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Neue Regulatory Services am BAV Institut
Seit dem 01.10.2023 ist die Firma alphachem in Lörrach Teil des BAV Instituts in Offenburg. Die Gründerin von alphachem, Dr. Petra Wirth, und Ihr Team sind seit über 25 Jahren anerkannte Spezialisten für alle regulatorischen Fragen bei Kosmetika. Zu den Kernleistungen für Kosmetika gehören die Erstellung von Sicherheitsberichten, sowie die Notifizierungen von Produkten. Diese Notifizierungen werden sowohl für EU-Produkte (CPNP-Meldung) als auch für Produkte für den Verkauf in Großbritannien (SCPN-Meldung) durchgeführt. Weiterhin bietet das BAV Institut den Service der sogenannten verantwortlichen Person (VP) an. Für jedes in der EU in Verkehr gebrachte Kosmetikum muss diese VP auf dem Etikett genannt sein. Die Regulatory Services für Kosmetika werden nicht nur für…
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Tentamus India is on business expansion spree, adding new verticals and labs
Tentamus India announced the plans for a magnificent business expansion, while giving an update on the company performance for last year. The company’s performance has seen significant growth in last financial year by registering 100% YoY sales, majorly driven by Pharma testing services. The Food testing services registered first commercial sales value from its operations and has got accredited by NABL as per ISO 17025 and multiple regulatory approvals including EIC, FSSIA, APEDA, making the lab one destination for all major food testing needs. Tentamus India has plans to launch additional food labs in key cities of the country, to further expand its presence in food testing sector. Following the…
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BDC Laboratories Introduces “Set-It-and-Forget-It” Radial Fatigue and Durability Test System for Stents and Stent Grafts
During the MD&M West, Biomedical Device Consultants and Laboratories (BDC Laboratories) introduced the RDT-7600i, an automated pulsatile fatigue and durability test system designed for easy compliance with ASTM F2477-23. Pulsatile, or radial, durability testing of endovascular implants requires months of dynamic cycling to execute 400 million cycles. Cycles that fall outside of predetermined tolerances become invalid and must be repeated as described in ASTM F2477-23. Learn more about the new radial fatigue and durability test system: https://www.bdclabs.com/testing-equipment/rdt-7600i-pulsatile-durability-test-system/ With the RDT-7600i and its companion software, the dynamic diametric strain of each station is automatically measured throughout a test using an optical micrometer. During operation, the micrometer documents each sample’s diametric strain…
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Partnership EpiLogic Gmbh and Tentamus India
EpiLogic GmbH and Tentamus India have joined forces to offer the services of EpiLogic in India. EpiLogic is currently the market leader in Europe with regards to fungicide resistance monitoring studies and is actively looking to expand its services internationally. India with a large agricultural sector and a fast-growing population, is highly depended on its food production. Fungal plant pathogens have a significant impact on the Indian food supply and food safety. Fungal plant pathogens can adapt and show resistance to modern fungicidal compounds. To secure and understand the effectiveness of current fungicides, reliable local resistance and adaptation monitoring is required. EpiLogic GmbH has more than 25 years of experience…
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BDC Laboratories Introduces Software to Simplify Complex GOA Determination for Prosthetic Heart Valves
Biomedical Device Consultants and Laboratories (BDC Laboratories) introduced its Statys® GOA software at MD&M West. This equipment-agnostic program simplifies and automates geometric orifice area (GOA) analysis in prosthetic heart valves. GOA analysis is a multi-dimensional imaging challenge because heart valve substitutes have complex geometries and perform nuanced movements. Statys® GOA is the first purpose-built software for quantitative comparison of heart valve leaflet opening area between hydrodynamic testing and accelerated wear testing. It’s designed to help engineering teams better comply with ISO 5840. Learn more about the software here: https://www.bdclabs.com/testing-equipment/statys-goa-software/ Statys® GOA automatically analyzes video and still images, overlays boundaries, and determines the GOA for each frame, making analysis efficient, accurate,…
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Tentamus Pharma UK Introduces Cutting-Edge MALDI-TOF for Rapid Microorganism Identification!
