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 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 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 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…

PIC/S ANEKS 1 (PEMBUATAN PRODUK STERIL) – PERALATAN NO VERSI ASLI VERSI TERJEMAHAN 56 A conveyor belt should not pass through a partition between a grade A or B area and a processing area of lower air cleanliness, unless the belt itself is continually sterilised (e.g.

PIC/S ANEKS 1 (PEMBUATAN PRODUK STERIL) – FASILITAS (BANGUNAN) NO VERSI ASLI VERSI TERJEMAHAN 46 In clean areas, all exposed surfaces should be smooth, impervious and unbroken in order to minimise the shedding or accumulation of particles or micro-organisms and to permit the repeated application of…

PIC/S ANEKS 1 (PEMBUATAN PRODUK STERIL) – PERSONALIA NO VERSI ASLI VERSI TERJEMAHAN 36 Only the minimum number of personnel required should be present in clean areas; this is particularly important during aseptic processing. Inspections and controls should be conducted outside the clean areas as far…

PIC/S ANEKS 1 (PEMBUATAN PRODUK STERIL) – PEMBUATAN SECARA ASEPTIK NO VERSI ASLI VERSI TERJEMAHAN 31 Components after washing should be handled in at least a grade D environment. Handling of sterile starting materials and components, unless subjected to sterilisation or filtration through a micro-organism-retaining filter…

PIC/S ANEKS 1 (PEMBUATAN PRODUK STERIL) – PRODUK YANG DISTERILISASI AKHIR NO VERSI ASLI VERSI TERJEMAHAN 28 Preparation of components and most products should be done in at least a grade D environment in order to give low risk of microbial and particulate contamination, suitable for…