Peroxide Sterilization Research Articles

Material compatibility of epoxies exposed to repeated low temperature vaporized hydrogen peroxide sterilization

ABSTRACT Through technological advancements, medical devices have evolved in their designs and have become more complex in both their design and materials of construction. Medical grade biocompatible epoxies are widely used in reusable medical devices. Choosing an epoxy that maintains its performance characteristics when subjected to repeated sterilization throughout the reusable medical device’s lifespan is a known challenge for medical device manufacturers. This study evaluated the material compatibility of seven cured 2-part and 1-part epoxies used in medical devices following exposure to 100 cycles in a low temperature vaporized hydrogen peroxide sterilizer. Six of the seven epoxies tested were found to be compatible with vaporized hydrogen peroxide sterilization based on qualitative, hardness and weight measurements conducted post exposure to 100 VHP cycles. The epoxies deemed to be compatible displayed no visual signs of physical defects, minimal reduction in hardness (≤2%) and total weight gain (≤2.9%). One of the epoxy samples did not maintain its texture and exhibited 17% loss in hardness post exposure to 100 VHP sterilization cycles and was found to be incompatible with the low temperature vaporized hydrogen peroxide process. This study verifies the need for material compatibility evaluations of epoxies prior to designing and developing a medical device while keeping in mind the application, lifecycle and intended use of medical devices.

Effects of sterilization and disinfection methods on digitally designed surgical implant guide accuracy: An in vitro study.

Surgical guides are commonly used to assist with dental implant placement. This study investigated the effects of five sterilization and disinfection methods on the accuracy of implant guides. Thirty surgical guides (five in each group) were designed and printed (with digital light processing technology) using different sterilization or disinfection methods categorized into six groups: hydrogen peroxide sterilization (group one); glutaraldehyde sterilization (group two); autoclaving (group three); plasma sterilization (group four); iodophor disinfection (group five); and blank group (group six). Verification was determined using three methods: distance and angle between the cross-shaped marks, deformation after superimposing the guides, and displacement and axial changes in the virtual implant. After disinfection and sterilization, the guides in the autoclaving and iodophor groups showed a more pronounced color change and the guidein the autoclaving group had visible cracks. More significant changes were observed in the H2O2, glutaraldehyde, autoclaving, and iodophor groups regarding deformation after superimposing the guides and the distance and angle between the cross-shaped marks. The average labial deformation values (mm) of the first through fifth groups of guides were 0.283, 0.172, 0.289, 0.153, and 0.188, respectively. All groups were statistically different from the blank group for displacement and axial changes of the virtual implant (p < 0.05). The sizes of almost all surgical guides changed after sterilization and disinfection treatments, with between-group differences. Plasma sterilization was more suitable for surgical guide sterilization because of the smaller deformations after treatment.

Detrimental Effects of Sterilization Types on Single-Use Coronary Angioplasty Catheters for Reuse: An Electron Microscopic Study.

Reuse of medical devices poses risks concerning technical issues and patient safety. In this study, we aimed to examine the structural changes in catheters that occur due to the reuse with the aid of electron microscopy. The effects of hydrogen peroxide (HP) and ethylene oxide (EO) sterilization on four percutaneous transluminal coronary angioplasty (PTCA) catheters and control PTCA catheters were examined by scanning electron microscope (SEM). Each catheter sample was divided into four parts during the SEM examination, and a total of 20 pieces were examined. Catheters were reprocessed through every regular sterilization step and used solely for the study, not in patients. Statistical evaluations of histological scoring made on images obtained from scanning electron microscopic images were made using the GraphPad Prism 8 program. Electron microscopical examination showed that HP sterilization caused more robust and deeper lines compared to EO. These distortions increased directly with the increase in the reprocessing cycle. In EO, no significant damage was detected within five cycles in contrast to HP; however, the harmful effects of EO were seen over five cycles. Unprocessed samples had no damage. Outer and inner deterioration was significantly higher in the EO>5 group and HP>5 group than in the control group. However, the bacterial contamination score in the EO>5 group was higher than the control group. Our findings showed that HP and EO sterilizations caused some deterioration in the inner and outer surfaces of PTCA catheter samples. We recommend reprocessing using EO, the least damaging method, when necessary, and paying attention not to exceed five cycles when necessary.

