Compounding

Question 1

primary engineering control
(sterile hood/isolator)

Answer 1

ISO class 5

Question 2

Secondary engineering control
(buffer room, anteroom if it opens a negative pressure buffer room, clean room)

Answer 2

ISO class 7

Question 3

Anteroom (if opens into a positive pressure)

Answer 3

ISO class 8

Question 4

HEPA filter

Answer 4

> 99.97% efficient in removing particles as small as 0.3 mircons

-needs to be recertified every 6 months

Question 5

gloved fingertip test

Answer 5

initially and annually

Question 6

media filled test

Answer 6

initially and annually

Question 7

Temperatures

Answer 7

-checked daily
-maintained at 68F (20C)

Question 8

air sampling

Answer 8

every 6 months

->3 CFU in ISO 5
->5 CFU in ISO 7
->100 CFU in ISO 8

Question 9

air pressure testing

Answer 9

daily

Question 10

deactivation and decontamination

Answer 10

2% bleach (Sodium Hypochloride) or peroxide

Question 11

Cleaning

Answer 11

germicidal detergent

Question 12

disinfection

Answer 12

sterile 70% isopropyl alcohol

Question 13

non-aqueous formulations

Answer 13

no later than 6 months (180 days) at room temp

Question 14

water-containing oral formulations

Answer 14

no later than 14 days when stored at controlled cold temperatures. Store in refrigerator

Question 15

water-containing topical/dermal and mucosal liquid and semisolid formulations

Answer 15

no later than 30 days at room temp

Question 16

CSP risk level: low

Answer 16

Room temp BUD: 48 hrs
Refrig temp BUD: 14 days
Frozen: 45 days

Question 17

CSP risk: medium

Answer 17

Room temp BUD: 30 hrs
Refrig temp BUD: 9 days
Frozen: 45 days

Question 18

CSP risk: high

Answer 18

Room temp BUD: 24 hrs
Refrig temp BUD: 3 days
Frozen: 45 days

Question 19

CSP risk: low and not in clean room

Answer 19

Room temp BUD: 12 hr
Refrig temp BUD: 12 hr

Question 20

immediate use

Answer 20

room temp BUD: 1 hr

Question 21

CSP low risk

Answer 21

< 3 ingredients (including diluent)
no more than 2 entries into 1 sterile container or device

Question 22

CSP medium risk

Answer 22

> 3 sterile ingredients OR
multiple doses of a sterile product w/drawn from the same vial to make several CSP of the same product

Question 23

CSP high risk

Question 24

SDC - outside an ISO 5 environment

Answer 24

1 hr from the time of puncture or opening

Question 25

SDC - inside an ISO 5 environment

Answer 25

up to 6 hrs from the time of puncture or opening

Question 26

SDC - ampule inside or outside ISO 5 environment

Answer 26

discard

Question 27

MDC - inside or outside ISO 5 environment

Answer 27

up to 28 days