Other | Apiway

What Are the Steps of the 510(k)-submission Process?

People who want to market their either Class I or Class II device products in the U.S, and the device is not exempt from 510(k), must file a Premarket Notification with the FDA, it is also known as FDA 510(k) submission. The 510(k) is a complex application to the FDA, because the application is to demonstrate that the device is safe and effective, and it is equivalent to another device which is on the market.

510(k) is a premarket technical document submitted to the FDA before a product enters the U.S. market to demonstrate that the product has the same safety and efficacy as a legally marketed comparable product in terms of intended use, design, materials, implementation standards, etc.

Who Must Submit a 510(k) Submission?

In general, manufacturers and specification developers who introducing a new device to the U.S. market; as well as repackers or relabelers who make labeling changes that significantly affect the device of safety or effectiveness must submit a 510(k) to the FDA.

What Are the Steps of the 510(k)-submission Process?

l Step1: the company or sponsor must submit an eCopy or eSTAR of 510(k) applications to the agency.

l Step2: after the company sponsor submit 510(k) to the FDA, and when the FDA receives the submission, they will issue either an acknowledge letter or a hold letter. Typically, a holder letter issued includes the following reasons: the user fee has not been paid or a valid eCopy or eSTAR has not been provided. Additionally, it is need to notice that an acknowledge letter is NOT a marketing clearance letter.

l Step3: at this step, the FDA conducts an Acceptance review based on the FDA guidance Refuse to Accept (RTA) Policy for 510(k)s, then the applications are either placed on RTA Hold or accepted for Substantive review.

l Step4: During the substantive review process, the lead reviewer conducts a comprehensive substantive review of 510(k) submission. The goal of this step is to determine whether a substantially equivalent decision can be reached.

l Step5: if the FDA reviewer consider does not have sufficient information to make an SE decision, they may consider Interactive Review. If the FDA chooses to continue with an Interactive Review, they will be using tools with telephone call or email communicates with the submitter. During the interactive review, the FDA reviewer may request additional information from the submitter. If the reviewer issues an Additional Information (AI) request to the company sponsor, the submission will put on hold.

l Step 6: after review, the FDA will issue a 510(k)-decision letter which is also a letter of final decision. If a 510(k) that receives an SE decision is considered "cleared“. If the submission cannot be cleared, the FDA suggest that the submitter voluntary withdraw the application to keep the information confidentially.

0 0

Post

Regulatory Consulting Services Help Gain a Competitive Edge in the North American Market

Proregulations is a newly emerging regulatory consulting firm that specializes in assisting medical device manufacturers and companies in navigating the complex process of registering their products with the U.S. Food and Drug Administration (FDA). With its comprehensive range of services, Proregulations helps medical devices to enter the lucrative North American market smoothly and efficiently.

“We have a team of expert consultants specializing in FDA medical device regulations,” said the Marketing Chief of Proregulations. “And with a long-standing core mission of ‘Value in Compliance’, our team is committed to offer a full-range of services that can greatly streamline the registration and approval process for medical devices, ultimately helping companies bring their innovation to patients in the United States and Canada.”

One of the key services provided by Proregulations is FDA medical device registration. This critical step is required for all medical devices marketed in the United States, ensuring that they meet the safety and efficacy standards set by the FDA. Proregulations guides companies through the complex registration process, assisting them in preparing the necessary documentation and navigating the regulatory requirements to ensure a smooth and successful registration.

Another essential service offered by Proregulations is FDA medical device 510(k) premarket notification. This process is necessary for most medical devices to gain FDA clearance before they can be marketed in the United States, especially for manufacturers and specification developers who introduce a new device to the U.S. market as well as for repackers or relabelers who make labeling changes that significantly affect the device of safety or effectiveness. The 510(k) submission demonstrates that the device is substantially equivalent to a legally marketed device, helping companies expedite the approval process. Proregulations provides expert guidance on preparing and submitting the 510(k) application, ensuring that all requirements are met for a timely approval.

In addition to FDA Medical Device Registration and 510(k) Premarket Notification, Proregulations also assists medical device companies in FDA medical device establishment registration and listing. Every establishment that produces or distributes medical devices in the United States is required to register with the FDA and provide a list of the devices being manufactured or distributed. Proregulations helps companies accurately complete the establishment registration and device listing, ensuring compliance with FDA regulations and enabling them to legally market their products in the U.S.

By partnering with Proregulations, medical device companies can expedite their entry into the North American market while ensuring compliance with all FDA regulatory requirements. The firm's team of experienced consultants offers tailored solutions to meet the specific needs of each client, providing personalized support throughout the registration and approval process.

