ИНДИВИДУАЛЬНЫЙ ПОДХОД К ВАШЕМУ ПРОИЗВОДСТВУ СТЕРИЛЬНОЙ НЕФАСОВАННОЙ ПРОДУКЦИИ
ПОЛНОСТЬЮ АВТОМАТИЗИРОВАННЫЙ
ЗАЩИТА ОБСЛУЖИВАЮЩЕГО ПЕРСОНАЛА
ПРОЦЕСС АСЕПТИЧЕСКОЙ ОБРАБОТКИ
Трудности, возникающие со стерильной нерасфассованной продукцией
Некоторые типы упаковок
Технологии компании Comecer для стерильной обработки и наполнения нефасованного порошка АФИ на Фармпроизводстве совместимы со всеми типами упаковок.
АЛЮМ. БОЧКА
БУТЫЛКОВИДНЫЙ МЕШОК
ПОЛИЭТИЛЕНОВАЯ БОЧКА
МНОГООБОРОТНАЯ БОЧКА
Изолятор или RABs?
ИЗОЛЯТОР — это строго раздельные (физически) барьерные системы, которые обеспечивают значительное снижение риска биоконтаминации.
Изолятор обеспечивает бескомпромисную и постоянную герметичность класса А внутренней зоны от откружающей среды.
RABS или барьерная система ограниченного доступа — это сочетание физического и аэродинамического барьера над областью асептического процесса. RABS является альтернативной методикой по обеспечению защиты от загрязнения, предназначенная для использования в чистых помещениях высокой классификации (минимум EU Уровень B – ISO 7) и основана на системе с меньшей технологической сложностью.
Почему Comecer предпочитает изолятор?
Учитывая полное разделение оператора и стерильной зоны, изолятор обеспечивает выполнение операций наряду с определенным уровнем автоматизации при значительных размерах партии. Это также относится к случаям, когда АФИ нуждается в длительной изоляции, здесь необходим изолятор. С другой стороны RABs используется при выполнении исключительно ручных операций и герметичность не актуальна.
Проектирование специализированного процесса
Все процессы со стерильной нерасфасованной продукцией имеют много общих особенностей, однако все применения имеют свои специфические требования и ограничения.
Поэтому компания Comecer перепроектирует специализированную конфигурацию системы и интегрирует новые решения в ранее установленные функциональные модули.
ISO 45001 Health and Safety Management System
ISO 14001 & ISO 50001 Environmental and energetic management system
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Technical cookies are technical cookies whose use does not require the user's consent. These cookies are essential to enable you to navigate a website and use its full functionality. Without these cookies, which are absolutely necessary, a website could not provide certain services or functions and browsing would not be as easy and easy as it should be. A cookie of this type is also used to store a user's decision on the use of cookies on the website. Technical cookies are essential and cannot be disabled using this feature. In general, however, cookies can be disabled completely in your browser at any time.
Statistical Cookies
Statistical cookies are used to monitor the performance of the site, for example, to know the number of pages visited or the number of users who have viewed a particular section. The analysis of these cookies generates anonymous and aggregated statistical data without any reference to the identity of the site's visitors. They are also useful to evaluate any changes and improvements to be made to the site itself.
Targeting cookies
Targeting cookies are cookies set by third parties such as YouTube, Facebook, Twitter. These cookies track your behavior such as playing videos or what tweets you have already viewed. If you do not consent to these cookies, you will not be able to watch videos on this website or use the social sharing feature. These cookies may be used by the cookie provider to create a profile of your interests and show you relevant advertisements on other sites. They do not directly store personal information but are based on the unique identification of your browser and Internet device.