PHRA 1445 chapter 4

air changes per hour (ACPH)

the number of times per hour the air in a cleanroom suite or C–SCA is exchanged through an HVAC system

air quality

the level of airborne contaminants in a sterile compounding environment

airflow testing

a quality assurance test conducted by certification personnel every six months to ensure adequate ACPH in ISO-classified areas and unclassified C–SCAs

anteroom

an ISO Class 8 (or cleaner) transition area where garbing, hand hygiene, CSP supply staging, and other preparatory activities take place prior to entering the buffer room

antineoplastic hazardous drug

a type of medication that destroys neoplasms or tumors

aseptic technique

a set of practices and procedures used to minimize the potential introduction of contaminants (including infections) into CSPs

beyond-use date (BUD)

the date and time after which a CSP must not be used

biological agent

a type of medicinal product created using biological processes; includes vaccines, allergy treatments, and gene therapy

biological safety cabinet (BSC)

BSC utilizes vertical airflow and other safeguards designed to protect the compounder from exposure to HDs

buffer room

an ISO Class 7 (or cleaner) room where PECs are physically located; may be referred to as the IV room or sterile compounding room

carbolic acid

an organic compound and early antimicrobial agent derived from tar which was used to disinfect surgical instruments, incisions, and dressings; also known as phenol

Category 1 CSP

a CSP that may be prepared in a PEC located in an unclassified SCA; has a BUD of 12 hours or less at controlled room temperature or 24 hours or less when refrigerated

Category 2 CSP

a CSP that is prepared in a PEC located in a buffer room; has a BUD greater than 12 hours at controlled room temperature and greater than 24 hours when refrigerated, provided that the CSP is compounded within all of the parameters identified in USP <797>

Certificate of Analysis (COA)

a certificate that attests the quality or effectiveness of a test media or sterile device based on product specifications

cleaning agent

an agent used to remove dirt and debris

cleanroom

an early surgical room in which carbolic acid was used to disinfect microorganisms in the operating sit

cleanroom suite

the combined anteroom and buffer room that delineates the sterile compounding environment

colony-forming unit (CFU)

the unit used to estimate colonies of viable bacteria or fungi on a media sample

compounded sterile preparation (CSP)

a preparation intended to be sterile that is created by combining, admixing, diluting, pooling, reconstituting, repackaging, or otherwise altering a drug product or bulk drug substance

compounding aseptic containment isolator (CACI)

a type of enclosed RABS that has an ISO Class 5 environment and is designed to protect sterile compounding personnel and the environment during the preparation of HDs

compounding aseptic isolator (CAI)

a type of enclosed RABS that provides the required ISO Class 5 environment for the preparation of nonhazardous CSPs

contact time

the time a disinfectant needs to remain wet on a surface to ensure its effectiveness; also known as dwell time

containment primary engineering control (C–PEC)

a ventilated PEC designed for the preparation of HDs because it protects the CSP, personnel, and the environment from contaminants; examples include a BSC and a CACI

containment segregated compounding area (C–SCA)

a type of Containment-Secondary Engineering Control (C-SEC) with nominal requirements for airflow and room pressurization as they pertain to HD compounding

coring

an undesired event in which a needle is incorrectly inserted into a vial stopper, thus tearing off a small piece of the stopper which falls into the sterile solution, thus contaminating it

direct compounding area (DCA)

the area within the ISO Class 5 PEC where critical sites are exposed to unidirectional, HEPA-filtered air; may also be called first air or the clean air zone

disinfectant

a chemical or physical agent used in inanimate surfaces to destroy bacteria, viruses, and fungi

dwell time

the time a disinfectant needs to remain wet on a surface to ensure its effectiveness; also known as contact time

dynamic operating conditions

conditions that mimic typical compounding activities to ensure accuracy during particle testing and during dynamic airflow smoke pattern testing

egress

an exit or access point of withdrawal

elixir

a sweetened liquid that typically contains alcohol and water, often compounded with a drug or medication that is intended for oral use; medieval alchemists often cited elixirs as having magical qualities such as prolonging life or reversing the aging process

first air

unidirectional, HEPA-filtered air that moves uninterrupted over the critical sites of supply items in the DCA of a PEC

hazardous drug (HD)

a drug defined by NIOSH that displays one or more of the following characteristics (in humans or animals): carcinogenicity, teratogenicity or other developmental toxicity, reproductive toxicity, organ toxicity at low doses, or genotoxicity; may also include a new drug that has structure and toxicity profiles that mimic existing drugs determined to be hazardous

heating, ventilation, and air conditioning (HVAC)

a ventilation system used to control indoor temperature and air quality in a facility

high-efficiency particulate air (HEPA) filter

a type of air filter that removes 99.97% of airborne particles measuring 0.3 micron or greater in diameter

horizontal laminar airflow workbench

a type of laminar airflow system (LAFS) that uses HEPA filtered, unidirectional, horizontal airflow to provide the ISO Class 5 environment needed to prepare CSPs

incompatibility

a state in which two or more solutions or ingredients within a solution are not suitable in combination, evidenced by the presence of precipitates, crystallized particles, flakes, or a darkening or coloring of a compounded solution or CSP

industrial cleanroom

a large cleanroom used in the manufacturing of sensitive equipment such as computer microchips and radar equipment

ingress

an entrance or a place of access

integrated vertical laminar flow zone (IVLFZ)

an airflow system built into a buffer room in which HEPA filters in the room’s ceiling direct airflow downward with the aid of panels; serves as a PEC and is designated as an ISO Class 5 area

International Organization for Standardization (ISO)

an organization that creates worldwide industrial and technical standards that often become laws or are used in setting standards for accreditation, certification, or credentialing requirements