Please visit https://www.proregulations.com/ to learn more information.

About

As an innovative and dynamic regulatory compliance solutions provider, Proregulations is capable of offering tailored solutions that ensure compliance with various laws and regulations for its customers. By leveraging the expertise and industry knowledge of Proregulations' consultants, companies can streamline the regulatory process, reduce time to market, and ultimately bring life-saving medical devices to patients in the United States and Canada.

0 0

Post

GLP Service Provider and Its Cutting-Edge Medical Device Services

Protheragen-ING Lab, a well-known and reputable Good Laboratory Practices (GLP) service provider, has recently unveiled its cutting-edge medical device services. With a track record of excellence and reliability in providing high-quality services to the pharmaceutical and biotechnology industries, Protheragen-ING Lab is now expanding its offerings to include comprehensive solutions for medical device development and testing.

Having earned a strong reputation for its expertise in GLP services, Protheragen-ING Lab offers a wide range of preclinical and clinical services to support drug development. The launch of Protheragen-ING Lab's medical device services marks a significant milestone in the company's evolution, further solidifying its position as a leader in the life sciences industry. The new service offerings include medical device safety testing, biocompatibility testing, validation and verification, and reusable medical device testing. These services are designed to help medical device manufacturers meet regulatory requirements and ensure the safety and effectiveness of their products.

Medical device safety testing is a critical component of the product development process, ensuring that medical devices meet regulatory requirements and are safe for use by patients. Protheragen-ING Lab's expert team of scientists and technicians are experienced in conducting a wide range of safety tests, including biocompatibility, cytotoxicity, genotoxicity, and hemocompatibility testing, among others. By partnering with Protheragen-ING Lab for medical device safety testing, companies can improve the quality and safety of their products while reducing the risk of regulatory issues.

Biocompatibility testing is another key service offered by Protheragen-ING Lab, helping medical device manufacturers assess the biological response of their products and ensure they are safe for use in patients. The company's state-of-the-art testing facilities and experienced team of scientists can provide a comprehensive evaluation of a device's biocompatibility, helping companies to identify potential risks and make informed decisions about product development.

Validation and Verification are essential for ensuring the accuracy and reliability of medical devices, and Protheragen-ING Lab has the expertise and capabilities to help companies meet these requirements. Whether it's verifying the performance of a new device or validating a manufacturing process, Protheragen-ING Lab's team of experts can provide the guidance and support needed to ensure compliance with regulatory standards.

Reusability is a key consideration in the design and development of medical devices, and Protheragen-ING Lab's reusable medical device testing services offer a comprehensive evaluation of a device's performance and durability over multiple uses. By partnering with Protheragen-ING Lab for reusable medical device testing, companies can ensure that their products meet the highest quality standards and are safe for use by patients.

Please visit https://labs.protheragen-ing.com/medical-device-service.html to learn more.

About

With a team of highly skilled scientists and technicians, Protheragen-ING Lab, a branch of Protheragen-ING, is committed to providing clients with accurate and reliable results that meet the highest quality standards. The company's dedication to customer satisfaction and commitment to excellence have made it a trusted partner for pharmaceutical and biotechnology companies worldwide. By offering a comprehensive range of lab synthesis and testing services, Protheragen-ING Lab is helping companies to navigate the complex regulatory landscape and bring safe and effective products to market.

0 0

Post

Supply of Varieties of Veterinary Products for Medical Studies

Protheragen-ING, a leading supplier of pharmaceutical products, has recently announced the launch of a wide range of veterinary products supply to cater to the growing demand for high-quality animal healthcare products. The company's new line of veterinary products includes feed vitamins, active pharmaceutical ingredients (APIs), excipients, amino acids, and minerals, all aimed at promoting the health and well-being of animals.

Protheragen-ING's veterinary products are designed to meet the specific nutritional needs of different animals, including livestock, poultry, and pets. The company's feed vitamins are essential for promoting overall health and growth in animals, while its APIs are used to treat various medical conditions in animals. Additionally, Protheragen-ING's excipients play a crucial role in improving the efficacy and stability of veterinary medications, ensuring that animals receive the necessary treatment.

In a statement, a spokesperson from Protheragen-ING highlighted the company's commitment to providing high-quality veterinary products that are safe, effective, and affordable. "We understand the importance of animal health and welfare, and our new line of veterinary products reflects our dedication to supporting the well-being of animals," the spokesperson said.

