Standar untuk Penanganan Obat-obatan Berbahaya, "tanda": [{"jenis":"warna","nilai":"#000000"},{"jenis":"fontSize","nilai":18},{"jenis":"fontFamily","nilai":"Times New Roman"}]}]}],"negara":{}},{"jenis":"blok","id":"uEAN-1749604355636","nama":"paragraph","data":{"version":1}",nodes":[{"type":"text","id":"oDWg-1749604355635","leaves":[{"text":"·","marks":[{"type":"color","value":"#000000"}",{"type":"fontSize","nilai"{13}}},{"text":"EN 12469 Performance Standards for Biological Safety Cabinets","marks":[{"type":"color","value":"#000000"},{"type":"fontSize","value":18},{"type":"fontFamily","value":"Times New Roman","state":{}},{"type":"block","id":"ytpX-1749604355638","name":"paragraph","data":{"version":1}",nodes":[{"type":"text","id":"iREg-1749604355637","leaves":[{"text":"· ","marks":[{"type":"color","nilai":"#000000"},{"jenis":"fontSize","nilai":13}]},{"teks":"FDA 21 CFR Bagian 11 Rekaman Elektronik dan Tanda Tangan Elektronik","merek":[{"jenis":"warna","nilai":"#000000"},{"jenis":"fontSize","nilai":18},{"jenis":"fontFamily","value":"Times New Roman"}]},{"text":".","marks":[{"type":"color","value":"#000000"},{"type":"fontSize","value":18},{"type":"fontFamily","value":"SimSun"}]}]}],"state":{}},{"type":"Blok""id":"RDJH-1749604459912","nama":"gambar","data":{"versi":1Kantor Waimao.163.com/site/api/pub/resource/download?key=6305325cf52e07a966646bd9ac67ea59273031b","lebarnya":841,"height":626},"nodes":[],"state":{}},{"type":"block","id":"PXrA-1749604355643","name":"paragraph","data":{"version":1},"nodes":[{"type":"text","id":"eDUJ-1749604355642","leaves":[{"text":"4.Pemilihan Materi","marks":[{"type":"bold"},{"type":"color","value":"#000000"},{"type":"fontSize","value":18},{"type":"fontFamily","value":"Times New Roman"}]}]}],"state":{}},{"type":"block","id":"NS0S-1749604355645","nama":"paragraph","data":{"version":1},"nodes":[{"type":"text","id":"h7S0-1749604355644","leafs":[{"text":"1. stainless steel: 304 atau 316L stainless steel, tahan korosi dan mudah dibersihkan;","marks":[{"type":"color","value":"#000000"},{"type":"fontSize","value":18},{"type":"fontFamily","value":"Times New Roman"}]}]}],"state":{}},{"type":"block","id":"eK1e-1749604355647","name":"paragraph","data":{"versi":1},"nodes":[{"type":"text","id":"ieD7-1749604355646","leafs":[{"text":"2. Epoxy Resin: Seamless dan tahan kimia;","marks":[{"type":"color","value":"#000000"},{"type":"fontSize","nilai"{18},{"type":"fontFamily","value":"Times New Roman"}]}]}],"state":{}},{"type":"block","id":"XwLX-1749604355649","name":"paragraph","data":{"version":1},"nodes":[{"type":"text","id":"Wqi0-1749604355648","leafs":[{"text":"3. Tempered Glass: Digunakan untuk jendela pengamatan dan penghalang;","marks":[{"type":"color","value":"#000000"},{"type":"fontSize","value":18},{"type":"fontFamily","value":"Times New Roman","state":{}},{"type":"block","id":"fEdo-1749604355651","name":"paragraph","data":{"version":1}",nodes":[{"type":"text","id":"ParJ-1749604355650","leaves":[{"text":"4.Lapisan antibakteri dan antistatik.","marks":[{"type":"color","value":"#000000"},{"type":"fontSize","value":18},{"type":"fontFamily","value":"Times New Roman"}]}]}],"state":{}},{"type":"block","id":"JsLN-1749604477209","name":"image","data":{"versi":1Kantor Waimao.163.com/site/api/pub/resource/download?key=63053258fc5c9a2a4dc4c68b3350715881c3f64","lebar":849,"height":638},"nodes":[],"state":{}},{"type":"block","id":"l9RF-1749604355656","name":"paragraph","data":{"version":1},"nodes":[{"type":"text","id":"PwKs-1749604355655","leaves":[{"text":"5.Pemasangan dan Pemeliharaan","marks":[{"type":"bold"},{"type":"color","value":"#000000"},{"type":"fontSize","value":18},{"type":"fontFamily","value":"Times New Roman"}]}]}],"state":{}},{"type":"block","id":"g5D3-1749604355658","nama":"paragraph","data":{"version":1},"nodes":[{"type":"text","id":"LbqB-1749604355657","leaves":[{"text":"1. Instalasi harus dilakukan dalam kondisi