Glass Syringe Research Articles

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.

Prevalence and Modes of Transmission of Hepatitis C Virus Infection: A Historical Worldwide Review.

Hepatitis C virus infection affects over 58 million individuals and is responsible for 290,000 annual deaths. The infection spread in the past via blood transfusion and iatrogenic transmission due to the use of non-sterilized glass syringes mostly in developing countries (Cameroon, Central Africa Republic, Egypt) but even in Italy. High-income countries have achieved successful results in preventing certain modes of transmission, particularly in ensuring the safety of blood and blood products, and to a lesser extent, reducing iatrogenic exposure. Conversely, in low-income countries, unscreened blood transfusions and non-sterile injection practices continue to play major roles, highlighting the stark inequalities between these regions. Currently, injection drug use is a major worldwide risk factor, with a growing trend even in low- and middle-income countries (LMICs). Emerging high-risk groups include men who have sex with men (MSM), individuals exposed to tattoo practices, and newborns of HCV-infected pregnant women. The World Health Organization (WHO) has proposed direct-acting antiviral (DAA) therapy as a tool to eliminate infection by interrupting viral transmission from infected to susceptible individuals. However, the feasibility of this ambitious and overly optimistic program generates concern about the need for universal screening, diagnosis, linkage to care, and access to affordable DAA regimens. These goals are very hard to reach, especially in LMICs, due to the cost and availability of drugs, as well as the logistical complexities involved. Globally, only a small proportion of individuals infected with HCV have been tested, and an even smaller fraction of those have initiated DAA therapy. The absence of an effective vaccine is a major barrier to controlling HCV infection. Without a vaccine, the WHO project may remain merely an illusion.

Effect of combination of essential oils on in vitro methane production, volatile fatty acid fractions and feed digestibility with goat rumen flora

Different combination of garlic oil (GO from Allium sativum L.), clove oil (CO from Eugenia spp.) and peppermint oil (P from Mentha piperita L.) as GO+PO (1:1), GO+CO (1:1), CO+PO (1:1) and GO+PO+CO (1:1:1) was evaluated in in vitro gas production test for their effect on total gas production, methane production, dry matter organic matter digestibility and volatile fatty acid fractions. The addition level was low (D1) at 0.25 g/L, medium (D2) at 0.5 g/L, and high (D3) at 1.0 g/L of fermentation medium. Concentrate mixture and bengal gram straw (Cicer arietinum L.) in 40:60 ratio was incubated with incubation medium containing goat rumen liquor for 24 h at 39°C in glass syringes. Three goats fed with concentrate pellet and Bengal gram straw served as donor of the rumen liquor. In vitro fluid pH varied between 6.50 to 6.59. Total gas production (mL/g DM) in control group was 154.07, at lower dose level (0.25 g/L) there was increase in gas production which significantly decreased at highest dose level. There was significant (P<0.05) decrease in the methane production (mL/g DM and mL/g DDM) on GO and PO supplementation together. At low dose level (D1, 0.25g/L) there was no statistically (P>0.05) significant difference in in vitro dry matter and organic matter digestibility with the addition of different EO combinations evaluated as compared to control except PO+ CLO (1:1). At dose level (D2 and D3) GO+PO combination led to a moderate decrease in the in IVDMD and IVOMD along with decrease in in vitro methane production. Fraction of propionic acid was higher on addition of garlic and peppermint oil together. There was relative decrease in the methanogens population with bacteria as housekeeping gene as expressed by RT-PCR amplification with GO+PO addition. Present study concluded that among the EOs combinations in vitro tested, garlic and peppermint oil combination (GO+PO) has better potential in reducing in vitro methane production with lower effect on in vitro digestibility.

