Pharmacokinetic comparison of subcutaneously administered CT-P13 (biosimilar of infliximab) via autoinjector and pre-filled syringe in healthy participants.

CT-P13, a biosimilar of infliximab, is used to treat inflammatory diseases that arise from immune system complications, resulting in excessive and persistent inflammation. The subcutaneous (SC) formulation of CT-P13 overcomes the drawback of prolonged administration associated with the intravenous (IV) infliximab biosimilar, necessitating autoinjector (AI) administration. This randomized, open-label, two-arm, parallel-group, single-dose clinical pharmacology study aimed to evaluate the pharmacokinetics (PK) and safety of CT-P13 SC administration via AI compared with the existing pre-filled syringe (PFS) method. A total of 147 healthy participants were randomized into two groups, of which 139 completed the study. Blood samples were collected from before CT-P13 SC administration to 2016 h after the start of the administration. Serum concentrations were analyzed using the Meso Scale Discovery electrochemiluminescence method. Geometric mean ratios (90% confidence interval) of the AUCinf (areas under the concentration-time curve from zero to infinity) and Cmax (The maximum serum concentration) for CT-P13 SC AI versus CT-P13 SC PFS groups, were 94.15% (85.02%-104.26%), 92.48% (84.66%-101.01%), respectively. CT-P13 SC AI and CT-P13 SC PFS achieved comparable PK because the 90% CI was within the predefined equivalence margin. At the end of the study, immunogenicity results revealed that 70 (97.22%) and 73 (98.65%) participants tested positive for anti-drug antibody (ADA) in the CT-P13 SC AI and CT-P13 SC PFS groups, respectively. They were tested positive for neutralizing antibodies. No other significant safety differences were observed between the treatment groups. In conclusion, both administrations demonstrated PK equivalence and were both safe and well-tolerated.

Thyroid fine needle aspiration specimen adequacy: a noninferiority study and cost-effectiveness comparison of puncture needles.

Needle selection plays a pivotal role in determining the success of fine needle aspiration (FNA) procedures. Two commonly utilized puncture needles for thyroid FNA are the conventional syringe needle and the stylet needle. Syringe needles are known for their cost-effectiveness in comparison to stylet needles. This study aimed to determine if FNA with syringe needles is non-inferior to FNA with stylet needles in terms of specimen adequacy while also comparing the direct costs associated with both needle types. A total of 220 thyroid nodules from 185 patients were prospectively included in this study. The same operator performed a total of four punctures on the same nodule twice using a syringe and a stylet needle. The results of this study show that the utilization of syringe needles for thyroid FNA was non-inferior to the use of stylet needles in terms of specimen adequacy. Cost analysis revealed that syringe needle FNA was not only less expensive (CNY 500.9 versus CNY 780) but also more effective (adequacy 85.91% versus 84.55%). In summary, given the global prevalence of FNA procedures, the economic considerations are paramount, and our findings support the routine use of syringe needles in thyroid FNA.

Syringe Access, Syringe Sharing, and Perceptions of HCV: A Qualitative Study Exploring the HCV Risk Environment in Rural Northern New England, United States.

The ongoing hepatitis C virus (HCV) epidemic in the United States disproportionately affects rural people who inject drugs (PWID). This study explores the HCV risk environment in rural northern New England by examining PWID experiences and perceptions of HCV and injection equipment-sharing practices. We performed a thematic analysis on semi-structured interviews conducted with 21 adults with a history of injection drug use from rural New Hampshire, Vermont, and Massachusetts between April 2018 and August 2019. Salient themes included: (1) limited and varied access to sterile syringe sources; (2) syringe scarcity contributing to the use of informal syringe sources (e.g., secondary syringe exchange or syringe sellers who purchased syringes from out-of-state pharmacies); (3) syringe scarcity contributing to syringe sharing; (4) linkages among decisions about syringe sharing and perceptions of HCV risk, HCV status, and interpersonal trust; and (5) confusion and misconceptions about HCV, including difficulty learning one's HCV status, inadequate HCV education, and misconceptions regarding HCV transmission and treatment. Efforts to prevent and eliminate HCV among rural PWID should expand syringe access, increase awareness of HCV as a serious but preventable risk, and acknowledge social connections as potential influences on syringe access and syringe-sharing decisions.

In-use stability of Rituximab and IVIG during intravenous infusion: Impact of peristaltic pump, IV bags, flow rate, and plastic syringes.

