STEMart, a US-based provider of comprehensive services for all phases of medical device development, proudly announces the launch of its new Sterile Barrier & Seal Integrity Testing services for medical device manufacturers to optimize packaging design and performance. This suite of tests ensures the safety and efficacy of medical devices by guaranteeing the integrity of their packaging throughout processing, distribution, and storage.
Medical devices, pharmaceuticals and other healthcare products rely on sterile packaging to maintain sterility until they reach the end user. Any breach in the sterile barrier can jeopardize patient safety, lead to infection, and compromise the efficacy of the sealed product. STEMart's new Sterile Barrier & Seal Integrity Testing solutions address these issues.
STEMart offers state-of-the-art technology and facilities for multiple strength and integrity testing of packaging to assist manufacturers in optimizing package design and performance. To ensure that medical packaging does not lose its integrity during processing or distribution, the company provides strength testing, including tensile and burst testing, and integrity testing (including bubble emission and dye immersion), as well as whole package integrity testing.
With expertise in consulting, package validation (including packaging and sterilization configurations), material qualification, and package development STEMart provides a full-service experience that supports manufacturers achieve regulatory goals and minimize compliance risks. For example, STEMart technicians meticulously examine empty packages or packaged products for wrinkles, unevenness or channeling at sealed seams. This Visual Inspection service helps identify potential issues early in the process. Peel testing is also offered to closely inspect peeled seams to assess package uniformity and defects or wear, providing further insight into seal strength and integrity.
The STEMart Whole Package Integrity Tests are a series of tests designed to assess the integrity of the entire finished product package. These comprehensive tests include both microbial and sterility testing to determine if any indicator organisms have penetrated the packaging. They are typically performed on various packaging formats, including pouches, trays, syringes, IV bags, tubing sets, vials, and containers.
STEMart is committed to innovating and enhancing its testing capabilities to meet the evolving needs of the medical device industry. These latest testing methods ensure every package maintains its sterility throughout the entire supply chain, enabling patient safety and peace of mind for healthcare professionals. STEMart will continue to provide its customers with the highest quality medical device packaging solutions.
By offering cutting-edge testing solutions, STEMart helps to ensure the quality and safety of the medical device packaging industry. If you have any questions or would like to learn more about the Medical Device Sterile Barrier & Seal Integrity Testing solutions, please visit https://www.ste-mart.com/sterile-barrier-seal-integrity-testing.htm.
About STEMart
STEMart is an industry-leading eCommerce platform incorporated with an extensive global footprint and a broad portfolio of more than 10,000 products. It aims to provide better lab materials, medical instruments and consumables, excellent technologies, and high-quality services to global customers in the fields of science, technology, and engineering, from the discovery stage upward to the manufacturing process. STEMart is dedicated to enhancing research and biotech production with simpler and safer protocols to access better health worldwide.
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STEMart, a US-based provider of comprehensive services for all phases of medical device development, proudly announces the launch of its comprehensive suite of Packaging Solutions to meet the unique needs of the pharmaceutical and medical device industries. These services are designed to ensure the quality, sterility, and regulatory compliance of medical devices throughout their lifecycle.
Packaging is an advertisement for a brand. Effective packaging that meets the needs of the pharmaceutical or medical device industry should be able to validate the quality of the seals and the overall packaging to ensure the stability of the packaged samples, the integrity for clinical trials and production runs, and the shelf life of the medication, thus providing safe and effective products to the marketplace.
“Packaging for terminally sterilized medical devices-Part 1: Requirements for materials, sterile barrier systems and packaging systems,” part of the International Organization for Standardization’s ISO 11607-1:2019, provides a general approach to the requirements for materials, prefabricated sterile barrier systems, sterile barrier systems and packaging systems intended to maintain the sterility of terminally sterilized medical devices until use.
STEMart offers state-of-the-art technology and facilities to provide comprehensive medical device packaging solutions, e.g., the Sterile Barrier / Seal Integrity Testing, Package Material Testing, Real-time Aging Testing, Transportation and Distribution Simulation Studies, and Accelerate Aging Testing. STEMart’s expertise in consulting, packaging validation (including packaging and sterilization configurations), material qualification, and packaging development provides a full-service experience that assists manufacturers in achieving regulatory goals and minimizing compliance risks.
