2. Materials and Methods
2.1. Study Design and Development Workflow
This study was designed as a preclinical prototype development and bench validation study of a dual-function polymer face shield incorporating an on-demand disinfectant reservoir for use in infection control workflows in medical practice. The methodological flow included: digital design, material selection, prototype fabrication, dimensional and gravimetric evaluation, bench functional testing, chemical and mechanical durability testing, ergonomic modeling and cost analysis.
No human participants, patients, biological samples, personal data, or clinical interventions were involved. Therefore, institutional ethical approval was not required for this preclinical technical phase. Future testing involving physicians or patients will only be conducted after approval by an institutional ethics committee and after obtaining written informed consent.
The main technical parameters were: consistency of the disinfectant dose, valve resealing, tightness, stability of tank attachment, chemical compatibility with alcohol-based disinfectant, mechanical durability, mass distribution and estimated cervical torque. Secondary parameters included the production cost of the prototype and the feasibility of modular tank use.
2.2. Device Design and Materials
The device has been designed as a reusable polymer face shield system that integrates facial and eye barrier protection with on-demand hand disinfection capability. The final assembly consisted of a transparent sight, a double-spring cranial frame, a removable side tank for disinfectant, a touch-activated self-sealing dispensing valve, a flexible sealing gasket and an adjustable rear elastic fixing band.
The visor was made of glycol-modified polyethylene terephthalate (PETG) polymer material, with final dimensions of 230 × 230 mm and a nominal thickness of 0.20 mm. PETG was selected due to its optical clarity, low weight, impact resistance, thermoformability and tolerance to alcohol-based cleaning agents and disinfectants [
15]. The cranial frame and tank components were designed for molten deposition modeling using PETG filament, while the gasket was designed from thermoplastic polyurethane (TPU 95A) to support cap sealing and leakage prevention.
The disinfectant tank was designed as a modular component with four interchangeable nominal capacities: 25 mL, 50 mL, 75 mL and 100 mL. The 100 mL tank was selected as the maximum load configuration for subsequent functional, durability and ergonomic testing. The tank has been designed for ambidextrous lateral mounting via a reversible male-female click-lock interface, allowing attachment on both sides of the cranial frame.
Mikrozid AF Liquid (Schülke & Mayr GmbH, Norderstedt, Germany) was used for compatibility and distribution tests. According to the manufacturer’s technical documentation, Mikrozid AF Liquid is an alcohol-based, aldehyde-free disinfectant containing ethanol and propan-1-ol [
16]. Prior to dispensing tests, the density of the disinfectant was experimentally determined and used to convert the dispensed mass into the delivered volume. The materials and components used for the development of the prototype are summarised in
Table 1.
Detailed Dispensing Valve Specifications: The valve is a commercial self-sealing, spring-loaded ball-type distributor (model V 100 SS, local supplier, Galati, Romania). The main body is made of stainless steel (AISI 304), with a sealing seat made of polytetrafluoroethylene (PTFE) and a stainless steel spring (wire diameter 0.3 mm, spring constant 2.5 N/mm). The valve opens when a force of approximately 8 12 N is applied to the actuator knob, moving the ball out of the seat, allowing fluid to flow. The internal volume of the chamber is designed to deliver a dose of ~3 mL per full stroke; The flow rate is limited by an internal hole of 1.5 mm. The valve is integrated into the tank outlet via a threaded connection (M10×1) with a rubber O-ring (NBR 70 Shore A) to prevent leaks. The outlet port of the valve is positioned outside the central optical field of the sight.
2.3. Prototype Fabrication
The prototype was digitally designed using Fusion 360, version 2.0.18961 (Autodesk Inc., San Francisco, CA, USA). Three-dimensional models of the cranial frame, reservoir body, reservoir cap, locking interface, valve housing, and gasket seat were generated as separate components to allow independent optimisation and replacement. All models were exported as STL files with high-resolution mesh settings before additive manufacturing. Slicing was performed using Ultimaker Cura, version 5.6.0 (UltiMaker, Utrecht, The Netherlands), and the generated toolpaths were inspected before printing to verify wall continuity, support distribution, and preservation of sealing surfaces.
Fused deposition modelling was performed using an Original Prusa i3 MK3S+ 3D printer (Prusa Research a.s., Prague, Czech Republic). PETG filament with a nominal diameter of 1.75 mm was used for the rigid components, including the cranial frame, reservoir body, reservoir cap, valve housing, and male–female locking interface. TPU 95A filament was used for the flexible sealing gasket. Before fabrication, the printer was calibrated for bed levelling, extrusion flow, and first-layer adhesion. Filament was stored in dry conditions and visually inspected before use.
