N.M. Admin. Code § 16.19.36.7

Current through Register Vol. 35, No. 23, December 10, 2024

Section 16.19.36.7 - DEFINITIONS

A."Air changes per hour" (ACPH) means the number of times a volume of air equivalent to the room passes through the room each hour.

B."Anteroom" means an ISO Class 8 or cleaner 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) contains a line of demarcation which is a visible line on the floor that separates the clean and dirty sides of the anteroom.

C."Aseptic processing" A method by which separate, sterile components (e.g., drugs, containers, or closures) are brought together under conditions that maintain their sterility. The components can either be purchased as sterile or, when starting with nonsterile components, can be separately sterilized prior to combining (e.g., by membrane filtration or by autoclave).

D."Aseptic technique" means proper manipulation of preparations to maintain sterility.

E."Batch" More than one CSP prepared as described in the MFR in a single, discrete process, and expected to have uniform character and quality, within specified limits.

F."Beyond-use date" (BUD) means 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.

G."Biological safety cabinet" (BSC) A ventilated cabinet that may be used for compounding. These cabinets are divided into three general classes (Class I, Class II, and Class III). Class II BSCs are further divided into types (Type A1, Type A2, Type B1, Type B2, and Type C1).

H."Biological safety cabinet (BSC), Class II" A ventilated cabinet with an open front and inward and downward unidirectional HEPA-filtered airflow and HEPA-filtered exhaust. A BSC used to prepare a CSP must be capable of providing an ISO Class five or better environment for preparation of the CSPs.

I."Buffer room" An ISO Class seven or cleaner room with fixed walls and doors where PEC(s) that generate and maintain an ISO Class five environment are physically located. The buffer room may only be accessed through the anteroom or another buffer room.

J."Category one CSP" A CSP that is assigned a BUD of 12 h or less at controlled room temperature or 24 h or less refrigerated that is compounded in accordance with all applicable requirements for Category one CSPs in USP/NF <797>.

K."Category two CSP" A CSP that may be assigned a BUD of greater than 12 h at controlled room temperature or greater than 24 h refrigerated that is compounded in accordance with all applicable requirements for Category 2 CSPs in USP/NF <797>.

L."Category three CSP" A CSP that may be assigned a BUD exceeding the limits in for Category two CSPs and is compounded in accordance with all applicable requirements for Category three CSPs in USP/NF <797>.

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

N."Cleaning" The process of removing substances (e.g., organic and inorganic material) from objects and surfaces, normally accomplished by manually or mechanically using water with detergents or enzymatic products.

O."Cleaning agent" An agent, usually containing a surfactant, used for the removal of substances (e.g., dirt, debris, microbes, and residual drugs or chemicals) from surfaces.

P."Cleanroom suite" A classified area that consists of both an anteroom and buffer room.

Q."Closed system vial-transfer device" means a vial-transfer system that allows no venting or exposure of substances to the environment.

R."Component" Any ingredient used in the compounding of a preparation, including any active ingredient, added substance, or conventionally manufactured product.

S."Compounded sterile preparations" (CSP's) 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 internal body cavities;

(6) ophthalmic drops and ointments; and

(7) implants.

T."Compounding aseptic containment isolator" (CACI) A type of RABS that uses HEPA filtration to provide an ISO Class five unidirectional air environment designed for the compounding of sterile HDs.

U."Compounding aseptic isolator" (CAI) A type of RABS that uses HEPA filtration to provide an ISO Class five unidirectional air environment designed for compounding of sterile non-HDs.

V."Compounding record" (CR) Documents the compounding of each CSP.

W."Container closure system" Packaging components that together contain and protect the dosage form. This includes primary packaging components and secondary packaging components, if the latter are intended to provide additional protection.

X."Containment ventilated enclosure" (CVE) A non-ISO classified full or partial enclosure that uses ventilation principles to capture, contain, and remove airborne contaminants through HEPA filtration and prevent their release into the work environment.

