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GMP ТРЕНИНГ-ЦЕНТР

О центре

 GMP тренинг-центр является структурным подразделением кафедры промышленной технологии лекарственных препаратов СПХФУ, включает в себя лабораторию контроля качества, участок твердых лекарственных форм и участок мягких и стерильных лекарственных форм, оснащённые современным оборудованием в рамках ФЦП "Реконструкция и техническое перевооружение государственного образовательного учреждения высшего профессионального образования "Санкт-Петербургская государственная химико-фармацевтическая академия Министерства здравоохранения Российской Федерации" в рамках создания центра превосходства по разработке инновационных лекарственных средств и технологий, включающего центр трансферта технологий и опытно-промышленное производство (Постановление РФ №91 от 17.02.2011).

Центр расположен на первом этаже учебного корпуса (СПб, ул. Проф. Попова, 4/6). GMP тренинг-центр построен по принципу модульных систем («комната в комнате») с комплектом инженерных систем. В помещениях GMP тренинг-центра поддерживается температура, влажность, перепад давлений. Центр обладает широкими возможностями в проведении практических курсов и тренингов на опытно-промышленном оборудовании, тестерах.

В состав GMP тренинг-центра входят:

1.     Участок твердых лекарственных форм (класс чистоты D). Здесь размещены пресс таблеточный однопуансонный, пресс таблеточный роторный, привод универсальный в комплекте с насадками, конический калибратор, миксер-гранулятор, смеситель конусных бинов,  установка псевдоожиженного слоя, коатер, шкаф сушильный вакуумный, блистерный автомат, этикетировочная машина,  автоматический счетчик количества продукции, машина капсулонаполняющая настольная ручная, а также измерительные  приборы.

2.     Участок мягких лекарственных форм (класс чистоты D). Здесь размещены привод универсальный в комплекте с насадками (смеситель для мазей и кремов планетарный, гомогенизатор, дозирующая машина для мазей), мешалки механические верхнеприводные, мешалки магнитные, водяная баня с циркуляцией.

3.     Участок стерильных лекарственных форм (класс чистоты C). Здесь размещены тоннельный автоклав, перистальтические насосы, измерительные приборы, бокс абактериальный, стерилизатор паровой передвижной, шкаф сушильный с принудительной конвекцией.

4.     Лаборатория контроля качества. Здесь размещены тестеры фирмы Erweka: растворения, распадаемости таблеток, истираемости таблеток, твердости таблеток, герметичности блистерной упаковки, сыпучести гранулированного материала, насыпной плотности, определения точки плавления суппозиториев, определения деформации суппозиториев, измерительные приборы, центрифуга лабораторная настольная, термостат, дозаторы.

Участки оснащены передвижными модулями Soft Capsule для отбора проб и передаточными окнами. На участках предусмотрены гардеробы,  переходные шлюзы со скамейкой, комнаты для подготовки технологической одежды, оснащенные стиральными машинами, помещения для приготовления дезрастворов и хранения специализированного уборочного инвентаря, а также моечные для очистки съемных частей оборудования.

Основными задачами Центра являются:

  • Подготовка высококвалифицированных кадров для фармацевтической отрасли в условиях максимально приближенных к реальному фармацевтическому производству.
  • Практическое обучение студентов в рамках прохождения производственной практики.
  • Проведение семинаров-тренингов для слушателей ЦПКС.
  • Выполнение договорных работ со сторонними организациями.

image002.jpg

Структура GMP тренинг-центра

image003.png

Участок твердых лекарственных форм

Помещение гранулирования, таблетирования и нанесения оболочек

image004.jpg

Участок твердых лекарственных форм

Помещение упаковки

Снимок.JPG

Участок мягких лекарственных форм

Помещение изготовления мазей, кремов и линиментов

image012.jpg

123.JPG

Участок стерильных лекарственных форм

124.JPG

Лаборатория контроля качества

image023.jpg

Практическое занятие у студентов 4 курса ФПТЛ



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