The main printing parameters for PETG components were as follows: 0.4 mm nozzle diameter, 0.20 mm layer height, three outer perimeters, 35% cubic infill, 245 °C nozzle temperature, 80 °C build-plate temperature, 45 mm/s printing speed, and 30% cooling fan speed after the initial layers. The reservoir body was printed in an orientation selected to maximise wall continuity and reduce the need for supports on fluid-contacting and sealing surfaces. The cap, valve housing, and locking interface were printed with the functional surfaces oriented to minimise post-processing in areas involved in sealing or mechanical retention. TPU 95A gaskets were printed using a 0.4 mm nozzle, 0.20 mm layer height, 100% infill, 225 °C nozzle temperature, and 50 °C build-plate temperature.
After printing, support structures were removed manually. Printed components were cleaned of residual filament strings and inspected visually for incomplete extrusion, layer separation, warping, surface irregularities, and defects affecting the locking or sealing interfaces. Particular attention was given to the reservoir wall, cap–reservoir contact area, gasket seat, valve housing, and male–female click-lock attachment interface. Components with visible structural defects, incomplete sealing surfaces, or deformation of functional interfaces were excluded from assembly.
The visor was fabricated from a transparent PETG sheet with a nominal thickness of 0.20 mm. The sheet was cut to final dimensions of 230 × 230 mm using a calibrated template and was laterally thermoformed over a curved mould to improve facial side coverage. After forming, the visor was inspected for surface distortion, edge irregularities, cracks, and optical-field obstruction. The visor was then attached to the double-arch cranial frame using press-fit fixation points, avoiding adhesive use on areas exposed to disinfectant or repeated cleaning.
Final assembly included the PETG cranial frame, transparent PETG visor, detachable PETG reservoir, TPU 95A sealing gasket, posterior elastic fixation band, and ball-type self-sealing dispensing valve. The reservoir was attached laterally through the male–female click-lock interface and checked for complete seating, absence of wobbling, and ease of detachment. The valve was mounted with its outlet positioned outside the central optical field of the visor to minimise interference with visibility during use.
Before functional and mechanical testing, assembled prototypes were conditioned for 24 h at 23 ± 2 °C and 45–55% relative humidity. After conditioning, each prototype underwent a final pre-test inspection to confirm correct assembly, reservoir seating, gasket placement, valve mobility, and absence of visible leakage or structural defects.
2.4. Dimensional, Mass, and Capacity Measurements
Dimensional measurements were performed using a digital calliper with 0.01 mm resolution (Mitutoyo Corporation, Kawasaki, Japan). The following parameters were measured: visor width, visor height, visor thickness, frame arch thickness, reservoir wall thickness, locking-interface width, cap diameter, valve-outlet diameter, and reservoir external dimensions. Measurements were performed at predefined locations selected according to the geometry and functional role of each component. Each measurement was performed three times at predefined points, and results were expressed as mean ± standard deviation.
Visor width and height were measured after cutting and thermoforming to verify preservation of the intended 230 × 230 mm geometry. Visor thickness was measured at three regions: central, superior, and lateral. Reservoir wall thickness was measured at the anterior, posterior, medial, and lateral walls, avoiding the cap thread, valve seat, and locking interface. The male–female click-lock interface was measured at the principal retention surfaces to confirm dimensional consistency before functional testing.
Mass measurements were performed using an analytical balance with 0.001 g resolution (Sartorius Lab Instruments GmbH & Co. KG, Göttingen, Germany). Before each measurement sequence, the balance was levelled and tared according to the manufacturer’s instructions. The following configurations were weighed in triplicate: visor alone, frame alone, empty reservoir, complete device without disinfectant, and complete device with 25 mL, 50 mL, 75 mL, and 100 mL disinfectant.
Reservoir capacity was verified gravimetrically. Each reservoir was filled to its functional fill line with distilled water at room temperature, avoiding overfilling and external surface wetting. Empty and filled masses were recorded, and the net mass was converted to volume using water density at the measured room temperature. Capacity verification was performed in triplicate for each reservoir size. A deviation within ±5% of nominal capacity was considered acceptable (
Table 2).
For disinfectant-filled configurations, the density of Mikrozid AF Liquid was determined experimentally before use by weighing 10 mL of disinfectant measured with a calibrated volumetric pipette. This density value was used for subsequent conversion of disinfectant mass into volume during dispensing-dose testing.