cleanroom;","marks":[{"type":"color","value":#000000},{"type":"fontSize","value":18},{"type":"fontFamily","value":"Times New Roman"}]}]}],"state":{}},{"type":"block","id":"MaBM-1749604355660","name":"paragraph","data":{"version":1},"nodes":[{"type":"teks","id":"TUVS-1749604355659","daun":[{"teks":"2. pembersihan dan desinfeksi teratur;","tanda":[{"jenis":"warna","nilai":"#000000"},{"jenis":"fontSize","nilai":18},{"jenis":"fontFamily","nilai":"Times New Roman","state":{}},{"type":"block","id":"IJUh-1749604355662","name":"paragraph","data":{"version":1}",nodes":[{"type":"text","id":"S5cA-1749604355661","leaves":[{"text":"3.Pemeriksaan berkala untuk integritas penyegelan dan pola aliran udara;","marks":[{"type":"color","value":"#000000"},{"type":"fontSize","value":18},{"type":"fontFamily","value":"Times New Roman"}]}]}],"state":{}},{"type":"block","id":"3bHI-1749604355664","name":"paragraf","data":{"version":1},"nodes":[{"type":"text","id":"7XLX-1749604355663","leaves":[{"text":"4. Penggantian filter berdasarkan frekuensi penggunaan.","marks":[{"type":"color","value":"#000000"},{"type":"fontSize","value":18},{"type":"fontFamily","value":"Times New Roman"}]}]}],"state":{}},{"type":"block","id":"NGSW-1749604355666","name":"paragraph","data":{"version":1,"style":{"textAlign":"right"}},"nodes":[{"type":"text","id":"xe2W-1749604355665","leaves":[{"text":"Guangzhou Cleanroom Construction Co., Ltd.","marks":[{"type":"color","value":"#000000"},{"type":"fontSize","value":18},{"type":"fontFamily","value":"Times New Roman"}]}]}],"state":{}},{"type":"block","id":"vWg1-1749604355669","name":"paragraph","data":{"version":1},"nodes":[{"type":"text","id":"1il2-1749604355667","leaves":[{"text":"Frequently Asked Questions (FAQ)","marks":[{"type":"bold"}]}]}],"state":{}},{"type":"block","id":"arkq-1749604591124","name":"paragraph","data":{"version":1}",nodes":[{"type":"inline","id":"sIMA-1749604591111","nama":"link","data":{"href":"https://www.gcccleanroom.com/607249358173544510.html"}",nodes":[{"type":"text","id":"07dj-1749604591123","leaves":[{"text":"1.Apakah Fasilitas Pengolahan Makanan Membutuhkan Kamar Bersih?","marks":[]}]}]}],"state":{}},{"type":"block","id":"pXtt-1749604591126","name":"paragraph","data":{"version":1},"nodes":[{"type":"inline","id":"AcpC-1749604591112","name":"link","data":{"href":"https://www.gcccleanroom.com/607255757179146266.html"},"nodes":[{"type":"text","id":"znZE-1749604591125","leafs":[{"text":"2.Pentingnya dan Aplikasi Global Pemasangan Air Shower di Pabrik Pengolahan Makanan","marks":[]}]}]}],"state":{}},{"type":"block","id":"fKqE-1749604591128","name":"paragraph","data":{"version":1},"nodes":[{"type":"inline","id":"X4nG-1749604591113","name":"link","data":{"href:"https://www.gcccleanroom.com/news/601051529793020000.html"},"nodes":[{"type":"text","id":"dPX2-1749604591127","leafs":[{"text":"3.Analisis mendalam dari spesifikasi outlet pasokan udara efisiensi tinggi dan volume udara yang sesuai","marks":[]}]}]}],"state":{}},{"type":"block","id":"wIkV-1749604591130","name":"paragraph","data":{"version":1},"nodes":[{"type":"inline","id":"HkHe-1749604591114","name":"link","data":{"href:"https://www.gcccleanroom.com/Cooperation-Proposal"},"nodes":[{"type":"text","id":"vKWY-1749604591129","leaves":[{"text":"4. Global Cleanroom Cooperation Proposal","marks":[]}]}],"state":{}},{"type":"Blok","id":"icTW-1749604591132","nama":"paragraph","data":{"versi":1},"nodes":[{"jenis":"inline","id":"cC6x-1749604591115","nama":"link","data":{"href":"https://www.gcccleanroom.com/news/665551799680901181.html"},"nodes":[{"type":"text","id":"Z9U1-1749604591131","leaves":[{"text":"5. Unlocking the Outstanding Mysteries of the FFU Test Bench","marks":[]}]}],"state":{}},{"type":"block","id":"dBMg-1749604591134","name":"paragraph","data":{"version":1},"nodes":[{"type":"inline","id":"qL14-1749604591116","name":"link","data":{"href":"https://www.gcccleanroom.com/news/637253365317656625.html"},"nodes":[{"type":"text","id":"vxaW-1749604591133","leaves":[{"text":"6. Metode