Y."Critical area" means an ISO Class five environment.

Z."Critical site" means 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.

AA."Designated person" Individual assigned to be responsible and accountable for the performance and operation of the facility and personnel as related to the preparation of CSPs. For pharmacies the designated person must be the pharmacist-in-charge. For clinic facilities the designated person must be the consultant pharmacist.

BB."Direct compounding area" (DCA) means a critical area within the ISO Class five primary engineering control (PEC) where critical sites are exposed to unidirectional HEPA-filtered air, also known as first air.

CC."Disinfectant" A chemical or physical agent used on inanimate surfaces and objects to destroy fungi, viruses, and bacteria. Sporicidal disinfectants are considered a special class of disinfectants that also are effective against bacterial and fungal spores.

DD."Dynamic airflow smoke pattern test" A PEC test in which a visible source of smoke, which is neutrally buoyant, is used to observe air patterns within the unidirectional space (i.e., the DCA) under dynamic operating conditions (see the entry for Dynamic operating conditions). This test is not appropriate for ISO Class seven or ISO Class eight cleanrooms that do not have unidirectional airflow (see the entry for Visual smoke study).

EE."Dynamic operating conditions" Conditions in the compounding area in which operating personnel are present and simulating or performing compounding. The conditions should reflect the largest number of personnel and highest complexity of compounding expected during routine operations as determined by the designated person(s).

FF."Garb" Items such as gloves, garments (e.g., gowns), shoe covers, head and facial hair covers, masks, and other items designed to reduce particle-shedding from personnel and minimize the risk of contamination of CSP(s).

GG."Hazardous drug" (HD) Any drug identified by at least one of the following six criteria: carcinogenicity, teratogenicity or developmental toxicity, reproductive toxicity in humans, organ toxicity at low dose in humans or animals, genotoxicity, or new drugs that mimic existing HDs in structure or toxicity. (Reference current NIOSH publications).

HH."High-efficiency particulate air (HEPA) filtration" Being, using, or containing a filter designed to remove ninety-nine and ninety-seven one-hundredths percent of airborne particles measuring zero and three-micron or greater in diameter passing through it.

II."Home care"means 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.

JJ."Integrated vertical laminar flow zone" (IVLFZ) A designated ISO Class five area serving as the PEC within an ISO Class seven or cleaner buffer room. In the IVLFZ, unidirectional airflow is created by placing HEPA filters over the entire surface of the worktables and by effective placement of air returns.

KK."ISO class" An air-quality classification from the International Organization for Standardization.

LL."Laminar airflow" means a non-turbulent, non-mixing streamline flow of air in parallel layers.

MM."Laminar airflow system" (LAFS) A device or zone within a buffer room that provides an ISO Class five or better air quality environment for sterile compounding. The system provides a unidirectional HEPA filtered airflow.

NN."Laminar airflow workbench" (LAFW) A device that is a type of LAFS that provides an ISO Class five or better air quality environment for sterile compounding. The device provides a unidirectional HEPA-filtered airflow.

OO."Line of demarcation" A visible line on the floor that separates the clean and dirty sides of the anteroom.

PP."Master formulation record" (MFR) A detailed record of procedures that describes how the CSP is to be prepared.

QQ."Media-fill test" A simulation used to qualify processes and personnel engaged in sterile compounding to ensure that the processes and personnel are able to prepare CSPs without contamination.

RR."Multiple-dose container" means 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.

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

TT."One-step disinfectant cleaner" A product with an EPA-registered (or equivalent) claim that it can clean and disinfect a nonporous surface in the presence of light to moderate organic soiling without a separate cleaning step.

UU."Parenteral product" means any preparation administered by injection through one or more layers of skin tissue.

VV."Pass-through chamber" An enclosure with sealed doors on both sides that should be interlocked. The pass-through chamber is positioned between two spaces for the purpose of minimizing particulate transfer while moving materials from one space to another.

