scholarly journals Sub-Visible Particle

2020 ◽  
Author(s):  
Keyword(s):  
Visible Particle

scholarly journals Is the Higgs a visible particle?

1997 ◽  
Vol 110 (4) ◽  
pp. 363-367 ◽  
Author(s):  
C. G. Bollini ◽  
M. C. Rocca
Keyword(s):  
Visible Particle

Submicrometer, micrometer and visible particle analysis in biopharmaceutical research and development

2020 ◽  
pp. 285-310
Author(s):  
Andrea Hawe ◽  
Daniel Weinbuch ◽  
Sarah Zölls ◽  
Angelika Reichel ◽  
John F. Carpenter
Keyword(s):  
Research And Development ◽  
Particle Analysis ◽  
Visible Particle

scholarly journals Bletilla striataMicron Particles Function as a Hemostatic Agent by Promoting Rapid Blood Aggregation

2017 ◽  
Vol 2017 ◽  
pp. 1-8 ◽  
Author(s):  
Chen Zhang ◽  
Rui Zeng ◽  
Zhencheng Liao ◽  
Chaomei Fu ◽  
Hui Luo ◽  
...  
Keyword(s):  
Low Cost ◽  
In Vivo Studies ◽  
Hemostatic Agent ◽  
Severe Bleeding ◽  
Promising Alternative ◽  
Bletilla Striata ◽  
Visible Particle ◽  
Injury Model

The human body cannot control blood loss without treatment. Available hemostatic agents are ineffective at treating cases of severe bleeding and are expensive or raise safety concerns.Bletilla striataserve as an inexpensive, natural, and promising alternative. However, no detailed studies on its hemostatic approach have been performed. The aim of this study was to examine the hemostatic effects ofB. striataMicron Particles (BSMPs) and their hemostatic mechanisms. We prepared and characterized BSMPs of different size ranges and investigated their use as hemostatic agent. BSMPs of different size ranges were characterized by scanning electron microscope. In vitro coagulation studies revealed BSMP-blood aggregate formation via stereoscope and texture analyzers. In vivo studies based on rat injury model illustrated the BSMP capabilities under conditions of hemostasis. Compared to other BSMPs of different size ranges, BSMPs of 350–250 μm are most efficient in hemostasis. As powder sizes decrease, the degree of aggregation between particles and hemostatic BSMP effects declines. The BSMP in contact with a bleeding surface locally forms a visible particle/blood aggregate as a physical barrier that facilitates hemostasis. Considering the facile preparation, low cost, and long shelf life ofB. striata, BSMPs offer great potential as mechanisms of trauma treatment.

Strategies for the Control of Visible Particles in Sterile Devices

2021 ◽  
Vol 64 (1) ◽  
pp. 1-17
Author(s):  
Dilip Ashtekar
Keyword(s):  
Particle Dispersion ◽  
Control Measures ◽  
Surveillance Program ◽  
Particle Removal ◽  
Material Transfer ◽  
Contamination Control ◽  
Visible Particle ◽  
Additional Control ◽  
Air Ionization ◽  
Particle Contamination

Abstract Currently, limited guidance is available for the contamination control of visible particles for the manufacture of sterile devices; thus, a comprehensive guidance is warranted. Sterile devices require stringent control of visible particulates to ensure proper functionality, performance assurance of sterility, reliability, patient safety, efficacy, and product quality. This paper outlines practical and science-based strategies to prevent/minimize visible particle contamination from non-process related extrinsic and process related intrinsic sources. Witness plates are proposed as a comprehensive strategy for the real time detection of visible particles, sources of extrinsic and intrinsic visible particles, and methods to identify particle types. Implementing the control measures described herein, which include air ionization units for the control and neutralization of static charges, would maximize device yield and quality, thus reducing rework and leading to increased profitability. Installing validated air ionization systems at appropriate manufacturing and processing locations, storage, product transfer areas, and gown-up rooms can significantly reduce visible particle contamination accumulation, dispersion, and yield losses. Implementing effective material transfer practices can further minimize the risk of introduction of unwanted particles and particle dispersion within classified areas. Also described are additional control measures, such as material systems and supply chain controls, good facility design, gowning practices, manufacturing equipment and tool controls, and manual visual inspections which would further contribute to the overall reduction of particle burden. Crucial elements of an effective particle removal process are the dry and wet cleaning processes and the facility surveillance program. Process-product-particle traceability matrices can serve as effective tools to promptly identify trends and reduce device conformity defects. For this paper, the meaning of the term particle only includes particulates and particulate matter. Microbial contamination control approaches, including facility decontamination, are outside the scope of this paper.

