Cerita Iki

Persyaratan : l   Keamanan ( safety )                  - formulasi                 - pemilihan eksipien l   Sterilitas ( sterility )                 - perlakuan; proses aseptis l   Stabilitas                 - proses; waktu simpan, fisik, kimia l   Scalability                 - skala linier setiap batch l   Produk Obat → kombinasi bahan aktif dan eksipien.                 Pengetahuan ttg : komposisi, fungsi, dan sifat/karakteristik   eksipien  ...

JENIS SEDIAAN : l   CAIRAN l   SEMISOLID l   PADAT; serbuk tabur PERSYARATAN : l   STERIL l   NON PIROGEN l   PROSES ; STERIL, ASEPTIS l   KEMASAN Personnel Cleansing and Gowning Responsibilities of Compounding Personnel Risk Level Classifications Verification of Accuracy and Sterilization Personnel Training and Assessment Environmental Quality and Control Equipment Storage and Beyond-Use Dating Definition of Compounded Sterile Products (CSP) – USP27 l   Preparations prepared according to the manufacturer’s labeled instructions and other manipulations that expose contents to potential contamination l   Preparations containing nonsterile ingredients or employ nonsterile components or devices that must be sterilized before administration l   Biologics, diagnostics, drugs, nutrients, and radiopharmaceuticals that possess either of the above two characteristics ...