NAPLEX Sterile Compounding

sterile compounding is used to prepare?

Injections (IV, IM, SC)

Eye drops

Irrigations

Pulmonary inhalations

Baths, soaks for live tissues/organs

Implants

USP ____ - sterile

797

SVP define

small volume parenteral

-IV bag with a volume ≤100 ml

LVP define

large volume parenteral

-IV bag with volume >100 ml

PEC define

primary engineering control

-sterile hood that provides ISO 5 air for sterile compounding

LAFW define

laminar airflow workbench

type of open front sterile hood (PEC); air flow in one direction

SEC define

secondary engineering control

-room containing ISO 7 air where sterile hood (PEC) is located; also called buffer room

SCA define

segregated compounding area

-designated space that contains ISO 5 but is not part of cleanroom suite

CAI define

compounding aseptic isolator

-type of closed front ISO 5 sterile hood used for nonhazardous drug compounding;

-known as glovebox

RABS define

restricted access barrier system

-any closed front ISO 5 sterile good (includes CAIs)

-referred to as glove box

physical space basics

all surfaces must be smooth, impervious, free from cracks/cabinets for easy cleaning

-stainless steel is often used

-no objects that shed particles (cardboard boxes)

the lower the particle count, the ____ the room

cleaner

the PEC (inside hood) must be at least ISO ___

5

SEC( buffer room) must be at least ISO ___

7

anteroom must be at least ISO ___

7 if negative pressure buffer room (ie. hazardous drug compounding)

8 if opens to positive pressure buffer room

handwashing, garbing, etc.

air changes per hour (ACPH) for a room with ISO 7 air

30 ACPH

air pressure inside the PEC and SEC are both ___ for nonhazardous drug compounding

positive - pushes air out to keep away from sterile products

types of sterile compounding areas: cleanroom suite

one or more sterile hoods inside a buffer room that is entered through an adjacent anteroom

contains pec (iso 5) inside sec (buffer room iso 7) and anteroom

types of sterile compounding areas: segregated compounding area (SCA)

a sterile hood, often an isolator (glovebox), with a closed front, located in a segregated space with unclassified air

the space in front of the HEPA filter is called ____ and the air coming directly out of HEPA filter is called the ____

direct compounding area (DCA)

first air

HEPA filter must be recertified by a specialist how often?

every 6 months and any time a PEC has been moved

a ____ is an open-front PEC where air flows in unidirectional lines from the HEPA filter, typically from the back of the hood, known as horizontal laminar flow

LAFW (laminar airflow workbench)

waste buckets underneath a CAI are ____ for sharps and nonhazardous waste

red

what is the line of demarcation

line which separates room into clean/dirty sections (in anteroom)

how are shoe covers applied?

one at a time while stepping over the demarcation line

where can an SCA NOT be?

adjacent to food preparation, warehouses, restrooms, windows/doors that connect to outdoors, high traffic flow areas

____ are useful for satellite pharmacies that are a distance away from main pharmacy in a large hospital, infusion centers, clinic, small hospitals

SCAs

each facility is required to have a ____ who is responsible for training and oversight of compounding staff

designated person

ant person who compounds must have documented ____ training and continuous training completed how often?

initial

every 12 months

Staff must demonstrate that they can follow adequate aseptic procedures for each of these items prior to independently compounding:

hand hygiene

garbing/gloving

cleaning/disinfecting

sterile drug preparation

adequate asceptic technique in hand hygiene, garbing, and gloving is demonstrated by

visual obersvation completed >/= 3 times

gloved fingertip and thumb test

both gloved fingertip test and media fill test must be completed by a compounder initially, then every ___ if compounding only category 1 and 2 CSPs OR every ____ if compounding category 3 CSPs

6 months

3 months

gloved fingertip test

immediately after completing hand hygiene and garbing/gloving, the evaluator collects a gloved fingertip sample from both hands of compounder by rolling pads of fingers and thumb over a plate with microbial growth agar (tryptic soy agar or TSA)

