This activity affords the student pharmacist the opportunity to prepare two sterile preparations while performing all required aseptic techniques to manage and maintain all ISO controlled environments. Students will gown and glove in the ISO 8 anteroom; weigh, wet, and dissolve ingredients in the ISO 7 pre-sterilization room; and conduct filtration, filling, crimping and sealing of finished preparations in the sterilization (finishing) room. All documentation will be entered in a master formulation record. Preparations will undergo visual observations. Samples will be prepared for sterility and endotoxin testing.
- Perform required tasks in an ISO 8 anteroom (e.g., gowning, forearm & hand sanitization, and gloving)
- Perform required tasks in an ISO 7 environment (e.g., pre-sterilization, weighing, wetting, pH adjusting, and solubilizing)
- Perform required tasks in an ISO 5 environment (e.g., filtration, vial filling, crimping, and labelling)
- Prepare two Compounding Sterile Preparations (CSP) from Master Formulation Records (MFR)
- Perform visual observations and finished preparation inspections
- Prepare appropriate quantities of samples for sterility testing
- Perform endotoxin testing on finished preparations