Leakage assessment of flexible pouches using dye penetration test with correlation to modeled bacterial aerosol challenge test

Moghimi, Nastaran; Park, Su‐il

doi:10.1007/s10068-017-0134-y

Cited by 7 publications

(3 citation statements)

References 8 publications

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“…Following the test, the filter was taken apart and the spread of the dye on the filter material was visually inspected. If a clear margin was observed on the filter paper where the dye had not spread to parts of the filter casing, it was assumed that the transfer medium had passed through the filter and not around it [ 13 , 14 ]. Therefore, it was assumed that filters which passed this test would have air flowing through the filter paper once connected to the anesthesia machine (Fig.…”

Section: Methodsmentioning

confidence: 99%

Development and validation of a 3D printed antiviral ventilator filter - a comparative study

Shaylor

Francis

Shaylor³

et al. 2021

BMC Anesthesiol

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Background The current coronavirus infectious disease 2019 (COVID-19) pandemic has caused unexpected pressure on medical supplies, interrupting supply chains and increasing prices. The supply of antiviral filters which form an essential part of the ventilator circuit have been affected by these issues. Three-dimensional (3D) printing may provide a solution to some of these issues. Methods We designed and tested 3D printed heat and moisture exchange (HME) and antiviral casing. For each casing we tested two different filter materials derived from a sediment water filter cartridge or 1.5-μm glass fiber filter paper. A polyurethane sponge was used for the HME. Each design was tested for circuit leak, circuit compliance, peak inspiratory pressure and casing integrity using methylene blue dye. Results We designed, produced, and tested two different types of antiviral filters with six different internal configurations. Overall, we tested 10 modified filter designs and compared them with the original commercial filter. Except for the combination of 1.5-μm filter paper and 5 mm sponge peak inspiratory pressure and circuit compliance of the filters produced were within the operating limits of the ventilator. All In addition, all filters passed the dye test. Conclusions Our filter may be of particular importance to those working in low middle-income countries unable to compete with stronger economies. Our design relies on products available outside the healthcare supply chain, much of which can be purchased in grocery stores, hardware stores, or industrial and academic institutions. We hope that these HMEs and viral filters may be beneficial to clinicians who face critical supply chain issues during the COVID-19 pandemic.

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Section: Methodsmentioning

confidence: 99%

Development and validation of a 3D printed antiviral ventilator filter - a comparative study

Shaylor

Francis

Shaylor³

et al. 2021

BMC Anesthesiol

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“…economic for SMEs as the equipment cost is inexpensive [28] Inspectors need direct access to the surface of the material…”

Section: They Should Be Harmlessmentioning

confidence: 99%

CHALLENGES FACED BY SMEs : A COMPREHENSIVE REVIEW OF NON-DESTRUCTIVE TESTING METHODS AND SOLUT

2023

IRJMETS

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Non-Destructive testing is an effective analysis technique that manufacturing firms use to assess the structure and properties of materials. In simple words, NDTs can help inspectors detect irregularities, external and internal defects without causing damage to the original material. The sole purpose of the study is to propose the most convenient method of NDT for small and medium manufacturing businesses. For this reason, we have critically investigated the economic prospects and effectiveness of different NDT methods that can minimize the investment of SMEs in the long run. The proposed method of inspection is cost-effective and efficient enough to detect surface and subsurface cracks in materials. The recommended automated visual inspection in this study requires a small database and low-cost equipment such as cameras and scanners to identify surface and subsurface irregularities. However, it does not require huge initial setup and maintenance costs as compared to Ultrasonic and Eddy Current testing. The automated setup in visual inspection is the best NDT method that SMEs can adopt to reduce manufacturing defects. In addition, this can save a substantial amount of time and effort for inspectors. Therefore, in contemporary manufacturing operations, Dye penetration and AVI are essential to meet the quality standards of products while minimizing overall cost and timeframe.

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“…The same is true for studies related to defects causing liquid leakages in flexible packaging. Either studies are related to microbial testing, like the one conducted by Moghimi et al (13,14) on flexible pouches, or they were done on rigid material, like the one by Mala and Li (15), which studied the flow characteristics of water in microtubes of fused silica and stainless steel and with diameters of 50 lm to 254 lm. For all these reasons, it was needed to initiate scientific studies to characterize microbial ingress and liquid leakage mechanisms for material typically used in SUS bag assemblies.…”

Section: Introductionmentioning

confidence: 99%

Single-Use System Integrity IV: A Holistic Approach Based on Compiled Scientific Study Data

Hogreve

2022

PDA Journal of Pharmaceutical Science and Technology

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This concluding article of the publication series provides an overarching summary of all study results presented in the three previous articles (1-3). Their interdependency in achieving a holistic approach to the integrity assurance of single-use systems (SUSs) employed in (bio)pharmaceutical manufacturing is finally illustrated. Two of those three studies were conducted to understand microbial ingress and liquid leak mechanisms in polymeric film material as determinants of the maximum allowable leakage limit (MALL) for SUSs using artificially created defects. The third study characterized gas flow through these defects-an essential variable for robust validation of physical integrity test methodologies based on gas flow. In all studies, the test samples used were 50 mm round patches of two ethylene vinyl acetate (EVA) multilayer films (300 lm and 360 lm thick) and a polyethylene (PE) multilayer film (400 lm thick). More than 1400 test samples with artificially created leaks were used in sizes ranging from 1 lm to 130 lm. The leaks were laser-drilled into the center of each patch. Microbial ingress and liquid leak testing under various process conditions resulted in a MALL of 2 lm for microbial integrity and the prevention of liquid leakages under most severe usecase conditions. The studies also demonstrated a close relationship between the occurrence of liquid leakage and microbial contamination. Different model solutions were used to evaluate the impact of liquid characteristics, mainly surface tension. The data were applied to build mathematical models for predicting the MALL under any intended use-case condition. By characterizing gas flow behavior over a broad pressure range using various defect sizes, it was possible to create formulas for three different flow regimes. These were suitable for calculating leak size in a defective product directly from the corresponding flow rate or vice versa. Finally, compilation of these different aspects enabled the authors to design and validate non-destructive physical integrity test methods having detection limits correlated to the MALL for SUSs.

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Leakage assessment of flexible pouches using dye penetration test with correlation to modeled bacterial aerosol challenge test

Cited by 7 publications

References 8 publications

Development and validation of a 3D printed antiviral ventilator filter - a comparative study

Development and validation of a 3D printed antiviral ventilator filter - a comparative study

CHALLENGES FACED BY SMEs : A COMPREHENSIVE REVIEW OF NON-DESTRUCTIVE TESTING METHODS AND SOLUT

Single-Use System Integrity IV: A Holistic Approach Based on Compiled Scientific Study Data

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