{"id":4947,"date":"2026-10-08T15:28:48","date_gmt":"2026-10-08T15:28:48","guid":{"rendered":"https:\/\/28.feihuaweiye.com\/eu-gmp-annex-1-requirements-for-sterile-filling-machine-complete-guide-%e3%80%90-part-3-%e3%80%91\/"},"modified":"2026-10-08T15:28:48","modified_gmt":"2026-10-08T15:28:48","slug":"eu-gmp-annex-1-requirements-for-sterile-filling-machine-complete-guide-%e3%80%90-part-3-%e3%80%91","status":"publish","type":"post","link":"https:\/\/28.feihuaweiye.com\/id\/eu-gmp-annex-1-requirements-for-sterile-filling-machine-complete-guide-%e3%80%90-part-3-%e3%80%91\/","title":{"rendered":"Persyaratan Lampiran 1 GMP Uni Eropa untuk Mesin Pengisian Steril | Panduan Lengkap \u3010 Bagian \u2013 3 \u3011"},"content":{"rendered":"<h4 class=\"translation-block\">Pertanyaan yang Sering Diajukan (FAQ)<\/h4>\n<p class=\"translation-block\">Pertanyaan 1: Apakah Lampiran 1 GMP Uni Eropa mewajibkan penggunaan isolator?<\/p>\n<p>A: Belum tentu. <strong><b>Lampiran 1<\/b><\/strong>\u00a0mengakui keduanya <strong><b>isolator<\/b><\/strong>\u00a0dan Sistem Penghalang Akses Terbatas <strong><b>(RABS)<\/b><\/strong>, asalkan mereka secara efektif mengendalikan risiko kontaminasi dan didukung oleh dokumen mengenai Kontaminasi <strong><b>Strategi Pengendalian (CCS)<\/b><\/strong>.<\/p>\n<p>&nbsp;<\/p>\n<p class=\"translation-block\">Pertanyaan 2: Bahan apa saja yang direkomendasikan untuk bagian-bagian mesin pengisian steril yang bersentuhan dengan produk?<\/p>\n<p>A: Komponen yang bersentuhan dengan produk biasanya dibuat dari<strong><b>\u00a0Baja tahan karat 316L,<\/b><\/strong>\u00a0dengan elastomer dan selang yang sesuai dengan standar FDA. Permukaan yang dipoles secara elektro dan sambungan yang higienis disarankan untuk memudahkan proses pembersihan dan sterilisasi.<\/p>\n<p>&nbsp;<\/p>\n<p>Pertanyaan 3: Apakah mesin pengisian steril dapat memenuhi kedua persyaratan tersebut? <strong>Lampiran 1 GMP Uni Eropa dan FDA<\/strong>\u00a0persyaratan?<\/p>\n<p>A: Ya. Banyak sistem pengisian aseptik modern dirancang untuk memenuhi <strong>Lampiran 1 GMP Uni Eropa, cGMP FDA<\/strong>, dan <strong>21 CFR Bagian 11 <\/strong>persyaratan tersebut, sehingga membuatnya cocok untuk produsen farmasi global.<\/p>\n<p>&nbsp;<\/p>\n<p class=\"translation-block\">Pertanyaan 4: Produk farmasi mana saja yang memerlukan peralatan pengisian yang sesuai dengan Lampiran 1?<\/p>\n<p class=\"translation-block\">A: Mesin pengisian steril yang sesuai dengan Lampiran 1 umumnya digunakan untuk tetes mata, obat suntik, semprotan hidung, anestesi inhalasi, cairan oral steril, vaksin, produk biologi, dan produk farmasi lainnya yang diproduksi secara aseptik.<\/p>","protected":false},"excerpt":{"rendered":"<p>Frequently Asked Questions (FAQ) Q-1: Does EU GMP Annex 1 require the use of isolators? A: Not necessarily. Annex 1\u00a0recognizes [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":4871,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[108],"tags":[],"class_list":["post-4947","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-gmp-fda-validation"],"_links":{"self":[{"href":"https:\/\/28.feihuaweiye.com\/id\/wp-json\/wp\/v2\/posts\/4947","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/28.feihuaweiye.com\/id\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/28.feihuaweiye.com\/id\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/28.feihuaweiye.com\/id\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/28.feihuaweiye.com\/id\/wp-json\/wp\/v2\/comments?post=4947"}],"version-history":[{"count":0,"href":"https:\/\/28.feihuaweiye.com\/id\/wp-json\/wp\/v2\/posts\/4947\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/28.feihuaweiye.com\/id\/wp-json\/wp\/v2\/media\/4871"}],"wp:attachment":[{"href":"https:\/\/28.feihuaweiye.com\/id\/wp-json\/wp\/v2\/media?parent=4947"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/28.feihuaweiye.com\/id\/wp-json\/wp\/v2\/categories?post=4947"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/28.feihuaweiye.com\/id\/wp-json\/wp\/v2\/tags?post=4947"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}