Implementation of Statistical Process Control: Evaluating the Mechanical Performance of a Candidate Silicone Elastomer Docking Seal

The National Aeronautics and Space Administration has been developing a novel docking system to meet the requirements of future exploration missions to low-Earth orbit and beyond. A dynamic gas pressure seal is located at the main interface between the active and passive mating components of the new docking system. This seal is designed to operate in the harsh space environment, but is also to perform within strict loading requirements while maintaining an acceptable level of leak rate. In this study, a candidate silicone elastomer seal was designed, and multiple subscale test articles were manufactured for evaluation purposes. The force required to fully compress each test article at room temperature was quantified and found to be below the maximum allowable load for the docking system. However, a significant amount of scatter was observed in the test results. Due to the stochastic nature of the mechanical performance of this candidate docking seal, a statistical process control technique was implemented to isolate unusual compression behavior from typical mechanical performance. The results of this statistical analysis indicated a lack of process control, suggesting a variation in the manufacturing phase of the process. Further investigation revealed that changes in the manufacturing molding process had occurred which may have influenced the mechanical performance of the seal. This knowledge improves the chance of this and future space seals to satisfy or exceed design specifications

Validation of Test Methods for Air Leak Rate Verification of Spaceflight Hardware

As deep space exploration continues to be the goal of NASAs human spaceflight program, verification of the performance of spaceflight hardware becomes increasingly critical. Suitable test methods for verifying the leak rate of sealing systems are identified in program qualification testing requirements. One acceptable method for verifying the air leak rate of gas pressure seals is the tracer gas leak detector method. In this method, a tracer gas (commonly helium) leaks past the test seal and is transported to the leak detector where the leak rate is quantified. To predict the air leak rate, a conversion factor of helium-to-air is applied depending on the magnitude of the helium flow rate. The conversion factor is based on either the molecular mass ratio or the ratio of the dynamic viscosities. The current work was aimed at validating this approach for permeation-level leak rates using a series of tests with a silicone elastomer O-ring. An established pressure decay method with constant differential pressure was used to evaluate both the air and helium leak rates of the O-ring under similar temperature and pressure conditions. The results from the pressure decay tests showed, for the elastomer O-ring, that neither the molecular flow nor the viscous flow helium-to-air conversion factors were applicable. Leak rate tests were also performed using nitrogen and argon as the test gas. Molecular mass and viscosity based helium-to-test gas conversion factors were applied, but did not correctly predict the measured leak rates of either gas. To further this study, the effect of pressure boundary conditions was investigated. Often, pressure decay leak rate tests are performed at a differential pressure of 101.3 kPa with atmospheric pressure on the downstream side of the test seal. In space applications, the differential pressure is similar, but with vacuum as the downstream pressure. The same O-ring was tested at four unique differential pressures ranging from 34.5 to 137.9 kPa. Up to six combinations of upstream and downstream pressures for each differential pressure were compared. For a given differential pressure, the various combinations of upstream and downstream dry air pressures did not significantly affect the leak rate. As expected, the leak rate of the O-ring increased with increasing differential pressure. The results suggested that the current leak test pressure conditions, used to verify spacecraft sealing systems with elastomer seals, produce accurate values even though the boundary conditions do not model the space application

Complications Occurring Through 5 Years Following Primary Intraocular Lens Implantation for Pediatric Cataract

Importance Lensectomy with primary intraocular lens (IOL) implantation is often used in the management of nontraumatic pediatric cataract, but long-term data evaluating the association of age and IOL location with the incidence of complications are limited. Objective To describe the incidence of complications and additional eye surgeries through 5 years following pediatric lensectomy with primary IOL implantation and association with age at surgery and IOL location. Design, Setting, and Participants This prospective cohort study used Pediatric Eye Disease Investigator Group cataract registry data from 61 institution- and community-based practices over 3 years (June 2012 to July 2015). Participants were children younger than 13 years without baseline glaucoma who had primary IOL implantation (345 bilateral and 264 unilateral) for nontraumatic cataract. Data analysis was performed between September 2021 and January 2023. Exposures Lensectomy with primary IOL implantation. Main Outcome and Measures Five-year cumulative incidence of complications by age at surgery (<2 years, 2 to <4 years, 4 to <7 years, and 7 to <13 years) and by IOL location (sulcus vs capsular bag) were estimated using Cox proportional hazards models. Results The cohort included 609 eyes from 491 children (mean [SD] age, 5.6 [3.3] years; 261 [53%] male and 230 [47%] female). Following cataract extraction with primary IOL implantation, a frequent complication was surgery for visual axis opacification (VAO) (cumulative incidence, 32%; 95% CI, 27%-36%). Cumulative incidence was lower with anterior vitrectomy at the time of IOL placement (12%; 95% CI, 8%-16%) vs without (58%; 95% CI, 50%-65%), and the risk of undergoing surgery for VAO was associated with not performing anterior vitrectomy (hazard ratio [HR], 6.19; 95% CI, 3.70-10.34; P < .001). After adjusting for anterior vitrectomy at lens surgery, there were no differences in incidence of surgery for VAO by age at surgery (<2 years, HR, 1.35 [95% CI, 0.63-2.87], 2 to <4 years, HR, 0.86 [95% CI, 0.44-1.68], 4 to <7 years, HR, 1.06 [95% CI, 0.72-1.56]; P = .74) or by capsular bag vs sulcus IOL fixation (HR, 1.22; 95% CI, 0.36-4.17; P = .75). Cumulative incidence of glaucoma plus glaucoma suspect by 5 years was 7% (95% CI, 4%-9%), which did not differ by age after controlling for IOL location and laterality. Conclusions and Relevance In this cohort study, a frequent complication following pediatric lensectomy with primary IOL was surgery for VAO, which was associated with primary anterior vitrectomy not being performed but was not associated with age at surgery or IOL location. The risk of glaucoma development across all ages at surgery suggests a need for long-term monitoring