For example, STEMart offers a wide range of strength and seal integrity testing services, including seal peel and burst testing, bubble emission testing, and dye migration testing to assess overall package integrity. Furthermore, STEMart provides a wide variety of options for package material testing. This in-depth analysis empowers manufacturers to optimize their packaging design and guarantee the best possible performance for their products.
In addition, STEMart takes quality assurance a step further by offering both real-time and accelerated aging testing. Real-time aging testing can help customers evaluate the preparation, sterilization, and storage of packaging materials/systems under real-time aging conditions during testing. For situations requiring a faster evaluation, STEMart offers accelerated aging tests that utilizes elevated temperatures to simulate real-time aging and artificially accelerate the aging process, providing valuable insights in a condensed timeframe.
With a commitment to excellence and a focus on safety, STEMart can provide medical device manufacturers with cost-effective, comprehensive services that deliver reliable results. The company's experts can evaluate medical devices and propose appropriate test plans to ensure regulatory compliance.
STEMart offers various services to ensure that medical devices are packaged effectively to maintain sterility, meet regulatory requirements, and deliver a positive brand experience. If you have additional questions or would like to find out more about Medical Device Packaging Solutions, please visit https://www.ste-mart.com/medical-device-packaging-solutions.htm.
About STEMart
STEMart is an industry-leading eCommerce platform incorporated with an extensive global footprint and a broad portfolio of more than 10,000 products. It aims to provide better lab materials, medical instruments and consumables, excellent technologies, and high-quality services to global customers in the fields of science, technology, and engineering, from the discovery stage upward to the manufacturing process. STEMart is dedicated to enhancing research and biotech production with simpler and safer protocols to access better health worldwide.
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STEMart, a US-based provider of comprehensive services for all phases of medical device development, is proud to announce the launch of its new Pilot Production Services for the medical device industry. These services allow manufacturers to test and refine their products prior to full-scale production, streamlining the development process of new medical devices and minimizing risk to save time and costs.
Pilot production is the process of manufacturing a device using a process that is close to or equivalent to the production process. It is a critical process for devices that are being tested in clinical trials or pilot markets prior to full-scale production. If a manufacturer's medical device is successful in a pilot market or clinical trial, it may be possible to move to full- scale production. However, if a medical device is found to be defective during the pilot production phase, rework may be required. Rework costs more time and money. Therefore, manufacturers need to find a medical device company that takes the integrity of the process seriously.
As a full-service provider specializing in medical device development, STEMart offers clients pilot production services to address critical aspects such as process development, design and construction of assembly tools and fixtures, process FMEA, device master records, design transfer to manufacturing, process validation, and manufacturing of clinical and low-volume commercial products. STEMart meticulously customizes its solutions to meet clients’ specific device requirements and budget during pilot production.
During the pilot manufacturing phase, STEMart's engineers will work closely with the contract manufacturer to develop the product design and quality assurance process and iteratively implement any necessary changes prior to full production, as design changes can be costly and significantly delay the project. STEMart’s experienced engineers can identify potential problems and difficulties, saving the customer significant time and money.
In addition, STEMart studies the customer's design and process for early iterative improvements, and the company's onsite talent and resources ensure that the client has the best possible process before committing to major capital expenditures. STEMart's team of experienced professionals has a proven track record of successfully helping its clients bring innovative medical devices to market. By partnering with STEMart for the pilot production needs, medical device manufacturers can benefit from STEMart's expertise, experience, and commitment to quality.
With a dedication to innovation and excellence, STEMart enables clients to achieve a seamless transition from pilot production to full-scale manufacturing, saving clients' time and costs. If you have additional questions or would like to find out more about Medical Device Pilot Production Services, please visit https://www.ste-mart.com/pilot-production-of-medical-devices.htm.
About STEMart
STEMart is an industry-leading eCommerce platform incorporated with an extensive global footprint and a broad portfolio of more than 10,000 products. It aims to provide better lab materials, medical instruments and consumables, excellent technologies, and high-quality services to global customers in the fields of science, technology, and engineering, from the discovery stage upward to the manufacturing process. STEMart is dedicated to enhancing research and biotech production with simpler and safer protocols to access better health worldwide.
