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STEMart Launches Comprehensive Flow Cytometry Services for Improved Cellular Analysis

STEMart, a US-based provider of comprehensive services for all phases of medical device development, recently announced its the launch of its comprehensive Flow Cytometry Services to meet the diverse needs of research, diagnostics, and clinical studies, offering scientists and clinicians access to powerful tools for detailed cellular analysis, including cellular functions, phenotypes, and ...

STEMart Announces Balloon Catheter Testing Services to Ensure Medical Device Safety and Regulatory Compliance

STEMart introduces Balloon Catheter Testing Services for the development of safe and effective medical devices.STEMart, a US-based provider of comprehensive services for all phases of medical device development, announces the expansion of its medical device testing capabilities and introduces Balloon Catheter Testing Services for the development of safe and effective medical devices. These...

STEMart Expands Services to Include Comprehensive Altitude Testing for Medical Devices

STEMart announces the expansion of its services to include comprehensive Altitude Testing.STEMart, a US-based provider of comprehensive services for all phases of medical device development, is pleased to announce the expansion of its services to include comprehensive Altitude Testing. This new offering will help medical device manufacturers ensure the safety and efficacy of their products...

STEMart Announces Comprehensive Real-Time Aging Testing Services for Medical Devices

STEMart announces the launch of its new Real-time Aging Testing services.STEMart, a US-based provider of comprehensive services for all phases of medical device development, is pleased to announce the launch of its new Real-time Aging Testing services to accurately assess the long-term performance and integrity of medical device packaging under real-world storage conditions. These services...

STEMart Announces Transportation and Distribution Simulation Services for Medical Device Manufacturers

STEMart announces the launch of its new Transportation and Distribution Simulation Services for the medical device industry.STEMart, a US-based provider of comprehensive services for all phases of medical device development, proudly announces the launch of its new Transportation and Distribution Simulation Services for the medical device industry. These enhanced services offer manufacturer...

STEMart Launches Comprehensive Medical Device Packaging Solutions

STEMart announces the launch of its Packaging Solutions for the pharmaceutical and medical device industries.[/SIZE][/FONT]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.[/SIZE][/FONT]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.[/SIZE][/FONT]âPackaging for terminally sterilized medical devices-Part 1: Requirements for materials, sterile barrier systems and packaging systems,â part of the International Organization for Standardizationâs 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.[/SIZE][/FONT]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. STEMartâs 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.[/SIZE][/FONT]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.[/SIZE][/FONT]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.[/SIZE][/FONT]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 companyâs experts can evaluate medical devices and propose appropriate test plans to ensure regulatory compliance.[/SIZE][/FONT]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 .[/SIZE][/FONT]About STEMart[/FONT][/SIZE][/FONT]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.[/SIZE][/FONT]

STEMART REVOLUTIONIZES MEDICAL DEVICE DEVELOPMENT WITH COMPREHENSIVE PROTOTYPING SERVICES

STEMart proudly announces the launch of its new Medical Device Prototyping Services.[/SIZE][/FONT]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[/FONT]. 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.[/SIZE][/FONT]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.[/SIZE][/FONT]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.[/SIZE][/FONT]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.[/SIZE][/FONT]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.[/SIZE][/FONT]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.[/SIZE][/FONT]STEMart offers a full range of services covering all stages of development to accelerate its clientsâ medical device programs. If you have additional questions or would like to find out more about Medical Device Prototyping Services, please visit .[/SIZE][/FONT]About STEMart[/FONT][/SIZE][/FONT]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.[/SIZE][/FONT]

Antimicrobial Preservative Effectiveness (APE)

