A syringe is a small, hand-held, plunger-operated device used for injecting liquids, measuring, and withdrawing fluids. They are commonly made of plastic and are frequently used in the medical field to administer injections and withdraw blood. However, syringes can also be used to dispense grease, making them an essential tool in many industrial and mechanical applications. While syringes are generally designed to work with liquids, they can also be used to dispense semi-solid materials, like grease. Grease is a thick, oily substance that is used to lubricate moving parts and prevent wear. It is often used in high-temperature or high-pressure environments where regular lubricants would break down. Grease is typically dispensed from a syringe by first melting it down to a liquid form. This can be done by heating the syringe in hot water or by using a special purpose grease heater. Once the grease is in liquid form, it can be injected into the desired area using the syringe. Syringes are an essential tool in many industries and applications where grease is used. They provide a quick and easy way to apply grease to moving parts, which can help prolong the life of machinery and equipment. In addition, syringes can be used to inject grease into hard-to-reach areas, making them an indispensable tool for many maintenance and repair tasks.
lubricating grease is not required for the syringe. Aside from sample cross contamination, grease may cause barrel damage, plunger seizing in the barrel, or barrel tears. Use a solvent compatible with the sample as well as a dry syringe to minimize the use of a dry syringe for sample lubrication.
Do Syringes Have Lubricant?
A lubricant is required to allow the plunger to pass through the barrel properly during the prefilled syringe procedure. Silicone oil is the most commonly used lubricant in the prefilled syringes industry.
For the stability test, a recombinant fusion protein, abatacept (Orencia), and a fully human recombinant immunoglobulin G1, adalimumab (Humira), were injected into a single-mL glass syringes that were free of silicone oil and silicone oil lubricated. resonant mass measurement and dynamic flow-characterization were used to estimate the amount of subvisible particles that result from agitation stress. Based on the results of these studies, new SOF polymer-based syringe materials have been demonstrated to be more stable in shipping and handling. The pharmaceutical market is gradually being introduced to syringes made of polymer based on the thermoplastic compound cyclic olefin polymer (COP). They perform well in terms of increasing break resistance, reducing surface reactivity, and maintaining compatibility with the broad pH range. In the present study, we placed two different pharmaceutical proteins, abatacept and adalimumab, in a 1.0mL glass and silicone oil-lubricated syringe barrel, each subjected to agitation stress comparable to that encountered by shipping drugs. In this study, oil was used to lubricate 1mL polymer syringes and glass syringes barrels.
PLAJEX syringe, developed in collaboration with COP, is a recently developed prefillable syringe that is made from COP and has a novel butyl rubber plunger stopper coated with a proprietary coating technique. Eisai Company, Ltd. (EI) purchased a recombinant fusion protein containing the extracellular domain of cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) and IgG1 antibodies. Life Technologies purchased phosphate-buffered saline buffer (PBS), pH 7.4 (10), and acetic acid from a supplier. During a 24-hour period, the concentration of sucrose in the water used for the adalimumab treatment was reduced by extensive nephrology treatment against a sample of antigens obtained from agarose water at 4C. A lyophilized abatacept sample, containing 250 mg of lyophilized abatacept, was injected into a 10 mL water bottle with ten mL of water. To diluted the protein solutions, a buffer was added to one end and a polyvinylidene fluoride syringe filter was used to filter them out at the other. Samples were analyzed using the Alliance 1100 HPLC system from Waters (Waters, Milford, MA), simultaneous UV absorbance detection at 215 and 280 nm with a TSK gel G3000SWXL column from Tosoh Bioscience (Tokyo, Japan), and PBS pH 7.4 as a mobile sample All formulations studied had high protein mass recovery, indicating a high level of protein mass recovery. Sedimentation velocity experiments were performed using a Beckman Coulter A60 Ti rotor (Beckman Ultracentrifugation) equipped with a 4-hole An60 Ti rotor and ProteomeLab XL-I analytical ultracentrifugation (Beckman Ultracentrifugation).
A digital particle 4200 was used to count protein particles that were visible in the presence of visible (micron-sized) protein particles. When samples were stressed at 1 mg/mL, two–10 times with the corresponding buffer were diluted. The presence of large aggregates can be explained by decreased transmission frequency at 350 nm during atmospheric stress in all samples. The amount of protein in supernatant after centrifugation from total sample amount was used to estimate the amount of insoluble aggregates after stress testing. The fraction of soluble aggregates remaining was estimated by size-exclusion chromatography after insoluble aggregates werecentrifugationd at 15,600g for 30 minutes. SEC detected a trace amount of dimers and oligomers in silicone oil-lubricated glass syringe samples. AUC-SV was used to calculate aggregate weights as well as aggregate weights (Fig.
1b). The AUC-SV measured aggregates slightly higher than SEC estimates. Differences in sample dilution during SEC analysis are likely to be the cause. When using both protein formulations, monomer losses are clearly visible in the form of samples taken with silicone oil-lubricated syringes. Microsensors were used in the experiments, with particle counts ranging from 0.5 to 2.0 millimeters. Large particles were found to be more abundant in glass-so-slightly larger samples than in other syringe types. The particle concentration for aceptbata PBS formulation was similar to that of SOF polymer and glass syringe samples.
Because the syringes were filled with silicone oil, particles were discovered to be higher than usual. The researchers discovered that circularity can be used to discriminate between protein particles and silicone oil droplets based on their properties. Because the protein in particles has a relatively small cumulative mass, it is nearly impossible to lose native protein when particles are formed. Polyolefin SOF samples had much larger particles than polymer SOF samples recorded. Protein particles are thought to form in rupture-prone proteins by the formation of layers of proteins adsorbed on the surface. Aggregate formation was not observed when protein solutions with COP beads were agitated with no headspace. Particle counts in silicone oil lubricated syringes were higher than those in SOF syringe samples.
As a result of silicone oil’s impact on protein adsorption to the surface and/or disruption of the formed layer, the number of particles on the surface increases. According to manufacturers, 0.7 mg of silicone oil is added to a polymer-based syringe and 1.0 mg of silicone oil is added to a glass syringe to lubricate the inner surface. As the acetate buffer thickens, a decreasing number of silicone oil droplets from the inner surface of the syringe is distributed, resulting in an increase in particle size. Adalimumab formulations prefilled in silicone oil-lubricated syringes with acetate buffer had a higher concentration of particles per container compared to PBS formulations (Suppl. Table S2) is a graphical representation of S2. Silicone oil lubrication resulted in the formation of insoluble aggregates and subvisible particles in samples of SOF glass and polymer-based syring films. According to this study, aggregates detected by SEC/AUC-SV and particle counts obtained from MFIs may be correlated.
The results of this study confirm that SOF polymer-based syringes PLAJEXTM can provide improved physical stability when shipping and handling biopharmaceuticals. For providing materials and Spectris analysis software, we would like to extend our gratitude to TOP Company, TOP Synthesis, TERUMO Company, and MALvern instruments. The journal BioPharmaceuticals (Biosci Bioeng) contains some of the most recent studies on protein aggregation and particle formation. Maa YF, Hsu CC, Basu P, Krishnan S, Thirumangalathu R, Randolph TW, Carpenter JF, Brems DN, Middaugh CR, and Winter G reviewed the methods for protein quantification with analytical ultracentrifugation and field flow fractionation. The goal of the paper is to present a step-by-step procedure for characterizing protein aggregates that do not contain parts. A microchannel resonator is used to characterize subvisible particles in protein therapeutic molecules. Prolonged agitation is associated with protein aggregation during protein breakdown. Excipients can have a positive impact on protein aggregation.