Low temperature vaporized hydrogen peroxide sterilization of 3D printed devices

BackgroundLow temperature vaporized hydrogen peroxide sterilization (VH2O2) is used in hospitals today to sterilize reusable medical devices. VH2O2 sterilized 3D printed materials were evaluated for sterilization, biocompatibility and material compatibility.Materials & methodsTest articles were printed at Formlabs with BioMed Clear™ and BioMed Amber™, and at Stratasys with MED610™, MED615™ and MED620™. Sterilization, biocompatibility and material compatibility studies with 3D printed materials were conducted after VH2O2 sterilization in V-PRO™ Sterilizers. The overkill method was used to evaluate sterilization in a ½ cycle. Biocompatibility testing evaluated the processed materials as limited contact (< 24-hours) surface or externally communicating devices. Material compatibility after VH2O2 sterilization (material strength and dimensionality) was evaluated via ASTM methods and dimensional analysis.Results3D printed devices, within a specific design window, were sterile after VH2O2 ½ cycles. After multiple cycle exposure, the materials were not cytotoxic, not sensitizing, not an irritant, not a systemic toxin, not pyrogenic and were hemo-compatible. Material compatibility via ASTM testing and dimensionality evaluations did not indicate any significant changes to the 3D printed materials after VH2O2 sterilization.ConclusionLow temperature vaporized hydrogen peroxide sterilization is demonstrated as a suitable method to sterilize 3D printed devices. The results are a subset of the data used in a regulatory submission with the US FDA to support claims for sterilization of 3D printed devices with specified materials, printers, and device design 1.

1419. Evaluation of a vaporized hydrogen peroxide sterilization technology for duodenoscopes

Abstract Background Current methods for reprocessing duodenoscopes, including double high-level disinfection, are not effective in eliminating bacterial contamination. Thus, there is a need to develop effective and safe sterilization technologies for duodenoscopes. Methods We examined the effectiveness of a new hydrogen peroxide gas plasma sterilizer designed for terminal sterilization of flexible endoscopes. The technology directs vaporized hydrogen peroxide into all internal endoscope channels with a short exposure time and includes a sterilization container that facilitates sterile storage after processing. Test organisms included Bacillus atrophaeus and Clostridioides difficile spores, Escherichia coli, Enterococcus faecium, and Candida auris inoculated on steel wires or dispersed throughout the internal channels with 5% fetal calf serum. Results The technology reduced &amp;gt;108 colony-forming units (CFU) of the vegetative organisms to undetectable levels. B. atrophaeus and C. difficile spores on steel wires were eliminated by the technology ( &amp;gt;6 log10 CFU reduction) and spores disperse throughout the channels were reduced by &amp;gt;5 log10 CFU. No damage to the endoscopes was observed. Conclusion The sterilization technology was highly effective in reducing contamination of duodenoscopes in laboratory testing. Our results support further investigation of this technology in reducing contamination of in-use endoscopes. Disclosures William Rutala, MS, MPH, PhD, Ideate Medical: Advisor/Consultant|Ideate Medical: Stocks/Bonds|Kinnos: Advisor/Consultant|Kinnos: Stocks/Bonds|PDI: Advisor/Consultant|PDI: Honoraria

Behavior and linkage mechanism of extracellular polymers, cell membrane peroxides and intracellular peroxidases during high concentration vaporized hydrogen peroxide sterilization

Vaporized hydrogen peroxide (VHP) sterilization has been widely used in the fields of medical care and pharmaceuticals. Extracellular polymeric substances (EPS) connected tightly to the cell membrane is first barrier that must be broken through, and less is known about direct change of cell membrane peroxides, and the linkage mechanism among EPS, cell membrane and intracellular damages is still unclear during high concentration VHP sterilization. After optimizing the VHP sterilization process of specific drug-packaging equipment based on the sterility assurance level of 10−6 cfu, we studied the degradation kinetics of exopolysaccharide, exoprotein, extracellular DNA, and investigated the changes of cell membrane lipid/protein peroxides and intracellular peroxidases, and discussed the linkage mechanism of microbial EPS, cell membrane and intracellular damages during high concentration VHP sterilization. The results indicated: (1) The order of degradation kinetics of microbial EPS was exopolysaccharide > exoprotein > extracellular DNA, it was the key to achieve fast and effective VHP sterilization that sufficient high concentration VHP (>400 ppm) was adopted to rapidly destroy EPS (>20 min), resulting in the serious destruction of proteins and lipids of cell membrane; (2) The key mechanism of short time sterilization using high concentration VHP was that the serious loss of the structure/function of cell membrane was the most fatal but the damage of intracellular enzymes and DNA was limited for bacterial cell living.

