Section 10 - USP 797 Flashcards
What is a compounded sterile product?
- A sterile product prepared according to manufacturer’s labeled instructions
- Preparation that must be sterilized before administration
What are the 3 risk-level classifications for compounded sterile products and how are they determined?
- Low, medium, and high
- Determined by potential for microbial, chemical, and physical contamination
What are compounders responsible for?
- Ensuring that CSPs are accurately identified, measured, diluted and mixed; and correctly purified, sterilized, packaged, sealed, labeled, stored, dispensed, and distributed
- Responsibilities include maintaining appropriate cleanliness conditions and providing labeling and supplementary instructions for proper clinical administration
What are low-risk level CSPs?
- Compounding from sterile commercial drugs using commercial sterile devices
- Involves only a few closed-system, basic aseptic transfers or manipulations
- Annual media-fill test for each person who compounds
- Occurs in class 100 environment
What are 2 examples of low-risk level CSPs?
- Using sterile needles and syringes to transfer sterile drugs from manufacturer’s original packaging
- Manually measuring and mixing no more than 3 sterile products to compound drug admixtures
What are medium-risk level CSPs?
- Pooling multiple sterile commercial products for multiple patients or products
- Involves complex aseptic manipulations
- Compounding occurs over prolonged period of time
- No antibacterial agents are added and drug administered over several days
- Quality assurance procedures include all steps for low-risk level
- More challenging annual media-fill evaluation of personnel
What are some examples of medium-risk level CSPs?
- PN fluids compounded using manual or automated devices
- Filling reservoirs of infusion devices w/ multiple sterile drug products
- Filling reservoirs of infusion devices w/ sterile drug solutions to be administered over several days at ambient temp
- Transfer of multiple ampoules or vials into single final sterile container
What are high-risk level CSPs?
- Prepared from nonsterile ingredients
- Sterile ingredients but exposed to less than class 100 clean room
- More than 6-hour delay from compounding to sterilization
- Purity of components assumed but not verified by documentation
- Quality assurance procedures include all steps for low-risk level
- Semi-annual media-fill evaluation of compounding personnel
- Simulation of each compounding sterilization using dry nonsterile media
What are some examples of high-risk level CSPs?
- Dissolving non-sterile bulk drug which will be sterilized
- Sterile items exposed to air quality less than class 100
- Storage of opened or partially used packages of manufactured sterile products that lack antimicrobial preservatives
- Measuring and mixing sterile ingredients in non-sterile devices before sterilization is performed
What is required after each procedure used for CSPs that requires some form of sterilization?
Documentation and validation
What should compounder evaluations consist of?
Formal written exam and practical evaluation of aseptic technique using growth media (media-fill method)
What are the physical plant and environmental requirements for each CSP risk level?
- Re-certification of laminar-airflow workbenches and clean rooms every 6 months
- Detailed cleaning and sanitizing procedures to maintain cleanliness of compounding environment
- Proper garb available and used by compounding personnel
What can aid w/ preparation of complex PN solutions?
Automated compounding devices (ACDs)
How can you make sure an ACD will accurately deliver the desired volume of ingredients?
- User must be adequately trained
- ACD must be properly calibrated
- Correct setup verified and maintained (correct solution containers hung on correct inlet tubing)
All finished CSPs must be checked by _____ before they are dispensed
A pharmacist, but someone other than the compounder