This study investigates the impact of intravenous (IV) infusion protocols on the stability of Intravenous Immunoglobulin G (IVIG) and Rituximab, with a particular focus on subvisible particle generation. Infusion set based on peristaltic movement (Medifusion DI-2000 pump) was compared to a gravity-based infusion system (Accu-Drip) at different flow rates. The impacts of different diluents (0.9 % saline and 5.0 % dextrose) and plastic syringes with or without silicone oil (SO) were also investigated. The results from the aforementioned particular case demonstrated that peristaltic pumps generated high levels of subvisible particles (prominently < 25 µm), exacerbated by increasing flow rates, specifically in formulations lacking surfactants. Other factors, such as diluent type and syringe composition, also increased the number of subvisible particles. Strategies that can help overcome these complications include surfactant addition as well as the use of SO-free syringes and a gravity infusion system, which aid in reducing particle formation and preserving antibody monomer during administration. Altogether, these findings highlight the importance of the careful selection of formulations and infusion protocols to minimize particle generation during IV infusion both for patients' safety and treatment efficacy.

Simple and Ultrasensitive Nanozyme-Linked Immunosorbent Assay for SARS-CoV-2 Detection on a Syringe-Driven Filtration Device.

This work proposed a simple and ultrasensitive nanozyme-based immunoassay on a filtration device for the detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) nucleocapsid protein (NP). Gold core porous platinum shell nanoparticles (Au@Pt NPs) were synthesized with high catalytic activity to oxidize 3,3',5,5'-tetramethylbenzidine, leading to an oblivious color change. The filtration device was designed based on the size difference of magnetic beads, filter membrane pore, and Au@Pt NPs. A simple, rapid, and consistent washing procedure can be performed with the help of a plastic syringe. This detection method could realize the quantitative detection of SARS-CoV-2 NP within 80 min for point-of-care needs. The limit of detection for the SARS-CoV-2 antigen was 0.01 ng/mL in buffer. The coefficients of variation of the assay were 1.78% for 10 ng/mL SARS-CoV-2 antigen, 2.03% for 1 ng/mL SARS-CoV-2 antigen, and 2.34% for the negative sample, respectively. The specificity of the detection platform was verified by the detection of various respiratory viruses. This simple and effective detection system was expected to promote substantial progress in the development and application of virus immunodetection technology.

Improvement of self-administration experience with a new injection device: Real-life experience with risankizumab in patients with psoriasis.

BACKGROUND: Trypanophobia or "needle phobia" represents a potential hindrance to the effective management of chronic diseases whenever an injectable therapy might be required, especially in case of frequent administrations. Psoriasis, a chronic dermatologic disease, can be effectively treated with biologic drugs administered subcutaneously. Thankfully, anti-IL-23 drugs require few administrations per year and are available in prefilled pens that hide the needle, thus representing a convenient option in patients with trypanophobia. METHODS: An observational multicentric study was conducted on patients with moderate-to-severe psoriasis who were treated with 75 mg × 2 risankizumab prefilled syringe therapy for more than 6 months and reported a loss of efficacy measured by the Psoriasis Area and Severity Index (PASI) from PASI 90 to PASI 75 attributed to a reduction of adherence due to trypanophobia. The patients were switched to 1 prefilled pen of risankizumab 150 mg and asked to fill out the Self-Injection Assessment Questionnaire (SIAQ) before and after the injection at week 0 and at the following administration after 12 weeks. Subjects scored each item of the SIAQ on a 5-point scale, scores were later transformed from 0 (worst experience) to 10 (best experience). RESULTS: Twenty-two patients were enrolled. The mean SIAQ predose domain scores were 5.5 for feelings about injection, 6.2 for self-confidence, and 6.4 for satisfaction with self-injection. After dose scores were higher (> 8.5) for each of the six domains at Week 0 and even higher after 12 weeks (> 9.0). CONCLUSIONS: User-friendly devices, such as prefilled pens, and a lower number of injections improved patient satisfaction in a group of patients with psoriasis on treatment with biologic drugs. We believe that treatment adherence could be positively influenced by such changes in the way of administration of a biologic treatment.

Comparison of the Cobalt Content in Needles Stainless Steel.

