Wir verfolgen bei der Standardisierung des branchenblichen Nest-and-Tub-Formats fr gebrauchsfertige Spritzen, Flschchen und Karpulen einen ganzheitlichen Ansatz. Dieser erhht die Automatisierbarkeit und schafft fr unsere Kunden einen Kostenvorteil entlang der gesamten Wertschpfungskette. FIOLAX ist der Premiumstandard fr die Herstellung von pharmazeutischen Glas-Primrverpackungen, wie Spritzen, Karpulen, Ampullen und Flschchen. For further information on Marketing cookies we use, please see the relevant section of our Data Protection Policy. Dies trgt dazu bei,das Kontaminationsrisiko zu reduzieren und die Prozessausbeute zu erhhen. Other services include washing and depyrogenation, plus the filling, stoppering and storage of samples under ICH conditions. You can narrow your preferences only to specific cookie categories. Wir brgen fr die gleichbleibend hohe Qualitt unserer Produkte, von der Standardqualitt bis hin zu mageschneiderten Lsungen fr hchste Kundenanforderungen. Andere Analysetechniken, wie Dichtigkeitsprfungen von Behlterverschlssen, werden von Kunden hufig gefordert, um sicherzustellen, dass ihre Behltersysteme genau so funktionieren, wie sie es bentigen. You can find further detailed information on all cookies listed by having a look at our Data Protection Policy. Common sources of inorganic particles include manufacturing byproducts, deposits from processing, particles from breakage, and flake-like particles from delamination. Further support for the toxicological assessment of E&L data is available from a collaboration partner. For this service, we also use Google Analytics as an advanced web measurement tool which provides valuable insights about the use of our website. Wir verwenden Marketing-Cookies fr eine bessere Ausrichtung unserer Anzeigen und die Bereitstellung von Inhalten, die speziell auf Ihr Interesse zugeschnitten sind. These studies involve method development and validation followed by the determination of leachables and cross-reaction products in a drug after storage in a closed container under accelerated and real-time test conditions. These cookies do not process any personal data and are e.g. Der Lebenszyklus eines Arzneimittels umfasst eine Reihe komplexer und intensiver Phasen, von der Entdeckung bis zur Vermarktung. SCHOTT has more than 40 years of experience in pharmaceutical packaging and is accredited according to DIN EN ISO/IEC 17025. Our website provides us with an anonymous measurement of web traffic which enables us to better understand our visitors and to improve the web experience and our content continuously. Dies ermglicht uns, unsere Besucher besser zu verstehen und das Web-Erlebnis und unsere Inhalte kontinuierlich zu verbessern. We support the life cycle of drugs, from research to the commercial phase. SCHOTT Pharma provides an extensive and scientifically proven product portfolio for the safe storage and administration of injectable drugs to patients all over the world. You can narrow your preferences only to specific cookie categories. After emptying the container, stereomicroscopy is used to look for altered regions of a container for further surface analysis to determine the most affected samples out of a set. The range of compliance test methods available for glass containers includes USP <660>, USP <211>, EP 3.2.1 (alkalinity, hydrolytic resistance, arsenic), as well as ISO 9626 and ISO 15350 (conformity of syringe needle diameter and composition). We define "session cookies as cookies we need to ensure the full functionality of our website. Treibhaus fr Glasinnovationen und High-Tech-Materialien. SIMS depth profiling, SEM cross-section analysis, and ICP-OES/MS solution analysis are used to determine the mechanism of drug-container interaction. Wir helfen Ihnen gerne weiter. ICH M7) for effective assessment of the results. Dies kann jedoch dazu fhren, dass einige Seiten nicht mehr korrekt angezeigt werden. Accelerated and real-time leachables studies Ohne Ihre Zustimmung werden keine Marketing-Cookies verwendet. We understand the complex requirements of injectable drugs. SCHOTT Pharma Consulting bietet whrend dieses Lebenszyklus ein umfassendes Spektrum an Support von analytischen Dienstleistungen wie Forschungs- und Entwicklungsstudien bis hin zur Optimierung von Abfllung und Fertigstellung. Sie knnen in den Einstellungen Ihres Browsers alle Cookies blockieren. Siliconization, coating and treatment, These tests involve the