Filtration performance, fit test and side effects of respiratory personal protective equipment following decontamination: Observations for user safety and comfort.

While facing personal protective equipment (PPE) shortages during the COVID-19 pandemic, several institutions looked to PPE decontamination and reuse options. This study documents the effect of two hydrogen peroxide treatments on filtration efficiency and fit tests as well as the side effects for volunteers after the decontamination of N95 filtering facepiece respirators (FFRs). We also propose an efficient and large-scale treatment protocol that allows for the traceability of this protective equipment in hospitals during PPE shortages. The effects of low-temperature hydrogen peroxide sterilization and hydrogen peroxide vapor (HPV) on two FFR models (filtration, decontamination level, residual emanation) were evaluated. Ten volunteers reported comfort issues and side effects after wearing 1h FFRs worn and decontaminated up to five times. The decontamination process does not negatively affect FFR efficiency, but repeated use and handling tend to lead to damage, limiting the number of times FFRs can be reused. Moreover, the recommended 24-h post-treatment aeration does not sufficiently eliminate residual hydrogen peroxide. Prolonged aeration time increased user comfort when using decontaminated FFRs. HPV and low-temperature hydrogen peroxide sterilization seem to be appropriate treatments for FFR decontamination when the PPE is reused by the same user. PPE decontamination and reuse methods should be carefully considered as they are critical for the comfort and safety of healthcare workers.

Geobacillus stearothermophilusandBacillus atrophaeusspores exhibit linear inactivation kinetic performance when treated with an industrial scale vaporized hydrogen peroxide (VH2O2) sterilization process

This study aims to determine the inactivation kinetics of Geobacillus stearothermophilus and Bacillus atrophaeus biological indicators, treated with vaporized hydrogen peroxide (VH2O2) at an industrial scale. There is an assumption that sterilization processes generate linear kinetic plots of treated biological indicators that are used for informing probability-based decision-making by the MedTech industry for effective sterilization treatments; however, this has not been reported for sterilization using VH2O2. Survivor curves were generated, and sterilization performances were separately determined using G. stearothermophilus and B. atrophaeus biological indicators following the development of appropriate process challenge devices (PCDs). Regression analysis revealed that the inactivation kinetics for VH2O2-treated microorganisms exhibited log linear profiles. The use of scanning electron microscope (SEM) revealed no significant topographical changes in the outer surface of these VH2O2-treated spores. Both biological indicators exhibited log linear inactivation kinetics when treated with an industrial scale vaporized hydrogen peroxide (VH2O2) sterilization process. Therefore, this novel finding corroborates and proves the appropriateness of using VH2O2 as a sterilization method in accordance with applicable ISO standards.

Qualification de stérilisateurs à basse température au peroxyde d’hydrogène : vers une meilleure harmonisation des pratiques ?

Comparing performance qualification procedures for low temperature vaporized hydrogen peroxide sterilization. Assessing conformity with draft standard ISO/DIS 22441. Qualification reports from several providers have been compared according to specific criteria: choices of cycles, loads, sterile barrier systems, probes, biological and chemical indicators; checking of packaging integrity and exposure to sterilizing agent. Six out of 8reports based on 4distinct sterilizers have been performed by third-party providers. Routine and process challenge devices are respectively used in 6and 3of these reports. Sizes and masses are never mentioned whereas load configuration is always specified. All reports use at least one biological indicator and 50% of them use one chemical indicator at a minimum. Most frequent wrapping materials are Ultra® and Tyvek® bags (respectively 50% and 37.5% of reports). Each qualification monitors per process pression and temperature, and 37.5% of them also quantify hydrogen peroxide concentration. Packaging integrity and environmental exposure are checked in respectively 50% and 12.5% of all reports. All reports have received providers approval. Qualification procedure is based on steam sterilization NF EN 14937standard, which seems unsuitable for low temperature process. The lack of autonomy, the heterogeneity of loads and measurement choices reveal a low harmonization of practices. New standard should dispel the doubts about this heterogeneity.

Comprehensive approach to utilize hydrogen peroxide sterilization and urea as nitrogen source for ethanol production from oil palm trunk

Comprehensive approach to utilize hydrogen peroxide sterilization and urea as nitrogen source for ethanol production from oil palm trunk

Does vaporized hydrogen peroxide sterilization affect the geometrical properties of anatomic models and guides 3D printed from computed tomography images?

