Елена Самтынова
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Роспотребнадзор установил правила для сохранения безопасности и качества вакцины Гам-Ковид-Вак на пути от производителя к потребителю, названном «холодовой цепью». Доставка и хранение вакцины для профилактики новой коронавирусной инфекции должны осуществляться в температурных условиях минус 18 градусов по Цельсию и ниже (постановление Главного государственного санитарного врача РФ от 3 декабря 2020 г. № 41 «Об утверждении санитарно-эпидемиологических правил СП 3.1.3671-20 «Условия транспортирования и хранения вакцины для профилактики новой коронавирусной инфекции (COVID-19) Гам-Ковид-Вак»).
Утвержденные правила должны соблюдаться на всех этапах транспортировки и хранения. Всего таких этапов предусмотрено четыре:
на первом этапе осуществляется доставка от производителя до организации оптовой торговли лекарственными средствами; второй этап предусматривает хранение организациями оптовой торговли и доставку вакцины до других организаций оптовой торговли, аптечных организаций, медорганизаций, имеющих лицензию на фармацевтическую и меддеятельность; на третьем этапе осуществляется хранение вакцины аптеками, медорганизациями с лицензией на фармацевтическую и меддеятельность и доставка вакцины до медицинских организаций и их подразделений, применяющих вакцину; четвертый этап подразумевает хранение вакцины непосредственно в прививочных и процедурных кабинетах, в которых проводится иммунизация.
В организациях, осуществляющих транспортирование вакцины и ее хранение, сотрудники должны пройти инструктаж по вопросам обеспечения сохранности качества вакцины.
Прописаны общие требования к оборудованию для транспортировки и хранения вакцины. В частности, следует обеспечить температурный режим минус 18 градусов по Цельсию и ниже в течение всего периода времени доставки и хранения вакцины, свободную циркуляцию воздуха при максимальной загрузке морозильного оборудования, замораживание хладоэлементов в комплекте с термоконтейнерами в качестве аварийных источников холода и другие требования.
В системе «холодовой цепи» могут использоваться термоконтейнеры, в том числе сумки-холодильники, хладоэлементы (сухой лед), авторефрижераторы. Если вакцина транспортируется не рефрижераторным транспортом, то она должна быть упакована в термоконтейнеры с соблюдением температурного режима (– 18 градусов по Цельсию и ниже) в течение всего времени. Термоконтейнеры могут использоваться как для одноразового, так и для многократного применения для перевозки вакцины с использованием сухого льда.
На поверхности термоконтейнера с сухим льдом должна быть размещена этикетка с обозначением опасного груза «сухой лед» и указанием массы сухого льда в килограммах. В приложении к правилам приведен расчет объема сухого льда для обеспечения поддержания нужного температурного режима.
Все важные документы и новости о коронавирусе COVID-19 – в ежедневной рассылке Подписаться
Предусмотрены требования к авторефрижераторам. Водители и экспедиторы должны быть ознакомлены с правилами техники безопасности при работе с сухим льдом, мерами сохранения вакцины в случае аварии, поломки транспорта, а также при дезинфекционных мероприятиях.
Хранить вакцину следует в морозильных камерах, морозильниках, в том числе в морозильниках-прилавках, в темоконтейнерах с хладоэлементами или сухим льдом. Установлены требования к регистрации поступления и отправления вакцины в специальном журнале на всех этапах «холодовой цепи» с указанием производителя, адреса производства, количества препарата в дозах, даты истечения срока годности, даты поступления, поставщика, показания термоиндикаторов, идентификационных номеров, Ф. И. О. ответственного работника, осуществляющего регистрацию.
Предусматриваются требования к оборудованию для контроля температурного режима. Также прописаны общие требования к организации экстренных мероприятий по обеспечению «холодовой цепи» в условиях ЧС.
Соответствующие правила вступают в силу с 8 декабря и будут действовать до 1 марта 2021 года.
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