Extended stability of the trastuzumab biosimilar ABP 980 (KANJINTI™) in polyolefin bags and elastomeric devices

2021 ◽  
Vol 10 (4) ◽  
pp. 153-171
Author(s):  
Lyndsay Davies ◽  
Katie Milligan ◽  
Mark Corris ◽  
Ian Clarke ◽  
Paul Dwyer ◽  
...  
Keyword(s):  
Monomer Concentration ◽  
Charge Heterogeneity ◽  
Storage Duration ◽  
Stability Indicating ◽  
Visible Particle ◽  
Physicochemical Stability ◽  
A Cell ◽  
Particle Counts ◽  
The Stability ◽  
Initial Results

Study Objectives: To investigate the quality and in-use stability of the trastuzumab biosimilar ABP 980 (KANJINTI™) in both concentrated multi-dose bags and following dilution and extended storage in intravenous (IV) bags and elastomeric devices, to address the stability requirements of diff erent global pharmacy practices. Methods: The eff ect of extended refrigerated storage plus exposure to in-use temperature conditions on KANJINTI™ (trastuzumab) solutions was assessed using a range of stability-indicating analytical methods, including appearance, pH, SEC, nonreducing CGE, reducing-CGE, CZE, sub-visible particle counting and potency by a cell-based proliferation inhibition assay. Stability of reconstituted 21 mg/mL solution stored in multi-dose bags and diluted samples at 0.3 mg/mL, 0.8 mg/mL and 4 mg/ mL in 0.9% w/v NaCl solutions stored in IV bags and elastomeric devices was determined over diff erent storage durations. Forced degraded samples exposed to room temperature and natural daylight were used to demonstrate the stability-indicating abilities of the methods. Results: No signifi cant changes were observed in the appearance, pH, monomer concentration, purity, charge heterogeneity, sub-visible particle counts or bioactivity, regardless of initial concentration, container or storage duration. Discussion: There was no indication of signifi cant changes to the physicochemical stability or bioactivity of any of the solutions following extended storage when compared to the initial results acquired on the day of preparation. Conclusion: The data presented has demonstrated the physicochemical stability and bioactivity of a range of KANJINTI™ (trastuzumab) solutions when prepared using controlled and validated aseptic processes, stored protected from light for extended periods at 2°C–8°C and subjected to in-use temperatures. The stability demonstrated in multi-dose bags and elastomeric devices provides additional preparation options to address diff erent global pharmacy practices and requirements.

scholarly journals Protein Sub-Visible Particle and Free Radical formation of a Freeze-Dried Monoclonal Antibody Formulation During Dropping

2020 ◽  
Author(s):  
Wei-Jie Fang ◽  
Jia-Wei Liu ◽  
Hong-Jian Zheng ◽  
Bin-Bin Shen ◽  
Xinyu Wang ◽  
...  
Keyword(s):  
Monoclonal Antibody ◽  
Free Radical ◽  
Radical Formation ◽  
Visible Particle ◽  
Freeze Dried ◽  
Free Radical Formation

scholarly journals Rubber Coring of Injectable Medication Vial Stoppers: An Evaluation of Causal Factors

2016 ◽  
Vol 1 (4) ◽  
Author(s):  
Philip Chennell ◽  
Daniel Bourdeaux ◽  
Quentin Citerne ◽  
Catherine Arnaud ◽  
Sylvie Cosserant ◽  
...  
Keyword(s):  
Optical Microscopy ◽  
Particle Creation ◽  
Particle Formation ◽  
Rubber Stopper ◽  
Causal Factors ◽  
Visible Particle ◽  
Risk Situation ◽  
Particle Length ◽  
Puncture Technique ◽  
Metal Needle