Synthesis of the magnetic composite of Ni-MOF-I in aqueous medium and its application in magnetic dispersive micro solid phase extraction of plasticizers from pharmaceutical samples

For the first time, this research presents the synthesis procedure and analytical application of Ni-MOF-I magnetic composite. The synthesis method was green and done in an aqueous medium. The composite was employed as an adsorbent in a magnetic dispersive solid phase extraction process followed by dispersive liquid–liquid microextraction for the extraction and preconcentration of some plasticizers from pharmaceutical samples stored in plastic containers. The Ni-MOF-I magnetic composite was characterized by applying Fourier transform infrared spectrophotometry, vibrating sample magnetometry, scanning electron microscopy, energy-dispersive X-ray, X-ray diffraction, and nitrogen adsorption/desorption analyses. For operating the extraction procedure, initially, the plasticizers were adsorbed onto the adsorbent particles by vortexing. Then, the plasticizers were desorbed from the adsorbent surface using a mL volume of 2-proponal. Subsequently, the obtained eluate phase was mixed with a mixture of 1,2-dibromoethane and 1,1,2-trichloroethane and then injected into deionized water using a glass syringe. Afterward, centrifugation was done to isolate the extractant from the aqueous phase. Eventually, one microliter of the sedimented phase was injected into gas chromatography-flame ionization detection. Acceptable analytical results such as high enrichment factors (355–415) and extraction recoveries (71–83 %), low limits of quantification (0.76–1.08 μg L−1) and detection (0.23–0.33 μg L−1), wide linear ranges (1.08–300 μg L−1), and satisfactory relative standard deviation values of 4.0–6.3 % (intra-day precision, n = 5) and 4.9–7.4 % (inter-day precision, n = 5) were achieved. The suggested procedure was used as a productive analytical method based on the Ni-MOF-I magnetic composite for the extraction and determination of some plasticizers from different pharmaceutical samples filled in plastic containers. Elimination of centrifugation, using 2-propanol as a green desorption/disperser solvent, detection of di-(2-ethylhexyl) phthalate in boric acid alcohol drop, and applying µL-level of the extraction solvent are the advantages of this proposed method.

A Comparison of Pumping Infusion-Induced Contamination With Different Syringe Types.

Health care providers use several types of syringes in their daily routine to provide or safely deliver therapeutic agents to patients. Pump infusion with a syringe (PIS) are used for the rapid delivery of large amounts of fluid or blood to patients in critical conditions, such as hypovolemic shock. Patients often experience bacterial infections, such as catheter-related bloodstream infections, specifically when they are in critical condition in the intensive care unit (ICU) after surgery or undergoing resuscitation in an emergency department. A previous study has shown that PIS may cause intraluminal contamination. This study compared PIS-induced contamination among different types of available syringes, including disposable plastic syringes produced by several companies, glass syringes, and syringes with plastic covers. The authors found that plastic syringes caused approximately equivalent PIS-induced contamination and that glass syringes caused substantially more contamination than plastic syringes. However, syringes equipped with a plastic cover exhibited no contamination. Furthermore, disinfection with ethanol completely prevented PIS-induced contamination. This study supports the evidence that PIS may cause bacterial contamination and that a thorough aseptic technique is needed, especially when using glass syringes. These findings highlight the need to develop alternative devices for rapid infusion.

A Review on Blow Fill Seal Machine

Abstract: For medical specialty that area unit administered by sure ways in which like pneumonic delivery, plastic ampoules offers several and points over glass ampoules, vials, or syringes. Plastic ampoules area unit manufacture victimisation blow–fill– seal (BFS) technology. within the BFS method plastic extrusion, molding, antiseptic filling in one line operation. not like tiny molecules, biological drug product, like proteins or being antibodies, area unit a lot of directed to degradation throughout process, which can end in degradation of activity or safety issues. The in operation conditions for a BFS method and therefore the nature of plastic ampoules provides several issues to the steadiness and integrity of biological drug product. during this article, the authors discuss issues within the development and producing of biological product victimisation the BFS method, as well as potential productexposure to elevated temperature, needs for leak detection, and packaging systems. They additionally highlight challenges and techniques for BFS method characterization and validation within the context of biopharmaceutical producing

In–syringe homogenous liquid–liquid extraction combined with ionic liquid based dispersive liquid–liquid microextraction for the extraction of aflatoxin B1 from edible vegetable oil samples prior to HPLC-FLD analysis