Cobalt (Co) alloys are used extensively in a wide range of medical devices due to their biocompatibility, durability, and properties. In 2017 the European Chemical Agency (ECHA) proposed to classify Co metal as a category 1B carcinogen (i.e. presumed to have carcinogenic potential for humans), as a reproductive hazard category 1B (i.e. presumed human reproductive toxicant) and as a category 2 mutagen. Even more, the European Medical Device Regulation (MDR) requires that medical devices contain > 0,1 w/w of substances that are category 1 A and 1B (CMR). As far as the European Medical Device Regulation, it is not specified if the Co content and concentration had to be determined/measured on the entire product or only on the product components. The object of this work is the comparison of Co profile in three different suppliers of stainless-steel needles as is and after being processed (i.e. sterilized) and then provide the proper interpretation and application of MDR requirements. The study and the extractable profile demonstrate the low cobalt content on needles and on a total syringe, thus suggesting to consider the Co content only on the syringe component.

Ebeam Technology - Transfer Technology for Pre-Sterilized RTU Components.

With increased demand on sealed packed, pre-sterilized ready-to-use (RTU) components like Syringes & Vials, the ebeam technology is used as transfer technology with surface decontamination for transfer of the RTU in a GRADE A environment like an Isolator.

Prefilled Ophthalmic syringes - New Possibilities in Terminal Sterilization.

In a joint study carried out by Gerresheimer, Sterigenics and Früh, it could be shown that also NO2 is well suited to terminally sterilize prefilled ophthalmic syringes. In detail 5 topics were addressed: (1) Compare EtO vs. NO2 penetration into the filled syringe; (2) Analyze gas ingress though 4 different plunger stoppers including silicone oil free and standard rubber plungers; (3) Scrutinize gas ingress through 2 different cap designs based on different elastomer properties; (4) Investigate gas permeation through COP plastic barrels compared to glass; (5) Check if the Tyvek®-layer has an influence on either sterilization.Depending on the needs a suitable sterilization method, packaging and syringe type can be suggested to customers.

A Novel Combined Approach to Better Predict Sealing Performance of Luer Lock Connectivity.

Luer systems, for example Luer-needle hub with syringe's Luer cone tip and its Luer lock Adapter, are common interface on medical devices. One of the key questions in this application is about the safety guaranty and dose accuracy. It is then crucial to study the sealing between these elements. In this study we combine the use of Finite Element Analysis (FEA) and Multiscale Contact Mechanics (MCM) to analyze the connectivity and sealing performance of a glass syringe and a plastic needle Luer hub.This methodology has been applied before to the contact between glass and rubber and this is the first time that it is used for the contact between glass and plastic materials. The use of FEA allows to calculate the contact pressures and the nominal area of contact. The surface topographies of the two surfaces were measured, over a wide wavelength range (mm to nm). Subsequently, the air and liquid interfacial flow (leakage) is calculated using Persson's MCM theory which considers the roughness and elasto-plasticity of the interfacial surfaces. The theoretical predictions are compared to experimental leak measurements by pressure decay method. Further analysis is conducted, evidencing the key features that are responsible for a good sealing.

Case Study: Compatibility Testing of Pre-Filled Syringe Stopper Technology with Vaporized Hydrogen Peroxide Terminal Sterilization Process.

STERIS and W.L. GORE collaborated on a case study testing the compatibility of a new prefilled syringe plunger design with VHP terminal sterilization. VHP chamber conditions require deep vacuum pulsing, which may represent challenges to prefilled syringe container integrity. The growing industry trend toward VHP sterilization is driven by the FDA search for alternative sterilization methods to EO and the recent publication of a VHP specific process standard. The purpose of the study is to test and report compatibility of the new 0.5 mL GORE IMPROJECT plunger, a silicone free syringe solution for ophthalmic application, with VHP sterilization. Various challenges have been reported when using conventional, siliconized, prefilled syringe systems for intravitreal injections such as subvisible particles, inflammation, silicone floaters, and intraocular pressure increases. The GORE plunger eliminates the need for silicone oil as a lubricant on the plunger and barrel, while meeting strict container closure and terminal sterilization requirements of ophthalmic applications. This case study presents successful results of deep vacuum VHP terminal sterilization process compatibility with the GORE plunger design and material composition. Test results include primary container integrity, stopper off-gassing/ingress, and visual inspection. Principles of VHP vacuum sterilization process, test cycle configuration, and its main parameters are presented.

Usability of the SB11 Pre-filled Syringe (PFS) in Patients with Retinal Diseases.