determination of applied coatings and treatments, such as silicone oil, barrier coating, hydrophobic coating, and the chemical strengthening of glass containers. Weitere Informationen zu den von uns verwendeten Marketing-Cookies finden Sie in dem entsprechenden Abschnitt unserer Datenschutzrichtlinie. Ohne Ihre Zustimmung werden keine Marketing-Cookies verwendet. These cookies do not process any personal data and are e.g. Responsibly. For further information on Marketing cookies we use, please see the relevant section of our Data Protection Policy. SCHOTT entwickelt und produziert Glas-Primrverpackungen, die auf die Bedrfnisse der Anwender zugeschnitten sind. Pharmaunternehmen profitieren von unserer langjhrigen Erfahrung im Bereich der Polymerbehlter. This helps enable reduced contamination risk and higher process yield. Detaillierte Informationen zu allen von uns verwendeten Cookies finden Sie in unserer "Datenschutzrichtlinie". Diese Cookies verarbeiten keine personenbezogenen Daten und dienen z. By clicking on the button Yes, I agree, you consent to the use of all cookies, including third-party services such as Google Analytics. Wir definieren "Session-Cookies" als Cookies, die wir bentigen, um die volle Funktionalitt unserer Website zu gewhrleisten. For further information on Google Analytics, please see the relevant section of our Data Protection Policy. Responsibly. You then send the samples to our laboratory, with a completed submission form, pro-forma invoice and material safety datasheet. Wir beraten Sie auch zu internationalen Normen und Vorschriften sowie zu unserer auf Ihre Bedrfnisse zugeschnittenen FIOLAX ACADEMY. Wir definieren "Session-Cookies" als Cookies, die wir bentigen, um die volle Funktionalitt unserer Website zu gewhrleisten. Weitere ausfhrliche Informationen zu allen aufgefhrten Cookies finden Sie in unserer Datenschutzrichtlinie. Dies ermglicht uns, unsere Besucher besser zu verstehen und das Web-Erlebnis und unsere Inhalte kontinuierlich zu verbessern. Sie knnen Ihre Einstellungen nur auf bestimmte Cookie-Kategorien einschrnken. Cell cultivation and fermentation processes in biopharmaceutical production bioreactors require optimal and reliably sterile conditions. B. dazu, sich die gewhlte Sprache der Website zu merken. For further information on Google Analytics, please see the relevant section of our Data Protection Policy. Whether you need more information, samples, a quote, or advice for a project, I would be delighted to talk to you. Particulate analysis (organic) However, doing this might prevent some pages from displaying correctly. You can also call us directly. Weitere Informationen zu den von uns verwendeten Marketing-Cookies finden Sie in dem entsprechenden Abschnitt unserer Datenschutzrichtlinie. Fr diesen Service nutzen wir auch Google Analytics als fortschrittliches Web-Analyse-Tool, das wertvolle Erkenntnisse ber die Nutzung unserer Website liefert. SCHOTTs extensive product line of high-quality Type I borosilicate glass, as well as Type III soda-lime glass tubing, has been designed to preserve active pharmaceutical ingredients to ensure their effectiveness. Details zu allen SCHOTT Produktionsstandorten weltweit, Compliance Managementsystem und SCHOTT Code of Conduct, Unser Engagement fr unsere Mitarbeiter*innen und die Gesellschaft, Unser Engagement fr Umwelt- und Klimaschutz, Unsere Qualitts-, Compliance- und Standortzertifikate zum Download. By clicking on the button Yes, I agree, you consent to the use of all cookies, including third-party services such as Google Analytics. (physicochemical tests) and ISO 8871 (particle count, UV, ash, density). We define "session cookies as cookies we need to ensure the full functionality of our website. You can also further specify your consent under the Change cookies settings option or continue browsing without these cookies. Samples are drawn from production lots and tested according to stipulated methods. Together, Key numbers and statistics from the global SCHOTT organization, SCHOTTs long-term business goals and ambitions for the future, Information on the SCHOTT Management Board and Supervisory Board, Over 130 years of exciting corporate and innovation history, One of the worlds leading centers for glass innovation, Details of all SCHOTT production sites around the world, The SCHOTT compliance management system and Code of Conduct, Our commitment to our employees and the communities around our sites, Our