Combination of in–syringe homogenous liquid–liquid extraction and ionic liquid based dispersive liquid–liquid microextraction has been employed for the extraction of aflatoxin B1 from edible vegetable oil samples. Firstly, a homogenous solution of oil sample containing the analyte and acetone (1.5 mL) is formed. Then, this homogenous state was broken by adding 100 µL of deionized water and the analyte was extracted into the produced fine droplets of acetone. In the following, acetone phase was taken and mixed with 65 µL of 1–hexyl–3–methylimidazolium tetrachloroferrate magnetic ionic liquid. The mixture was injected to sodium chloride solution (5 %, w/v) by a glass syringe. The ionic liquid droplets were collected by an external magnet and then, they were used for the determination step by high–performance liquid chromatography equipped with fluorescence detector. Under the optimum conditions, low limit of detection (13 ng kg−1) and quantification (44 ng kg−1), wide linear range (44–1 × 106 ng kg−1), acceptable extraction recovery (69 %), and good precision (relative standard deviations ≤ 4.0 %) were obtainable using the proposed method. These results verify the high capability of the proposed method for screening aflatoxin B1 in the various edible vegetable oil samples. Performing the method in syringe barrel provide easy collection of the extraction solvent without the need for centrifugation. Combination of homogenous liquid–liquid extraction with the microextraction procedure leads to obtain sensitive detection limits. The use of ionic liquid removed the necessity of centrifugation for separation of the extractant.

The Effect of Dietary Fermented Grape Pomace Supplementation on In Vitro Total Gas and Methane Production, Digestibility, and Rumen Fermentation

The aim of this study comprises the effect of fermented grape pomace (FGP) in experimental total mixed rations (TMR) at different rates (0, 7.5%, 15%, and 22.5%) on the in vitro cumulative gas production (6th, 12th, 18th and 24th hours), methane production, ruminal fermentation values, pH and ammonia-nitrogen and straight and branched short-chain fatty acids (SCFA and BCFA) concentration. The method of in vitro total gas production was carried out in glass syringes. Ruminal in vitro methane production linearly decreased by adding up to 22.5% FGP in experimental TMR (p < 0.05). The molarities of acetic, propionic, butyric, and valeric acids in the in vitro fermentation fluid linearly decreased with the addition of FGP to TMR (p < 0.05). FGP up to 22.5% in experimental TMRs decreased the molarity of iso-valeric acid and iso-butyric acid from BSCFAs (p < 0.05). As a result, it was concluded that the use of FGP, containing a low level of total condensed tannins (TCTs), up to 22.5% in the experimental TMR based on dry matter (DM) did not adversely affect the in vitro ruminal fermentation value and had an anti-methanogenic effect. In addition, some SCFA (acetic, propionic, butyric, and valeric acids) molarities and iso-acid BSCFA (iso-butyric and iso-valeric acid) did not change up to 15% rate of FGP in the ration. Still, these values decreased by using a 22% rate of FGP. The dose-dependent effect of FGP on ruminal iso-acids has been associated with the ability of TCTs to inhibit ruminal protein degradation partially.

Suitability of Short- and Long-Term Storage of Volatile Organic Compounds Samples in Syringe-Based Containers: A Comparison Study.

The employment of advanced analytical techniques and instrumentation enables the tracing of volatile organic compounds (VOCs) in vestigial concentrations (ppbv-pptv range) for several emerging applications, such as the research of disease biomarkers in exhaled air, the detection of metabolites in several biological processes, and the detection of pollutants for air quality control. In this scope, the storage of gaseous samples is crucial for preserving the integrity and stability of the collected set of analytes. This study aims to assess the suitability of three commercially available syringes as air containers (AC) that are commonly used for the collection, storage, isolation, and transportation of samples: glass syringes with glass plungers (AC1), and two plastic syringes, one with plastic plungers (AC2), and one with rubbered plungers (AC3). For this purpose, 99 air samples with different times of storage (from 10 min to 24 h) were analyzed using a Gas Chromatography-Ion Mobility Spectrometry device and the degradation of the samples was properly assessed by comparing the changes in the VOCs' emission profiles. The quality of the method was assured by via the measurement of the blank's spectra before each experimental run, as well as by the consecutive measurement of the three replicates for each sample. A statistical analysis of the changes in the VOCs' emission patterns was performed using principal component analysis (PCA). The results, with a total explained variance of 93.61%, indicate that AC3 is the most suitable option for the long-term storage of air samples. Thus, AC3 containers demonstrated a higher capacity to preserve the stability and integrity of the analytes compared to AC1 and AC2. The findings of the short-term effects analysis, up to 1 h, confirm the suitability of all analyzed syringe-based containers for sample-transferring purposes in onsite analysis.

