Badan Pengawas Obat dan Makanan Republik Indonesia ...

Aneks 1 – Pembuatan Produk Sterildilakukan di lingkungan Kelas A denganlatar belakang Kelas B.32. Proses pembuatan larutan yang akandisterilisasi secara filtrasi hendaklahdilakukan di lingkungan Kelas C; bilatidak dilakukan filtrasi, penyiapan bahandan produk hendaklah dilakukan dilingkungan Kelas A dengan latarbelakang Kelas B.33. Penanganan dan pengisian produk yangdibuat secara aseptis hendaklahdilakukan di lingkungan Kelas Adengan latar belakang Kelas B.34. Transfer wadah setengah-tertutup, yangakan digunakan dalam proses bekukering(freeze drying) hendaklah,sebelum proses penutupan denganstopper selesai, dilakukan di lingkunganKelas A dengan latar belakang KelasB atau dalam nampan transfer yangtertutup di lingkungan Kelas B.35. Pembuatan dan pengisian salep, krim,suspensi dan emulsi hendaklahdilakukan di lingkungan Kelas Adengan latar belakang Kelas B, apabilaproduk terpapar dan tidak akan disaring.Annex 1 – Manufacture of SterilePharmaceutical Productslater in the process, should be done in aGrade A environment with Grade Bbackground.32. Preparation of solutions which are to besterile filtered during the process shouldbe done in a Grade C environment; ifnot filtered, the preparation of materialsand products should be done in a GradeA environment with a Grade Bbackground.33. Handling and filling of asepticallyprepared products should be done in aGrade A environment with a Grade Bbackground.34. Transfer of partially closed containers,as used in freeze drying, should, prior tothe completion of stoppering, be doneeither in a Grade A environment withGrade B background or in sealedtransfer trays in a Grade B environment.35. Preparation and filling of sterileointments, creams, suspensions andemulsions should be done in a Grade Aenvironment, with a Grade Bbackground, when the product isexposed and is not subsequentlyfiltered.PERSONALIA36. Hanya personalia dalam jumlah terbatasyang diperlukan boleh berada di areabersih; hal ini penting khususnya padaproses aseptis. Inspeksi danpengawasan hendaklah dilaksanakansedapat mungkin dari luar area bersih.37. Personalia yang bekerja di area bersihdan steril hendaklah dipilih secaraseksama untuk memastikan bahwamereka dapat diandalkan untuk bekerjadengan penuh disiplin dan tidakmengidap suatu penyakit atau dalamkondisi kesehatan yang dapatmenimbulkan bahaya pencemaranmikrobiologis terhadap produk.PERSONNEL36. Only the minimum number of personnelrequired should be present in cleanareas; this is particularly importantduring aseptic processing. Inspectionsand controls should be conductedoutside the clean areas as far aspossible.37. Personnel required to work in clean andsterile areas should be selected withcare to ensure that they may be reliedupon to observe the appropriatedisciplines and are not subject to anydisease or condition which wouldpresent any microbiological hazard tothe product.Edisi 2009 - 23 - 2009 Edition