PIC/S ANEKS 1 (PEMBUATAN PRODUK STERIL) – PENGAWASAN MUTU NO VERSI ASLI VERSI TERJEMAHAN 125 The sterility test applied to the finished product should only be regarded as the last in a series of control measures by which sterility is assured. The test should be validated…

PIC/S ANEKS 1 (PEMBUATAN PRODUK STERIL) – PENYELESAIAN PRODUK STERIL NO VERSI ASLI VERSI TERJEMAHAN 116 Partially stoppered freeze drying vials should be maintained under Grade A conditions at all times until the stopper is fully inserted. Vial setengah tertutup dari produk beku harus selalu dipertahankan…

PIC/S ANEKS 1 (PEMBUATAN PRODUK STERIL) – FILTRASI PRODUK YANG TIDAK DAPAT DISTERILKAN DALAM WADAH AKHIRNYA NO VERSI ASLI VERSI TERJEMAHAN 110 Filtration alone is not considered sufficient when sterilisation in the final container is possible. With regard to methods currently available, steam sterilisation is to…

PIC/S ANEKS 1 (PEMBUATAN PRODUK STERIL) – STERILISASI DENGAN ETILEN OKSIDA NO VERSI ASLI VERSI TERJEMAHAN 104 This method should only be used when no other method is practicable. During process validation it should be shown that there is no damaging effect on the product and…