INTRODUCTION: SB11 (Byooviz™; Samsung Bioepis Co., Ltd.) is a ranibizumab (Lucentis®; Genentech, Inc.) biosimilar targeting vascular endothelial growth factor A for the treatment of retinal diseases. The pre-filled syringe (PFS) presentation of SB11 offers an alternative administration method to the vial, with the potential for enhanced safety and efficient syringe preparation. The objective of this study was to assess the ability of healthcare professionals (HCPs) to follow the instructions for use to prepare and administer SB11 PFS intravitreal (IVT) injections to patients with neovascular age-related macular degeneration (nAMD) or macular edema secondary to retinal vein occlusion (RVO). METHODS: This study was an open-label, single-arm, single-dose clinical study to evaluate the usability of the SB11 PFS in patients with nAMD or macular edema secondary to RVO. Four HCPs prepared and administered 0.5 mg SB11 PFS IVT injections to 34 patients. Product use task completion (12 tasks in total) was assessed by independent observers. Safety was assessed up to 7 days after injection of the investigational product. RESULTS: A total of 34 patients were enrolled and completed the study. All 12 tasks were successfully completed in 34 (100%) patients without a use-related failure. Most patients (32 patients, 94.1%) experienced no adverse events (AEs), whereas 2 (5.9%) patients experienced three treatment-emergent AEs (TEAEs) which were mild to moderate in severity. There were no severe or serious TEAEs reported during the study. CONCLUSIONS: This study showed that HCPs were able to successfully prepare and administer the SB11 PFS via IVT injection. No unexpected safety issues were identified. The SB11 PFS is a promising alternative for therapeutic administration of SB11 in patients with retinal disease. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT06176963; EudraCT number 2021-003566-12.

Genotypic and morphological identification of opportunistic microorganisms in triple-syringe tubing from dental units.

BACKGROUND: In Mexico and around the world, water in dental units, including triple syringes, comes from municipal chlorinated water mains. The microbial contamination of dental unit water systems constitutes a risk factor for opportunistic infections. OBJECTIVES: The present work aimed to identify the bacteria present in the triple-syringe water lines of dental units at a dental school of a public university in Mexico, with a hypothesis that opportunistic bacteria of importance to human health would be found. MATERIAL AND METHODS: A cross-sectional study was carried-out. A total of 100 samples of triple-syringe tubing from dental units operated by a dental school of a public university in Mexico were analyzed before and after their use in dental practice. Bacterial biofilm was cultured and isolated from the tubing, using standard microbiological methods, and then the species present were identified through 16S rRNA gene sequencing. The characterization of the biofilm was performed by means of scanning electron microscopy (SEM). RESULTS: Bacterial growth was observed in 20% of the non-disinfected and 10% of the disinfected samples, with 11 strains isolated. Six genera and 11 bacterial species were genetically identified. Coagulasenegative staphylococci (CoNS), considered opportunistic human pathogens, were among the most critical microorganisms. Scanning electron microscopy revealed a thick polymeric matrix with multiple bacterial aggregates. CONCLUSIONS: Opportunistic bacteria from human skin and mucous membranes were detected. Under normal conditions, these bacteria are incapable of causing disease, but are potentially harmful to immunosuppressed patients.

When Are "Paraphernalia" Critical Medical Supplies?

Evidence of harm reduction interventions' morbidity and mortality benefits is abundant and of high quality, so there are good reasons for regional and national groups to advocate for more widespread distribution of legally regulated "drug paraphernalia," including needles, syringes, and fentanyl test strips. But lack of consistency among states' laws means that patients' interstate travel can subject them to being charged with possession of illegal items. This commentary on a case offers guidance to clinicians looking to help patients understand legal risks of interstate travel with supplies that are prescribed or recommended to reduce harms of their drug use and explores the ethical responsibilities of physicians in jurisdictions that legally prohibit these harm reduction interventions.

Effect of a brush tip on in-office bleaching gels in an attachable syringe: Hydrogen peroxide penetration, bleaching efficacy and amount of gel expended.