fundamental commitment to the environment and climate protection, Our quality, compliance, and location certificates available to download, The chemical durability of primary packaging is vital in preventing drug-container interaction. You can find detailed information on all cookies we use by having a look at our Data Protection Policy. SCHOTT laboratories are DIN EN ISO/IEC 17025 accredited (DAkkS and ILAC requirements) and FDA-registered. Zellkultur- und Fermentationsprozesse in Bioreaktoren fr die biopharmazeutische Produktion erfordern optimale und zuverlssig sterile Bedingungen. SCHOTT pharma services offers material conformity testing according to current USP, EP, and JP guidelines, along with selected ISO, ASTM, and in-house methods. SCHOTT pharma services expertise in system performance tests is based on long-term experience and a deep knowledge of glass, coatings, polymer and elastomer components. Inorganic particles need to be isolated via filtration and analyzed for chemical composition by SEM/EDS, Raman microscopy, FTIR and morphology by SEM-EDS to identify and determine the root cause. Detaillierte Informationen zu allen von uns verwendeten Cookies finden Sie in unserer "Datenschutzrichtlinie". Wir setzen Standards bei Glasrhren und Primrverpackungen aus Glas und Polymer. Glass composition, This test identifies the chemical glass composition of primary packaging containers and manufacturer based on a comprehensive database of published glass compositions. Die umfangreiche Produktpalette von SCHOTT an hochwertigem Borosilikatglas Typ I sowie an Kalknatronglasrohr Typ III wurde dafr entwickelt, pharmazeutische Wirkstoffe wirksam erhalten zu knnen. used for remembering chosen site language. International regulations stipulate that the selection and qualification of a pharmaceutical container includes extractables and leachables testing. Das Angebot wird durch regulatorische Untersttzung, einer globalen Prsenz sowie durch mgliche gemeinsamen Behlterentwicklungen abgerundet. Glass delamination screening begins with visual inspection by eye and camera methods to detect flake-like particles. A combination of tests investigating the container surface, the near-surface region, and the solution determine the risk of glass delamination. Such interaction can lead to glass delamination, particle formation or leachables from the container, resulting in market recall. You can block all cookies in your browser's settings. Google Analytics itself does not process any personal data, however, we will not use it without your consent. We offer a complete process that will take you from initial request to effective solution. You can also further specify your consent under the Change cookies settings option or continue browsing without these cookies. We use cookies on this site in order to ensure site functionality, measure web traffic and if you consent, to improve your user experience and to provide content tailored specifically to your interests. Responsibly. Whether its the safe storage or reliable administering of drugs such as biologics, biosimilars, vaccines, and other therapeutics, we offer a broad range of solutions for pharmaceutical companies, biotechs, and CDMOs. The range of compliance test methods available for rubber components includes EP 3.2.9. SCHOTT Pharma Analytics laboratories are accredited according to DIN EN ISO/IEC 17025 and FDA-registered. Durch Einsatz modernster Technologie fhrt unser umfassendes Angebot an Analysemethoden zu Lsungen, die vollstndige Konformitt mit optimaler Leistung verbinden. Elemental impurities (USP <232>, ICH Q3D) are determined using validated methods by high resolution ICP-MS, while extractable and leachable silicone is determined by GF-AAS. We offer testing according to current EP, USP, and JP regulatory guidelines, plus ICH recommendations. No marketing cookies are used without your consent. With over 40 years of experience in pharmaceutical testing, SCHOTT has developed an excellent range of analytical methods. SCHOTT is the innovative and reliable one-stop-partner for the pharmaceutical industry. Google Analytics selbst verarbeitet keine personenbezogenen Daten, wir verwenden es jedoch nicht ohne Ihre Zustimmung. Our high level of quality management is also confirmed by regular customer quality audits. Our portfolio ranges from syringes and cartridges to vials and ampoules, all made using Type I borosilicate glass and high-grade pharmaceutical