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STEMart, a US-based provider of comprehensive services for all phases of medical device development, proudly announces the launch of its new Medical Device Prototyping Services. Using the latest technologies, these reliable prototyping solutions can help medical device companies streamline the development process and test new products quickly and cost-effectively, saving time and resources.
Prototyping is the process of creating a primary version of a product for visualization and conceptualization. In general, prototypes fall into two main categories: functional and non-functional. Functional prototypes give people an idea of the basic form and function of a product. Non-functional prototypes are used to provide people with a non-digital representation of the product. In the case of medical device prototyping, a functional prototype is not a prototype that can be used in the marketplace because it is not the final product, but rather a functional example that can be used to develop a better version of the final product.
Prototyping plays a crucial role in the medical device development process. It produces functional samples based on precise design and material specifications for use in product testing and evaluation and commercial demonstrations. These samples allow manufacturers to perform engineering and design validation and determine if changes are needed before moving to mass production and commercial distribution. In addition, prototypes facilitate team alignment by providing a clear representation of the device concept, thereby improving collaboration.
Furthermore, although end-customers (e.g., physicians, nurses, and surgeons) cannot use the medical device prototype directly, they can physically interact with it, offering valuable feedback before significant resources are invested in full-scale production. Overall, prototyping contributes to successful medical device development.
With a commitment to innovation and excellence, STEMart offers reliable rapid prototyping solutions to meet the needs of the medical device industry. These prototyping services provide significant value in confirming the feasibility or attractiveness of an idea, comparing the functionality of different concepts, and eliminating costly mistakes early on, helping manufacturers streamline the development process, saving time and resources that may be wasted pursuing flawed concepts.
STEMart utilizes the latest technologies, including 3D printing (e.g., stereolithography and fused deposition modeling), computer numerical control (CNC) machining, screw and photochemical machining, photochemical machining, and reactive injection molding, to produce complete and reliable prototypes for medical device companies. With this high-fidelity demonstrator, manufacturers can put their ideas into practice and gather feedback, input, and validation.
STEMart offers a full range of services covering all stages of development to accelerate its clients' medical device programs. If you have additional questions or would like to find out more about Medical Device Prototyping Services, please visit https://www.ste-mart.com/medical-device-prototyping.htm.
About STEMart
STEMart is an industry-leading eCommerce platform incorporated with an extensive global footprint and a broad portfolio of more than 10,000 products. It aims to provide better lab materials, medical instruments and consumables, excellent technologies, and high-quality services to global customers in the fields of science, technology, and engineering, from the discovery stage upward to the manufacturing process. STEMart is dedicated to enhancing research and biotech production with simpler and safer protocols to access better health worldwide.
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STEMart, a US-based provider of comprehensive services for all phases of medical device development, is proud to announce the launch of its innovative Medical Device Development Services covering various product categories, including medical imaging devices, surgical equipment, therapeutic devices, patient monitoring, drug delivery systems, emergency care systems, oral appliances, and automated lab equipment.
Today's healthcare and life sciences companies face significant cost pressures and the need to develop new and innovative products in shorter timeframes. Medical device companies have to overcome many significant challenges to bring new products to market. In addition to the high cost of the entire product design, development, and manufacturing process, medical device product development often involves cutting-edge technologies and stringent regulatory requirements that further complicate the process.
To address these challenges, STEMart offers a full range of services covering all stages of development to accelerate clients' medical device projects from initial concept through product design, development and validation to manufacturing and launch. Clients will have a multidisciplinary and specialized technical partner to support all aspects of the project, making well-defined and informed decisions to avoid costly mistakes, ensure desired quality and accelerate time to market.
From Concept & Requirement Definition and Development, STEMart's team gathers all the information necessary to create well-defined medical device designs that ensure reliable performance and regulatory compliance, helping clients turn brand new medical devices or early concepts into focused, detailed engineering solutions. The company's engineers help solve complex mechanical, electronic, and software challenges to deliver high-performance medical devices.
STEMart's Product Prototyping and Testing services are valuable for confirming the feasibility or appeal of an idea, comparing the functionality of different concepts, and avoiding costly mistakes early on. This phase also includes risk management activities, technical validation of prototypes, functional testing, and human factors/usability evaluation.