-plates are incubated then inspected after ≥7 days

-if organisms are present, TSA will be used as food source and they will replicate (spots/CFUs/contamination will be seen)

passing a gloved fingertip test:

-after garbing - passing requires ___ consecutive gloved fingertip samples, taken after garbing, with ___ CFUs for both hands

3

zero

passing a gloved fingertip test:

-after media fill testing - passing requires at least ___ sample taken from each hand immediately after completion of media fill test, with ____ CFUs total for both hands

1

≤ 3

media fill test

used to determine if compounder is preparing in aseptic manner

-compounder prepares small IV bag or vial using tryptic soy broth (TSB) instead of drug. multiple manipulations (transfers with same syringe) are done and product is incubated to check for bacterial growth

____ means contamination is present in a media fill test

turbidity

passing a media fill test:

-if liquid stays clear after ____ days of incubation, compounder has passed

14 days

SEC or buffer room temp should be checked how often? and how should it be maintained? (temp/humidity)

once daily

20C or 68F

humidity at 60% or less

temperature in the CSP storage areas (fridge, freezer) should be monitored at least ____

daily

air sampling (iso) for contaminants is performed at least how often?

every 6 months

surface sampling for contaminants must be performed how often?

-areas touched most frequently, test at end of compounding shift before cleaning/disinfecting

every 30 days at end of compounding shift

air pressure testing is done to confirm the correct ____ between two spaces and ensure airflow is unidirectional

differential

should PECs be kep running at all times?

yes, preferably

what happens if there is a power outage (PEC)

all compounding must stop

clean and disinfect PEC

apply sterile 70% IPA prior to re-starting compounding

the PEC must be on for at least how long after a power outage is fixed before compounding can begin?

30 minutes

cleaning the PEC (products/how often)

daily and anytime contamination is suspected

-use 70% IPA every 30 minutes throughout day

-first PEC is cleaned with detergent, then disinfected, then 70% IPA is applied

-sporicidal disinfectant is required, but less often

sterile, ___ wipes are used to clean PEC

low-lint

order of cleaning for a PEC

clean ceiling of hood from back to front

clean back of hood from top to bottom

clean IV bar and hooks

clean side walls from back to front

clean anything kept in the hood (equipment)

clean bottom (work area) surface from back to front

do not start compounding until surfaces have ____

dried

PEC, pass-through chambers, work surfaces outside PEC and floors must be cleaned and disinfected how often?

daily

walls, doors, ceilings, storage shelves/bins, and equipment outside PEC must be cleaning and disinfected how often?

monthly

how often is sopricidal disinfectant used?

monthly

cleaning v disinfecting v sporicidal

removes organics and inorganic contaminants

destroys microbes

destroys vegetative spores

Garbing Technique

-Remove coats/rings/makeup/etc

-Don head, facial covers, face mask, shoe covers while stepping over demarcation line, optional eye shield

-Hand hygiene with soap/warm water, clean fingernails, wash for ≥30 seconds

-Dry hands with low lint towels

-Don low lint gown

-Enter buffer area

-Apply alcohol based hand scrub

-Don sterile, powder free gloves

-Sanitize gloves with 70% IPA

if working in an SCA and it is left for any reason, ____ is required

regarbing

___ syringes are commonly used for sterile compounding to transfer drugs/additives from and onto sterile containers

hypodermic (parenteral)

do not use a syringe the ___ size of the amount needed (plunger can become dislodged)

exact

____ make secure, leak free connections between syringes/needles and IV lines. ends twist together to form a tight seal

luer lock

a ____ or ____ is required when withdrawing liquid from the ampule to remove glass (after snapping the neck)

filter needle

filter straw

why are some drugs available as powders?

because they are unstable as a solution

SVPs are often ____ onto a LVP

piggybacked

____ are available as prepared IV bags or prefilled syringes; not compounded

ready to use medications (RTUs)

ready to use vial/bag systems

Add-Vantage

Minibag Plus

what does an automated compounding device (ACD) do?

