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

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. in a sterilising tunnel).

Konveyor tidak boleh melewati partisi antara area kelas A atau B dan area proses dengan tingkat kebersihan udara lebih rendah, kecuali konveyor itu disterilkan secara terus menerus (misalnya dengan terowongan sterilisasi).

57 As far as practicable equipment, fittings and services should be designed and installed so that operations, maintenance and repairs can be carried out outside the clean area. If sterilisation is required, it should be carried out, wherever possible, after complete reassembly. Sebisa mungkin peralatan, fitting dan servis harus dirancang dan dipasang agar kegiatan, perawatan dan perbaikan dapat dilakukan di luar area bersih. Jika sterilisasi diperlukan, sebisa mungkin harus dilakukan setelah pemasangan ulang selesai.

58 When equipment maintenance has been carried out within the clean area, the area should be cleaned, disinfected and/or sterilised where appropriate, before processing recommences if the required standards of cleanliness and/or asepsis have not been maintained during the work. Bila perawatan peralatan dilakukan di dalam area bersih, area harus dibersihkan, didisinfeksi dan/atau disterilisasi bila diperlukan, sebelum proses dimulai kembali jika standar kebersihan dan/atau asepsis yang dipersyaratkan tidak dapat dipertahankan selama pekerjaan berlangsung.

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