BackgroundMaterial extrusion is used to 3D print anatomic models and guides. Sterilization is required if a 3D printed part touches the patient during an intervention. Vaporized Hydrogen Peroxide (VHP) is one method of sterilization. There are four factors to consider when sterilizing an anatomic model or guide: sterility, biocompatibility, mechanical properties, and geometric fidelity. This project focuses on geometric fidelity for material extrusion of one polymer acrylonitrile butadiene styrene (ABS) using VHP.MethodsDe-identified computed tomography (CT) image data from 16 patients was segmented using Mimics Innovation Suite (Materialise NV, Leuven, Belgium). Eight patients had maxillary and mandibular defects depicted with the anatomic models, and eight had mandibular defects for the anatomic guides. Anatomic models and guides designed from the surfaces of CT scan reconstruction and segementation were 3D printed in medical-grade acrylonitrile butadiene styrene (ABS) material extrusion. The 16 parts underwent low-temperature sterilization with VHP. The dimensional error was estimated after sterilization by comparing scanned images of the 3D printed parts.ResultsThe average of the estimated mean differences between the printed pieces before and after sterilization were − 0,011 ± 0,252 mm (95%CI − 0,011; − 0,010) for the models and 0,003 ± 0,057 mm (95%CI 0,002; 0,003) for the guides. Regarding the dimensional error of the sterilized parts compared to the original design, the estimated mean differences were − 0,082 ± 0,626 mm (95%CI − 0,083; − 0,081) for the models and 0,126 ± 0,205 mm (95%CI 0,126, 0,127) for the guides.ConclusionThis project tested and verified dimensional stability, one of the four prerequisites for introducing vaporized hydrogen peroxide into 3D printing of anatomic models and guides; the 3D printed parts maintained dimensional stability after sterilization.

Submerged Bioreactor Production of Geobacillus stearothermophilus ATCC 7953 Spores for Use as Bioindicators to Validate Hydrogen Peroxide Inactivation Processes

In the food and pharmaceutical industries, evaluating the sterilization performance preceding aseptic production processes is of central importance. In the case of hydrogen peroxide sterilization of solid surfaces, bioindicators (BI) consisting of spores of Bacillus atrophaeus or Geobacillus stearothermophilus are used to validate the effectiveness and efficiency of the inactivation procedure. Commercial production of G. stearothermophilus is commonly performed on agar plates, where cultivation and sporulation conditions are not well-defined. Therefore, the produced BI can vary in their resistance, which in turn creates unacceptable uncertainties in the evaluation of aseptic processes. Submerged production in the bioreactor would allow more control over sporulation conditions, while reducing production time, resistance variability, and avoidance of false-positive or false-negative test results. In addition, submerged production of G. stearothermophilus so far was a challenge to achieve sufficiently high spore concentrations for BI production. This study reports on the development of a method for submerged production of G. stearothermophilus spores (pH 7.0, 57 °C, 30% pO2) that can achieve 1.6 × 107 spores/mL with a resistance against 35% H2O2 at 25 °C of D25°C,35% H2O2 = 73 s. This resistance ranks within the range of commercially available BI, making the results directly transferable to industrial applications.

Flexible gastrointestinal endoscope processing challenges, current issues and future perspectives

At present, the most frequent method for processing flexible gastrointestinal (GI) endoscopes is cleaning followed by high-level disinfection as terminal sterilization is often not practicable. Post-processing monitoring studies consistently show high levels of positive cultures remaining on endoscopes, which can lead to patient infection and even fatality. The processing deficiency is attributed to the complex design of endoscopes, incomplete cleaning, formation of biofilms and lack of margin of safety with high-level disinfection. To demonstrate that flexible GI endoscopes can be practicably terminally sterilized. An endoscope sterilization cycle was developed in a vaporized hydrogen peroxide sterilization system. The cycle was used to study the sterilization of flexible GI endoscopes which included colonoscopes and duodenoscope and material compatibility for both original flexible GI endoscopes and those experimentally modified endoscopes using compatible materials. Testing demonstrated that the vaporized hydrogen peroxide can sterilize flexible GI endoscopes (colonoscopes, duodenoscope) with a sterility assurance level of 10-6. Additionally, no recoverable survivors were detected when devices were artificially soiled with hard water and serum. Material compatibility test results demonstrated that replacing molybdenum disulphide lubricant with a graphite-based inert lubricant can make them compatible with vaporized hydrogen peroxide sterilizers. Flexible GI endoscopes can be practicably terminally sterilized using vaporized hydrogen peroxide sterilization technologies if their materials are revised to become compatible.