A simple and portable vacuum assisted headspace solid phase microextraction device coupled to gas chromatography based on covalent organic framework/metal organic framework hybrid for simultaneous analysis of volatile and semi-volatile compounds in soil

Various microextraction methods have demonstrated a positive effect when assisted by vacuum. However, working with such systems is often laborious, they often require expensive and non-portable vacuum pumps, and may even suck off some sample vapor or solid particles during the evacuation process. To address these issues, a simple, and affordable vacuum-assisted headspace solid-phase microextraction (HS-SPME) device was developed in this study. The device, named In Syringe Vacuum-assisted HS-SPME (ISV-HS-SPME), utilizes an adjustable 40 mL glass syringe as a vacuum provider and sampling vessel. A new fiber coating, made from a hybrid of covalent triazine-based frameworks and metal-organic frameworks (COF/MOF), was prepared and characterized by Fourier transform infrared spectrometry, field emission scanning electron microscopy, energy dispersive X-ray, X-ray diffraction, thermogravimetric analysis, and Brunauer–Emmett–Teller techniques for use in the ISV-HS-SPME. By optimizing parameters such as extraction temperature, extraction time, desorption temperature, desorption time, and, humidity using a simplex method, the ISV system was found to increase the extraction efficiency of polycyclic aromatic hydrocarbons (PAHs) and benzene, toluene, ethylbenzene, and xylenes (BTEX) in solid samples by up to 175%. The determinations were followed by GC-FID measurements. Compared to three commercially available fibers, the ISV-HS-SPME device with the COF/MOF (2DTP/MIL-101-Cr) fiber exhibited significantly higher peak areas for PAHs and BTEX. The linear dynamic ranges for BTEX and PAHs were 7.1–9000 ng g−1 and 0.23–9000 ng g−1, respectively, with limits of detection ranging from 2.1–5 ng g−1 for BTEX and 0.07–1.6 ng g−1 for PAHs. The relative standard deviation of the method was 2.6–7.8% for BTEX and 1.6–6.7% for PAHs. The ISV-HS-SPME was successfully used to simultaneously determine PAHs and BTEX in polluted soil samples with recoveries ranging from 80.4 to 108%.

Development of a Liquid-Phase Microextraction Method Prior to HPLC Analysis of Quercetin in Food Samples.

In this research, an efficient, fast, low-cost and easy-to-use liquid-phase microextraction method was established to measure quercetin in onion and tomato before analysis by HPLC instrument. Herein, a rotatable central composite design-response surface methodology and artificial neural network were applied to model, optimize and predict the affecting factors on the microextraction procedure. Here, a minimal level of extractant was applied in the absence of a disperser. The cloudy state was formed by repeatedly suctioning and injecting the mixture of the aqueous solution and extractant with a glass syringe. Due to this procedure, a turbid solution composed of the very fine droplets of extractant dispersed in the aqueous solution was created, the contact surface was significantly enlarged and the quercetin was promptly extracted. The optimum values for the proposed method included 284μL of 1-undecanol as the organic extractive solvent, pH of sample 3.3, the number of air injected nine times and speed and duration of centrifugation 4,000rpm and 5min. The linear range and detection of limit were achieved at 20-4,000 and 6μgL-1, respectively. RSD% was obtained ˂4.93% (n = 5). This model was applied to monitor quercetin in tomato and onion samples.

Incompatibility of Some Prefilled Glass Syringes and Luer-Activated Needleless Valve Connectors

Some needleless Luer-activated valve connectors with internal pins are not compatible with certain prefilled glass syringes. The internal pin can block the glass syringe tip and prevent drug administration.Nurses should be aware of this risk and assist in evaluating the Luer-activated valve connectors used in their organization.