AbstractPurpose:Coring of a medication vial’s rubber stopper has been reported as a major cause of visible particle presence in injectable preparations. In this study, we investigated and quantified visible particle formation caused by coring associated with four potential causal factors.Methods:The factors studied were: nature of the rubber stopper; rubber stopper thickness, type of metal needle bevel used to pierce the stopper, and puncture technique. For each one of 16 different situations, 40 medication vial rubber stoppers were punctured, and the contents filtered. The filters were then examined under optical microscopy and particles present counted and measured.Results:The incidence of particle formation ranged from 0 % to 75 %, depending on the situation. Particle length was on average of 0.98±0.39 mm. The situation that gave the most particles (75 %; 30/40) was obtained when using a short bevelled needle, a 4 mm thick chlorobutyl vial stopper and with a puncture angle of 90°. Whilst a puncture technique reduced particle formation by more than 50 % for the most at risk situation, but without eliminating particle formation (residual formation of 22.5 %; 11/40), the use of a blunt bevelled needle totally eliminated the incidence of visible particle creation. The thickness of the rubber and the nature of the elastomer seemed to be linked to coring incidence, but in lesser proportions.Conclusion:Puncturing the stoppers using a technique with a 45° puncture angle reduced particle formation, but only the use of a blunt metal needle totally eliminated it.

Characterization of Suspended Particles in Some Pulp and Paper Mill Effluent Plumes

1977 ◽  
Vol 34 (6) ◽  
pp. 791-797 ◽  
Author(s):  
J. K. Leslie
Keyword(s):  
Particle Surface ◽  
Pulp Mill ◽  
Paper Mill ◽  
Suspended Particles ◽  
Pulp And Paper Mill ◽  
Particle Surface Area ◽  
Paper Mill Effluent ◽  
Visible Particle ◽  
Effluent Flow Rate

Some physical characteristics of the suspended particles from seven pulp mill effluent plumes were analyzed electronically. An effluent flow rate of 1.2 m3∙s−1 contained a mean of 75.9 × 109 μm3∙ℓ−1 particulate volume in a size range of 3.2–84.0 μm "diameter." The visible particle surface area was 334.8 cm2∙ℓ−1, and there were 1045 × 103 particles∙ml−1. A slight increase in size was detected as the particles aged in the plume. The transported particulates were reduced by dispersion and sedimentation to approximately 5% by a transit of less than 1 km, but effluent was still detectable 2 km from the point source.

scholarly journals Effect of Fatty Acid Composition in Polysorbate 80 on the Stability of Therapeutic Protein Formulations

2021 ◽  
Author(s):  
Melissa A. Pegues ◽  
Karol Szczepanek ◽  
Faruk Sheikh ◽  
Seth G. Thacker ◽  
Baikuntha Aryal ◽  
...  
Keyword(s):  
Biological Activity ◽  
Fatty Acid Composition ◽  
Fatty Acid ◽  
Acid Composition ◽  
Particle Formation ◽  
Therapeutic Protein ◽  
Stress Conditions ◽  
Polysorbate 80 ◽  
Visible Particle ◽  
The Stability

Abstract Purpose Polysorbate excipients are commonly used as surfactants to stabilize therapeutic proteins in formulations. Degradation of polysorbates could lead to particle formation and instability of the drug formulation. We investigated how the fatty acid composition of polysorbate 80 impacts the degradation profile, particle formation, and product stability under stress conditions. Methods Two polysorbate 80-containing therapeutic protein formulations were reformulated with either Polysorbate 80 NF synthesized from a fatty acid mixture that contains mainly oleic acid (≥58%) or a version of polysorbate 80 synthesized with high oleic acid (>98%). Stress conditions, including high temperature and esterase spiking, were applied and changes to both the polysorbate and the therapeutic protein product were investigated for stability, purity, innate immune response and biological activity. Results The addition of esterase and storage at 37°C led to significant hydrolysis of the polysorbate and increases in sub-visible particle formation for both polysorbates tested. The fatty acid composition of polysorbate 80 did not directly alter the stability profile of either therapeutic protein as measured by size exclusion chromatography, or significantly impact innate immune response or biological activity. However, formulations with Polysorbate 80 NF showed greater propensity for sub-visible particle formation under stress conditions. Conclusions These results suggest that composition of fatty acids in polysorbate 80 may be a promoter for sub-visible particulate formation under the stress conditions tested but may not impact protein aggregation or biological activity.

Subvisible and Visible Particle Analysis in Biopharmaceutical Research and Development

2015 ◽  
pp. 261-286
Author(s):  
Andrea Hawe ◽  
Sarah Zölls ◽  
Angelika Freitag ◽  
John F. Carpenter
Keyword(s):  
Research And Development ◽  
Particle Analysis ◽  
Visible Particle
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