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…

PIC/S ANEKS 1 (PEMBUATAN PRODUK STERIL) – TEKNOLOGI PENIUPAN/PENGISIAN/PENYEGELAN NO VERSI ASLI VERSI TERJEMAHAN 26 Blow/fill/seal units are purpose built machines in which, in one continuous operation, containers are formed from a thermoplastic granulate, filled and then sealed, all by the one automatic machine. Blow/fill/seal equipment…

PIC/S ANEKS 1 (PEMBUATAN PRODUK STERIL) – TEKNOLOGI ISOLATOR NO VERSI ASLI VERSI TERJEMAHAN 21 The utilisation of isolator technology to minimise human interventions in processing areas may result in a significant decrease in the risk of microbiological contamination of aseptically manufactured products from the environment.

PIC/S ANEKS 1 (PEMBUATAN PRODUK STERIL) – PEMANTAUAN RUANG BERSIH DAN PERANGKAT UDARA BERSIH NO VERSI ASLI VERSI TERJEMAHAN 8 Clean rooms and clean air devices should be routinely monitored in operation and the monitoring locations based on a formal risk analysis study and the results…

PIC/S ANEKS 1 (PEMBUATAN PRODUK STERIL) – KLASIFIKASI RUANG BERSIH DAN PERANGKAT UDARA BERSIH NO VERSI ASLI VERSI TERJEMAHAN 4 Clean rooms and clean air devices should be classified in accordance with EN ISO 14644-1. Classification should be clearly differentiated from operational process environmental monitoring. The…

PIC/S ANEKS 1 (PEMBUATAN PRODUK STERIL) – UMUM NO VERSI ASLI VERSI TERJEMAHAN 1 The manufacture of sterile products should be carried out in clean areas entry to which should be through airlocks for personnel and/or for equipment and materials. Clean areas should be maintained to…