In response to the evolving regulatory landscape, the pharmaceutical sector is required to move beyond simple microorganism enumeration. The revised Annex 1 mandates the identification of microorganisms to the species level. Tentamus Pharma UK, a leading name in pharmaceutical testing within the UK, is excited to present its latest addition to the testing collection – the Matrix-Assisted Laser Desorption/Ionisation Time-of-Flight (MALDI-TOF) mass spectrometer. This cutting-edge instrument takes centre stage in the pharmaceutical industry, especially following the recent updates to EudraLex Annex 1 (Manufacture of Sterile Products) in August 2023, underscoring the critical need for precise microorganism identification. Tentamus Pharma UK rises to this challenge with the introduction of MALDI-TOF, offering…
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QS certification obligation for meat and meat products logistics companies
Since 01.01.2024, logistics companies that transport meat and meat products as subcontractors for QS-approved companies in the slaughtering, cutting, processing and meat wholesale sectors are also obliged to provide proof of QS certification to their clients. Due to the large number of logistics companies to be certified, QS, Qualität und Sicherheit GmbH in Bonn has set up a further transitional regulation until March 31, 2024. According to this, logistics companies to be certified must have signed a valid certification contract with an approved QS certification body and an audit date must have already been agreed before March 31, 2024. In this case, the client of the logistics company can list…
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QS Zertifizierungspflicht für Logistiker Fleisch und Fleischwaren
Seit dem 01.01.2024 sind auch Logistik Unternehmen, die als Subunternehmer für QS zugelassene Betriebe im Bereich Schlachtung, Zerlegung, Verarbeitung, und Fleischgroßhandel Fleisch und Fleischwaren transportieren, verpflichtet, gegenüber ihren Auftraggebern eine QS Zertifizierung nachzuweisen. Aufgrund der Vielzahl an zu zertifizierenden Logistik Unternehmen hat die QS, Qualität und Sicherheit GmbH in Bonn eine weitere Übergangsregelung bis zum 31.03.2024 eingerichtet. Danach müssen zu zertifizierende Logistik Unternehmen mit einer zugelassenen QS Zertifizierungsstelle einen gültigen Zertifizierungsvertrag geschlossen haben und es muss bereits ein Audit Termin vereinbart worden sein, der vor dem 31.03.2024 liegt. In diesem Fall kann der Auftraggeber des Logistik Unternehmens seinen Auftragnehmer als zugelassenen QS Lieferanten listen. Findet das Audit und die Zertifizierung…
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Dolmar Laboratory Develops New Method For Early Detection Of Acetic Bacteria In Wine
One of the reasons why the organoleptic properties of wine can vary, causing rejection by the consumer, is the presence of acetic bacteria in high proportions. Alejandro Parra (Head of the Instrumental Analysis Department at Dolmar Laboratory), together with Aroa Ovejas (Head of the Microbiology Department) and in collaboration with the Institute of Vine and Wine Sciences of La Rioja (Spain), has based his doctoral thesis and published an article in the well-known scientific journal Foods MDPI, on the development of a new culture medium that allows early detection of these bacteria, crucial for the corresponding treatment of wine before its organoleptic properties are affected. During the winemaking process, avoiding…
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One Scientific’s Successful „Introduction to Food Microbiology“ Course!
One Scientific proudly announces the successful delivery of our first "Introduction to Food Microbiology" course to one of our largest clients this year. The positive feedback we received reaffirms the quality and relevance of the course content. Reviews from participants: "Super relevant course content!" – Quality Manager "What a great day!" – Technical Manager Course Highlights: Types of organisms Significance in foods Factors affecting the growth and survival of microorganisms in foods Sources of microorganisms Lab tour Microbiological risk assessment How to decide which organisms are significant in your factory/process Interpreting microbiology results Our training has received excellent acclaim for its content and relevance. We are pleased to announce that…