ISO Class 5

an environment appropriate for sterile compounding, containing no more than 3,520 particles of 0.5 micron per cubic meter of air; previously referred to as a Class 100 environment

laboratory cleanroom

a sterile environment used by personnel to prepare biologic agents and pharmaceuticals

laminar airflow system (LAFS)

an airflow system that uses a blower to force air either horizontally or vertically across the DCA of a PEC; provides the ISO Class 5 (or better) environment mandated by USP <797> for sterile compounding procedures; examples include an LAFW, an IVLFZ, and a BSC

leak testing

a test performed on HEPA filters to ensure their integrity

line of demarcation

a line that is typically indicated by a colored line or by two different-colored tiles on the floor of an anteroom; one color designates the dirty side of the anteroom and one color designates the clean side of the anteroom

needlestick

an accidental penetration of a needle into the skin of an individual preparing a CSP

nonporous material

a type of material having a smooth, nonpermeable surface that is easy to clean and that does not provide cracks, holes, or pores in which contaminants might collect

outer six-inch zone

the outermost edge of a horizontal LAFW, closest to the compounder and farthest from airflow origin at the HEPA filter; this area is considered a poor environment for the preparation of CSPs because of the mix of potentially contaminated room air with HEPA-filtered air

particulate matter

any unwanted, solid substance within a CSP; may be created by incorrect aseptic technique or from mixing two incompatible solutions or ingredients

pass-through

an opening between two areas that allows the passage of items

pharmaceutical

a drug manufactured or compounded for medicinal use

pharmaceutical isolator

an enclosed PEC that has a built-in decontamination system that distributes a sporicidal agent throughout the PEC; this process is followed by a purge of air to remove any residual chemicals

positive pressure

the air pressure within an area that is greater than the air pressure outside that area; positive pressure ensures that the airflow moves outward from the buffer room, through the anteroom, and then toward the unclassified pharmacy area; also refers to the pressure within a sealed container such as a vial or empty evacuated container

prefilter

a BSC or a CACI component that has the same design and function as the prefilter on a horizontal laminar airflow workbench (LAFW); that is, room air is passed through the prefilter to remove large contaminants and then is compressed and channeled through the HEPA filter of a C–PEC

pressure cascade

the process in which air flows from a higher-pressure area to a lower-pressure area

pressure differential

the difference in pressure measurements between two areas

pressure differential monitor

an instrument designed to measure the difference in air pressure between the unclassified pharmacy area and the anteroom and buffer room; measurement is indicated by a column of water that moves up and down in response to the relative pressure being measured

primary engineering control (PEC)

a laminar airflow cabinet, workbench, or hood that provides an ISO Class 5 environment in which CSPs are prepared; previously called a Class 100 environment

quality assurance (QA)

a program of established standards for maintaining the consistent quality of CSPs; defined by a facility’s standard operating procedures

recovery time

a short period (typically one minute or less) in which sterile compounding activities must pause to allow a PEC to resume ISO Class 5 air quality after an access door is opened in a RABS

release testing

a quality assurance process that involves the inspection of a CSP for particulates; may also involve testing the CSP for pH, sterility, and endotoxins

restricted access barrier system (RABS)

a fully enclosed PEC that has glove ports to provide a physical separation between the DCA and the surrounding areas

robotic device

a device that may be used as a PEC or within a PEC that is preprogrammed with standard orders to prepare commonly used CSPs

secondary engineering control (SEC)

the sterile compounding environment, including the anteroom and buffer room or an SCA; the environment leading to the ISO Class 5 primary engineering controls (PECs) or hoods

segregated compounding area (SCA)

an unclassified pharmacy area that may only be used by sterile compounding personnel for the preparation of Category 1 CSPs, which have a BUD of 12 hours or less at controlled room temperature or 24 hours or less when refrigerated

shadowing

an interruption of airflow from a PEC’s HEPA filter to the critical site of any supply item, which may result in contamination

sporicidal agent

a type of disinfectant that is effective against bacterial and fungal spores

staging

the wiping of the exterior surfaces of sterile compounding equipment and supply items with a sporicidal agent, sterile disinfectant, or sterile 70% IPA

surface sampling

a test that uses growth media to detect unacceptable levels of microbial growth on surfaces in a cleanroom suite as well as evaluates the cleaning and disinfection procedures of sterile compounding personnel

tacky mat

a mat comprised of multiple layers of a pressure-sensitive, adhesive substance designed to trap dirt and other loose substances clinging to the soles of shoes; adheres to the floor of the unclassified pharmacy area at the threshold of the anteroom; topmost layer must frequently be removed and discarded

thermal anemometer

a heated sensor that measures air velocity; the higher the velocity, the greater the cooling rate of the sensor

tincture

an oral liquid extract compounded from herbs

touch contamination

contamination caused when the critical site of a supply item is touched by the compounder’s finger or hand, the PEC’s surface, or any nonsterile item, or by introducing any contaminant into the ISO Class 5 compounding area; the most common and dangerous form of contamination of CSPs

unclassified pharmacy area

an area outside the cleanroom suite that does not need to meet ISO air cleanliness standards

US Environmental Protection Agency (EPA)

a federal agency whose mission is to protect human health and the environment, which includes the safety review of chemicals in the workplace

velometer

an instrument that measures the speed of air

viable air sampling

the collection and incubation of air samples in a growth media to detect microbial growth

zone of turbulence

the area directly behind a supply item within the DCA as well as the contaminated area that runs along the entire outer six-inch edge of a PEC where HEPA filtered air mixes with room air; CSPs must not be prepared in the zone of turbulence; the outer six-inch edge of the PEC is also referred to as the outer six-inch zone