USP

API

Active Pharmaceutical Ingredient

BUD

beyond use date

Compounding

the preparation, mixing, assembling, alternating, packaging and labeling of a drug, drug delivery device in accordance with a licenses practitioner's prescription, medication order, initiative based on the practitioner / patient / pharmacist / compounder relationship in the course of professional practice

Manufacturing

The production, propagation, conversion, or processing of a drug or device

What is the first step of Personal Hygiene and Garbing?

Personnel preparation

- remove any items that are not easily cleanable and might interfere with garbing

What is the second step of Personal Hygiene and Garbing?

Hand Hygiene

a. wash hands with soap and water for at least 30 seconds

b. Dry hands with disposable towels

c. Don gloves

What is the third step of Personal Hygiene and Garbing?

Garb and Glove requirements

* Garb must be replaced immediately if it becomes visibly soiled

USP 797

sterile compounding

USP 795

non -sterile compounding

USP 800

hazardous drugs

Category 1 CSPs

compounded under the LEAST controlled environmental condition

Category 2 CSPs

Require more environmental controls and testing than category 1

Category 3 CSPs

Undergo sterility testing, supplemented by endotoxin testing when applicable, and have more requirements than category 2 for personnel qualification, use of sterile garb, use of sporadical disinfectants, frequency of environmental monitoring, and stability determination

Why are people the greatest source of contamination

1. People shed skin

2. People create aerosols

3. Personal Hygiene

All sterile compounding inside the hood should take place at least ____ ____ into the hood to prevent contamination from the room air

6 inches

True or False : paper, pens, calculator and labels can be in the hood

False

For swabbing the rubber top of the vial with an alcohol prep using from strokes in a unidirectional sweeping motion how many times do you have to do this?

At least 3 times

what part of the syringe should you never touch?

the top or the plunger

Coring

A core or hole in the rubber top of the vial

Should you break the ampule towards or away from the HEPA filter

away

What type of sterile isopropyl should someone use to clean the compounding area prior to the beginning of each shift?

70%

What direction should you clean the hood?

Clean from back to front and top to bottom and avoid contact and contamination for the HEPA filter

In most cases you should use the smallest syringe possible to draw up your complete volume, but what is the exception?

Chemotherapy

What is considered an active pharmaceutical ingredient (API)?

acetaminophen

When must non sterile compounding work surfaces be cleaned?

At the beginning and end of each shift and after spills

What type of water should be used for rinsing equipment in non sterile compounding ?

Purified water

What is the recommended BUD for non preserved aqueous CNSP stored in the refrigerator

14 days

What must be documented in a Master Formulation Record?

Detailed preparation instructions and storage requirements

What is the purpose of a Certificate of Analysis

To certify that a component meets quality specifications

What should be done immediately if garb becomes visibly soiled during non sterile compounding

Replace it immediately

According to USP <795>, what is the minimum BUD for an oil-based non-aqueous preparation

90 days

In non sterile compounding, what is the requirement for the storage of components and equipment

off the floor, in a designated area

What is one reason a CNSP might require a shorter BUD than the standard?

If a component has a shorter expiration date

What type of airflow is used in a vertical laminar airflow hood?

Downward

What is true regarding a Category 3 CSP

it has the most stringent requirements

What is the purpose of gloved fingertip and thumb sampling

To assess garbing and hygiene competency

How often must surface sampling be performed in category 3 CSP environments?

weekly

Which of the following would invalidate asceptic technique

placing labels inside the hood

Which ISO class must the buffer / clean room meet

ISO class 7

What is the preferred method of terminal sterilization

Steam sterilization

What should be done before breaking open an ampule

Clean the neck with alcohol