Badan Pengawas Obat dan Makanan Republik Indonesia ...

Aneks 1 – Pembuatan Produk Steril66. Peralatan, fiting dan sarana lain, sejauhmemungkinkan, hendaklah dirancangdan dipasang sedemikian rupa sehinggakegiatan, perawatan dan perbaikandapat dilaksanakan dari luar areabersih. Jika proses sterilisasi diperlukanhendaklah dilakukan setelah perakitankembali selesai, bila memungkinkan.67. Bila standar kebersihan tidak dapatdipertahankan saat dilakukan pekerjaanperawatan yang diperlukan di dalamruang bersih, ruang tersebut hendaklahdibersihkan, didisinfeksi dan/ataudisterilkan sebelum proses dimulaikembali.68. Instalasi pengolahan dan sistemdistribusi air hendaklah didesain,dikonstruksi dan dirawat untukmenjamin agar air yang dihasilkanmemenuhi persyaratan mutu yangsesuai. Hendaklah dipertimbangkanagar perawatan sistem air mencakupprogram pengujian yang diperlukan.Sistem hendaklah tidak dioperasikanmelampaui kapasitas yang dirancang.69. Hendaklah dilakukan validasi danperawatan terencana terhadap semuaperalatan seperti sterilisator, sistempenanganan dan penyaringan udara,ventilasi udara dan filter gas sertasistem pengolahan, penyimpanan danpendistribusian air; persetujuan untukpenggunaan kembali setelah dilakukanperawatan hendaklah dicatat.Annex 1 – Manufacture of SterilePharmaceutical Products66. As far as practicable, equipment, fittingsand services should be designed andinstalled so that operations,maintenance and repairs can be carriedout outside the clean area. If sterilizationis required, it should be carried out aftercomplete reassembly whereverpossible.67. When equipment maintenance has beencarried out within the clean area, thearea should be cleaned, disinfectedand/or sterilized where appropriate,before processing recommences if therequired standards of cleanliness and/ora sepsis have not been maintainedduring the work.68. Water treatment plants and distributionsystems should be designed,constructed and maintained so as toensure a reliable source of water of anappropriate quality. Considerationshould be given to include a testingprogramme in the maintenance of awater system. The system should not beoperated beyond their designedcapacity.69. All equipment such as sterilizers, airhandling and filtration systems, air ventand gas filters, water treatment system,generation, storage and distributionsystems should be subject to validationand planned maintenance; its approveduse following maintenance should berecorded.SANITASI70. Sanitasi area bersih sangatlah penting.Area tersebut hendaklah dibersihkansecara menyeluruh sesuai programtertulis. Bila menggunakan disinfektanhendaklah memakai lebih dari satujenis. Pemantauan hendaklah dilakukansecara berkala untuk mendeteksiperkembangan galur mikroba yangresisten. Dengan mempertimbangkanefektivitasnya yang terbatas, lampuultraviolet hendaklah tidak digunakanuntuk menggantikan disinfektan kimiawi.SANITATION70. The sanitation of clean areas isparticularly important. They should becleaned thoroughly in accordance with awritten programme. Where disinfectantsare used, more than one type should beemployed. Monitoring should beundertaken regularly in order to detectthe development of resistant strains ofmicro organisms. In view of its limitedeffectiveness, ultraviolet light should notbe used as a substitute for chemicaldisinfection.Edisi 2009 - 30 - 2009 Edition