All dimensional, mass, and capacity data were recorded in a structured database and reported descriptively. No inferential statistical testing was applied to these measurements, as they represented repeated technical measurements against predefined acceptance criteria.
2.5. Functional Bench Testing
Functional bench testing evaluated dispensing consistency, valve resealing, leak-tightness, pressure resistance, and reservoir attachment stability. All tests were performed at 23 ± 2 °C and 45–55% relative humidity. The 100 mL reservoir was selected for functional testing because it represented the maximum-capacity and maximum-load configuration of the modular system. All acceptance criteria were predefined before testing.
Dispensing-dose consistency was tested using the 100 mL reservoir filled with Mikrozid AF Liquid. Before testing, disinfectant density was determined by weighing 10 mL of disinfectant measured with a calibrated volumetric pipette. The reservoir was mounted on the face-shield frame in the standard operating position. For each activation, the dispensed fluid was collected in a pre-weighed container and weighed using the analytical balance. The valve was activated manually using the same operating direction and full-stroke movement for each test activation. A total of 100 consecutive activations were performed. Dispensed mass was converted to volume using the measured disinfectant density. Mean dose, standard deviation, 95% confidence interval, range, coefficient of variation, failed activations, and post-activation dripping were recorded. As secondary practical observations, early priming behaviour, perceived changes in activation resistance, and visible superficial wear at the valve or attachment interface were also noted qualitatively.
Manual actuation force was measured during the first 10 valve activations using a digital force gauge. The force required to fully depress the dispensing valve was recorded and compared with the 8–12 N operating range specified for the valve mechanism. Qualitative handling with gloved hands was also noted by two testers as a preliminary practical observation.
Valve resealing was assessed after each activation by observing the outlet for 30 s. Any delayed dripping, incomplete closure, or spontaneous leakage was recorded. Leak-tightness was further evaluated by filling the reservoir with 100 mL disinfectant and maintaining it for 30 min in six orientations: upright, inverted, right lateral, left lateral, 45° anterior tilt, and 45° posterior tilt. The reservoir was weighed before and after each positional test to detect fluid loss. Mass loss <0.1 g and absence of visible leakage were considered acceptable.
Static pressure resistance was assessed by connecting the filled 100 mL reservoir to a low-pressure testing system and gradually increasing the internal pressure to 0.2 bar. Pressure was maintained for 10 min and monitored using a digital manometer. After pressure loading, the reservoir was inspected for leakage at the cap, valve, gasket, reservoir wall, and locking interface. Wall deformation was measured with a digital calliper before and after testing. The pressure-resistance test was considered successful if no leakage occurred and post-test deformation remained ≤0.2 mm.
Attachment stability was evaluated using 100 attachment–detachment cycles of the reservoir click-lock interface. After every 20 cycles, the interface was inspected for wear, cracks, wobbling, incomplete locking, and loss of retention, with distinction between superficial cosmetic wear and functionally relevant loosening or structural damage. Retention force was measured using a digital force gauge in three directions: vertical, lateral, and anterior-posterior. The interface was considered mechanically acceptable if it resisted ≥10 N of traction in all directions without detachment or structural damage (
Table 3).
2.6. Chemical Compatibility and Mechanical Durability
Chemical compatibility was evaluated using both complete reservoirs and flat PETG specimens. This assessment was performed because PETG was selected for its reported chemical tolerance and suitability for use with cleaning agents and alcohol-based disinfectants [
15]. Flat PETG specimens measuring 20 × 20 × 1.2 mm were immersed in Mikrozid AF Liquid for 14 days at 25 ± 2 °C using an immersion protocol for plastics exposed to liquid chemical agents. Mikrozid AF Liquid was selected as the test disinfectant according to the manufacturer’s technical documentation and its alcohol-based composition, containing ethanol and propan-1-ol [
16]. Specimens were evaluated at baseline, 24 h, 7 days, and 14 days.
In addition to immersion testing, repeated wiping resistance was evaluated on flat PETG visor specimens. Each specimen underwent 50 manual wiping cycles using Mikrozid AF Liquid applied with a disposable non-woven wipe. After wiping, specimens were inspected visually and under 20× magnification for scratching, clouding, surface roughening, or loss of optical clarity. Optical transparency at 550 nm and mass change were measured after completion of the wiping cycles.