Protheragen-ING's veterinary feed amino acids are vital for promoting muscle growth, tissue repair, and overall health in animals, making them an essential component of any animal's diet. The company's feed minerals, on the other hand, play a crucial role in maintaining proper bone development, muscle function, and overall health in animals.

Customers can rest assured that Protheragen-ING's veterinary products are manufactured using state-of-the-art technology and adhere to stringent quality control measures to ensure their safety and efficacy. The company's products undergo rigorous testing and quality assurance processes to meet industry standards and regulatory requirements, giving customers peace of mind when using them for their animals.

Some of the veterinary products supplied by Protheragen-ING are listed below:

Fenbendazole (CAS 43210-67-9), Dicyclanil (CAS 112636-83-6), Sulfanilamide (CAS 63-74-1), Halquinol (CAS 8067-69-4), L-lysine hydrochloride (CAS 10098-89-2), DL-methionine (CAS 59-51-8), L-threonine (CAS 72-19-5), glutamine (CAS 56-85-9), valine (CAS 7004-03-7), cystine (CAS 923-32-0), L-ascorbic acid (vitamin C) (CAS 50-81-7), Betaine Hydrochloride (CAS 590-46-5), Choline chloride (CAS 67-48-1), N,N-Dimethylacetamide (CAS 127-19-5), Benzyl Benzoate (CAS 120-51-4), Polyethylene Glycol 400 (CAS 25322-68-3), calcium gluconate (CAS 299-28-5), magnesium oxide (CAS 1309-48-4), and more.

With the launch of its new line of veterinary products, Protheragen-ING is poised to become a trusted partner for veterinarians, animal breeders, and pet owners looking to provide the best possible care for their animals. The company's dedication to quality, innovation, and customer service sets it apart as a trust-worthy supplier in the veterinary pharmaceutical industry.

For more information about Protheragen-ING's new line of veterinary products, please visit the website https://www.protheragen-ing.com/veterinary-products.html.

About

With state-of-the-art manufacturing facilities and professional R&D teams, Protheragen-ING is committed to help its customers achieve cost-effective improvements in their R&D productivity. Meanwhile, as the demand for high-quality veterinary products continues to grow, Protheragen-ING remains committed to expanding its product offerings and meeting the evolving needs of the animal healthcare market.

0 0

Post

Protheragen-ING Joins the DCAT Association

In exciting news, Protheragen-ING officially become a member of the Drug, Chemical & Associated Technologies (DCAT) Association.

This move marks a significant milestone for Protheragen-ING and highlights the company's commitment to collaboration, innovation, and growth within the global pharmaceutical community.

By joining forces with DCAT, Protheragen-ING, a supplier of Vitamin C Products, API Products, Pharmaceutical Excipients, Packaging & Equipment, Veterinary Products, aims to contribute to the advancement of drug development and manufacturing.

The Significance of DCAT

DCAT is a non-profit and member-supported global business development association.

The members are multinational companies directly involved in the entire pharmaceutical manufacturing value chain: from raw materials, intermediates, and active pharmaceutical ingredients to formulation development, pharmaceutical manufacturing, distribution, packaging, and related supply chain services.

DCAT has a unique membership model integrating innovative and generic drug manufacturers and suppliers of ingredients, development and manufacturing services and related technologies.

DCAT provides a platform for its member companies to foster collaboration, share industry knowledge and promote networking opportunities.

Protheragen-ING's membership in DCAT provides companies with a number of key benefits.

Collaboration and Innovation

Protheragen-ING's membership in the DCAT association marks an exciting chapter in our company's journey of further growth and innovation.

The decision to join DCAT emphasizes our commitment to collaboration and innovation. By becoming a member, we align ourselves with like-minded organizations dedicated to advancing drug development and manufacturing.

0 0

Post

Hydrogel Microneedle Patch Technology to Increase Drug Loading Capacity

CD Formulation, a leading pharmaceutical contract service company, has recently unveiled groundbreaking hydrogel microneedle patch technology aiming at increase the drug loading capacity and enhance drug delivery efficiency.

The new technology represents a significant advancement in the field of transdermal drug delivery. The hydrogel microneedle patch consists of a patch with tiny microneedles made of hydrogel, which can deliver drugs directly into the skin. This innovative approach not only improves drug absorption but also allows for a higher drug loading capacity, enabling patients to receive the required dosage more effectively.

The Chief Scientist at CD Formulation commented on the technology, stating, "Our hydrogel microneedle patch technology represents a breakthrough in drug delivery systems. By utilizing the unique properties of hydrogel and microneedles, we have developed a system that can significantly enhance the delivery of therapeutic agents to patients."

