Ch. 15 Non-Sterile Compounding

Compounding

process of combining or altering ingredients to create a medication

Describe the classification of compounded drugs

Non-sterile

1. Nonhazardous

2. Hazardous

Sterile

1. Nonhazardous

2. Hazardous

What determines whether a compound should be sterile or non-sterile?

Formulation

What determines whether a compound is hazardous or nonhazardous?

The properties of the drug itself

What formulations are considered nonsterile?

- Oral formulations

- Topicals

- Nasal products

- Vaginal products

- Ear products

- Rectal products

What formulations are considered Sterile?

- Intravenous

- Intramuscular

- Subcutaneous

- Inhalations

- Eye drops

What organization sets the standards for compounded preparations?

USP (United States Pharmacopeia)

USP 795

Non-sterile compounding

USP 797

Sterile compounding

USP 800

Hazardous drugs

USP 795 breaks non-sterile compounding into what 3 categories?

- Simple : Following basic instructions

- Moderate : Requires calculations or specialized procedures

- Complex : Requires special training/facilities

The physical non-sterile compounding space requires what types of water?

- Potable : "Drinkable" from the tap to wash hands/equipment with

- Purified : to use in water-containing formulations & to rinse equipment

What organization sets the standards for air quality in sterile compounding?

ISO (International Standards Organization)

What should the air quality be at inside the sterile hood?

ISO 5

What should the air quality be at inside the buffer area?

ISO 7

What should the air quality be at the antreroom?

ISO 8 if it enters into a positive pressure buffer room

ISO 7 if it enters into a negative pressure buffer room

How many particles per m3 do the following terms represent?

- ISO 5

- ISO 7

- ISO 8

- ISO 5 : 3,250

- ISO 7 : 325,000

- ISO 8 : 3,250,000

HEPA filters are _______ % efficient in removing particles as small as 0.3 microns wide or larger.

99.7%

In a biological safety cabinet, which way does the air flow?

Vertically (HEPA filter located at top of the sterile hood)

In a laminar flow workbench, which way does the air flow?

Horizontally (HEPA filter located at back of the sterile hood)

Direct Compounding Area (DCA)

A critical area within the ISO Class 5 primary engineering control (PEC) where critical sites are exposed to unidirectional HEPA-filtered air, also known as first air.

How often must the HEPA filter be recertified?

every 6 months

The air pressure in the PEC & SEC are (positive/negative) in nonhazardous compounding

positive

The air pressure in the PEC & SEC are (positive/negative) in hazardous compounding

negative

Surfaces within the compounding facility must be smooth, impervious, and free from cracks and crevices. (True/False)

True

What is the Primary Engineering Control (PEC)?

Room or device that provides an ISO 5 environment for sterile compounding

What is the Secondary Engineering Control (SEC)?

room that contains PEC (also called buffer area)

What does the Anteroom contain?

sink, cabinets, and benches to facilitate garbing

Line of Demarcation

A visible line within the anteroom that separates the clean side from the dirty side. Shoe covers are put on one at a time before stepping over the line

Segregated Compounding Area (SCA)

A designated area with unclassified air that can be used to prepare low-risk CSPs.

CSPs prepared in a SCA have a BUD of __________.

12 Hours

The _____________ list contains a record of hazardous drugs

NIOSH

What types of drugs are considered hazardous?

- Carcinogenic

- Teratogenic

- Genotoxic

- Organ toxicity at low doses

- Labeled by the manufacturer with special handling instructions

Safety Data Sheet (SDS)

Safety documents required by OSHA to be accessible to all employees working with hazardous materials. Provides info on PPE, first aid procedures, and spill clean-up procedures

Hazard Communication Program

- Each facility must have a designated individual responsible for creating SOPs

- Must have a written plan

- Before handling hazardous drugs, fertile men & women must confirm in writing that they understand the risks

What class must the BSC be for hazardous sterile compounding?

class II or class III

Containment Ventilated Enclosures (CVEs)

powder containment hoods with HEPA-filtered air and negative air pressure used for non-sterile compounding only

Compounding Aseptic Containment Isolator (CACI)

Closed front C-PECs (gloveboxes)that can be located in a buffer room, but are often located in a C-SCA

Air Changes Per Hour (ACPH)

- In space where non-sterile hazardous drugs are compounded

12 ACPH

Air Changes Per Hour (ACPH)

- In a sterile C-SEC

30 ACPH

Air Changes Per Hour (ACPH)

- In a C-SCA

12 ACPH

Air that has been contaminated with hazardous drugs must be _________________ exhausted.

externally

What is an alternative to external exhaust?

