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Definitions
Laminar Airflow Workbenches
Hazardous Medications
Quality Assurance
ISO Categories
100
An area where the primary engineering control is physically located. Activities that occur in this area include the preparation and staging of components and supplies used when compounding compounded sterile products.
What is the buffer area?
100
Air moves outward from the HEPA filter at this rate.
What is 90 +/- 20 feet per minute?
100
Hazardous medications should be prepared here.
What is a biological safety cabinet (i.e. vertical flow hood)?
100
The number of times a compounder must demonstrate a successful gloved finger tip test prior to compounding.
What is 3 times?
100
Entails measuring the number of particles in the air of a this size.
What is larger than 0.5 microns?
200
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 at risk of direct contact with air (e.g. ambient room or HEPA filtered), moisture (e.g. oral and mucosal secretions), or touch contamination.
What is a critical site?
200
Air that moves in sheets or layers in parallel lines outward to prevent the development of eddies is called this.
What is laminar?
200
All hazardous compounded products must be placed in a sealable bag labeled as this.
What is cytotoxic?
200
Compounders who engage in low and medium risk compounding must pass a gloved finger tip test this often.
What is annually?
200
The buffer room must have air of this ISO category.
What is ISO 7?
300
The air exiting the HEPA filter in a unidirectional air stream that is essentially particle free?
What is first air?
300
Air is filtered by the HEPA filter to this approximate efficiency.
What is 99%?
300
Standards for the preparation of hazardous medications.
What is USP <800>?
300
Compounders who engage in high risk compounding must pass a gloved finger tip test this often.
What is semiannually?
300
The ante room must have air of this ISO category.
What is ISO 8?
400
A room that is at a higher pressure than the adjacent spaces and, therefore, the net airflow is out of the room.
What is a positive pressure room?
400
The HEPA filter must be tested this often.
What is every 12 months?
400
Compounders who routinely work with hazardous medications should have blood tests this often.
What is at baseline then yearly?
400
Sterilization of media when doing media fill testing must be accomplished when a compounder engages in this level of compounding.
What is high risk?
400
The direct compounding area must have air of this ISO category.
What is ISO 5?
500
A critical area within the ISO Class 5 primary engineering control where critical sites are exposed to unidirectional HEPA-filtered air, also know as first air.
What is the direct compounding area?
500
A 3X width of product created by items in the laminar airflow workbench is called this.
What is the zone of turbulence?
500
Chemotherapeutic drugs to which long term exposure may cause changes in DNA of cells and result in cancer are called this.
What is carcinogenic?
500
A program intended to provide a mechanism for monitoring, evaluating, correcting, and improving the activities and processes associated with compounding.
What is the quality assurance program?
500
This ISO category has less than 3,520 particles smaller than 0.5 micron in diameter per metered squared floating around in the air.
What is ISO 5?