Sterile Compound

Question 1

ISO rating for PEC

Answer 1

5

Question 2

ISO rating for SEC

Answer 2

7

Question 3

ISO for anteroom

Answer 3

8

Question 4

What is ACPH for ISO 7?

Answer 4

30

Question 5

What is ACPH for ISO 8?

Answer 5

20

Question 6

What is a DCA

Answer 6

The space in front of the HEPA filter

Question 7

What is first air

Answer 7

Air coming out of HEPA filter

Question 8

How often is HEPA filter changed?

Answer 8

Q6H by specialist

Question 9

What is a laminar airflow workbench

Answer 9

Open front PEC where the air flows in unidirectional lines from the HEPA filter

Question 10

Wha is the horizontal laminar airflow?

Answer 10

Filtered air flows out (positive pressure)

Question 11

What are the strategies to maintain air quality in the PEC

Answer 11

1. Do not obstruct first air, especially the area where the needle enters the vial
2. Don’t block airflow from HEPA filter with hands or supplies
3. Place items correctly to avoid turbulence → avoid contamination

Question 12

When is an anteroom ISO 7 vs 8?

Answer 12

Nonhazardous: 7 or 8
Hazardous: 7

Question 13

What are the criteria for garbing compentency evaluations

Answer 13

≥3 times and includes visual observation of procedures and the gloved findertip test

Question 14

How often should the gloved fingertip test and media filled test be completed?

Answer 14

Q6H (category 1 and 2 CSP)
Q3M (category 3 CSP)

Question 15

What is the gloved fingertip test?

Answer 15

Sample of each hand → plates intubates after ≥7 days → CFU is contamination

Question 16

How do you pass gloved fingertip test?

Answer 16

After garbing: 3 consecutive samples with 0 CFUs
After media-filled: 1 sample from each hand after immediate completion of test with ≤3 CFU total for both hands

Question 17

What is the media filled test?

Answer 17

Testing if compounder is preparing CSPs in an aseptic manner → turbidity means contamination

Question 18

What is a passing media-filled test?

Answer 18

Liquid stays clear after 14 days

Question 19

How often should temperatures in CSP storage area be checked?

Answer 19

QD

Question 20

How often is air sampling?

Answer 20

Q6M

Question 21

How often is surface sampling?

Answer 21

Q30D for pass through spaces and classified areas

Areas touched most frequently should be checked at the end of compounding shift

Question 22

How is a PEC disinfected and cleaned?

Answer 22

Sterile 70% IPA

Question 23

How long should a PEC be running before compounding?

Answer 23

30 min

Question 24

Materials required to clean PEC

Answer 24

PEC is cleaned QD:
- Steril 70% IPA is apples Q30M

PEC is cleaned with a detergent → disinfectant → 70% IPA

Wiped with a low-lint wipe

Cleaned top to bottom, back to front, cleanest to dirtiest

Question 25

How to clean PEC?

Answer 25

1. Clean ceiling 2. Clean the back of the hood 3. Clean IV bar 4. Clean sides 5. Clean anything kept in hood 6. Clean bottom surface

Question 26

How often to use sporaciadal disinfectant?

Answer 26

QM

Question 27

What room do you garb

Answer 27

Anteroom

Question 28

How to don garb?

Answer 28

1. Remove jewelry, makeup, watches 2. Don head and facial covers → shoe cover stepping over line of demarcation 3. Hand hygiene >30 secs fingertips to elbow 4. Dry with lint free towel 5. Don gown and disposable gloves 6. Enter the SEC and apply alcohol-based surgical scrub to dry. Chlorhexadine is used as alternative or Betadine 7. Don sterile powder free gloves 8. Sanitize gloves with 70% IPA

Question 29

Can a gown be reused

Answer 29

If it is not visibly soiled it can be stored in anteroom

Question 30

Selection of syringe

Answer 30

Smallest syringe that can hold the desired amount of solution (do not use exact size)

Question 31

How do you recap syringes?

Answer 31

You don't

Question 32

How to draw out med from ampules?

Answer 32

Filter needle or filter straw

Question 33

How to pull liquid from a vial?

Answer 33

Inject a volume of air equal to the volume of drug that is withdrawn

Question 34

Section of fluid for reconstitution?

Answer 34

Sterile water for injection Bacteriostatic water for injection or a diluent supplied by manufacturer

Question 35

What is the difference between SVP and LVP

Answer 35

SVP: ≤100 mL LVP: >100 mL

Question 36

How to set up items in the sterile hood?

Answer 36

1. Wipe off all components with 70% IPA prior to bringing it to PEC 2. Work within 6 inched of front 3. Place items side by side 4. Do not obstruct air flow 5. Open packages outside of PEC

Question 37

What is the syringe pull back method?

Answer 37

Pharmacist can verify the actual volume in the syringe

Question 38

What is the purpose of visual inspection>

Answer 38

Against a dark background for particulates, cored pieces, precipitates, and cloudiness Lightly squeezed for leakage

Question 39

Compounds that should not be sterilized by heat? How are they sterilized then?

Answer 39

Proteins are sterilized with filtration of 0.22 micron filter

Question 40

What is a bubble-point test

Answer 40

Checks filter integrity to determine the pressure required to see bubbles out of the filter

Question 41

Requirements for immediate use CSPs?

Answer 41

Uncontrolled (no PEC) BUD: 4 hrs

Question 42

Requirements for Category 1 CSP?

Answer 42

ISO 5 PEC in SCA Room temp BUD: 12 hrs Refrigerated BUD: 24 hrs

Question 43

Requirements for Category 2 CSP?

Answer 43

ISO 5 PEC in cleanroom Room temp BUD: 1-45 days Refrigerated BUD: 4-60 days Frozen BUD: 45-90 days

Question 44

Requirements for Category 3 CSP?

Answer 44

ISO 5 PEC in cleanroom with additional requirements Room temp BUD: 60-90 days Refrigerated BUD: 90-120 days Frozen BUD: 120-180 days

Question 45

BUD of single dose containers (vials, bag, syringes in ISO 5)?

Answer 45

Up to 12 hrs after opening

Question 46

BUD of SDC (ampul, inside or outside ISO5)

Answer 46

Must be discarded if open

Question 47

BUD of MDC

Answer 47

28 days