The hydrogel microneedle patch technology has been subjected to extensive research and testing by CD Formulation's team to prove its accuracy and efficacy. According to a recent study published in the Journal of Macromolecular Bioscience, the hydrogel microneedle patch could effectively deliver a variety of drugs, including small molecules and bioactive compounds, with improved efficiency and precision.

The key advantage of the hydrogel microneedle patch technology is its ability to increase drug loading capacity compared to traditional drug delivery systems. The microneedles in the patch create tiny channels in the skin that allow for the rapid and controlled release of drugs, ensuring that therapeutic agents are delivered directly to the target site. This targeted delivery approach minimizes potential side effects and maximizes therapeutic benefits for patients.

Moreover, the hydrogel microneedle patch is designed to be painless and easy to use, making it a convenient option for patients who require regular drug administration. The patch can be applied to the skin like a bandage and removed after the drug has been delivered, providing a discreet and hassle-free drug delivery experience.

Please visit https://msmn.formulationbio.com/hydrogel-microneedle-patch-technology.html to learn more.

About CD Formulation

With ongoing advancements in drug delivery systems, the future of pharmaceuticals looks bright. Over the past decade, CD Formulation has been working tirelessly to bring more innovations to this field. Its introduction of hydrogel microneedle patch technology marks a significant milestone. With the ability to increase drug loading capacity and enhance drug delivery efficiency, this technology has the potential to revolutionize the way therapeutic agents are administered to patients, leading to improved outcomes and better patient care.

0 0

Post

The Latest Innovations in Microneedle Eye and Lip Patch Technologies

In recent years, microneedle patches have emerged as a revolutionary technology in the beauty and skincare industry. These patches are designed to deliver active ingredients directly into the skin, providing targeted treatments for a variety of concerns. One area where microneedle patches have shown significant promise is in the treatment of the delicate skin around the eyes and lips. In this article, we will explore the latest innovations in microneedle eye and lip patch technologies, including advancements in manufacturing processes and delivery methods.

Microneedle Eye and Lip Patch

Microneedle patches for the eyes and lips are small, adhesive patches that are infused with microneedles made of dissolvable materials such as hyaluronic acid or collagen. These microneedles are designed to penetrate the outer layer of the skin, creating tiny channels that allow for the efficient delivery of active ingredients. In the case of eye and lip patches, these active ingredients are often targeted towards specific concerns such as fine lines, dark circles, or dryness.

Technologies for Manufacturing Microneedle Eye and Lip Patch

The manufacturing of microneedle eye and lip patches requires precision and attention to detail. Innovations in this field have focused on creating patches that are comfortable to wear, easy to apply, and effective in delivering active ingredients. One key advancement has been the development of microneedle patches that can be applied directly to the skin without the need for additional tools or equipment. This makes them ideal for at-home use, allowing consumers to easily incorporate them into their skincare routines.

Another important aspect of manufacturing microneedle patches is the design of the microneedles themselves. Recent innovations have led to the creation of microneedles that are thinner and more flexible, reducing the risk of skin irritation or discomfort during application. Additionally, advances in microneedle technology have allowed for the incorporation of multiple layers of microneedles in a single patch, increasing the efficiency of active ingredient delivery.

The Latest Innovations in Microneedle Eye and Lip Patch Technologies

One of the most exciting recent innovations in microneedle eye and lip patch technologies is the use of biodegradable materials for the microneedles. These materials break down naturally in the skin, eliminating the need for patch removal and reducing the risk of irritation or allergy. Additionally, biodegradable microneedles are more environmentally friendly, making them a sustainable choice for skincare products.

Another advancement in microneedle patch technology is the use of microfluidic channels for active ingredient delivery. These channels allow for precise control over the release of active ingredients, ensuring that they are delivered in the right concentration and at the right time. This technology also allows for the incorporation of a wider range of active ingredients, including peptides, vitamins, and antioxidants, providing a more comprehensive skincare solution.

Summary

In conclusion, the latest innovations in microneedle eye and lip patch technologies have the potential to revolutionize the way we treat the delicate skin around the eyes and lips. Advances in manufacturing processes, materials, and delivery methods are making these patches more effective, comfortable, and convenient to use. With continued research and development, microneedle patches are poised to become a staple in the skincare routines of consumers worldwide.

0 0

Post

Efficacy Evaluation of Oral Thin Films: Ensuring Therapeutic Efficacy and Safety

A breakthrough in CD formulation has enabled researchers to evaluate the efficacy of oral thin films, ensuring both therapeutic efficacy and safety. This new development has the potential to revolutionize the way oral medications are tested and administered, leading to more precise and effective treatments for a wide range of medical conditions.

