Skills III Midterm

core skills in USP Chapter 797

• proper use of PEC

• calculations and measuring

• hand hygiene and garbing

• cleaning and disinfecting

t or f: USP Chapter 797 guidelines apply only to compounding pharmacists

false

what does the abbreviation “CSP” used in Chapter 797 refer to

compounded sterile preparations

t or f: the USP develops guidelines and enforces compliance with these guidelines

false

what term is defined as "combining, admixing, diluting, pooling, reconstituting, repackaging or otherwise altering substance to create sterile medication"

sterile compounding

who is responsible for the performance and operation of the facility and personnel as related to the preparation of CSP's?

the designated person(s)

can techniques or procedures other than those mentioned in USP Chapter 797 may be used when compounding sterile preparations?

yes, if they are validated and noninferior

what type of air pressure is required for non-hazardous sterile compounding?

positive pressure (higher quality air to lower quality air)

what type of air pressure is required for hazardous sterile compounding?

negative pressure (lower quality air to higher quality air)

how is air velocity measured

ACPH

how is particles measured

particles per m³

how is air pressure differentials measured

inches of water column

requirements of the buffer room

• ISO class 7

• considered SEC

line of demarcation

designates clean and dirty areas of the ante room

airflow pattern consistent with positive pressure compounding suite

from PEC, into Buffer room, into Ante Room, then into unclassified area

t or f: the same equipment, environment and techniques should be used to prepare both non-hazardous and hazardous CSPs.

false

t or f: Category 1 CSPs may be compounded in a SCA or cleanroom suite

true

what type of storage will provide the longest BUD for Category 1 CSP

refrigerator

what type of additional testing will allow for extended BUD for Category 2 CSPs

sterility testing

t or f: category 1, 2 and 3 CSPs can be compounded from 1 or more non-sterile components.

true

training and competency in Sterile Compounding Principles and Practices for compounders is

• required at least every 12 months

• supplemented by SOPs

which organization(s) enforces pharmaceutical standards

• regulatory bodies

• accrediting/credentialing organizations

• can be interpreted on the state level

organizations that recognize USP-NF

• FDA

• CDC

• CMS

• department of defense

• NABP

core skills as described in USP 797

• proper use of PEC

• calculations and measuring

• hand hygiene and garbing

• cleaning and disinfecting

USP 797 does not include

• administration of medication

• preparation of medication according to approved label

the designated person(s) is responsible for

• creating and implementing the training program

• ensuring personnel are initially trained and qualified, and remain qualified

the written training program for compounding CSPs as described in USP 797 must describe

• the required training

• frequency of training

• process for performance evaluation

hand hygiene/garbing and aseptic technique evaluations for category 1 and 2 CSP must be done

• initial - 3 successful completions in succession

• every 6 months

hand hygiene/garbing and aseptic technique evaluations for category 3 CSP must be done

• initial - 3 successful completions in succession

• every 3 months

hand hygiene/garbing and aseptic technique evaluations for those doing direct oversight and not compounding must be done

• initial - 3 successful completions in succession

• every 12 months

DCA

direct compounding area

HEPA filters are designed to remove 99.9% of airborne particles measuring

0.3 microns or greater

where are HEPA filters found

both PECs and SECs

for non-hazardous compounding, there must be a minimum ___ water column differential between adjacent rooms

0.020 inch of water column

PEC

• Primary Engineering Control

• provides an ISO Class 5 environment

• LAFW, CAI, CACI

• device where critical compounding occurs

SEC

• Secondary Engineering Control

• the area in which the PEC is located

• ante room, buffer room, SCA

ISO Class 5 particle concentration requirements

< 3,520 particles/m²

ISO Class 7 particle concentration requirements

< 352,000 particles/m²

ISO Class 8 particle concentration requirements

< 3,520,000 particles/m²

an ISO Class 8 ante room requires

• > 20 ACPH

• at least 15 ACPH from HVAC through HEPA in ceiling

• < 3,520,000 particles/m²

an ISO Class 7 buffer room requires

• > 30 ACPH

• at least 15 ACPH from HVAC through HEPA in ceiling

• < 352,000 particles/m²

clean room suite

buffer area + ante room

SCA requirements

• visible perimeter

• contain a PEC

• be appropriately controlled

• appropriate for Category 1 CSPs only

immediate use CSP requirements

• aseptic techniques must be followed - written SOPs

• personnel must be trained and demonstrated competency

• CSP must be prepared according to evidence-based info

• no more than 3 different sterile products

• unused starting components from a single-dose container must be discarded or the single-dose container must be used for one patient only

