Sterile compounding

sterile compounding is used to prepare

injections, iv, intramuscular, sc

eye drops

irrigations

pulmonary inhalations

CSP meaning

compounded sterile product (drug made via sterile compounding

SVP

small volume parenteral (IV container <100mL

LVP

large volume parenteral (IV container >100mL)

PPE

personal prtective equipment

PEC

primary engineering control (the sterile hood)

LAFW

laminar airflow workbench

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

SEC

secondary engineering control the room contains ISO 7 air where the sterile hood (PEC) is located

SCA

segregated compounding area dessignated space that provides ISO 5 sterile hood but is not part of the cleanroom suite

CAI

Compounding Aseptic Isolator

a type e of closed front PEC used for nonhazardous compounding known as a glovebox

RABS

Restricted access barrier system; any closed front ISO 5 sterile hood; also known as glovebox

in sterile compounding surfaces must be

smooth, impervious making them easy to clean and disinfect,. Stainless steel equipement is often used

ISO sets the standard for

the lower the particle count the ____ the air

air quality

cleaner

ISO 5

PEC

ISO 7

SEC

ISO 8

Anteroom

what is the air changes per hour (ACPH)

the number of times that the air is replaced in the room

for a room with ISO 7 air there must be at least how many ACPH

30

the air pressure for PEC and SEC are both what?

positive for nonhazardous drug compounding

what is a cleanroom suite

one or more sterile hoods ( ISO 5 PECS) inside an ISO 7 buffer room that is entered through an adjacent anteroom

segregated compounding area

has ISO 5 PEC, often an isolator glovebox with unclassified air

the space in front of the HEPA filter is

direct compounding area

the air coming directly out of the HEPA filter is called

first air

the hepa filter must be

recertified by a specialist every 6 months

in LAFW air lows how?

unidirectional; horizontal laminar airflow

a compounding aspetic isolator is often located where?

segragated compounding area

training is done how often

every 12 months

initial training and continuous traning

aseptic procedures

hand hygiene

garbing

sterile drug preparation

which test tests gloving

gloved fingertip test

which test tests sterile drug preparation

media fill test

the gloved finger tip test and the meida fill test must be dinw how often

initially and every 6 months if compounding categry 1 and 2 CSPs

what happens in the gloved fingertip test

evaluator collects gloved sample from eash hand

plates are incubated. spots that form are called CFUs and indicate contamination

passing a gloved fingertip test

after garbing: passing requires three consecutive gloved fingertip samples with zero CFUs

after media fill test: passing requires at least one sample taken from each hand immediately afterf completion of the media fill test with less than or equal to 3 CFUs

what does the media fill test consist of

used to determine if compounder is preparing CSPs in an aseptic manner

turbidity means contamination is present

passing a media fill test

if the liquid stays clear after 14 days of incubation the compounder has passed the test

temperature monitoring

must be documented; should be monitored at least daily

what is air and surface testing

tests to ensure the environment for compounding sterile products is acceptably free of contaminants

air sampling for contaminants must performed how often

every 6 months

surface sampling for contaminants is performed how often

every 30 days. Areas touched most frequently should be tested at the end of the compounding shift

air pressure testing using a a continuous monitoring device to confirm

the correct differential between two spaces and ensure that the air flow is unidirectional

the PEC should be on for how long before compounding begins

at least 30 minutes

PECS are preferably kept

running at all times

need to be cleaned and disinfected then sterile 70% isopropyl alcohol is applied

what kind of wipes are used to wipe the PEC

low tint

how are PECS cleaned

top to bottom, back to front meaning the cleanest areas are cleaned first and the dirtiest areas are cleaned last. slightly overlapping unidirectional strokes

what is the order of cleaning PECs

ceiling

back

bar

side walls

where does garbing occur

anteroom

In CAI what king od garbing occurs

hand hygeine and sterile powder-free gloves

minimum gar attire includes

head cover, shoe covers, a gown, gloves, and face mask

steps to garbing

remove coats, rings, watches, and makeup. artificial or long nails are not permitted

don head and facial hair covers and face masks , then show covers while stepping over the line pf demarcation

perform hand hygeine with soap and warm water

clean under finger nails

wash hands and forearms up to the elbows for at least 30 minutes

don a low tint gown disposable gowns are preferred

apply an alcohol based surgical hand scrub. Chlorhexidine is used but povidine iodine can be used if allergic reaction to chlorhexidine

don sterile powder free gloves

sanitize the gloves wuth sterile 70% IPA routinely

what is a luer locks

they make secure leak free connections between syringes, needles, cathethers and IV lines

what is required when drawning liquid from an ampule

filter needle or filter straw

example of ready to use vial/bag system

ADD-vantage

technology in sterile compounding (2)

automated compounding devices that aseptically transfer ingredients. should be interfaced with the electronic health record to prevent transcriptiond errors

IV workflow management systems automate the preparation, verification through barcode scanning as well as photo captuure

all equipments should be wiped off with

sterile 70% IPA to remove contaminants prior to being brought into the PEC

All work within the PEC MUST be performed at what distance

at least 6 inches from the front

place all items how?

side by side. nothing should be between the sterile objecr and HEPA filter

sterile syringes must be opnedd how

along the seal inside the PEC to avoid shedding (release of particles)

what is coring

it occurs when a small piece of rubber from the stopper is aspirated into the needle. Look for small cored pieces floating near the top pf the solution during the visual insptection

how to open an ampule

open by snapping the neck away from you

visual inspection. supervising pharmacist should

verify that the correct volume of product is in the syringe before compounding continues

what is the syringe pull back method

when the pharmacist verifies the volume in an empty syringe after the compounding is completed

how are finished CSPs inspected

immediately after preparation and check for precipitates, cored pieces, particulates. the container should be lightly squeezed to check for leakage

what is a category1 CSP

they are placed in a segregated compounding area. they require shorter BUDs

what is the BUD for a category 1 CSPs

SC <12 hours at controlled room temperature and <24 hours if refrigerated

category 2 CSPs are made in

cleanroom suite and have longer BUDs

category 3 BUDs

longer BUDs up to 180 days

have specific requirements and include sterility testing

category 2 room temperature BUD limit

1-45 days

category 2 refrigerated BUD limit

4-60 days

category 2 frozen BUD limit

45-90 days

category 3 room temperature BUD limit

60-90 days

category 3 refrigerated BUD limit

90-120 days

category 2 frozen BUD limit

120-180 days

the master formulation record

CSPs prepared for more than one patient or from non sterile ingredients

compounding record

needed for Category 1,2, and 3 CSPs for any immediate use CSPs for more than one patient

CSP labeling requirements

Name, amounts or concentration of ingredients, route of administration, storage requirements

auxilary labels should be placed on CSPs that requre

special handling