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 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.

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

PIC/S ANEKS 1 (PEMBUATAN PRODUK STERIL) – SANITASI NO VERSI ASLI VERSI TERJEMAHAN 61 The sanitation of clean areas is particularly important. They should be cleaned thoroughly in accordance with a written programme. Where disinfectants are used, more than one type should be employed. Monitoring should…