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Metode sterilisasi yang sering digunakan oleh industri produk produk steril yaitu yaitu metode sterilisasi akhir, Menurut Parenteral Drugs Dr ugs Asociation Asocia tion Technocal Technocal Monograph (2005) meode sterilisasi akhir diantaranya diantaranya adalah metode overkill dan
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Metode Overkill
Metode overkill adalah metode sterilisasi menggunakan pemanasan dengan uap panas pada suhu 1210C selama 15 menit yang mampu memberikan minimal reduksi setingkat log 12 dari mikroorganisme-mikroorganisme yang memiliki nilai D minimal 1 menit.
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Metode ini dapat digunakan untuk bahan yang tahan panas seperti zat anorganik. Kriteria sterilitas yang digunakan adalah probabilitas mikroba yang hidup tidak lebih besar dari 1 mikroorganisme dalam 1 0-6 unit (S. Lukas, 2006).
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Sterilisasi Bioburden
metode sterilisasi yang yang memerlukan memer lukan monitoring ketat dan terkontrol terhadap bahan mikroba sekecil mungkin di beberapa beberapa lokasi jalur produksi sebelum menjalani proses sterilisasi lanjutan dengan den gan tingkat sterilitas yang dipersyaratkan SAL yaitu 10-6 (S. Lukas, 2006)
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Sterilisasi bioburden merupakan proses sterilisasi berdasarkan jenis dan konsentrasi isolat bioburden dari sediaan yang telah ditentukan sebelumnya dimana pemanasan akhir yang digunakan tidak lagi harus mencapai 1210C atau selama 15 menit, sehingga produk-produk yang dihasilkan dengan metode ini selain dijamin steril, bebas partikel namun
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Pada
sterilisasi bioburden digunakan bakteri Geobacillus stearothermophillus sebagai indikator biologis karena merupakan mikroorg
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Sesuai dengan den gan perkembangan kedokteran yang membutuhkan jenis cairan yang lebih beragam beragam contohny infus engandung nutrisi
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STUDI NILAI D ( D-value)
Studi untuk menentukan jumlah dan ketahanan panas mikroorganisme dalam produk
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STUDI NILAI D ( D-value)
Sterilisasi ini dapat dilakukan melalui pendekatan nilai D ( D-valu D-value). Nilai D adalah waktu dalam menit ang dibutuhkan untuk mengurangi populasi
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Nilai
D bisa ditentukan dengan menggunakan bakteri dalam bentuk spora yang didapat dari lingkungan produksi atau yang diisolasi dari produk.
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Uji Cemaran Mikroba
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Metode perhitungan nilai D
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