Sterile Compounding

Question 1

What 3 types of medications must be prepared in sterile environment?

Answer 1

Ophthalmics, inhalations, IV

Question 2

What does ISO class tell us?

Answer 2

Number of particles per volume of air of a specified particle size. The lower the count, the cleaner the air.

Question 3

The farther away from the PEC, the dirtier the air, the PEC must be ISO class of at least ___. the buffer area must be at least ISO class ____. The ante area (garbing and hand washing area) should be ISO class at least ____ if it opens into a positive pressure room, or must be at least ___ if opens into a negative pressure room.

Answer 3

PEC requires ISO 5
Buffer room requires ISO 7
Ante room, if opens to positive pressure buffer room ISO 8
Ante room, if opens to negative pressure buffer room ISO 7

Question 4

The PEC is the cleanest area where a CSP can be made. How frequently should the PEC be cleaned?
What should it be cleaned with?

Answer 4

Before each shift, before and after every batch of drugs, every 30 minutes and whenever it needs it (after spill or contamination).
70% IPA and lint-free wipes

Question 5

How many particles are contained per M^3 in an ISO 5, 6, 7, 8 environment?

Answer 5

ISO 5 = cleanest 3,520
ISO 6 = 35,200
ISO 7 = 352,000
ISO 8 = 3,520,000
Every ISO class beyond 5... just add one 0 to the end.

Question 6

The PEC must have at least how many air changes per hour?

Answer 6

30 ACPH

Question 7

What is the most common PEC used for preparing non-hazardous drugs?

Answer 7

Laminar flow hood. Air moves at the same speed, same direction in parallel lines.

Question 8

What are biological safety cabinets?

Answer 8

A negative pressure hood that is used to prepare hazardous CSPs such as chemotherapy.

Question 9

What are isolators and what kinds of drugs can be prepared in these hoods?

Answer 9

Isolators are ISO 5 hoods (often called glove boxes) that are allowed to be in unclassified air such as a satellite pharmacy. Can be used to compound both hazardous and non-hazardous drugs.

Question 10

When comparing hazardous drugs in an isolator , what type of isolator must be used and what pressure is required?

Answer 10

Containment isolators which have negative pressure

Question 11

When compounding non-hazardous drug in an isolator, what type of pressure required in these?

Answer 11

Just regular aseptic isolators, they do not have to be containment. They require positive pressure.

Question 12

What are segregated compounding areas? What BUD is assigned to products prepared in this environment?

Answer 12

The PEC is placed in a segregated compounding area that has unclassified air. Shorter BUD of 12 hours. These are usually for pharmacies that don’t have room for IV room.

Question 13

What test is used to evaluate gloving and garbing technique? How does one pass this test? How frequently are employees require to do this test?

Answer 13

Gloved fingertip test
3 consecutive gloves fingertip samples with zero CFU’s for both hands.
Initial training, and annually for anyone preparing low and medium risk CSPs.

Question 14

What is used to evaluate the aseptic technique of compounding personnel? How frequently must employees be tested?

Answer 14

Media fill test

Initially, at least annually for low/med risk and 2 times per year for high-risk.

Question 15

Where is garbing physically performed?

Answer 15

Ante-room

Question 16

How to clean the hood?

Answer 16

First, clean with germicidal detergent then disinfect with 70% IPA.
Top to bottom, back to front and cleanest to dirtiest
Order: Ceiling, grill, sides/IV bar and hooks, then bottom

Question 17

The hood can remain always on but must be turned on for at least how many mins prior to use?

Answer 17

30 mins

Question 18

During visual inspection of CSP, what should you be looking for?

Answer 18

Correct volume of the product (before personnel continues compounding)

Question 19

What are the 6 characteristics of low risk CSPs?

Provide an example

Answer 19

1. Sterile ingredients
2. Sterile equipment
3. No more than 3 ingredients
4. No more than 2 entries into any 1 container
5. Use only closed or sealed systems
6. Limited to transferring, measuring and mixing manipulations
   EX: reconstituting single dose vial with sterile water and transferring into IV bag of NS

Question 20

What are the 3 characteristics of a medium risk CSP?

Provide example

Answer 20

1. Multiple individual or small doses of sterile products combined to prepare a CSP for multiple patients or for one patient on multiple occasions
2. More than 3 ingredients
3. Complex aseptic manipulations
   Ex: Using a MDV of Abx and transferring single-doses to several bags of NS for multiple patients. (batch preparation) Ex: PN

Question 21

2 main characteristics of high risk CSP?

Example

Answer 21

1. Non sterile ingredients
2. Non sterile equipment
   EX: CSPS from bulks containers, preparations that require sterilization, and products made with non sterile components

Question 22

2 main characteristics of immediate use CSPs?

Example

Answer 22

1. Only for emergency purposes
2. Must be administered within 1 hour
   EX: Preparing IV stat medication in emergency or ambulance

Question 23

When is the only time a CSP can be used after an already assigned BUD?

Answer 23

Sterility testing

Question 24

What is the BUD of a low risk CSP stored at room temp? Refrigerator? Frozen?

Answer 24

Room Temp: 48 hours
Fridge: 14 days
Frozen: 45 days

Question 25

What is the BUD of a medium risk CSP stored at room temp? Refrigerator? Frozen?

Answer 25

Room temp: 30 hours
Fridge: 9 days
Frozen: 45 days

Question 26

What is the BUD of a high risk CSP stored at room temp? Refrigerator? Frozen?

Answer 26

Room temp: 24 hours
Fridge: 3 days
Frozen: 45 days