aseptically transfer ingredients into a sterile final container

automated compounding devices should be interfaced with the EHR to prevent transcription errors

the EHR to prevent transcription errors

what do IV workflow management systems (IVWMS) do?

automate preparation, verification, tracking, and documentation, of CSPs

-barcode scanning, photo capture

all work within the PEC must be performed at least ___ from the front

6 inches

place all items in the sterile hood ____

side by side

the volume of solution drawn into a syringe is measured at the point of ___ between the rubber piston and the side of the syringe barrel

contact

___ occurs when a small piece of rubber from the stopper is aspirated into the needle, and is put into the solution in a vial

coring

look for small ___ pieces floating near the top of the solution during visual inspection of the CSP

cored

what is the syringe pull back method?

occurs when the pharmacist verifies the volume in an empty syringe AFTER compounding is done

this is NOT recommended

terminal sterilization is required for CSPs that are compounded with any ____ ingredients

nonsterile

types of terminal sterilization

steam sterilization (with autoclave)

dry heat sterilization (depyrogenation)

filtration

How can CSPs that are heat-labile be sterilized? (heat sensitive eg. proteins, hormones, insulin)

filtration using sterile 0.22 micron filter

if filtering is used for sterilization, the manufacturer might require a test for filter integrity such as the ?

bubble point test

what is the bubble point test

test that determines the pressure required to see bubbles out of a filter

endotoxins from gram ____ are more potent and represent a serious threat

negative

pyrogens come from using equipment washed with ____ water

tap

how to avoid pyrogens

glassware and utensils should be rinsed with sterile water and depyrogenated using dry-heat (steam) sterilization with an autoclave

category 1 sterile compounding

what

prepared in ISO 5 PEC that is placed in an SCA (unclassified air)

-higher risk of contamination

-shorter BUD, no sterility test needed

RT: ≤12 hours

Fridge: ≤24 hours

category 2 sterile compounding

made in a cleanroom suite

-longer BUD, sterility testing may be needed

category 3 sterile compounding

-specific requirements

-longer BUD, some require sterility testing

category 3 sterile compounding - BUD up to a max of ____

180 days

which has highest risk of contamination: category 1, 2, or 3

1 has higher risk than 3

-to determine appropriate BUD

BUD for products made emergently in suboptimal conditions

BUD: 4 hours

BUD

CSP category

category 1

environment

ISO 5 PEC in SCA

RT: ≤12 hours

Fridge: ≤24 hours

freezer: N/A

BUD

CSP category

category 2

environment

ISO 5 PEC in clean room

RT: 45 days

Fridge: 60 days

freezer: 90 days

BUD

CSP category

category 3

environment

ISO 5, clean room + sterility or other

RT: 90 days

Fridge: 120 days

Freezer: 180 days

sterility testing is required for which category?

3

optional for cat 2 to increase BUD

BUD for single dose container (vial, bag, bottle syringe inside ISO 5)

up to 12 hours from puncture or opening

BUD for single dose container (ampule inside or outside ISO 5)

any used contents left in ampule must be discarded

BUD for multi dose container (inside or outside ISO 5)

up to 28 days from puncture or opening

the ____ is needed for CSPs prepared for more than one patient or from nonsterile ingredients

master formulation record

is a CSP is prepared for more than one patient for from nonsterile ingredients, what must be recorded in the compounding record?

vendor

lot number

expiration date

CSP label requirements

Names of ingredients

Amounts of ingredients

Total volume

BUD

dosage form

Route of administration

Storage requirements

internal identification number (order number, barcode)

QA vs QC

QA ensures compounding process is consistent

QC induces sampling, testing, documentation of results

most CSPs including IV solutions and ophthalmic products, should be ___ to human blood

isotonic

compounded preparations that require a narrow pH range will need a ____ that can resist changes in pH

buffer system