During the Pilot Production phase, STEMart brings together project, manufacturing, and quality engineers to oversee the development of production tooling and production line configuration, perform process validation, and complete risk management activities, including the Process FMEA.
Additionally, STEMart's Testing and Verification services ensure that products meet functionality, reliability, usability, and safety requirements through rigorous verification and validation testing. STEMart will also provide comprehensive and rigorous program management oversight during the full manufacturing phase.
Whether developing a new device or improving an existing one, STEMart has the experience to help clients address the design, engineering, manufacturing and regulatory challenges unique to the medical device development process. The company's engineers, physicists, industrial designers, and regulatory and manufacturing experts can work with the client's team to ensure the best possible outcome.
If you have additional questions or would like to find out more about STEMart's Medical Device Development Services, please visit https://www.ste-mart.com/medical-device-development-service.htm.
About STEMart
STEMart is an industry-leading eCommerce platform incorporated with an extensive global footprint and a broad portfolio of more than 10,000 products. It aims to provide better lab materials, medical instruments and consumables, excellent technologies, and high-quality services to global customers in the fields of science, technology, and engineering, from the discovery stage upward to the manufacturing process. STEMart is dedicated to enhancing research and biotech production with simpler and safer protocols to access better health worldwide.
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STEMart, a US-based provider of comprehensive services for all phases of medical device development, announced the launch of its new Force Degradation Services to help pharmaceutical and medical device companies evaluate the stability of their drug candidates and finished products under a variety of stress conditions, ensuring their safety and efficacy throughout their shelf life.
Forced degradation studies are used to demonstrate the molecular chemical behavior of processed products that may undergo degradation. These studies are typically performed prior to final formulation as they provide a rapid screening of material stability under external stress. It is important to note that in forced degradation studies, the degradation products generated in the stressed sample are referred to as "potential" degradation products, which may or may not be formed under the relevant storage conditions.
STEMart now offers various Forced Degradation Services, including hydrolytic degradation, oxidative degradation, photolytic degradation and thermolytic degradation. STEMart can provide comprehensive services to assist manufacturers in meeting regulatory goals and minimize compliance risk through extensive expertise.
Degradation by hydrolysis is hydrolytic degradation. Hydrolysis reactions are usually catalyzed by acids or bases. STEM recommends that hydrolytic degradation be performed at temperatures around 70 degrees Celsius, with a reflux condenser installed to avoid evaporation losses and a small number of glass beads or ceramic tiles used to avoid collisions, and that stress reflux always be performed in a fume hood.
Oxidative degradation is one of the most common mechanisms of drug degradation and is usually performed at room temperature under dark conditions. It is not recommended to perform it at higher temperatures because at higher temperatures the rate of reaction in solution may actually decrease due to the reduction of oxygen content in the solvent. Typical Stress Conditions: 24 hours exposure to 3% hydrogen peroxide or 5% to 20% degradation, whichever comes first.
Photolytic degradation is degradation that results from exposure to UV or visible light. Typical exposure conditions for this type of forced degradation study are three exposures to 1.2 million lux-hours of visible light and 200 watt-hours per square meter of UV light.
Pyrolytic degradation studies include various reactions such as pyrolysis, hydrolysis, decarboxylation, isomerization, rearrangement, and polymerization. These reactions determine the melting point of the analyte. The general procedure is to stress and monitor the samples for one week, during which time the samples are tested to achieve a degradation rate of 5% to 20%, and the molecule is considered stable if no degradation occurs after more severe stress is applied.
If you have additional questions about Force Degradation Services or would like to find out more about Medical Device Testing services, please visit https://www.ste-mart.com/forced-degradation.htm.
About STEMart
STEMart is an industry-leading eCommerce platform incorporated with an extensive global footprint and a broad portfolio of more than 10,000 products. It aims to provide better lab materials, medical instruments and consumables, excellent technologies, and high-quality services to global customers in the fields of science, technology, and engineering, from the discovery stage upward to the manufacturing process. STEMart is dedicated to enhancing research and biotech production with simpler and safer protocols to access better health worldwide.
