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Certification Review
Compounded Sterile Products
| Question | Answer |
|---|---|
| USP <795> | The United States Pharmacopeia establishes nonsterile compounding requirements. |
| USP <797> | sterile compounding requirements |
| Bacteriostatic water for injection USP | Is sterile water with antimicrobial agents that can be used for injection. |
| Purified water USP | Is not intended for parenteral administration; it is used in the reconstitution of oral products. |
| Water for injection USP | Is not sterile and cannot be used in aseptic compounding of sterile products. |
| Sterile water for irrigation USP | Has been sterilized but contains no antimicrobial agents. It is used as an irrigating solution. |
| ante area | Is an area in which all preparations for IV admixtures are gathered, including labels and gowning and drug materials. Hand hygiene, garbing, staging of components, order entry, and other particle-generating activities are performed . Must maintain a mi |
| buffer area | Hoods are kept and IV preparations take place. |
| clean area | Is a space where microbial containment is kept at a specific level to ensure a certain level of cleanliness. |
| critical site | Is an area exposed to air or touch, such as a vial, needle, or ampule. |
| Normal saline solution | Is used for extracellular fluid replacement. |
| Lactated Ringer’s solution | Is used for fluid and electrolyte replacement. |
| D5W | Is used for hydration and calorie replacement. |
| D10W, D20W, and D50W | Are used for insulin shock and calorie replacement. |
| Which is the in-use time for a multi-dose container in an ISO 5 environment? | 28 days |
| Which BUD should be assigned for a category 2 compounded sterile product if a sterility test is performed and a preservative was added to the sterile product? | 42 days |
| How often must the clean room be tested for compliance with air standards? | Every 12 months |
| How often must the ante area be tested for compliance with air standards? | Every 6 months |
| Safety Data Sheets | Provide information on potential health hazards associated with a medication. |
| How often must surface sampling be performed in ISO Class 5, 7, and 8 environments? | Monthly |
| How often must nonviable air sampling be performed in ISO Class 5, 7, and 8 environments? | Every 6 months |
| 70% IPA | Is used to decontaminate supplies in the DCA ( Direct Compounding Area). |
| What is the correct sequence in donning personal protective equipment? | The sequence to donning personal protective equipment is as follows: shoe covers, hair/beard covers, mask, gown, and gloves |
| compounding record | Includes date prepared, names of ingredients, manufacturer of each ingredient, lot number and expiration date of each ingredient, amounts of weight or volume of each ingredient, dosage form of each ingredient, assigned pharmacy lot number, pharmacy BUD, |
| formulation record (FR) | Is a list of ingredients, the preparation methods, safety requirements, beyond-use date (BUD), and references for the compounder. It also contains the steps involved in compounding the product. |
| What is the minimum amount of time that hands be washed prior to compounding? | 30 seconds |
| alcohol-based hand rub | Used to sanitize an individual’s hands. |
Created by:
mparcasio