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Apakah Fasilitas Pengolahan Makanan Butuh Kamar Bersih?","Tanda:[]}]}]}],"state":{}},{"jenis":"blok","id":"bTsc-1749634285988","nama":"paragraf","data":{"versi"{},"nodes":[{"type":"inline","id":"LumY-1749634285973","name":"link","data":{"href":"https://www.gcccleanroom.com/607255757179146266.html"},"nodes":[{"type":"text","id":"yuL1-1749634285987","leaves":[{"text":"2. The Importance and Global Applicability of Installing Air Shower in Food Processing Plants","marks":[]}]}]],"state":{}},{"type":"block","id":"Teuw-1749634285990","name":"paragraph","data":{"version":1},"nodes":[{"type":"inline","id":"jQ0N-1749634285974","name":"link","data":{"href":"https://www.gcccleanroom.com/news/601051529793020000.html"},"nodes":[{"type":"text","id":"iwuc-1749634285989","leafs":[{"text":"3. 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The Selection of Air Conditioning Control Systems for Cleanrooms","marks":[]}]}]}],"state":{}},{"type":"block","id":"TniE-1749634286000","name":"paragraph","data":{"version":1},"nodes":[{"type":"inline","id":"dMAm-1749634285979","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.html"},"nodes":[{"type":"text","id":"vCAR-1749634285999","leafs":[{"text":"8. Convenient Food Factory Pass Windows: Memperkuat Hambatan Keamanan Makanan dan Meningkatkan Efisiensi Produksi secara signifikan dengan Solusi Inti","marks":[]}]}],"state":{}},{"jenis":"block","id":"tytw-1749634286002","name":"paragraph","data":{"version":1},"nodes":[{"type":"inline","id":"w2pv-1749634285980","name":"link","data":{"href":"https://www.gcccleanroom.com/news/664835391644901427.html"},"nodes":[{"type":"text","id":"7Q5C-1749634286001","leafs":[{"text":"9. Apa itu Air Shower? Memahami Cara Memurniakan Udara dalam Satu Artikel","marks":[]}}]}],"state":{}},{"type":"block","id":"U2Ea-1749634286004","nama":"paragraph","data":{"versi":1},"nodes":[{"jenis":"inline","id":"VTLz-1749634365806","nama":"link","data":{"href":"https://www.gcccleanroom.com/news/597455417000939550.html"},"nodes":[{"type":"text","id":"Xm21-1749634365807","leaves":[{"text":"10. Masalah dan Solusi Umum untuk Ruang Berubah Pabrik Makanan","marks":[]}]}},{"type":"text","id":"ejpN-1749634365794","daun":[{"teks":"","tanda":[{"jenis":"warna","nilai":"#000000"},{"jenis":"fontSize","nilai":16},{"jenis":"fontFamily","nilai":"Times New Roman"}]}]}],"state":{}},{"jenis":"blok","id":"k1Aw-1749634233958","nama":"paragraph","data":{"version":1},"nodes":[{"type":"text","id":"N6Vl-1749634233957","leaves":[{"text":"","marks":[]}]}],"state":{}}]">Sistem Esensial untuk Kepatuhan GMP
Dalam rekayasa ruang bersih biofarmaceutika, peralatan desinfeksi dan pembersih adalah fasilitas penting untuk memastikan lingkungan produksi memenuhi persyaratan GMP.Berikut adalah 8 sistem inti dan aplikasi mereka:
1Sistem Pengekangan BIBO (Bag-In/Bag-Out)
Sistem BIBO adalah perangkat perlindungan keamanan untuk mengganti filter HEPA, sesuai dengan standar ruang bersih ISO 14644-1.
·Operasi tertutup sepenuhnya untuk mencegah penyebaran kontaminasi
·Cocok untuk lemari biosafety dan sistem HVAC
·Sesuai dengan GMP EU Annex 1 persyaratan ketat untuk produk steril
2. Membersihkan Workstation
Sistem pembersih khusus yang dirancang untuk peralatan kamar bersih, memenuhi persyaratan USP <1072> dan GMP:
·Fungsi pencucian, pencucian dan pengeringan terintegrasi
·Menggunakan WFI (Water for Injection) sebagai media pencucian akhir
·Memenuhi persyaratan validasi ASTM E3106-18
3. Isolator steril
Sistem tertutup yang dirancang sesuai dengan ISO 14644-7 dan EU GMP Annex 1:
·Memberikan lingkungan steril ISO Kelas 5 (Kelas 100)
·Sistem sterilisasi VHP terintegrasi (Vaporized Hydrogen Peroxide)
·Cocok untuk pengisian aseptik dan operasi transfer produk
4. Steril-negatif tekanan pengisi isolasi
Sistem isolasi yang dirancang khusus sesuai dengan:
·Panduan Pengolahan Aseptik FDA AS (2004)
·Menjaga tekanan negatif untuk mencegah kontaminasi silang
·Sistem pemantauan partikel online terintegrasi (PMS)
5. VHP HVAC Sterilisasi Sistem
larutan sterilisasi HVAC berbasis hidrogen peroksida:
·Memenuhi standar validasi sterilisasi ISO 14937
·Mencapai pengurangan 6-log dari Geobacillus stearothermophilus
·Cocok untuk sterilisasi kamar bersih kelas B dan C
6. VHP Hood Fumigasi Pass-Through
Perangkat transfer khusus untuk sterilisasi tutup kamar bersih:
·Sesuai dengan standar IEST-RP-CC003.4
·Mengakhiri siklus sterilisasi dalam waktu 30 menit
·Sistem verifikasi indikator biologis terintegrasi
7Isolator Produksi Terapi Sel
Sistem produksi GMP yang dirancang khusus untuk produk terapi sel:
·Mengikuti pedoman FDA CGT (2020) dan persyaratan EMA ATMP
·Inkubator CO2 terintegrasi dan modul operasi kriogenik
·Memenuhi 21 CFR Bagian 11 persyaratan catatan elektronik
8. GMP Pakaian mesin cuci-pengering
Peralatan pembersih profesional yang memenuhi persyaratan GMP pada Annex 1:
·Validasi PQ sesuai dengan standar ASTM E3106
·Memberikan catatan pembersihan yang dapat dilacak
·Cocok untuk membersihkan peralatan stainless steel dan plastik
Standar Internasional yang relevan:
·ISO 14644-1:2015 Ruang bersih dan lingkungan terkontrol terkait
·EU GMP Annex 1:2022 Produksi Produk Steril
·USP <1072> Disinfeksi Ruang Bersih dan Lingkungan Terkontrol Lainnya
·Panduan FDA untuk Produk Obat Steril Industri (2004)
·ISO 14937:2009 Sterilisasi produk perawatan kesehatan - Persyaratan untuk validasi