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STEMart, a US-based provider of comprehensive services for all phases of medical device development, has announced the launch of its new Filter Testing Services for pharmaceutical and medical device manufacturers. These services are designed to help manufacturers ensure the safety and efficacy of their products by verifying the performance of filters used in the manufacturing process.
Filtration sterilization is an important unit operation in the aseptic manufacturing process. It requires proper process validation to verify the performance of the filters used for sterilization filtration. Filter testing is used to evaluate a filter’s ability to separate microorganisms of various sizes and helps manufacturers determine membrane pore size. This test is also an excellent batch release test. Test data can also be used as an effective marketing tool.
STEMart provides comprehensive facility and process validation for medical devices. With extensive expertise in Filter Testing, STEMart can provide a full service experience to assist manufacturers in meeting regulatory goals and minimizing compliance risks. The comprehensive Filter Testing services are guided by “Sterile Drug Products Produced by Aseptic Processing – Current Good Manufacturing Practice”, the FDA guidance document for industry, which outlines the general considerations the FDA believes should be taken into account when performing filter testing for a medical device.
STEMart offers a wide range of Filter Testing services. For example, Retention Capacity and Filtration Efficiency Test demonstrates the filter’s ability to remove all bacteria from a liquid bacterial suspension under specified conditions according to ASTM 838-05. Validation of the filtration process takes into account all factors that may affect the performance of the filter, such as pH, viscosity and compatibility of the material being filtered with the filter, flow rate, pressure, temperature, and hydraulic shock.
Filter Extractables Test identifies and quantifies compounds that have the potential to become leachables. Suitability Test verifies that the filter meets all requirements under product and process conditions, including, but not limited to, resistance to high temperatures, resistance to fatigue under pressure and flow changes, and resistance to high pressure changes.
Based on ISO 10992 and ISO 18562 standards, FDA guidelines, ASTM (American Society for Testing and Materials) standards and other international guidelines, STEMart’s experts have many years of experience in a wide range of testing services for Class I, II and III medical devices and can help clients ensure that every aspect of the medical device is properly tested.
If you have additional questions about Filter Testing or would like to find out more about Medical Device Testing services, please visit https://www.ste-mart.com/filter-testing.htm.
About STEMart
STEMart is an industry-leading eCommerce platform incorporated with an extensive global footprint and a broad portfolio of more than 10,000 products. It aims to provide better lab materials, medical instruments and consumables, excellent technologies, and high-quality services to global customers in the fields of science, technology, and engineering, from the discovery stage upward to the manufacturing process. STEMart is dedicated to enhancing research and biotech production with simpler and safer protocols to access better health worldwide.
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STEMart, a US-based provider of comprehensive services for all phases of medical device development, has announced the launch of its Disinfection Efficacy Studies Services in various standards to ensure the safety of medical devices. The services can be performed to evaluate the effectiveness of disinfectants against a wide range of microorganisms, including bacteria, yeast, viruses, and fungi.
Good Manufacturing Practices (GMP) regulations and FDA guidelines require biologic/pharmaceutical manufacturers to demonstrate that hazardous residues or organisms have been adequately removed during cleaning to a predetermined level of safety, thereby eliminating contamination of equipment.
Disinfectant testing is used to prove that cleaning and disinfecting procedures are effective enough to remove or inactivate microorganisms such as bacteria, yeast, fungi, viruses, molds and mycoplasmas. Before a new disinfectant can be introduced to the market, its disinfectant efficacy must be determined. Typical test materials include household and industrial disinfectants, sporicides, fungicides, and hand sanitizers. Meanwhile, deficiencies in cleaning and disinfection validation can result in the issuance of 183 warning letters by the FDA due to the potential release of unsafe products.
STEMart now offers comprehensive Disinfection Efficacy Studies Services to help medical device manufacturers to evaluate the efficacy of disinfectants against a wide range of microorganisms, including bacteria, yeast, fungi, and viruses. These services are guided by the AOAC Chapter 6 and USP <1072> to evaluate a disinfectant against a panel of clinically significant microorganisms and spores.