Why Your Products Need APE Testing?[/SIZE][/FONT][/SIZE][/FONT]An antimicrobial or preservative is defined as a chemical substance that will kill microorganisms or inhibit the growth of microorganisms, usually added to nonsterile products to protect them from microbiological contamination. If your product will be on the market, it is advised that it has been validated to be free from microbiological contaminants through [/SIZE][/FONT]Antimicrobial Preservative Effectiveness (APE)[/FONT] Testing.[/SIZE][/FONT][/SIZE][/FONT]Antimicrobial Preservative Effectiveness (APE) Testing , also know as Antimicrobial Effectiveness Testing (AET) or Preservative Efficacy Testing (PET) is a microbial challenge methodology performed to evaluate if the chosen preservative is appropriate for a product formulation. This test measures the effectiveness of antimicrobial preservatives to inhibit the growth of microorganisms during the manufacturing process or product use.[/SIZE][/FONT][/SIZE][/FONT]Antimicrobial effectiveness must be illustrated on all injections packaged in multiple-dose containers, multiple-dose topical and oral forms, and other dosage forms that contain antimicrobial preservatives. This test should be performed on all aqueous-based products including ophthalmic, otic, nasal, oral, irrigation, and dialysis fluids.[/SIZE][/FONT][/SIZE][/FONT]How To Perform APE Testing?[/SIZE][/FONT][/SIZE][/FONT]Both the EP 5.1.3 and the USP <51> give out guidance for conducting validation of the Recovery Method to determine the ability of the routine testing procedure to identify challenge microorganisms in the presence of a product. The potential of the media used in this process is accepted to promote microbial growth if the product appears antimicrobial properties.[/SIZE][/FONT][/SIZE][/FONT]To evaluate the antimicrobial effectiveness of a product, the product is inoculated with a prescribed quantity of specified microorganisms. The common five Antimicrobial Preservative Efficacy test organisms are Candida Albicans, Staphylococcus Aureus, Escherichia Coli, Pseudomonas aeruginosa, and Aspergillus brasiliensis. The effectiveness of the preservative is evaluated by comparing the initial level of microorganisms to the test material at various time intervals over a period of 28 days at a specified temperature. The reduction of microorganisms is calculated logarithmically.[/SIZE][/FONT][/SIZE][/FONT]STEMart [/FONT]offers multiple methods for Antimicrobial Preservative Effectiveness Testing following the USP General Chapter 51 on Antimicrobial Effectiveness Testing, as well as European Pharmacopoeia and other international standards. Our scientific testing will provide you with reliable and replicate testing results to help you determine whether or not your product is effective in this area, and you can submit data that is required by the appropriate regulatory agency.[/SIZE][/FONT][/SIZE][/FONT]If you have any questions about Antimicrobial Preservative Effectiveness Tests or would like to find out more about our services, please feel free to [/SIZE][/FONT]contact us[/FONT].[/SIZE][/FONT][/SIZE][/FONT]

Antibiotic Potency Test

What is Antibiotic Potency Test?A microbiological potency assay measures the bioactivity or potency of an antibiotic by the degree of growth repression on susceptible microorganisms at different concentrations. All antibiotic products must go through potency testing prior to market release.Both the EP and the USP require testing of antibiotic potency using microbiological assays for some p...

Acute Systemic Toxicity & Pyrogenicity

The biocompatibility systemic toxicity tests are in vivo systemic tests used to evaluate the impairment or activation of a system, rather than the impairment of individual cells or organs. Acute systemic toxicity tests and pyrogenicity tests are included in the systemic toxicity tests.Acute Systemic Toxicity TestingAcute toxicity is considered to be the adverse effects that occur after adm...