The development of oral thin films has gained significant traction in the pharmaceutical industry due to their ease of use, quick disintegration, and improved bioavailability. However, one of the major challenges faced by pharmaceutical companies is the accurate assessment of the efficacy and safety of these films, which can be difficult to evaluate using traditional methods.

Traditional methods of evaluating the efficacy of oral medications have often been limited by the inability to accurately measure the drug's concentration in the body. This has led to challenges in determining the optimal dosage and timing of administration, which can impact both the effectiveness and safety of the treatment. However, with the launch of efficacy evaluation services by CD Formulation, researchers can now more accurately assess the bioavailability and pharmacokinetics of oral thin films.

By utilizing a combination of cutting-edge analytical techniques, CD Formulation is able to analyze the drug release kinetics, bioavailability, and pharmacokinetics of oral thin films with unprecedented accuracy.

“In general, an oral thin film efficacy evaluation project would involve the following processes. First, the team would conduct extensive preclinical investigations to ascertain the safety and effectiveness of the oral thin films. Factors like drug release kinetics, absorption, metabolism, and possible toxicity during the preclinical stage would be assessed. Next, the absorption, distribution, metabolism and excretion of oral film drugs will be meticulously evaluated. Finally, the physical, chemical, and microbiological stability of the oral films under different environmental conditions will also be evaluated to ensure shelf life and continued effectiveness,” said Marketing Chief of CD formulation.

The key to CD Formulation's success lies in its ability to customize the formulation of oral thin films based on the specific requirements of each drug. By optimizing the composition of the film, the company can ensure that the drug is released in a controlled manner, maximizing its therapeutic efficacy while minimizing potential side effects.

This level of precision is essential in ensuring the safety of patients, as it allows pharmaceutical companies to monitor and adjust the dosage of the drug to achieve the desired therapeutic effect without compromising on safety. By conducting comprehensive efficacy evaluations using CD Formulation's advanced formulation techniques, pharmaceutical companies can streamline the drug development process and bring novel treatments to market more efficiently.

In addition to enhancing the evaluation of oral thin films, CD Formulation's formulation technology also has the potential to improve the overall effectiveness of drug delivery systems. By optimizing the formulation of oral thin films, pharmaceutical companies can overcome challenges such as poor solubility, low bioavailability, and inconsistent drug release, leading to better treatment outcomes for patients.

Please visit https://www.formulationbio.com/efficacy-evaluation-of-oral-thin-film.html to learn more.

About CD Formulation

Over the past years, CD Formulation has been strengthening its innovation in drug formulation and analytical testing, hoping to bring advancement to the pharmaceutical industry and also aiming to improve patient care on a global scale. By revolutionizing the evaluation of oral thin films, the company is paving the way for more efficient and effective drug delivery systems that prioritize patient safety and therapeutic efficacy. As the pharmaceutical industry continues to evolve, CD Formulation's innovative approach is sure to set a new standard for drug development and improve the lives of patients worldwide.

0 0

Post

Stability Analysis: A Meaningful, Impactful and At-the-Forefront Tool for Pharmaceutical Science

In the field of pharmaceutical science, stability analysis plays a crucial role in ensuring the safety and efficacy of pharmaceutical products. It is a complex and multifaceted process that requires thorough investigation and understanding of various influencing factors. Stability analysis consists of different methods such as influencing factors analysis, long-term accelerated shelf-life testing, and light stability analysis, each of which plays a significant role in determining the stability and shelf-life of pharmaceutical products. In this article, we will explore the importance of stability analysis in pharmaceutical science and highlight some key techniques used in this field.

Pharmaceutical Analysis

Pharmaceutical analysis is a branch of analytical chemistry that deals with the analysis of pharmaceutical substances, including drugs, their formulations, and their compatibility with various excipients. This field is critical for ensuring the quality and safety of medicines, as well as for meeting regulatory requirements. Analytical techniques such as chromatography, spectroscopy, and mass spectrometry are commonly used in pharmaceutical analysis to identify and quantify active pharmaceutical ingredients and impurities.

Pharmaceutical Stability Analysis

Pharmaceutical stability analysis is a key aspect of pharmaceutical development and quality control. It involves studying the physical, chemical, and microbiological properties of drugs under various conditions to determine their stability over time. Stability analysis helps pharmaceutical companies ensure that their products remain safe and effective throughout their shelf life, as well as meet regulatory requirements.