Disinfectant efficacy testing includes three main test parameters: chemical agent, test microorganisms, and typical facility surfaces. In addition, disinfectant regimens for cleanrooms, isolators, and other controlled areas must be validated against the manufacturing process. Customers may participate in STEMart’s Disinfectant Efficacy Program when environmental monitoring data indicates a change in the common environmental flora or an organism has developed resistance to current chemical disinfectants, in addition to the emergence of a new chemical agent, or when there are changes in the facility that may increase bioburden challenges above normal operating levels.
STEMart’s services include three components: study protocol development, standard disinfection procedure implementation, and comprehensive evaluation studies. With extensive experience in designing and conducting disinfectant studies with a wide range of organisms, surfaces, and disinfectants, STEMart offers customized study protocols and specific methods depending on the client’s project needs. STEMart can also streamline test combinations to meet client budgets, timelines, and regulatory requirements.
STEMart offers comprehensive Disinfection Efficacy Studies Services in various standards. If you have additional questions or would like to learn more about medical device testing services, please visit https://www.ste-mart.com/disinfection-efficacy-studies.htm.
About STEMart
STEMart is an industry-leading eCommerce platform incorporated with an extensive global footprint and a broad portfolio of more than 10,000 products. It aims to provide better lab materials, medical instruments and consumables, excellent technologies, and high-quality services to global customers in the fields of science, technology, and engineering, from the discovery stage upward to the manufacturing process. STEMart is dedicated to enhancing research and biotech production with simpler and safer protocols in order to access better health worldwide.
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STEMart, a US-based provider of comprehensive services for all phases of medical device development, has announced the launch of its Rapid Endotoxin Testing Services to help medical device manufacturers quickly and accurately assess the endotoxin levels in their products.
Bacterial endotoxins are lipopolysaccharides (LPS) bound to the bacterial cell wall and released when the bacteria rupture or break down. They consist of three major components, O antigen, core oligosaccharide, and lipid A molecule. Endotoxin contamination of blood can cause a variety of adverse biological effects, including inflammatory responses, immune system invasion, septic shock, and adult respiratory distress syndrome.
According to the FDA guidance document 'Pyrogen and Endotoxins Testing: Questions and Answers', the endotoxin limit for a medical device depends on the intended use of the device and who the device is intended to come into contact with. For products in contact with the cardiovascular and lymphatic systems, the limits are 0.5 EU/mL or 20 EU/device. For devices in contact with cerebrospinal fluid, the limit is 0.06 EU/mL or 2.15 EU/device. Low endotoxin limits are recommended for devices in contact with the intraocular environment.
Measuring endotoxin in various medical device materials is critical to assessing product safety and reducing risk. With increased regulatory scrutiny of medical device endotoxin in national and international approval processes, endotoxin testing has become increasingly important for medical device products, especially injectable and implantable products. Currently, the primary method used to detect and quantify endotoxin or LPS is the Limulus Amebocyte Lysate (LAL) assay. In addition, photometric and mass spectrometry (MS)-based techniques are applied for some assays.
STEMart now offers Rapid Endotoxin Testing services for the rapid quantitative analysis of endotoxins to help manufacturers make fast, reliable decisions about the safety of medical devices. The testing methods include a range of endotoxin testing instruments, FDA-licensed reagents and software, and a proprietary cartridge. With these rapid testing methods, customers can improve sample management, reduce testing time, and accelerate product manufacturing.
STEMart offers comprehensive sterility testing for sterile, non-pyrogenic products. STEMart's extensive expertise in microbiology and sterility testing provides a full-service experience that helps manufacturers meet regulatory goals and minimize compliance risk. Whether developing a new device or improving an existing one, STEMart has the experience to guide clients through the design, engineering, manufacturing and regulatory challenges unique to the medical device development process.
If you have additional questions about Rapid Endotoxin Testing for medical devices or would like more information about other medical device services, please visit https://www.ste-mart.com/rapid-endotoxin-testing-for-medical-devices.htm.
About STEMart
STEMart is an industry-leading eCommerce platform incorporated with an extensive global footprint and a broad portfolio of more than 10,000 products. It aims to provide better lab materials, medical instruments and consumables, excellent technologies, and high-quality services to global customers in the fields of science, technology, and engineering, from the discovery stage upward to the manufacturing process. STEMart is dedicated to enhancing research and biotech production with simpler and safer protocols to access better health worldwide.
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