PHRM 534 Cleaning and Disinfecting and BUD

What is an example of a germicidal agent?

PREempt Plus

When is PREempt Plus used?

For daily cleaning of floors, counter, high touch surfaces, pass throughs and sinks

For cleaning supplies that enter the cleanroom as they pass the line of demarcation or in pass through

What is an example of a sporicidal agent?

Peridox

When is Peridox used?

For monthly cleaning of all areas listed in daily cleaning plus walls, ceilings and exterior of PECs and shelves

What is an example of a disinfecting agent?

Sterile 70% isopropyl alcohol (IPA)

When is sterile 70% IPA used?

Disinfecting the PECs, work surfaces and high touch surfaces, supplies prior to breaking the plane of PECs, critical sites on vials/IV bag/ampule, hands prior to entering the ISO class 5 environment

How do all compounding supplies and materials need to be wiped down before entering the cleanroom?

Must be wiped down with germicidal agent prior to entry into the cleanroom through pass through or movement across the line of demarcation

How do all compounding supplies and materials used within the PECs need to be wiped down?

Must be wiped down again using sterile 70% IPA prior to crossing the plane of the ISO class 5 environment

How do critical sites need to be wiped down?

Must be wiped with sterile 70% IPA swabs and allowed to dry immediately prior to compounding

How are PECs cleaned?

Cleaning occurs from cleanest to dirtiest areas of PECs using non-shedding sterile wipes

Wiping should include a 50% overlap of each stroke

PECs must first be cleaned with a sterile germicidal agent once a day followed by disinfection with sterile 70% IPA

Each surface should be cleaned with a new wipe or new side of the wipe

What is the cleaning order for PECs?

Ceiling of the PECs

HEPA filter grate

Side of the PECs

Deck of the PECs

Define an auxiliary label

An additional sticker placed on a product to draw special attention to certain information

Define beyond use date (BUD)

The date, or hour and date, after which a CSP must not be used

Determined from the date and time that preparation of the CSP is initiated

Define expiration date

The time during which a product can be expected to meet the requirements of the USP-NF monograph or maintain expected quality provided it is kept under the specified storage conditions

Define stability

How long the medication retains its desired effect while stored

Stability information is provided by the manufacturer

Define sterility

Absence of microorganisms and viruses

Our compounding techniques are designed to limit exposure

USP 797 standardizes sterility techniques

Compare the BUDs of cleanroom suites and SCAs

Cleanroom suite = LONGER BUD can be applied because of better air quality

SCA = SHORTER BUD can be applied because of worse air quality than cleanrooms

What is the BUD for a CSP made in an SCA that will be stored at room temperature?

≤ 12 hours

What is the BUD for a CSP made in an SCA that will be stored in a refrigerator?

≤ 24 hours

What is the BUD for a CSP made in a cleanroom suite that was aseptically prepared without sterility testing and that will be stored at room temperature?

4 days

What is the BUD for a CSP made in a cleanroom suite that was aseptically prepared without sterility testing and that will be stored in the refrigerator?

10 days

Define aseptic preparation

Compounding ONLY with sterile ingredients

Compounding with non sterile ingredients followed by sterilization by filtration

Define terminal sterilization

Compounding with sterile and/or non sterile ingredients

Sterilization methods = dry heat, steam, irradiation