Mass change was measured using the analytical balance. Dimensional changes were measured using the digital calliper. Optical transparency was measured at 550 nm using a UV–Vis spectrophotometer (Shimadzu Corporation, Kyoto, Japan). Surface integrity was assessed under 20× magnification using a stereomicroscope (Leica Microsystems GmbH, Wetzlar, Germany). The following material changes were recorded: swelling, clouding, cracking, surface roughening, colour alteration, stress-crazing, and delamination.
Complete 100 mL reservoirs were filled with Mikrozid AF Liquid and stored under two exposure conditions: 7 days at 25 ± 2 °C and 48 h at 60 ± 2 °C. After exposure, the reservoirs were inspected for leakage, deformation, transparency changes, valve function, and cap sealing integrity.
Mechanical durability was assessed through 50 fill–drain cycles, followed by static leakage inspection and valve-function testing. In addition, a 1 m drop test was performed on the filled reservoir in three orientations: lateral impact, cap-side impact, and valve-side impact. Five consecutive drops were performed for each orientation, resulting in a total of 15 impact events. After each impact, the reservoir was inspected for visible cracks, cap displacement, valve damage, leakage, loss of attachment stability, superficial impact marks, and dimensional deformation at the impact area. Valve function was reassessed after drop testing by performing five additional dispensing activations.
Acceptance criteria for chemical and mechanical testing were predefined before analysis. The reservoir and PETG specimens were considered acceptable if mass change was ≤1%, optical-transparency loss was ≤5%, dimensional deformation was ≤0.2 mm, no visible cracks were detected, no stress-crazing was observed at 20× magnification, valve function was preserved, and no leakage occurred.
2.7. Ergonomic Modelling, Cost Analysis, and Data Handling
Ergonomic assessment was based on measured device mass, estimated centre-of-mass position, and cervical torque calculation. The atlanto-occipital region was considered the reference rotational axis for modelling the anterior load generated by the face-shield system, in accordance with anatomical and biomechanical descriptions of atlanto-occipital motion [
17]. Three device configurations were analysed: the basic shield without reservoir, the shield with an empty reservoir, and the shield with the 100 mL reservoir filled with disinfectant.
The centre of mass was estimated experimentally by balancing each configuration on a horizontal edge and measuring the distance from the headband reference point. The effective lever arm was calculated as the distance between the estimated centre of mass and the assumed atlanto-occipital rotational axis. Cervical torque was calculated according to the following formula:
where τ represents torque in N·m, W represents gravitational force in newtons, and r represents the effective lever arm in metres. Gravitational force was calculated as:
where m represents mass in kilograms. Torque values were reported in both N·m and N·cm.
Cost analysis was performed using a bottom-up approach based on direct material consumption. The estimated prototype cost included the PETG visor sheet, PETG filament, TPU gasket material, valve component, elastic fixation band, fastening elements, and estimated material loss during fabrication. Labour costs, equipment depreciation, packaging, sterilisation validation, regulatory approval, quality-control certification, and industrial-scale production costs were not included in the prototype-level estimate.
All quantitative data were entered into a structured electronic database. Statistical analysis was performed using GraphPad Prism, version 10.2.0 (GraphPad Software, Boston, MA, USA). Because this was a preclinical prototype-development and benchtop validation study without human participants, biological samples, or clinical comparison groups, the statistical analysis was primarily descriptive.
Continuous variables obtained from repeated technical measurements were expressed as mean ± standard deviation. When relevant, 95% confidence intervals for means were calculated using the t distribution according to the number of repeated measurements. Minimum values, maximum values, ranges, coefficients of variation, and percentage changes from baseline or nominal values were also calculated when appropriate. Dispensing-dose consistency was assessed using the mean dispensed volume, standard deviation, 95% confidence interval, range, and coefficient of variation across repeated valve activations.
For reservoir-capacity verification, dimensional measurements, mass measurements, and material-compatibility testing, results were expressed as absolute values and percentage deviations from baseline or nominal values. Chemical compatibility was assessed by comparing post-exposure mass change, dimensional deformation, and optical-transparency loss with predefined technical acceptance criteria. These criteria included mass change ≤1%, dimensional deformation ≤0.2 mm, optical-transparency loss ≤5%, absence of visible cracking, absence of stress-crazing under 20× magnification, preserved valve function, and absence of leakage.
No inferential statistical tests were applied because the study did not include independent biological, clinical, or experimental comparison groups designed for hypothesis testing. Accordingly, no sample-size calculation was performed. The objective of the statistical analysis was to verify whether the prototype met predefined technical performance criteria rather than to assess clinical efficacy or between-group differences.