Subacute & Subchronic Toxicity

The Biocompatibility Subacute and Subchronic Toxicity test is used to evaluate the toxicity effects likely to arise from repeated exposures would have on a patient, including any compound toxicity effects. This test determines the systemic effect of repeated doses of materials or their extracts for no less than 24 hours and no greater than 10% of the total lifespan of the test animal.[/SIZE][/FONT][/SIZE][/FONT]Subacute toxicity (repeat-dose toxicity) focuses on adverse effects occurring after a single or repeated exposures to a test material per day during a period of 14 to 28 days. Subchronic toxicity indicates the adverse effects of a substance resulting from repeated exposure to a toxic agent over a period of several weeks or months. The subacute and subchronic toxicity studies include full clinical pathology (clinical chemistry, hematology, and coagulation), necropsy and organ weights, as well as histopathology. These tests can either be conducted with full histopathology or limited tissue evaluation.[/SIZE][/FONT][/SIZE][/FONT]Standard for [/SIZE][/FONT]Subacute & Subchronic Toxicity[/FONT] Testing[/SIZE][/FONT][/SIZE][/FONT]"Tests for systemic toxicity", part eleven of the Biological evaluation of medical devices standards(ISO 10993-11), gives out the general considerations that should be taken into account when evaluating the potential of inducing subacute/ subchronic toxicity of a medical device. It outlines the procedure of studies to assess the potential of medical devices and their constituent materials to induce systemic toxicity.[/SIZE][/FONT][/SIZE][/FONT][IMG]https://www.ste-mart.com/static/img/Subacute-Subchronic-Toxicity-1.jpg" alt="Subacute & subchronic toxicity tests during drug development.[/IMG]Fig. 1 Subacute & subchronic toxicity tests during drug development. (Denny, 2017)[/SIZE][/FONT][/SIZE][/FONT]The usual animals of choice for the subacute and subchronic toxicity tests are mice, rats, or rabbits, and oral, dermal, inhalation, intravenous, intraperitoneal, or subcutaneous application of the test substance may be used based on the considered application of the biomaterial.[/SIZE][/FONT][/SIZE][/FONT]General Procedures of Subacute & Subchronic Toxicity Testing[/SIZE][/FONT][/SIZE][/FONT]ÃÂ [/SIZE][/FONT]Administering mice or rats with a dose of 0.9% normal saline or cottonseed extract of the test biomaterial over a 14-day period;[/SIZE][/FONT][/FONT]ÃÂ [/SIZE][/FONT]Observing the test animals once daily for signs of toxicity;[/SIZE][/FONT][/FONT]ÃÂ [/SIZE][/FONT]Recording animal weights on Day 0, Day 7, and Day 14;[/SIZE][/FONT][/FONT]ÃÂ [/SIZE][/FONT]On day 14, collecting blood samples for hematology and clinical chemistry analysis;[/SIZE][/FONT][/FONT]ÃÂ [/SIZE][/FONT]Conducting a gross necropsy and collecting lesions.[/SIZE][/FONT][/FONT]STEMart [/FONT]offers biocompatibility Subacute & Subchronic Toxicity testing following the biocompatibility guidelines modified for medical devices. The testing is designed and performed based on the route of exposure to the body including the oral, dermal, and inhalation exposures.[/SIZE][/FONT][/SIZE][/FONT]If you have additional questions about Subacute & Subchronic Toxicity testing or would like to find out more about our services, please feel free to [/SIZE][/FONT]contact us[/FONT].[/SIZE][/FONT][/SIZE][/FONT] [/SIZE][/FONT]Reference[/SIZE][/FONT][/SIZE][/FONT]1. [/SIZE][/FONT]Denny, Kevin H., [/SIZE][/FONT]et al.[/SIZE][/FONT] "Acute, subacute, subchronic, and chronic general toxicity testing for preclinical drug development." [/SIZE][/FONT]A Comprehensive Guide to Toxicology in Nonclinical Drug Development[/SIZE][/FONT] 109-127(2017).[/SIZE][/FONT][/FONT]

Chemical Characterization

Chemical Characterization is a powerful methodology for addressing biocompatibility endpoints, providing a risk assessment of biocompatibility using chemical, biocompatibility, and patient exposure data. Chemical Characterization involves the extraction of the device with various solvents, chemical analysis of compounds extracted from the device, and an evaluation of the toxicological risk...

Sensitization (ISO 10993-10)

Sensitization testing is used to assess the potential of chemicals and medical devices to cause a delayed hypersensitivity reaction following a single or repeated exposure to the body. Sensitization is one of the three most common biocompatibility tests required to ensure the safety of medical devices."Tests for irritation and skin sensitization", part ten of the Biological evaluation of m...

Irritation (ISO 10993-10)

Irritation represents local tissue inflammation response to chemicals, without a systemic immunological component, and irritation is characterized by inflammation, redness, swelling, heat, or pain. Irritation testing is used to assess the potential of a medical device to cause an immediate irritation reaction in the skin, mucosal, or ocular tissues following a single or repeated exposure t...

Risk Assessments

Risk analysis is used for the evaluation of potential risk problems that could be encountered in connection with the use of a medical device. Biological hazards, risk characterization, and toxicological risk assessment are required to ensure the safety of a novel medical device and meet the requirements of marketplaces. Standard for Risk AssessmentsRisk assessments are instructed by FDA re...

Genetic Toxicology Testing

Genetic toxicology testing evaluates the potential of the test material to induce the gene mutation or chromosome damage using a range of bacterial, mammalian cells in vitro and in vivo test systems. STEMart offers multiple test types for genotoxicity biocompatibility testing, following the OECD guidelines modified for medical devices and performing under GLP conditions.Genetic Toxicology ...

Hemocompatibility Testing

Hemocompatibility testing is designed for medical devices contacting circulating blood. Biomaterials that contact blood could have cellular effects and humoral effects including thrombosis, embolism, activation of the coagulation, etc. For devices contacting with circulating blood, hemocompatibility testing is generally required as a biocompatibility assessment.STEMart offers multiple test...

Cytotoxicity Testing

Cytotoxicity testing is a sensitive method to assess the biocompatibility of a material extracted through a specific cell culture media following exposure of the extracted fluid to L929 cells. This test is performed on raw materials in the manufacturing process, all medical devices contacting patients, and devices undergoing a sterilization validation.STEMart provides a wide range of in vi...