Influencing Factors Analysis

Influencing factors analysis is an important part of stability analysis that involves identifying and studying the various factors that can affect the stability of a drug. These influencing factors may include temperature, humidity, light, oxygen, pH, and the presence of impurities. By understanding how these factors influence the stability of a drug, pharmaceutical scientists can develop effective strategies to optimize its stability and shelf life.

Long-term Accelerated Shelf-life Testing

Long-term accelerated shelf-life testing, also known as Accelerated Aging Testing, is a crucial technique used in stability analysis to predict the shelf life of a drug under accelerated conditions. This involves subjecting the drug to higher temperatures and humidity levels than usual to accelerate the degradation process. By monitoring the physical, chemical, and microbiological changes in the drug over time, scientists can predict its stability and shelf life under normal storage conditions.

Light Stability Analysis

Light stability analysis is another important technique used in stability analysis to study the effect of light exposure on the stability of a drug. Light can cause the degradation of certain drugs, leading to a decrease in their potency and safety. By studying the impact of light on the stability of a drug, pharmaceutical scientists can develop appropriate packaging materials and storage conditions to protect the drug from light-induced degradation.

In conclusion, stability analysis is a critical tool in pharmaceutical science that helps ensure the quality, safety, and efficacy of medicines. By studying the physical, chemical, and microbiological properties of drugs over time and under various conditions, pharmaceutical scientists can optimize the stability of drugs and predict their shelf life. Techniques such as influencing factors analysis, long-term accelerated shelf-life testing, and light stability analysis play a crucial role in this process. Overall, stability analysis is a meaningful, impactful, and at-the-forefront tool for pharmaceutical science that benefits both pharmaceutical companies and patients.

0 0

Post

Sputtering Target Materials

Alfa Chemistry has recently introduced a wide range of sputtering target materials designed specifically for the semiconductor industry. These targets come in various purities and sizes to cater to different manufacturing needs and requirements. The company's extensive product line includes metals, nonmetals, alloys, antimonides, arsenides, borides, carbides, fluorides, nitrides, oxides, selenides, silicides, sulfides, and tellurides, each with unique properties and applications.

The metal sputtering targets offered by Alfa Chemistry include a variety of high-purity materials such as aluminum, copper, gold, silver, and titanium. These metals are essential for depositing thin films onto semiconductor substrates, helping to enhance conductivity and performance in electronic devices. With Alfa Chemistry's high-quality metals sputtering targets, manufacturers can achieve precise and uniform film deposition, resulting in improved device performance and reliability.

In addition to metals, Alfa Chemistry also provides sputtering targets made from borides, which are known for their high melting points and excellent chemical stability. Boride sputtering targets are commonly used in the production of wear-resistant coatings and cutting tools, as well as in the aerospace and automotive industries. Alfa Chemistry's boride sputtering targets are available in various compositions and purities, ensuring that manufacturers can find the right material for their specific applications.

For semiconductor manufacturing processes that require nonmetallic materials, Alfa Chemistry offers a range of sputtering targets made from materials such as carbides, nitrides, oxides, and more. These nonmetallic sputtering targets are crucial for deposition processes that involve dielectric materials, insulators, and optical coatings. With Alfa Chemistry's high-purity nonmetallic sputtering targets, manufacturers can achieve precise control over film thickness, optical properties, and other key parameters to meet the exact requirements of their applications.

Alfa Chemistry's commitment to quality and innovation is evident in the wide range of sputtering target materials it offers for the semiconductor industry. By providing sputtering targets of different purities and sizes, the company ensures that manufacturers have access to the materials they need to achieve the highest levels of performance and reliability in their semiconductor products. Some of the top-quality sputtering targets are listed below:

Praseodymium Sputtering Target (CAS 7440-10-0), Tin Sputtering Target (CAS 7440-31-5), Cobalt Sputtering Target (CAS 7440-48-4), Copper Sputtering Target (CAS 7440-50-8), Lead Telluride Sputtering Target (CAS 1314-91-6), Zinc Telluride Sputtering Target (CAS 1315-11-3), Carbon Sputtering Target (CAS 7782-42-5), Zirconium-Nickel Sputtering Target (CAS 11146-74-0), Aluminum-Iron Sputtering Target, Gallium Antimonide Sputtering Target (CAS 12064-03-8), Indium Arsenide Sputtering Target (CAS 1303-11-3), Molybdenum Boride Sputtering Target (CAS 12007-97-5), Zirconium Carbide Sputtering Target (CAS 12070-14-3), Ytterbium Fluoride Sputtering Target (CAS 13760-80-0), Hafnium Nitride Sputtering Target (CAS 25817-87-2), Thulium Oxide Sputtering Target (CAS 12036-44-1), Tantalum Selenide Sputtering Target (CAS 12039-55-3), Chromium Silicide Sputtering Target (CAS 12018-36-9), Arsenic Sulfide Sputtering Target (CAS 1303-33-9), Zinc Telluride Sputtering Target (CAS 1315-11-3), and more.

