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797 Sterile preparations

Terms in this set (26)

Ante area
An area in which all preparations for IV admixtures are gathered, including labels, gowning, and drug materials
aseptic processing
a mode of processing pharmaceutical and medical products that involves the separate sterilization of the product and of the package (containers,-closures or packaging material for medical devices) and the transfer of the product into the container and its closure under at least ISO Class 5 conditions.
Beyond-use date (BUD)
the date or time a drug or material can no longer be used; drug is ineffective after this date
biological safety cabinet
a vertical laminar flow hood used to provide protection for the worker, the work environment, and the drug
buffer area
an area where the primary engineering control (PEC) is physically located. Activities that occur in this area include the preparation and staging of components and supplies used when compounding CSPs.
Cleanroom
is a space designed specifically to keep all airborne particles out
Compounding Aseptic Containment Isolator (CACI)
a CAI designed to provide worker protection from exposure to undesirable levels of airborne drug throughout the compounding and material transfer processes and to provide an aseptic environment for compounding sterile preparations. 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 ventilation.
Compounding Aseptic Isolator (CAI)
an isolator cabinet designed to contain all contaminants;prevents contaminants from escaping IVs and being transferred to surrounding area
critical area
An ISO Class 5 environment
Critical site
Any opening or pathway that is at risk for contact with air or touch contamination
Direct Compounding Area (DCA)
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.
disinfectant
any chemical agent used to destroy or inhibit the growth of harmful organisms
first Air
the air exiting the HEPA filter in a unidirectional air stream that is essentially particle free
hazardous drugs
drugs are classified as hazardous if studies in animals or humans indicate that exposures to them have a potential for causing cancer, developmental or reproductive toxicity, or harm to organs.
Labeling
providing identifying, promotional, or other information on package labels
Media-fill test
a test used to qualify aseptic technique of compounding personnel or processes and to ensure that the processes used are able to produce sterile product 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.
Multiple-Dose Container
a multiple-unit container for articles or preparations intended for parenteral administration only and usually containing antimicrobial preservatives.
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.
Pharmacy Bulk Package
a container of a sterile preparation for parenteral use that contains many single doses. The contents are intended for use in a pharmacy admixture program and are restricted to the preparation of admixtures for infusion or, through a sterile transfer device, for the filling of empty sterile syringes. The closure shall be penetrated only one time after constitution with a suitable sterile transfer device or dispensing set, which allows measured dispensing of the contents.
positive pressure room
a room that is at a higher pressure than the adjacent spaces and, therefore, the net airflow is out of the room.
single dose container
a single-unit container for articles or preparations intended for parenteral administration only. It is intended for a single use. A single dose container is labeled as such.
Segregated Compounding Area
A designated space, either a demarcated area or room, that is restricted to preparing
low-risk level CSPs with 12-hour or less BUD. Such area shall contain a device that provides unidirectional airflow of ISO Class 5 air quality for preparation of CSPs and shall be void of activities and materials that are extraneous to sterile compounding.
Sterilizing Grade Membranes
Membranes that are documented to retain 100% of a culture of 107 microorganisms of a
strain of Brevundimonas (Pseudomonas) diminuta per square centimeter of membrane surface under a pressure of not less than
30 psi (2.0 bar).
sterilization by filtration
Passage of a fluid or solution through a sterilizing grade membrane to produce a sterile effluent.
Terminal sterilization
process of sterilizing articles after they have been used and before putting them into circulation again
unidirectional flow
Airflow moving in a single direction, in a robust and uniform manner, and at sufficient speed to reproducibly sweep particles away from the critical processing area.
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