GMP: GOOD MANUFACTURING PRATICE The preparations implying the highest microbiological risk (aseptic compounding, sterile product handling, preparations which may not undergo process-end sterilisation) require aseptic procedures inside isolators guaranteeing a sterile environment within a class “D” area. Iteco Engineering (www.itecoeng.com) is an Italian company specialising in the design and construction of controlled atmosphere gloveboxes, isolators, shielded isolator cells and special equipment for protection from chemical, toxic and radioactive materials designed for companies, laboratories and organisations active in the chemical, pharmaceutical/radiopharmaceutical, and nuclear industries. It produces an innovative Class ISO 5 laminar flow isolator (up to UNI EN ISO 14644-7-ISO 10648-EEC-GMP standards) for sterile pharmaceutical preparations, mainly intended for stem cell preparation and processing, amniotic membrane preparation, injectable preparations in hospital pharmacies and cell marking in nuclear medicine departments (in this case, the equipment is fully shielded).
- Applications: : aseptic
- Options and accessories: : laminar flow