Please visit the website https://semiconductor.alfachemic.com/products/sputtering-targets.html to learn more.

About

With a commitment to quality, innovation, and customer satisfaction, Alfa Chemistry provides a wide selection of high-quality materials, enabling semiconductor manufacturers to achieve the desired thin film properties and device performance, driving innovation and advancement in the semiconductor industry.

0 0

Post

Zinc Gluconate

Zinc gluconate is a white to almost white solid that is soluble in water, practically insoluble in anhydrous ethanol and methylene chloride. It is a popular form for the delivery of zinc as a dietary supplement providing 14.35% elemental zinc by weight.

Application as a dietary supplement

The trace element zinc is critical to many biological processes. Zinc gluconate is a dietary supplement for the purpose of providing zinc. It mainly has the following functions.

Maintaining appetite

Zinc deficiency leads to taste decline, anorexia and partial food. As a dietary supplement, zinc gluconate is beneficial to maintain the normal appetite of the human body.

Promoting growth and development

Zinc deficiency in children and adolescents leads to growth retardation and gut microbiota dysbiosis. When zinc deficiency is severe, it will caused “dwarf” and poor intellectual development. As a dietary supplement, zinc gluconate can promote the growth and development of children and adolescents.

Enhancing human immunity

Sufficient zinc can effectively ensure the development of the thymus, and the normal differentiation of T lymphocytes, which promotes cellular immune function. Therefore, zinc gluconate is beneficial to enhance human immunity[1].

Promoting vitamin A absorption

Zinc deficiency affects the metabolism of vitamin A, which protects normal vision. As a dietary supplement, zinc gluconate is beneficial to promote vitamin A absorption.

Application in the treatment of common cold

Zinc gluconate is also used against rhinoviruses, which are considered the main pathogens of the common cold. ICAM-1 is a receptor presents on nasal epithelium and in rhinovirus structure. Rhinoviruses attach to endothelial cells via ICAM-1 to produce inflammation and other common immune responses. The mechanism of action of zinc gluconate is that the dissolved zinc ions compete with the ICAM-1 receptors to prevent rhinovirus attachment and replication in nasal epithelial cells for reducing inflammation in nasal tissues[2]. Studies have demonstrated that zinc gluconate effectively and significantly shortens the duration of the common cold when it was administered within 24 hours after the onset of symptoms.

0 0

Post

Phosphorus Catalysts

Phosphorus catalysts are widely used in organic chemistry laboratories to convert acetic acid and formaldehyde into acrylic acid or used to catalyze hydrodesulfurization (HDS) and hydrodenitrogenation (HDN). It also plays an important role in photocatalyst or electrocatalyst by combining phosphorus with carbon materials or other metals and metal derivatives such as TiO2.

Catalyst Used in Organic Chemistry Lab: Vanadium phosphorus oxide catalyst (VPO) can convert acetic acid and formaldehyde into acrylic acid for the conversion of oxidized butane to maleic anhydride or for certain condensation reactions. Various metal (Zr, Zn, Ni, Nb, Mo, Mn, Fe, Cu, Cr, Ce and Co) were used to dope VPO catalysts. Because of the changes in deped VPO catalysts, such as redox properties, catalytic performance and particle size, these catalysts showed significantly different performance compared with typical VPO catalysts.
Phosphorus reacts with most elements of the periodic table to form a diverse class of compounds known as phosphides. The catalysts are mainly based on transition metal phosphides catalyst which can be used to catalyze hydrodesulfurization (HDS) and hydrodenitrogenation (HDN). The below reaction sequence (Figure. 2) describes how the Ni-P catalyst affects the major observations on the reaction, i.e. the occurrence of an SN2 step and the involvement of a piperidinium ion intermediate.
Catalyst based on Black Phosphorus: As a new two-dimensional material, black phosphorus (BP) has extraordinary catalytical properties because of its unique electronic, optical, and structural properties. Due to its advanced electrocatalytic properties, BP supported by thin film (BP-Ti) can catalyze the oxygen evolution reaction (OER). The OER activity of this catalyst can be developed by designing the BP grown on a carbon nanotube network (BP-CNT). In addition, a combination of two-dimensional (2D) black phosphorus (BP) and graphitic carbon nitride (CN) was designed and used as a metal-free photocatalyst. This new photocatalyst meets the requirement of green chemistry because it is a metal-free photocatalyst. During the irradiation of BP/CN in water with >420 and >780 nm light, H2 gas was produced, respectively. The Figure.3 depicts how the photocatalyst works. Due to the interfacial interaction between BP and CN, enhanced photocatalytic performance is achieved and efficient charge transfer occurs. Moreover, the BP@TiO2 hybrid photocatalysts provide enhanced photo-catalytic performance under light irradiation in the environmental and biomedical fields.
Phosphorus-Doped Graphite Layers: The P-doped graphite layers were prepared by pyrolysis of toluene and triphenylphosphine. P-doped graphite—a typical metal-free catalyst—shows high electrocatalytic activity, long-term stability, and excellent tolerance to cross-over effects of methanol in the oxygen reduction reaction, which plays an important role in electrochemical conversion in fuel cells, in an alkaline medium.