Redundant HEPA filters

Hazardous drugs must be stored separately from nonhazardous drugs in a negative pressure room with at least _____ ACPH

12 ACPH

Compounding staff must adequately demonstrate the following before being cleared to compound sterile products.

- Hand hygiene

- Garbing/Gloving

- Cleaning & Disinfecting

- Sterile Drug Preparation

Gloved fingertip test

- assesses aseptic technique (hand hygiene & garbing/gloving)

- If preparing low-med risk CSPs, then test is required annually

- If preparing high risk CSPs, then test is required semiannually

- The initial test must have 0 CFUs (performed 3 consecutive times)

- Ongoing tests must have < 3 CFUs total

Media-Fill Test

- assesses the ability to prepare CSPs in an aseptic manner

- If preparing low-med risk CSPs, then test is required annually

- If preparing high risk CSPs, then test is required semiannually

- Tryptic Soy Broth (TSB) is the growth medium utilized to facilitate microbe growth if any is present in the product

- If the IV bag remains clear after 14 days, the test has been passed, cloudy/turbid = failed

Temperature Monitoring

The temperature of the Buffer room should be checked how often, and at what temperature should it be at?

- Checked daily

- ≤ 20℃

Temperature Monitoring

The temperature of the refrigerator should be checked how often, and at what temperature should it be at?

- daily (twice if vaccines within)

- 2-8℃

Temperature Monitoring

The temperature of the freezer should be checked how often, and at what temperature should it be at?

- daily (twice if vaccines present)

- -25 to -10℃ or -50 to -15℃ (if vaccines within)

How often must air sampling be done?

Every 6 months

Surface Sampling

- What agar is typically used?

- How often should it be done?

- What time of day should it be done?

- Tryptic soy agar

- USP requires surface testing "Periodically"

- Performed at the end of the day

Air Pressure

Air flow should be (unidirectional/multidirectional) in compounding facilities?

Unidirectional

Air Pressure

How often should air pressure be checked?

at least daily

In order to help surfaces stay clean, it is preferred that PECs remain running at all times. What should be done if the PEC stops running?

- Cleaned with germicidal detergent followed by disinfection with 70% isopropyl alcohol

- After cleaning it must be ran for at least 30 minutes before compounding can continue

- if it is a C-PEC, it will require a more thorough sanitation process

When wiping the PEC, describe the wiping motion that is recommended

Slightly overlapping, unidirectional strokes

starting from the back and working forward

Rank the following portions of the PEC by which is cleaned first

Bottom surface, Ceiling, Side walls

Ceiling > Side walls > Bottom surface

When Sanitizing an area used for hazardous compounding, in what order should these steps be performed?

- Disinfection

- Deactivation/Decontamination

- Cleaning

Deactivation > Cleaning > Disinfection

Waste Bins

- Black

- Yellow

- Red

- Black : Bulk HD waste

- Yellow : Trace HD waste

- Red : Infectious waste

Spill Kit Contents

What things should be found within a spill kit?

- Gown, gloves N95 respirator

- HD waste bag with scoop & scraper

- HD spill report exposure form

When compounding and cleaning hazardous drugs, 2 pairs of chemotherapy-rated gloves (ASTM D6978) must be worn, but when receiving & storing HDs a single pair of gloves can be used (True/False)

True

Describe Garbing for Sterile Compounding

(1.) Don hair covers & face masks

(2.) Don shoe covers, Stepping over line of demarcation with each foot once covered. (Don a 2nd pair of shoe covers if it is a hazardous sterile drug)

(3.) Wash from fingertips to elbows with soap and water for at least 30 seconds

(4.) Don a gown

(5.) Enter the buffer room and apply an alcohol-based hand scrub and allow to dry before donning sterile gloves

(6.) Sanitize the sterile gloves with 70% Isopropyl alcohol (apply two pairs of gloves if working with hazardous sterile drugs)