compliance; a time-and-motion study to assess the effect of prefilled flush syringes on clinician workflow and economic costs; and staff satisfaction surveys. Since 2022, overall SABSI decreased by 21 % and intravenous catheter SABSI decreased by 10 %. Local PIVC infection reduced by 55 %. Ongoing audits demonstrate improvement for all quality statements of the Standard, including documentation of insertion attempts (from 32 % to 65 %) and overall documentation (from 74 % to 83 %). Use of ultrasound for difficult insertion increased from 21 % to 30 %. Documentation of consumer education and consent improved from 47 % to 80 %. Time-and-motion observations identified a 49-s time saving using prefilled flush syringes. Staff satisfaction scored above 90 %. Implementation of the bundle resulted in SABSI reduction, reduced local PIVC infection, greater compliance with the Standard, nursing time savings, and improved staff satisfaction.

Purpose This study explores the integration of digital twin (DT) technology within technology transfer (TT) processes, focusing on a case study involving a pharmaceutical Contract Development and Manufacturing Organization. It aims to identify barriers to effective TT, propose mitigation strategies and develop a tailored project management methodology. Design/methodology/approach The research includes a literature review of TT barriers, interviews with professionals and an analysis of agile project management methodologies (Scrum, Kanban and eXtreme Programming). DT applications were simulated to assess their potential in optimizing the production process of prefilled syringes. Findings The proposed methodology effectively mitigates TT barriers, including communication, organizational and knowledge-related challenges. Simulations demonstrated the potential of DT technology in reducing process delays and enhancing decision-making, particularly by improving resource availability rather than setup times. Research limitations/implications The methodology relies heavily on inter-organizational collaboration and a “lean” mindset. Further validation is required for broader applications, especially in complex or multi-organizational contexts. Practical implications By integrating DT technology and agile management approaches, organizations can accelerate TT processes, enhance quality and reduce completion times, leading to a more efficient resource allocation and faster Return on Investment (ROI). Originality/value This study is among the first to combine DT technology with a hybrid agile project management methodology to address barriers in TT processes. Its findings contribute to both academic research and practical applications in industrial settings.