SO 13408-1:2008 specifies the gener

SO 13408-1:2008 specifies the general requirements for, and offers guidance on, processes, programmes and procedures for development, validation and routine control of the manufacturing process for aseptically-processed health care products.

ISO 13408-1:2008 includes requirements and guidance relative to the overall topic of aseptic processing. Specific requirements and guidance on various specialized processes and methods related to filtration, lyophilization, clean-in place (CIP) technologies, sterilization in place (SIP) and isolator systems are given in other parts of ISO 13408.

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JADI 13408-1:2008 menentukan persyaratan umum, dan menawarkan bimbingan pada, proses, program dan prosedur untuk pengembangan, validasi dan rutin kontrol proses manufaktur untuk diproses secara aseptik produk perawatan kesehatan.ISO 13408-1:2008 mencakup persyaratan dan bimbingan relatif terhadap topik keseluruhan aseptik pengolahan. Persyaratan tertentu dan bimbingan pada berbagai proses khusus dan metode berkaitan filtrasi, lyophilization, teknologi bersih di tempat (CIP), sterilisasi di tempat (SIP) dan sistem isolator diberikan dalam bagian lain dari ISO 13408.