Flashcards in Ch 19 P 36 Compounding Sterile Preparations Deck (49)
Air changes per hour (ACPH)
The number of times a volume of air equivalent to the room passes through the room each hour.
An ISO Class 8 or better area where personnel hand hygiene and garbing procedures, staging of components, order entry, CSP labeling, and other high-particulate generating activities are performed. It is also a transition area that:
(1) provides assurance that pressure relationships are constantly maintained so that air flows from clean to dirty areas; and
(2) reduces the need for the heating, ventilating, and air-conditioning (HVAC) control system to respond to large disturbances.
Proper manipulation of preparations to maintain sterility.
More than one unit of a compounded preparation that is intended to have uniform character and quality within specified limits, prepared in a single process, and completed during the same and limited time period.
The date, or as appropriate, date and time, after which a compounded preparation is not to be used and is determined from the date and time the preparation is compounded.
Biological safety cabinet
A ventilated cabinet that provides ISO Class 5 environment for CSP’s, provides personnel, preparation, and environmental protection having an open front with inward airflow for personnel protection, downward high-efficiency particulate air (HEPA)-filtered laminar airflow for preparation protection, and HEPA-filtered exhausted air for environmental protection.
An area where the primary engineering control (PEC) is physically located. Activities that occur in this area include the staging of components and supplies used when compounding CSP’s.
Independent third party documentation declaring that the specific requirements of USP/NF <797> (USP General Chapters: <797> Pharmaceutical Compounding-Sterile Preparations) have been met.
A room in which the concentration of airborne particles is controlled to meet a specified airborne particulate cleanliness class. Microorganisms in the environment are monitored so that a microbial level for air, surface, and personnel gear are not exceeded for a specified cleanliness class.
Closed system vial-transfer device
A vial-transfer system that allows no venting or exposure of substances to the environment.
Compounded sterile preparations (CSP)
Include, but are not limited, to the following dosage forms which must be sterile when administered to patients:
(1) parenteral preparations;
(2) aqueous bronchial and nasal inhalations;
(3) baths and soaks for live organs and tissues;
(4) injections (e.g. colloidal dispersions, emulsions, solutions, suspensions);
(5) irrigations for wounds and body cavities;
(6) ophthalmic drops and ointments; and
(7) tissue implants.
Compounding aseptic containment isolator (CACI)
An enclosed ISO Class 5 environment workspace for compounding of hazardous sterile preparations, provides personnel protection with negative pressure and appropriate ventilation and provides preparation protection by isolation from the environment and high-efficiency particulate air (HEPA)-filtered laminar airflow. Air exchange with the surrounding environment should not occur unless the air is first passed through a microbial retentive filter (HEPA minimum) system capable of containing airborne concentrations of the physical size and state of the drug being compounded. Where volatile hazardous drugs are prepared, the exhaust air from the isolator should be appropriately removed by properly designed building ventilation.
Compounding aseptic isolator (CAI)
An enclosed ISO Class 5 environments for compounding pharmaceutical ingredients or preparations. It is designed to maintain an aseptic compounding environment within the isolator throughout the compounding and material transfer processes. Air exchange into the isolator from the surrounding environment should not occur unless the air has first passed through a microbial retentive filter (HEPA minimum).
An ISO Class 5 environment.
A location that includes any component or fluid pathway surfaces (e.g., vial septa, injection ports, beakers) or openings (e.g., opened ampules, needle hubs) exposed and at risk of direct contact with air (e.g., ambient room or HEPA filtered), moisture (e.g., oral and mucosal secretions), or touch contamination. Risk of microbial particulate contamination of the critical site increases with the size of the openings and exposure time.
Direct compounding area
A critical area within the ISO Class 5 primary engineering control (PEC) where critical sites are exposed to unidirectional HEPA-filtered air, also known as first air.
An agent that frees from infection and destroys disease-causing pathogens or other harmful microorganisms, but may not kill bacterial and fungal spores. It refers to substances applied to inanimate agents, usually a chemical agent, but sometimes a physical one.
Drugs classified as hazardous if studies in animals or humans indicate exposures to them have a potential for causing cancer, development or reproductive toxicity or harm to organs. (Reference current NIOSH publications).
Health care provided in the patient’s home (not a hospital or skilled nursing facility) by either licensed health professionals or trained caregivers. May include hospice care.
Administration begins not later than one hour following the start of the compounding procedure. For those events in which delay in preparation would subject patient to additional risk and meeting USP/NF <797> (Immediate-Use CSP Provision) criteria.
Air containing no more than 100 particles per cubic foot of air of a size at least 0.5 micron or larger in diameter (3520 particles per cubic meter).
Air containing no more than 10,000 particles per cubic foot of air of a size at least 0.5 micron or larger in diameter (352,000 particles per cubic meter).
Air containing no more than 100,000 particles per cubic foot of air of a size at least 0.5 micron or larger in diameter (3,520,000 particles per cubic meter).
A non-turbulent, non-mixing streamline flow of air in parallel layers.
Laminar airflow workbench (LAFW)
A ventilated cabinet for compounding of sterile preparations. Provides preparation protection with high-efficiency particulate air (HEPA) filtered laminar airflow, ISO Class 5. Airflow may be horizontal (back to front) or vertical (top to bottom) in direction.
A test used to qualify aseptic technique of compounding personnel or processes and to ensure that the processes used are able to produce sterile preparation without microbial contamination. During this test, a microbiological growth medium such as soybean-casein digest medium is substituted for the actual drug product to simulate admixture compounding. The issues to consider in the development of a media-fill test are media-fill procedures, media selection, fill volume, incubation, time, and temperature, inspection of filled units, documentation, interpretation of results, and possible corrective actions required.
Multiple dose contianer
A multiple-unit container for articles or preparations intended for parenteral administration only and usually containing antimicrobial preservatives. Once opened or entered, a multiple dose container with antimicrobial preservative has a BUD of 28 days unless otherwise specified by the manufacturer.
Negative pressure room
A room that is at a lower pressure than the adjacent spaces and therefore, the net flow of air is into the room.
Any preparation administered by injection through one or more layers of skin tissue.