WW."Personal protective equipment" (PPE) meansitems such as gloves, gowns, respirators, goggles, face shields, and others that protect individual workers from hazardous physical or chemical exposures.

XX."Pharmacy bulk packages" means 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.

YY."Plan of care" means 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.

ZZ."Positive pressure room" means a room that is at a higher pressure than the adjacent spaces and, therefore, the net airflow is out of the room.

AAA."Primary engineering control" (PEC) A device or zone that provides an ISO Class five air quality environment for sterile compounding.

BBB."Process validation" means documented evidence providing a high degree of assurance that a specific process will consistently produce a preparation meeting its predetermined specifications and quality attributes.

CCC."Product" means 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.

DDD."Quality assurance" means 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.

EEE."Quality control" means 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.

FFF."Reconstitution" The process of adding a diluent to a conventionally manufactured product to prepare a sterile solution or suspension.

GGG."Repackaging" The act of removing a sterile product or preparation from its original primary container and placing it into another primary container, usually of smaller size without further manipulation.

HHH."Restricted-access barrier system" (RABS) An enclosure that provides HEPA-filtered ISO Class five unidirectional air that allows for the ingress and/or egress of materials through defined openings that have been designed and validated to preclude the transfer of contamination, and that generally are not to be opened during operations. Examples of RABS include CAIs and CACIs.

III."Secondary engineering control" The area where the PEC is placed (e.g., a cleanroom suite or an SCA). It incorporates specific design and operational parameters required to minimize the risk of contamination within the compounding area.

JJJ."Segregated compounding area" A designated space, area, or room that is not required to be classified and is defined with a visible perimeter. The SCA must contain a PEC and is suitable for preparation of Category one CSPs only.

KKK."Single-dose container" means 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.

LLL."Sporicidal disinfectant" A chemical or physical agent that destroys bacterial and fungal spores when used in sufficient concentration for a specified contact time. It is expected to kill all vegetative microorganisms.

MMM."Stability" The extent to which a product or preparation retains physical and chemical properties and characteristics within specified limits throughout its expiration or BUD.

NNN."Standard operating procedure" (SOP) means a written protocol detailing the required standardsfor performance of tasks and operations within a facility.

OOO."Sterile Compounding" The process of combining, admixing, diluting, pooling, reconstituting, repackaging, or otherwise altering a drug product or bulk drug substance to create a sterile preparation.

PPP."Sterility" The absence of viable microorganisms.

QQQ."Sterilization by filtration" means passage of a fluid or solution through a sterilizing grade membrane to produce a sterile effluent.

RRR."Sterilizing grade filter" means filter membranes that are documented to retain one hundred percent 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 zero and twenty-two mm or zero and two mm pore size.

SSS."Terminal sterilization" means the application of a lethal process (e.g., steam, dry heat, irradiation) 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.

UUU."Unidirectional airflow" Air within a PEC moving in a single direction in a uniform manner and at sufficient velocity to sweep particles away from the DCA.

VVV."USP" means United States pharmacopeia.

WWW."Visual smoke study" A test, used in ISO Class seven and ISO Class eight rooms that do not have unidirectional airflow, in which a visible source of smoke, which is neutrally buoyant, is used to verify an absence of stagnant airflow. This test does not need to be performed under dynamic operating conditions and is not appropriate for PECs (see the entry for Dynamic airflow smoke pattern test).

XXX."Workflow management system" Technology comprised of hardware and/or software that allows for automation to assist in the verification of components of, and preparation of, CSPs and to document components and processes.

N.M. Admin. Code § 16.19.36.7

16.19.36.7 NMAC - N, 06-28-14, Amended by New Mexico Register, Volume XXVI, Issue 05, March 16, 2015, eff. 3/22/2015, Amended by New Mexico Register, Volume XXXV, Issue 15, August 13, 2024, eff. 8/13/2024