polymer. Extractables studies determine the amount of organic and inorganic substances extracted from primary packaging materials that could potentially migrate into the drug product. For this service, we also use Google Analytics as an advanced web measurement tool which provides valuable insights about the use of our website. Based on your feedback, we will provide a quotation, comprising a detailed study protocol and further information, including sample requirements. Responsibly. Common sources of organic particles include those of human nature (skin, hair), fibers (clean room cloth, filters), and formulation precipitates or secondary packaging material, such as polymer boxes or shrink wrap. Indem Sie auf die Schaltflche "Ja, ich stimme zu" klicken, stimmen Sie der Verwendung aller Cookies zu, einschlielich der Dienste von Drittanbietern wie Google Analytics. Weitere Informationen zu Google Analytics finden Sie im entsprechenden Abschnitt unserer Datenschutzrichtlinie. used for remembering chosen site language. B. dazu, sich die gewhlte Sprache der Website zu merken. SCHOTT has over 40 years of experience in analytics, combining an expert team with the latest technology for precise results. SCHOTT pharma services offers a range of analytical tests to assess any potential risks and find strategies to avoid them, including drug compatibility and delamination studies, container inspection, and particle analysis. Fr diesen Service nutzen wir auch Google Analytics als fortschrittliches Web-Analyse-Tool, das wertvolle Erkenntnisse ber die Nutzung unserer Website liefert. Indem Sie auf die Schaltflche "Ja, ich stimme zu" klicken, stimmen Sie der Verwendung aller Cookies zu, einschlielich der Dienste von Drittanbietern wie Google Analytics. Rubber materials and coatings are identified using a combination of analytical methods. Es ist nicht nur bruchfest, leicht und transparent, sondern bietet auch eine Vielzahl von Designs. Organic particles need to be assessed in the same manner as inorganic. SCHOTT ist ein innovativer, zuverlssiger und ganzheitlicher Partner fr die Pharmaindustrie. The material conformity tests of pharmaceutical glass containers assist pharmaceutical companies in ensuring that the primary packaging container complies with pharmacopeia regulations. Together, Key numbers and statistics from the global SCHOTT organization, SCHOTTs long-term business goals and ambitions for the future, Information on the SCHOTT Management Board and Supervisory Board, Over 130 years of exciting corporate and innovation history, One of the worlds leading centers for glass innovation, Details of all SCHOTT production sites around the world, The SCHOTT compliance management system and Code of Conduct, Our commitment to our employees and the communities around our sites, Our fundamental commitment to the environment and climate protection, Our quality, compliance, and location certificates available to download. However, doing this might prevent some pages from displaying correctly. We use marketing cookies for better targeting our ads and providing a content tailored specifically to your interest. Von den technischen Eigenschaften ber die Verarbeitung bis hin zu den Qualittsstandards stehen wir Ihnen bei allen Fragen zur Seite, um jeden Schritt so reibungslos wie mglich zu gestalten. Diese Cookies messen anonym den Verkehr auf unserer Website. Questionnaire for Extractables & Leachables Studies, Best Practices for Glass Delamination Testing Studies - IPI, Silicone oil induced effects in pharmaceutical glass vials - Pharmind, Compendial Testing Regulatory Compliance - IPI, Comparative Extractables Study - ONdrugDelivery, Predictive and real-time delamination studies, Elastomeric closure components compliance. The material conformity tests of elastomeric closures for pharmaceutical packaging assist pharmaceutical companies in ensuring that the elastomeric closure complies with pharmacopeia regulations. Samples are drawn from production lots and tested according to stipulated methods. Mit ber 40 Jahren Erfahrung in der pharmazeutischen Prfung kann SCHOTT Sie durch jede Phase der Entwicklung einer idealen pharmazeutischen Verpackung begleiten. With over 40 years of experience in analytics and specialized testing of pharmaceutical packaging, SCHOTT pharma services offers a combination of expertise and state-of-the-art analytical technology.
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