OBJECTIVE: Evaluate the penetration of hydrogen peroxide (HP) into the pulp chamber, bleaching efficacy (BE) and amount of gel expended during in-office bleaching using an applicator brush tip and conventional tip from different commercial brands. MATERIALS AND METHODS: 104 human premolars were randomly distributed into thirteen groups (n = 8) according to the commercial brand: DSP White Clinic 35 % Calcium (DW), Nano White 35 % (NW), Total Blanc One-Step 35 % (TS), Whiteness HP Blue 35 % (WB), Potenza Bianco Pro SS 38 % (PB), Opalescence XTra Boost 40 % (OB), no bleaching (negative control), and application method: applicator brush tip and conventional tip for all groups. Initial HP concentration (%) was determined via titration and pH was measured with digital pH meter. Concentration (µg/mL) of HP into the pulp chamber was measured using UV-Vis spectrophotometry, the BE (ΔE*ab, ΔE00 and ΔWID) was evaluated with a digital spectrophotometer, and the amount of gel expended was evaluated using a precision analytical digital balance. Statistical analysis included two-way ANOVA, Tukey's, and Dunnett's test. Comparison between HP into the pulp chamber vs BE was performed with Person's correlation (α = 0.05). RESULTS: Brush tip demonstrated a low amount of HP in the pulp chamber compared to the conventional method for all bleaching gels (p < 0.0003), as well as lower amount of gel expended (p < 0.002). The brush tip did not result in a significant difference in BE compared to the conventional (p > 0.05). No correlations were found between both factors (p > 0.05). CONCLUSION: Brush tip showed lower penetration of HP in the pulp chamber and a reduced volume of spent gel when compared to the conventional tip, for all commercial brands. CLINICAL RELEVANCE: Brush tip is recommended for bleaching gels in an attachable syringe due to its ability to reduce the penetration of HP into the pulp chamber and minimize the amount of bleaching gel used.

Mechanical release of homogenous proteins from supramolecular gels.

A long-standing challenge is how to formulate proteins and vaccines to retain function during storage and transport and to remove the burdens of cold-chain management. Any solution must be practical to use, with the protein being released or applied using clinically relevant triggers. Advanced biologic therapies are distributed cold, using substantial energy, limiting equitable distribution in low-resource countries and placing responsibility on the user for correct storage and handling. Cold-chain management is the best solution at present for protein transport but requires substantial infrastructure and energy. For example, in research laboratories, a single freezer at -80 °C consumes as much energy per day as a small household1. Of biological (protein or cell) therapies and all vaccines, 75% require cold-chain management; the cost of cold-chain management in clinical trials has increased by about 20% since 2015, reflecting this complexity. Bespoke formulations and excipients are now required, with trehalose2, sucrose or polymers3 widely used, which stabilize proteins by replacing surface water molecules and thereby make denaturation thermodynamically less likely; this has enabled both freeze-dried proteins and frozen proteins. For example, the human papilloma virus vaccine requires aluminium salt adjuvants to function, but these render it unstable against freeze-thaw4, leading to a very complex and expensive supply chain. Other ideas involve ensilication5 and chemical modification of proteins6. In short, protein stabilization is a challenge with no universal solution7,8. Here we designed a stiff hydrogel that stabilizes proteins against thermal denaturation even at 50 °C, and that can, unlike present technologies, deliver pure, excipient-free protein by mechanically releasing it from a syringe. Macromolecules can be loaded at up to 10 wt% without affecting the mechanism of release. This unique stabilization and excipient-free release synergy offers a practical, scalable and versatile solution to enable the low-cost, cold-chain-free and equitable delivery of therapies worldwide.

The silicone depletion in combination products induced by biologics.

Silicone oil (SO) migration into the drug product of combination products for biopharmaceuticals during storage is a common challenge. As the inner barrel surface is depleted of SO the extrusion forces can increase compromising the container functionality. In this context we investigated the impact of different formulations on the increase in gliding forces in a spray-on siliconized pre-filled syringe upon storage at 2-8 °C, 25 °C and 40 °C for up to 6 months. We tested the formulation factors such as surfactant type, pH, and ionic strength in the presence of one monoclonal antibody (mAb) as well as compared three mAbs in one formulation. After 1 month at 40 °C, the extrusion forces were significantly increased due to SO detachment dependent on the fill medium. The storage at 40 °C enhanced the SO migration process but it could also be observed at lower storage temperatures. Regarding the formulation factors the tendency for SO migration was predominantly dependent on the presence and type of surfactant. Interestingly, when varying the mAb molecules, one of the proteins showed a rather stabilizing effect on the SO layer resulting into higher container stability. In contrast to the formulation factors, those different stability outcomes could not be explained by interfacial tension (IFT) measurements at the SO interface. Further characterization of the mAb molecules regarding interfacial rheology and conformational stability were not adequately able to explain the observed difference. Solely a hydrophobicity ranking of the molecules correlated to the stability outcome. Further investigations are needed to clarify the role of the protein in the SO detachment process and to understand the cause for the stabilization. However, the study clearly demonstrated that the protein itself plays a critical role in the SO detachment process and underlined the importance to include verum for container stability.