Lab-in-syringe automated protein precipitation and salting-out homogenous liquid-liquid extraction coupled online to UHPLC-MS/MS for the determination of beta-blockers in serum

A sample preparation method involving tandem implementation of protein precipitation and salting-out homogenous liquid-liquid extraction was developed for the determination of beta-blockers in serum. The entire procedure was automated using a computer-controlled syringe pump following the Lab-In-Syringe approach. It is based on the denaturation of serum proteins with acetonitrile followed by salt-induced phase separation upon which the proteins accumulate as a compact layer at the interphase of the solutions. The extract is then separated and diluted in-syringe before being submitted to online coupled UHPLC-MS/MS. A 1 mL glass syringe containing a small stir bar for solution mixing at up to 3000 rpm, was used to deal with sample volumes as small as 100 μL. A sample throughput of 7 h−1 was achieved by performing the chromatographic run and sample preparation procedure in parallel. Linear working ranges were obtained for all analytes between 5 and 100 ng mL−1, with LOD values ranging from 0.4 to 1.5 ng mL−1. Accuracy values in the range of 88.2–106% and high precision of <11% RSD suggest applicability for routine analysis that can be further improved using deuterated standards.

Ruminal Degradation of Taurine and Its Effects on Rumen Fermentation In Vitro

Taurine accounts for approximately 0.1% of an animal’s body. It cannot be used for protein synthesis but plays a wide range of important roles in the animal body. Taurine does not exist in plants, while mammals can only synthesize 30–40% of the taurine they need. Supplementing taurine to beef cattle may be necessary to improve their nutrient utilization and health status. However, no data are available regarding the metabolism of taurine in the rumen. Two in vitro trials were conducted to investigate the ruminal degradability of taurine and its effects on rumen fermentation. In Trial 1, Tilley and Terry’s in vitro rumen fermentation technique was used for incubation. As treatments, two levels of taurine, i.e., 0 and 10 mg, were added into plastic tubes containing 0.4000 g of feed mixture with a calibrated volume of 50 mL. Three adult cattle fitted with rumen cannulas were used as the donors for rumen fluid. The incubation was carried out at 39 °C for 48 h. The results showed that the taurine degradability increased with incubation time (p &lt; 0.001) while its 2 h-degradability reached 99%. Taurine decreased the 48 h-dry matter degradability (DMD) (p = 0.008) and increased the 24 h- and 48 h-pH (p = 0.005; p = 0.018), respectively. In Trial 2, the Hohenheim gas test was used for incubation. Four levels of taurine, i.e., 0, 5, 10 and 20 mg, were added into glass syringes containing 0.2000 g feed mixture with a calibrated volume of 100 mL as treatments. The rumen fluid donors were the same as in Trial 1. The incubation was carried out at 39 °C for 48 h. The results showed that taurine increased the 48 h-pH (p &lt; 0.001) linearly, decreased the cumulative gas production (p &lt; 0.001) and the total volatile fatty acids (VFA) concentration (p = 0.014), and quadratically affected the ammonia–nitrogen (p &lt; 0.001) and microbial crude protein (MCP) concentrations (p &lt; 0.001). It was concluded that taurine was highly degradable in rumen fermentation. Taurine inhibits ruminal fermentation by decreasing DMD, VFA and gas production while improving MCP synthesis on a dose-dependent basis.

Stopper Movement and Headspace (Air Bubble Size) Limitations for 2.25mL Prefilled Syringe.

The Sterile Barrier is one of the most important aspects of the Container Closure Integrity (CCI) for a prefilled syringe (PFS or syringe). This crucial barrier enables the protection of the syringe contents from contamination. The plunger stopper (stopper) is naturally in a stationary position that is controlled by the static friction between the plunger stopper and the syringe barrel wall. When an applied force is greater than the static friction which is commonly known as the Break Loose force, the plunger stopper will move. This movement can occur when the pressure differential between the gaseous headspace inside the syringe and the external atmosphere is large enough that the force exerted on the stopper exceeds the Break Loose force of the syringe. This can occur during altitude or temperature changes incurred during aerial or mountainous transport. In such conditions, the stopper movement can further be increased if an air bubble is introduced between the liquid fill in the syringe and the stopper during the stoppering process. This paper, therefore, discusses the relationship between stopper movement and initial headspace (air bubble size/ABS) in a 2.25mL Type I glass syringe using theoretical and empirical approaches. The results showed the maximum initial headspace needed to enable CCI at specified altitudes and plunger stopper movements for the syringe-plunger stopper combination used in the study. Empirical data also indicated that CCI can be maintained for this syringe-plunger stopper combination with up to 9mm initial headspace at altitudes up to 17,000 feet.

