Ch 19 P 36 Compounding Sterile Preparations

Question 1

Air changes per hour (ACPH)

Answer 1

The number of times a volume of air equivalent to the room passes through the room each hour.

Question 2

Ante-area

Answer 2

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.

Question 3

Aseptic technique

Answer 3

Proper manipulation of preparations to maintain sterility.

Question 4

Batch

Answer 4

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.

Question 5

Beyond-use-date

Answer 5

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.

Question 6

Biological safety cabinet

Answer 6

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.

Question 7

Buffer area

Answer 7

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.

Question 8

Certification

Answer 8

Independent third party documentation declaring that the specific requirements of USP/NF <797> (USP General Chapters: <797> Pharmaceutical Compounding-Sterile Preparations) have been met.

Question 9

Cleanroom

Answer 9

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.

Question 10

Closed system vial-transfer device

Answer 10

A vial-transfer system that allows no venting or exposure of substances to the environment.

Question 11

Compounded sterile preparations (CSP)

Answer 11

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.

Question 12

Compounding aseptic containment isolator (CACI)

Answer 12

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.

Question 13

Compounding aseptic isolator (CAI)

Answer 13

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).

Question 14

Critical area

Answer 14

An ISO Class 5 environment.

Question 15

Critical site

Answer 15

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.

Question 16

Direct compounding area

Answer 16

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.

Question 17

Disinfectant

Answer 17

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.

Question 18

Hazardous Drugs

Answer 18

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).

Question 19

Home care

Answer 19

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.

Question 20

Immediate use

Answer 20

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.

Question 21

ISO 5

Answer 21

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).

Question 22

ISO 7

Answer 22

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).

Question 23

ISO 8

Answer 23

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).

Question 24

Laminar airflow

Answer 24

A non-turbulent, non-mixing streamline flow of air in parallel layers.

Question 25

Laminar airflow workbench (LAFW)

Answer 25

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.

Question 26

Media-fill test

Answer 26

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.

Question 27

Multiple dose contianer

Answer 27

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.

Question 28

Negative pressure room

Answer 28

A room that is at a lower pressure than the adjacent spaces and therefore, the net flow of air is into the room.

Question 29

Parenteral product

Answer 29

Any preparation administered by injection through one or more layers of skin tissue.

Question 30

Personal protective equipment (PPE)

Answer 30

Items such as gloves, gowns, respirators, goggles, face shields, and others that protect individual workers from hazardous physical or chemical exposures.

Question 31

Pharmacy bulk packages

Answer 31

A container of a sterile preparation for parenteral use that contains many single doses. Contents are intended for use in a pharmacy admixture program and are restricted to use in a suitable ISO Class 5 environment.

Question 32

Plan of care

Answer 32

an individualized care plan for each patient receiving parenteral products in a home setting to include the following:

                            (1) description of actual or potential drug therapy problems and their proposed solutions;
                            (2) a description of desired outcomes of drug therapy provided;
                            (3) a proposal for patient education and counseling; and
                            (4) a plan specifying proactive objective and subjective monitoring (e.g. vital signs, laboratory test, physical findings, patient response, toxicity, adverse reactions, and noncompliance) and the frequency with which monitoring is to occur.

Question 33

Positive pressure room

Answer 33

A room that is at a higher pressure than the adjacent spaces and, therefore, the net airflow is out of the room.

Question 34

Preparation

Answer 34

A CSP that is a sterile drug or nutrient compounded in a licensed pharmacy or other healthcare-related facility pursuant to the order of a licensed prescriber; the article may or may not contain sterile products.

Question 35

Primary engineering control

Answer 35

A device or room that provides an ISO Class 5 environment for the exposure of critical sites when compounding CSP’s. Such devices include, but may not be limited to, laminar airflow workbenches (LAFW’s), biological safety cabinets (BSC’s), compounding aseptic isolators (CAI’s), and compounding aseptic containment isolators (CACI’s).

Question 36

Process validation

Answer 36

Documented evidence providing a high degree of assurance that a specific process will consistently produce a preparation meeting its predetermined specifications and quality attributes.

Question 37

Product

Answer 37

A commercially manufactured drug or nutrient that has been evaluated for safety and efficacy by the FDA. Products are accompanied by full prescribing information, which is commonly known as the FDA-approved manufacturer’s labeling or product package insert.

Question 38

Quality assurance

Answer 38

A program for the systematic monitoring and evaluation of the various aspects of a service or facility to ensure that standards of quality are being met.

Question 39

Quality control

Answer 39

A system for verifying and maintaining a desired level of quality in a preparations or process, as by planning, continued inspection, and corrective action as required.

Question 40

Secondary engineering control

Answer 40

The ante area and buffer area or cleanroom in which primary engineering controls are placed.

Question 41

Segregated compounding area

Answer 41

A designated space, either a demarcated area or room, that is restricted to preparing low-risk level CSP’s 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 CSP’s and shall be void of activities and materials that are extraneous to sterile compounding.

Question 42

Single-dose container

Answer 42

A single-dose, or a single-unit, container for articles or preparations intended for parenteral administration only. It is intended for a single use. Examples of single-dose containers include prefilled syringes, cartridges, fusion-sealed containers, and closure-sealed containers when so labeled.

Question 43

Standard operating procedure

Answer 43

A written protocol detailing the required standards for performance of tasks and operations within a facility.

Question 44

Sterile

Answer 44

Free from bacteria or other living microorganisms.

Question 45

Sterilization by filtration

Answer 45

Passage of a fluid or solution through a sterilizing grade membrane to produce a sterile effluent.

Question 46

Sterilization grade membranes

Answer 46

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. Such filter membranes are nominally at 0.22 mm or 0.2 mm porosity, depending on the manufacturer’s practice.

Question 47

Terminal sterilization

Answer 47

The application of a lethal process (e.g., steam under pressure or autoclaving) to sealed containers for the purpose of achieving a predetermined sterility assurance level of usually less than 10−6, or a probability of less than one in one million of a non-sterile unit.

Question 48

Unidirectional flow

Answer 48

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 or testing area.

Question 49

USP

Answer 49

United States pharmacopeia