References

Neher, H. T.; Kelton, S. C. (1952) 'Preparation of Acrylic Esters'. U.S.Patent 2582911.
Nagaki, D.; Weiner, H.; Chapman, J. T.; Scates, M. O.; Locke, A. S.; Peterson, C. J. (2012) "Catalysts for Producing Acrylic Acids and Acrylates." U.S. Patent 2012/0289743.
Zhu, Yun‐Pei, et al. (2015) 'Direct Synthesis of Phosphorus‐Doped Mesoporous Carbon Materials for Efficient Electrocatalytic Oxygen Reduction.', ChemCatChem, 7.18, 2903-2909.

0 0

Post

Failure Analysis of Artificial Implanted Bone Plate Material

The metal fatigue problems are virtually ubiquitous, and failure of artificially implanted bone material is one of them. Failure analysis of artificially implanted bone material largely determines the reliability of artificially implanted bone products and is an important issue that must be faced in the development of artificially implanted bone products.

Failure analysis of artificially implanted bone materials is an important part of accident investigation, which can help determine the nature of failure, whether it is overload fracture, fatigue failure, wear or mixed failure mode. In addition, it also helps to find out the main causes of failure, such as improper operation, excessive actual load, flaws in the material itself, defects in the weld, unreasonable geometric design resulting in stress concentration, or other unreasonable design. Knowing the nature and the cause of the failure will be of great help to prevent and improve similar failure accidents, and improve the quality and reliability of the product.

Here, metal fatigue analysis methods for artificial implanted bone plate material are introduced.

Fracture Analysis

The fracture of the metal plate actually records the information about the whole process of crack initiation, expansion and instability. SEM, EDX and other characterization methods are used to qualitatively and quantitatively analyze the structural features of the fracture surface and can provide strong evidence for the determination of fracture failure mode.

Azevedo C R F et al. qualitatively analyzed the structural characteristics of the fracture surface of the metal plate and its surrounding tissues by using SEM and EDX methods. They found that the service environment of the bone plate affects the fracture failure of the bone plate. The fracture and corrosion of the joint between the bone plate and the screw often occur. Under the action of the fretting corrosion mechanism, the plate fails due to the lower nominal stress and the uniaxial bending load.

In Vitro Simulation Analysis

In vitro simulation studies are widely used in medical implants, which can effectively avoid the disadvantages of studying objects as organisms and being difficult to deploy. Using an in vitro test to simulate a fracture plate fixation model, or to simulate a similar working environment and stress state with a bone plate in human service is an important means to study the failure process of bone plate. Kanchanomai et al. used artificial synthetic bone and locking compression plate to simulate the bearing and stress state of the femur under human gait, and achieved fatigue test under the same stress state and four-point bending state, simulating the fracture process caused by the fatigue of the bone plate during the walking of the patient.

References

Proverbio E, Bonaccorsi L M. (2002) ‘Microstructural analysis of failure of a stainless steel bone plate implant’ J Fail Anal Prev, 1(4): 33-38.
Azevedo C R F, Jr E H. (2002) ‘Failure analysis of surgical implants in Brazil’. Eng Fail Anal, 9(6): 621-633.
Azevedo C R F. (2003) ‘Failure analysis of a commercially pure titanium plate for osteosynthesis’. Eng Fail Anal, 10(2): 153-164.
Micic I D, Kim K C, Shin D J, et al. (2009) ‘Analysis of early failure of the locking compression plate in osteoporotic proximal humerus fractures’. J Orthop Sci. 14(5): 596-601.

0 0

Post