• administration must begin within 4 hours

• the CSP must be labelled unless the person who compounded it is the person administering it

Category 1 CSP

• least controlled environmental conditions

• shortest assigned BUD

Category 3 CSP

• most extensive requirements

• sterility testing, endotoxin testing when applicable

• more personnel qualification requirements

• more stringent garbing requirements, more disinfectant requirements

• more frequent environmental monitoring

• longest BUD

compounding areas and devices must be certified

• initially and at least every 6 months

• redesign

• relocation

• other changes affecting airflow

certification must include

• airflow testing - airflow velocity, air exchange rate, pressure differential between adjacent rooms, tested under dynamic operating conditions

• HEPA filter integrity testing - leak testing

• total particle count - tested under dynamic operating conditions

• dynamic airflow smoke pattern test - performed for each PEC, under dynamic operating conditions

an ISO Class 5 PEC requires

< 3,520 particles/m²

how to calculate displaced volume

total volume - added volume

what does the displaced volume represent

the volume of the sterile powder inside the vial

features of displaced volume

• the DV for a specific vial from a specific manufacturer will remain constant

• the DV for a specific drug may vary depending on the manufacturer

“fixed” variables when considering displaced volume

• the displaced volume

• the amount of drug in a vial

why is it important to take displaced volume into account

• the patient will not receive an accurate dose if DV is not considered

• you can adjust final concentration when necessary

what are the critical sites on an uncovered needle

• bevel tip

• bevel heel

• shaft

• hub

what are the critical sites on a covered needle

hub

what are the critical sites on the syringe when the plunger is extended

• syringe tip

• plunger

diluent

the solution that will be used to reconstitute a sterile powder

vehicle

the solution that will “carry” or contain the drug additive

large volume vehicles

> 100 mL

injection port on an IV bag

where medication is added

set port on an IV bag

where administration tubing is attached

aseptic technique

• the set of procedures used to keep objects and areas free of harmful microorganisms

• minimizes infection for patients

• considered a core skill for compounding personnel

t or f: USP 797 describes minimum standards and then compounding facilities develop SOPs to meet the guidelines and ensure sterility of CSPs

true

tacky mats

must not be placed within the ISO classified area

critical sites

• must be wiped with sterile 70% IPA in the PEC and allowed to dry

• include vial stoppers and injection ports of IV bags

compounding personnel should inspect components before use to ensure

• component is appropriate in appearance

• packaging of component is intact

• component is within manufacturers expiration date

t or f: It is appropriate to store a small amount of frequently used essential items (needles, syringes, alcohol wipes, etc) in the buffer room

true

t or f: Best practice is to have the PEC running continuously

true

the direct compounding area is

• inside the PEC

• 6 inches from the front and sides

• 2-3 inches from the back screen

items in the PEC

• should be essential items only

• should be placed in order of use

• should be spaced to allow airflow between objects

If your gloved hands move outside of the DCA while compounding, you should

spray gloves with sterile 70% IPA and rub them to dry

t or f: If you touch a vial stopper after it has been swabbed with alcohol (touch contamination) you will need to discard the vial and restart the compounding procedure

false

t or f: Your IV bag should be placed in the PEC in a position with the injection port pointing at the HEPA filter

true

sterilization is required if

• 1 or more nonsterile starting component is used

• nonsterile devices or supplies are used

sterilization methods

• terminal - preferred

• steam

• filtration with 0.22 micron filter or smaller

Which of the following represent a failure of the designated person(s) responsibilities under USP 797?

• personnel begin compounding independently before demonstrating competency in required sterile compounding skills

• a technician with conjunctivitis continues compounding without evaluation

• an ISO class 5 PRC remains in service despite a missed certification interval

• written competency is completed by personnel every 24 months

Which of the following statements correctly compare a cleanroom suite and an SCA?

both utilize an ISO-classified PEC for sterile compounding

Which of the following are appropriate practices to follow prior to and when performing hand hygiene before sterile compounding?

