USP <797> Flashcards
What is the intent of chapter 797 of the USP?
- to prevent hard and fatality to patients
What can harm and fatality to patients be caused by?
- microbial contamination
- excessive bacterial endotoxin content
- large errors in strength and incorrect ingredients
Compounded sterile produce is a dosage unit of what?
- a sterile product prepared according to the manufacturer’s labeled instructions
- preparations that must be sterilized before administration
What does low risk level microbial contamination involve?
- characterized by or requires:
- 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
What are some examples of low risk contamination products?
- using sterile needles and syringes to transfer sterile drugs from the manufacturer’s original packaging
- manually measures and mixing no more than three sterile products to compound drug admixtures
What does medium risk level contamination involve?
- characterized by or requires:
- pooling multiple sterile commercial products for multiple patients or products
- involves complex aseptic manipulations
- compounding occurs over a prolonged period of time (complex procedures)
- no antibacterial agents are added and drug administered over several
- quality assurance procedures include all steps for low-risk level
- more challenging annual media-fill evaluation of personnel
What are some example of medium risk contamination products?
- PN fluid compounded using manual or automated devices
- filling reservoirs of infection devices with multiple sterile drug products
- filling reservoirs of infusion devices with sterile drug solutions to be administered over several day at ambient temperatures
- transfer of multiple ampoules or vials into a single final sterile container
What does high risk level contamination involve?
- characterized by or require:
- preparation from non sterile ingredients
- sterile but exposed to less than class 100 cleanroom
- more than 6 hour delay from compounding to sterilization
- purity of components is assumed but not verified by documentation
- quality assurance procedures include all steps for low risk level
- semiannual media-fill evaluation of compounding personnel
- simulation of each compounding sterilization using dry non sterile media
What are some examples of high risk level contamination?
- 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 packaged of manufactured sterile products that lack antimicrobial preservatives)
- measuring and mixing sterile ingredients in non-sterile devices before sterilization is preformed
What should compounder evaluations include?
- a formal written exam and practical evaluation of aseptic technique using growth media (media-fill method)
- a personnel must be properly trained before commencing any compounded and evaluated annually in low and medium risk level compounding
Laminar airflow workbenches and cleanrooms every _____
6 months
Complex preparing parenteral solutions can be aided by using ______
automated compounding devices
Expiration limits of compounded sterile products are based on ____ and ____
risk level and chemical stability
What is the guidelines for putting expiration dates on solid and non-aqueous liquids prepared from commercially available dosage forms?
25% of the remaining expiration date of the commercial product or 6 months, whatever comes earlier
What are the guidelines for putting an expiration date on solid and non-aqueous liquids from bulk ingredients?
- up to 6 months
