Produk Steril Archives

PIC/S ANEKS 1 (PEMBUATAN PRODUK STERIL) – PENGAWASAN MUTU

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

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

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

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…

PIC/S ANEKS 1 (PEMBUATAN PRODUK STERIL) – STERILISASI CARA RADIASI

PIC/S ANEKS 1 (PEMBUATAN PRODUK STERIL) – STERILISASI CARA RADIASI NO VERSI ASLI VERSI TERJEMAHAN 98 Radiation sterilisation is used mainly for the sterilisation of heat sensitive materials and products. Many medicinal products and some packaging materials are radiation-sensitive, so this method is permissible only when…

PIC/S ANEKS 1 (PEMBUATAN PRODUK STERIL) – STERILISASI CARA PANAS KERING

PIC/S ANEKS 1 (PEMBUATAN PRODUK STERIL) – STERILISASI CARA PANAS KERING NO VERSI ASLI VERSI TERJEMAHAN 97 The process used should include air circulation within the chamber and the maintenance of a positive pressure to prevent the entry of non-sterile air. Any air admitted should be…

PIC/S ANEKS 1 (PEMBUATAN PRODUK STERIL) – STERILISASI CARA PANAS BASAH

PIC/S ANEKS 1 (PEMBUATAN PRODUK STERIL) – STERILISASI CARA PANAS BASAH NO VERSI ASLI VERSI TERJEMAHAN 94 Both temperature and pressure should be used to monitor the process. Control instrumentation should normally be independent of monitoring instrumentation and recording charts. Where automated control and monitoring systems…

PIC/S ANEKS 1 (PEMBUATAN PRODUK STERIL) – STERILISASI CARA PANAS

PIC/S ANEKS 1 (PEMBUATAN PRODUK STERIL) – STERILISASI CARA PANAS NO VERSI ASLI VERSI TERJEMAHAN 90 Each heat sterilisation cycle should be recorded on a time/temperature chart with a sufficiently large scale or by other appropriate equipment with suitable accuracy and precision. The position of the…

PIC/S ANEKS 1 (PEMBUATAN PRODUK STERIL) – STERILISASI

PIC/S ANEKS 1 (PEMBUATAN PRODUK STERIL) – STERILISASI NO VERSI ASLI VERSI TERJEMAHAN 83 All sterilisation processes should be validated. Particular attention should be given when the adopted sterilisation method is not described in the current edition of the European (or other relevant) Pharmacopoeia or when…

PIC/S ANEKS 1 (PEMBUATAN PRODUK STERIL) – PENGOLAHAN

PIC/S ANEKS 1 (PEMBUATAN PRODUK STERIL) – PENGOLAHAN NO VERSI ASLI VERSI TERJEMAHAN 64 Precautions to minimise contamination should be taken during all processing stages including the stages before sterilisation. Tindakan pencegahan untuk meminimalkan kontaminasi harus dilakukan pada semua tahap pengolahan termasuk tahap sebelum sterilisasi.