• keep fingernails short, clean and free of polish

• wash hands and forearms for at least 30 seconds

• dry hands and forearms completely with low-lint disposable towels

• avoid touching the sink

• do not apply soap while using nail picks

• rinse from fingertips to elbows

Which (is) are true regarding garbing requirements used in a USP <797> compliant sterile compounding facility?

• donning and doffing garb should not occur in the same area at the same time

• the facility must establish and document its garbing order in its standard operating procedures

• hair covers and masks may be reused within the same shift by the same person if there is no contamination

• no universal garbing sequence - USP 797 states each facility is required to establish and document their own sequence

Which statement BEST describes a cleaning agent?

a substance used to remove contaminants and residues from surfaces

Which test or activity is specifically used to evaluate a compounder's ability to perform proper hand hygiene and garbing?

gloved fingertip sampling

Which of the following statements is true regarding media fill testing?

media fill testing should simulate the most difficult and challenging aseptic compounding procedures performed at the specific facility.

Which of the following is(are) practices that help maintain sterility while compounding a sterile preparation in a PEC located in a cleanroom suite?

• positioning critical sites so they remain exposed to first air during manipulation

• disinfecting vial stoppers with sterile 70% IPA and allowing them to dry before puncturing

• keeping syringe tips, needle hubs, and other critical sites protected until they are ready for use

• arranging and space supplies appropriately within the PEC so that larger items do not interfere with airflow to critical sites

• working 6 inches inside the hood and from the sides

During aseptic manipulation in a cleanroom suite, which of the following are considered critical sites?

• the exposed stopper of vial after disinfection

• the exposed tip of a syringe luer connection after the cap has been removed

• the exposed administration port of an IV bag after its protective cover has been removed

• the extended plunger of a syringe

Per USP 797, which of the following information must be included in the compounding record?

• recorded NDC, lot number, and expiration date of each component

• documentation of inspection and verification of the final CSP

• assigned BUD and storage requirements

Category 1 BUD requirements

• must be prepared in an ISO class 5 or better PEC

• PEC may be located in an unclassified SCA or within a cleanroom suite

Category 2 BUD requirements

• must be prepared in an ISO class 5 or better PEC

• PEC must be located in a cleanroom suite - ISO class 8 positive-pressure room

Category 3 BUD requirements

• must be prepared in an ISO class 5 or better PEC

• PEC must be located in a cleanroom suite - ISO class 8 positive-pressure room

• enhanced personnel competency

• additional garbing and environmental monitoring requirements

• increased frequency of sporicidal disinfectant application

• stability data must be obtained using a stability-indicated analytical method

• particulate-matter testing is conducted once per formulation

• requires sterility testing

• requires bacterial endotoxin testing when compounded from one or more nonsterile components

Immediate use BUD requirements

• direct and immediate administration to a patient

• aseptic processes

• physical and chemical compatibility of the drugs

• no more than 3 different sterile products

• any unused starting component from a single-dose container must be discarded after preparation or not used for more than one patient

• administration begins within 4 hours following the start of preparation

• unless administered by the person who prepared it or administration is witnessed by the preparer, the CSP must be labeled

Category 1 BUD

• room temp: <12 hrs

• refrigerated: < 24 hrs

Category 2 BUD (aseptically processed, no sterility testing)

• prepared from only sterile products:

  • room temp: 4 days

  • refrigerated: 10 days

  • frozen: 45 days

• not prepared from only sterile products:

  • room temp: 1 day

  • refrigerated: 4 days

  • frozen: 45 days

Category 2 BUD (aseptically processed, sterility tested and passed)

• room temp: 30 days

• refrigerated: 45 days

• frozen: 60 days

Category 2 BUD (terminally sterilized, no sterility testing)

• room temp: 14 days

• refrigerated: 28 days

• frozen: 45 days

Category 2 BUD (terminally sterilized, sterility tested and passed )

• room temp: 45 days

• refrigerated: 60 days

• frozen: 90 days

Category 3 BUD (aseptically processed, sterility tested and passed)

• room temp: 60 days

• refrigerated: 90 days

• frozen:120 days

Category 3 BUD (terminally sterilized, sterility tested and passed)

• room temp: 90 days

• refrigerated: 120 days

• frozen: 180 days

Immediate use BUD

4 hours after beginning of preparation