Perhitungan Kapasitas Pendingin di Ruang Bersih","marks":[]}]}]}],"state":{}},{"type":"block","id":"W9cP-1749604591136","name":"paragraph","data":{"versi":1},"nodes":[{"type":"inline","id":"kcJG-1749604591117","name":"link","data":{"href":"https://www.gcccleanroom.com/news/676792744632000512.html"},"nodes":[{"type":"text","id":"pz3q-1749604591135","leafs":[{"text":"7. The Selection of Air Conditioning Control Systems for Cleanrooms","marks":[]}}]}],"state":{}},{"type":"block","id":"r35j-1749604591138","name":"paragraph","data":{"version:1},"nodes":[{"type":"inline","id":"Pzxy-1749604591118","name":"link","data":{"href":"https://www.gcccleanroom.com/Convenient-Food-Factory-Pass-Windows-Strengthening-Food-Safety-Barriers-and-Significantly-Boosting-Production-Efficiency-with-a-Core-Solution (Menyempurnakan-Keamanan-Makanan-Bandaran-dan-Sangat-Meningkatkan-Efisiensi-Produksi-dengan-Solusi-Intinya).html"},"nodes":[{"type":"text","id":"OtdZ-1749604591137","leafs":[{"text":"8.Memperkuat Hambatan Keamanan Makanan dan Meningkatkan Efisiensi Produksi secara signifikan dengan Solusi Inti","marks":[]}]}]}],"state":{}},{"type":"block","id":"yht0-1749604591140","name":"paragraph","data":{"version":1},"nodes":[{"type":"inline","id":"CjPi-1749604591119","name":"link","data":{"href:"https://www.gcccleanroom.com/news/664835391644901427.html"},"nodes":[{"type":"text","id":"MYD0-1749604591139","leafs":[{"text":"9. Apa itu Air Shower?"tanda":[]}]}]}],"state":{}},{"type":"block","id":"eIKy-1749604591142","name":"paragraph","data":{"version":1},"nodes":[{"type":"inline","id":"t7ai-1749604591120","name":"link","data":{"href":"https://www.Gcccleanroom.com/news/597455417000939550.html"},"nodes":[{"type":"text","id":"aRHt-1749604591141","leafs":[{"text":"10. Common Issues and Solutions for Food Factory Changing Rooms","marks":[]}]},{"type":"teks","id":"ueTR-1749604591143","leafs":[{"text":"","marks":[]}]}],"state":{}}]">1. Definisi Perabot Laboratorium untuk Teknik Biofarmaceutical Cleanroom
Perabot laboratorium untuk rekayasa ruang bersih biofarmaceutical mengacu pada perabot khusus yang dirancang untuk lingkungan yang bersih, memenuhi persyaratan yang ketat untuk kebersihan, ketahanan korosi,dan sterilitas dalam produksi biofarmaceuticalPerabot semacam itu biasanya terbuat dari bahan seperti baja tahan karat atau resin epoksi, yang memiliki sifat pembersih yang mudah, tahan debu, dan antibakteri.
2. Jenis dan Fitur Utama
1Bangku Laboratorium Ruang Bersih: Menyediakan lingkungan bersih lokal untuk operasi aseptik;
2. Kabinet Keamanan Biologi: Melindungi operator dan lingkungan dari bahaya biologis;
3Bersih.kamarLemari penyimpanan: Simpan bahan dan reagen dengan aman di lingkungan yang bersih;
4Bersih.kamarMeja kerja laboratorium: permukaan kerja yang tahan korosi dan mudah dibersihkan;
5Bersih.kamarPergiKotakMemungkinkan transfer bahan yang aman antara zona kebersihan yang berbeda.
3. Standar Desain dan Persyaratan
Perabot laboratorium untuk rekayasa ruang bersih biofarmaceutika harus sesuai dengan standar internasional berikut:
·ISO 14644-1 Ruang Bersih dan Lingkungan Terkontrol yang Terkait
·GMP (Praktik Manufaktur yang Baik)
·USP < 800> Standar untuk Penanganan Obat Berbahaya
·EN 12469 Standar Kinerja untuk Lemari Keamanan Biologi
·FDA 21 CFR Bagian 11 Catatan Elektronik dan Tanda Tangan Elektronik.
4. Pemilihan Bahan
1Baja tahan karat: 304 atau 316L baja tahan karat, tahan korosi dan mudah dibersihkan;
2. Epoxy Resin: Tanpa jahitan dan tahan kimia;
3Kaca tempered: Digunakan untuk jendela pengamatan dan penghalang;
4Lapisan khusus: Lapisan antibakteri dan antistatik.
5. Pemasangan dan Pemeliharaan
1Pemasangan harus dilakukan dalam kondisi kamar bersih;
2. Pembersihan dan desinfeksi teratur;
3. Pemeriksaan berkala untuk integritas penyegelan dan pola aliran udara;
4Penggantian filter berdasarkan frekuensi penggunaan.
Guangzhou Cleanroom Construction Co., Ltd.
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