Opportunities for the application of real-time bacterial cell analysis using flow cytometry for the advancement of sterilization microbiology.

Medical devices provide critical care and diagnostic applications through patient contact. Sterility assurance level (SAL) may be defined as the probability of a single viable micro-organism occurring on an item after a sterilization process. Sterilization microbiology often relies upon using an overkill validation method where a 12-log reduction in recalcitrant bacterial endospore population occurs during the process that exploits conventional laboratory-based culture media for enumeration. This timely review explores key assumptions underpinning use of conventional culture-based methods in sterilization microbiology. Consideration is given to how such methods may limit the ability to fully appreciate the inactivation kinetics of a sterilization process such as vaporized hydrogen peroxide (VH2O2) sterilization, and consequently design efficient sterilization processes. Specific use of the real-time flow cytometry (FCM) is described by way of elucidating the practical relevance of these limitation factors with implications and opportunities for the sterilization industry discussed. Application of FCM to address these culture-based limitation factors will inform real-time kinetic inactivation modelling and unlock potential to embrace emerging opportunities for pharma, medical device and sterilization industries including potentially disruptive applications that may involve reduced usage of sterilant.

Research on the sterilization effect of hydrogen peroxide and equipment optimizatio

Hydrogen peroxide sterilization is widely used in food packaging, public health and other fields. The sterilization effect is related to the vaporization spray time and nozzle parameters. This paper uses AnsysFluent software to mathematically simulate the flow field and concentration distribution of vaporized hydrogen peroxide in the sterilization space; and verify the correctness of the numerical simulation results through field experiments. UDF module is used to describe the component concentration of the nozzle, and the distribution of vaporized hydrogen peroxide is analyzed by changing the nozzle spray angle and spray speed of the equipment, and the spray time T required to reach the standard concentration in the sterilization space is the shortest and the hydrogen peroxide dosage Q is the minimum For the goal, optimize the design parameters. The results show that when the spray speed is 4.8m/s and the spray angle is -18°, the spray time required to reach the sterilization standard is the shortest, and the amount of hydrogen peroxide is the least. This article provides a theoretical basis for the improvement of vaporized hydrogen peroxide sterilization equipment.

Evaluation of Low-Temperature Sterilization using Hydrogen Peroxide Gas Containing Peracetic Acid.

In low-temperature sterilization for the medical field, hydrogen peroxide sterilization is widely used for its safety. However, its low penetrability and residual amount of sterilant are major concerns. Recently, the combination of hydrogen peroxide and peracetic acid has been found to enforce sporicidal effect, with low concentration in hydrogen peroxide. The application of this finding in medical sterilization is still very limited. To elucidate the combination effect, we compare peracetic acid containing hydrogen peroxide gas sterilizer and conventional hydrogen peroxide gas (plasma) sterilizers. The sterilant penetrability was examined in hollow load process challenge devices with inner diameters of 1 and 2 mm and lengths of 1, 2, and 3 m. As a result, peracetic acid containing hydrogen peroxide gas sterilizer demonstrated total inactivation with all diameters and lengths and achieved the highest sterilant penetrability in this study. The amount of residual sterilant on the surface of the sterilized object was 4.2 μg/cm2, which corresponds to half amount of those of conventional hydrogen peroxide gas sterilizers. These results suggest that the addition of peracetic acid to hydrogen peroxide gas sterilizer can enhance sterilization efficiency and safety.

Sterilizálási lehetőségek a fogászatban. Rugalmas anyagok csírátlanításának korlátai egy eset kapcsán

In everyday dental practice, sterility is essential. Sterilizing different materials can require different methods. In the case of heat sensitive and elastic materials, most common techniques are not suitable because they need to be treated on lower temperature, not to lose their physical properties. For instance, if rubber dam is divested of elasticity, it is useless in restorative dentistry thereafter. Sterilizing rubber dam sheets is not a frequent process, but in certain cases it can be necessary. In such a situation, dentists have to choose between rare and hard-to-reach options. In our referral, we summarize the possibilities of sterilization, focusing on plasma sterilization and hydrogen-peroxide vapor sterilization. During the treatment of our presented case with a deep subgingival fracture line, affecting the crown and the root surface as well, we applied a rubber dam sheet, sterilized with hydrogen-peroxide vapor in order to use adhesive technique. Orv Hetil. 2020; 161(3): 110-115.

