USP 797 Exam Questions with Complete Solutions

USP 797 Exam Questions with Complete Solutions Proper procedures and aseptic technique__________the risk of contamination. a. greatly decrease b. somewhat increase c. somewhat decrease d. have no effect on - ANSWER a. greatly decrease __________contamination is the principle source of compounded sterile preparations contamination. a. Filter b. Touch c. Water d. Air - ANSWER b. touch Cleaner air reduces the risk of contamination during compounding. a. True b. False - ANSWER a. true Compounding isolators incorporate a different set of techniques than laminar airflow workbenches. a. True b. False - ANSWER a. true Eating, drinking, and gum chewing are allowed in the ante area but not inside the buffer area surrounding the laminar air flow workbenches. a. True b. False - ANSWER b. false Generally, aseptic manipulations should be performed at least__________inches inside the workbench. a. 6 b. 9 c. 18 - ANSWER a. 6 The direct compounding area is the__________. a. entire sterile compounding area b. buffer area c. area inside the laminar airflow workbench - ANSWER c. area inside the laminar airflow workbench Primary engineering controls must be certified__________,whenever the workbench is moved, or if filter damage is suspected. a. every 6 months b. yearly c. weekly d. when problems are reported - ANSWER a. every 6 months HEPA filters should be cleaned periodically with sterile 70% isopropyl alcohol. a. True b. False - ANSWER b. false The primary source of contamination inside a buffer area is__________. a. a HEPA filter b. humans c. leaks d. broken ampules - ANSWER b. humans Although isolators give users mobility, flexibility, and dexterity, a cleanroom reduces the risk of coming into direct contact with harmful compounds. a. True b. False - ANSWER b. false Biological Safety Cabinets and Compounding Aseptic Containment Isolators are used to prepare hazardous drugs. a. True b. False - ANSWER a. true If a laminar flow workbench is turned off between aseptic processing sessions, it must be operated long enough to be free of room air in the critical area for at least__________. a. 10 minutes b. 30 minutes c. 3 hours d. 30 seconds - ANSWER b. 30 minutes Which of the following DOES NOT introduce contamination? a. Dust b. Dirt c. Pollen d. Skin flakes e. Lint f. Cosmetics g. All of the above can introduce contamination - ANSWER g. all of the above USP <797> contains specific requirements for the design and maintenance of appropriate cleanroom facilities. For all risk levels, the policies and procedures you establish must be__________. a. strictly followed to be effective b. occasionally followed when time allows c. followed on a case-by-case basis - ANSWER a. strictly followed to be effective A laminar airflow workbench placed in a portion of the pharmacy (but not in the buffer area) is called a__________. a. certified clean area b. certified ante area c. segregated compounding area d. satellite compounding room - ANSWER c. segregated compounding area A buffer area used for the preparation of non-hazardous drugs is under positive pressure. a. True b. False - ANSWER a. true