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…

PIC/S ANEKS 1 (PEMBUATAN PRODUK STERIL) – PRINSIP NO VERSI ASLI VERSI TERJEMAHAN The manufacture of sterile products is subject to special requirements in order to minimise risks of microbiological contamination, and of particulate and pyrogen contamination. Much depends on the skill, training and attitudes of…