How to Sterilize 3D Printed Objects for Surgical Use? An Evaluation of the Volumetric Deformation of 3D-Printed Genioplasty Guide in PLA and PETG after Sterilization by Low-Temperature Hydrogen Peroxide Gas Plasma

Introduction: In the present time, there is rapid development in the application of 3D printing technology in surgery. One of the challenges encountered by the surgeon is the sterilization of these 3D-printed objects for use in the operating room. Materials and Methods: Forty-two identical cutting guides used for genioplasty were 3D-printed: twenty-one in Polylactic acid (PLA) and twenty-one in Polyethylene terephthalate glycol (PETG). The guides were CT scanned after printing. They were then sterilized with the low-temperature hydrogen peroxide gas plasma technique (Sterrad®). A CT scan of the guides was also performed at T1 (after printing) and T2 (after sterilization). A software (Cloudcompare ®) was then used to accurately compare the volume of each guide at T0 (the initial computer-aided designed guide) vs T1 and T1 vs T2. Statistical analysis was then performed. Results: Although there are differences that are statistically significant for each series between T0 and T2 and T1 and T2 for both PLA and PETG, this had no impact on the clinical use of sterilized objects using hydrogen peroxide sterilization technique because these morphological differences were minimal at less than 0.2mm. Conclusion: Morphological deformations induced by the hydrogen peroxide sterilization are sub-millimeter and acceptable for surgical use. The hydrogen peroxide sterilization is, therefore, an alternative to avoid the deformation of 3D-printed objects made from PLA and PETG during conventional steam sterilization (autoclave). To the best of our knowledge, this is the first study regarding the morphologic deformation of 3D-printed objects in PLA and PETG after sterilization for medical use.

Performance and microbiological safety testing after multiple use cycles and hydrogen peroxide sterilization of a 5-mm vessel-sealing device.

To evaluate the functional and microbiological safety of a single-use laparoscopic vessel-sealing device in a multiuse setting. Ex vivo study. Twelve 5-mm LigaSure Maryland jaw devices. Handsets underwent repeated test cycles until failure. The handset packaging was opened, and handsets were agitated in phosphate-buffered saline (PBS). The PBS was removed, centrifuged, and submitted for culture. Canine ovariectomy was simulated on cadaveric tissue, after which vascular seal quality was evaluated by pressure testing of sealed porcine carotid arteries. The handsets were cleaned and sterilized with hydrogen peroxide gas and repackaged. Mean ± SD cycles to failure was 7.7 ± 2.8, with a minimum of 4 and a maximum of 12 use cycles achieved. Eleven of the 12 handsets failed by failure of handset activation after depression of the activation trigger. Only 1 handset failed to hold an adequate vascular seal under 300 mm Hg of pressure. No handset exhibited positive bacterial culture at any cycle. The sterilization method used in this study resulted in an excellent microbiological safety profile. Most of the handsets failed by activation button failure. Under the conditions of this study, hydrogen peroxide sterilization achieved microbiological safety. Handsets can successfully be reused until activation button failure without negative effects on the vascular seal or increased risk of infection to the patient.

A Ground Support Biobarrier (GSB) for recontamination prevention

Planetary Protection organizations at the National Aeronautics and Space Administration (NASA), the European Space Agency (ESA), and other space agencies around the world are charged with protecting icy moons and Mars Special Regions, areas that carry an increased potential for life, from Earth biological contamination. During the spacecraft assembly process subsystems undergo functional testing, a task that verifies critical components can survive from launch through the duration of the mission. Despite efforts to keep spacecraft clean during these ground testing operations, as well as during transportation, recontamination frequently occurs and results in the need to re-clean the spacecraft, putting stress on the spacecraft assembly critical path. In response, the Biotechnology and Planetary Protection Group (BPPG) at NASA Jet Propulsion Laboratory (JPL) has designed a Ground Support Biobarrier (GSB) capable of protecting flight hardware continuously from an up-to 150 °C Heat Microbial Reduction (HMR) sterilization through hardware integration with the spacecraft, itself. The biobarrier consists of aluminum brackets bolted together and covered with thin aluminum sheets sealed via epoxy. The base plate of the biobarrier contains bolt connections and a gasket to ensure that all venting is through the HEPA-filtered vent when the biobarrier is closed. Additionally, the GSB allows for vapor hydrogen peroxide (VHP) sterilization as well as the ability to functionally test hardware without opening the barrier. The GSB provides a safety-net against microbiological re-contamination during critical functional testing, decreasing the need for re-cleaning and reducing schedule impact risk.