A Multiradionuclide Automatic Dispensing System for Syringes of Radiopharmaceuticals: The Effect on Operator Hand Dose.

The radiation exposure of the hands of nuclear medicine laboratory technicians is largely due to the dispensing of radiopharmaceuticals into syringes. To reduce this exposure, a multiradionuclide automatic dispensing system (ADS) for syringes of radiopharmaceuticals was introduced. The aim of this study was to determine the effect of this ADS on hand dose compared with manual dispensing. Methods: The total hand dose per month for all personnel (12 technicians) was measured with ring dosimeters at the base of the index finger for 13 mo: 7 mo with manual syringe dispensing (radiopharmaceuticals containing 99mTc,18F, 177Lu, 68Ga, 90Y, and 223Ra) and 6 mo with ADS (automatic: radiopharmaceuticals containing 18F and 177Lu; manual: radiopharmaceuticals containing 99mTc, 68Ga, 90Y, and 223Ra). Results: The mean total hand dose per month was reduced from 52.8 ± 10.2 mSv with manual dispensing to 21.9 ± 2.7 mSv with ADS (P < 0.001), which is an absolute decrease of 59%. Meanwhile, the total handled activity increased from 369 to 505 GBq (P < 0.001). 18F-containing radiopharmaceuticals were the most commonly dispensed, at 182 GBq per month. The increase in total handled activity was largely due to an increase in 177Lu (from 25 to 123 GBq), partially because of the introduction of [177Lu]Lu-PSMA-I&T. When correcting for this increase in handled activity, the hand dose was reduced by 69%. Conclusion: The introduction of a multiradionuclide syringe ADS decreased the hand dose to personnel by 69% when corrected for the increase in handled activity. Expanding the number of radiopharmaceuticals being dispensed by the system could potentially further decrease personnel hand dose.

Vaccine preparation time, errors, satisfaction, and preference of prefilled syringes versus RSV vaccines requiring reconstitution: randomized, time and motion study.

AIM: The current study compared preparation time, errors, satisfaction, and preference for a prefilled syringe (PFS) versus two RSV vaccines requiring reconstitution (VRR1 and VRR2) in a randomized, single-blinded time and motion study. METHODS: Pharmacists, nurses, and pharmacy technicians were randomized to a preparation sequence of the three vaccines. Participants read instructions, then consecutively prepared the three vaccines with a 3-5-min washout period in between. Preparations were video recorded and reviewed by a trained pharmacist for preparation time and errors using predefined, vaccine-specific checklists. Participant demographics, satisfaction with vaccine preparation, and vaccine preference were recorded. Within-subjects analysis of variance was used to compare preparation time. Mixed-effects Poisson and ordered logistic regression models were used to compare the number of preparation errors and satisfaction scores, respectively. RESULTS: Sixty-three pharmacists (60%), nurses (35%), and pharmacy technicians (5%) participated at four sites in the United States. The least squares mean preparation time per dose for PFS was 141.8 s (95% CI = 156.8-126.7; p <.0001) faster than for VRR1, 103.6 s (95% CI = 118.7-88.5; p <.0001) faster than for VRR2, and 122.7 s (95% CI = 134.2-111.2; p <.0001) faster than the pooled VRRs. Overall satisfaction (combined "Very" and "Extremely") was 87.3% for PFS, 28.6% for VRR1, and 47.6% for VRR2. Most participants (81.0%) preferred the PFS vaccine. LIMITATIONS: The study is limited by the inability to completely blind observers. To minimize the effects of order, we utilized a 3-sequence block design; however, the order in which the vaccines were prepared may have affected outcomes. Participants were assessed once, whereas if repeated preparations were performed there may have been trained efficiencies gained for each vaccine. CONCLUSION: PFS vaccines can greatly simplify the vaccine preparation process, allowing administrators to prepare almost four times more doses per hour than with vial and syringe systems.