Diabetes: my life and nursing – from glass syringes to hybrid closed loops

Diabetes: my life and nursing – from glass syringes to hybrid closed loops

Use of Dual Optical Tweezers and Microfluidics for Single-Molecule Studies.

Visual biochemistry is a powerful technique for observing the stochastic properties of single enzymes or enzyme complexes that are obscured in the averaging that takes place in bulk-phase studies. To achieve visualization, dual optical tweezers, where one trap is fixed and the other is mobile, are focused into one channel of a multi-stream microfluidic chamber positioned on the stage of an inverted fluorescence microscope. The optical tweezers trap single molecules of fluorescently labeled DNA and fluid flow through the chamber and past the trapped beads, stretches the DNA to B-form (under minimal force, i.e., 0 pN) with the nucleic acid being observed as a white string against a black background. DNA molecules are moved from one stream to the next, by translating the stage perpendicular to the flow to enable the initiation of reactions in a controlled manner. To achieve success, microfluidic devices with optically clear channels are mated to glass syringes held in place in a syringe pump. Optimal results use connectors permanently bonded to the flow cell, tubing that is mechanically rigid and chemically resistant, and which is connected to switching valves that eliminate bubbles that prohibit laminar flow.

Measurement of internal diameters of capillaries and glass syringes using gravimetric and optical methods for microflow applications.

Microflow measurement devices are used in several science and health applications, mainly drug delivery. In the last decade, several new methods based on optical technology were developed, namely the front tracking and interferometric method, in which the knowledge of the inner diameter of the syringe or the capillary used is critical. Only a few National Metrology Institutes (NMIs) can perform inner diameter measurements below 1 mm, which requires expensive technology. Therefore, IPQ, in cooperation with CETIAT, CMI and UNIDEMI, under the EMPIR project 18HLT08 MeDDII - Metrology for Drug Delivery, developed new measurement methods for small inner diameter tubes based on the gravimetric principle and optical methods in order to simplify the apparatus used for this type of measurements without increasing uncertainty. The gravimetric experimental setup consists of measuring the liquid volume on a specific length of the glass tube. The optical method used is based on the front track principle that uses a high-resolution camera and ImageJ software, to determine the diameter at both ends of each capillary. To validate the developed methods, a comparison was performed between CETIAT, CMI and IPQ and the results obtained were all consistent. This work allowed the determination of inner diameter of syringes or capillaries using two different methods with relative expanded uncertainties from 0.1 to 0.5% (k=2), that can be applied for flow measurements using optical technology.

Effect of Primary Packaging Material on the Stability Characteristics of Diazepam and Midazolam Parenteral Formulations.

Diazepam and midazolam are formulated in autoinjectors for parenteral administration to decrease seizures in the case of emergency. However, the compatibility of these lipophilic drugs with the primary packaging material is a key part of drug formulation development. In this work, diazepam and midazolam were packaged in glass syringes as parenteral solutions using two different elastomeric sealing materials (PH 701/50 C BLACK and 4023/50 GRAY). Syringes were stored at three different storage temperatures: 4, 25, and 40 °C. At different time points over 3 years, physical appearance, benzodiazepine sorption on the sealing elastomeric materials, and drug content in solution were assayed. A detailed study on the adsorption profile of both benzodiazepines on the elastomeric gaskets was performed, indicating that the novel rubber material made of bromobutyl derivatives (4023/50 GRAY) is a better choice for manufacturing autoinjectors due to lower drug adsorption. Diazepam showed a better stability profile than midazolam, with the latter solubilised as a hydrochloride salt in an acidic pH that can affect the integrity of the elastomer over time. The amount of drug adsorbed on the surface of the elastomer was measured by NIR and correlated using chemometric models with the amount retained in the elastomeric gaskets quantified by HPLC.

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.