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Calculations + Compounding > Commounding Basics > Flashcards

Commounding Basics Flashcards

1
Q

Which USP Chapter is for Non-Sterile Compounding?

A

USP 795

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2
Q

Which USP Chapter is for Sterile Compounding?

A

USP 797

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3
Q

Which USP Chapter for Hazardous?

A

USP 800

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4
Q

What is the ISO rating for Anteroom if it opens into a negative pressure SEC?

A

ISO 7

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5
Q

What is the ISO rating for Anteroom if it opens into a positive pressure SEC?

A

ISO 8

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6
Q

What is the ISO rating for the Primary Engineering Control (PEC)?

A

ISO 5
this means there are 3,520 particles = cleanest air
0.5 microns

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7
Q

How often should the HEPA filter be recertified for sterile compounding space?

A

6-months or when PEC is moved

HEPA filter for 0.3 microns

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8
Q

Cleanroom suite requirements for sterile hoods

A

ISO 5 for inside the hoods
ISO 7 buffer room

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9
Q

What type of airpressure MUST be used for hazardous compounding?

A

Negative pressure

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10
Q

Laminar Airflow Workbench (LAFW)

A

Open front PEC where filtered air runs horizontally

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11
Q

Compounding Aseptic Workbench

A

Closed front PEC “glovebox” so air stays in the PEC

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12
Q

Segregated Compounding Area

A

used when cleanroom is not an option. Deisgnated area with “unclassified air” and NEEDS to have CAI (closed front PEC)

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13
Q

What is the MAX beyond use date for sterile products made in a SCA?

A

12 hour BUD

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14
Q

What hazardous drugs types are included on the NIOSH list?

A

Carcinogenic
Tertaofenic
Genotoxic
Toxic to organs at low doses
labeled by manufacturer as toxic

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15
Q

What are some examples of drugs on the NIOSH list?

A

Mifepristone
Chloramphenicol
Warfarin
Fluconazole
Abacavir, Entecavir, Zidovudine
Isotretinoin
Ganciclovir
Dronedarone
Paroxetine
Dexrazoxane
Exenatide, Liraglutide
AEDs
Clonazepam
Colchicine
Ivabradine, Spironolactone
Ribavirin
Androgens/Estrogens/Progesterones
Dutasteride, Finasteride
Mithimazole, Propylthiouracil
Deferiprone
Dihydroerotamine
Apomorphine, Rasagiline
Bosentan
Ziprasidone
Cyclosporine, Mycophenolate, Tacrolimus, Sirolimus

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16
Q

How often should staff do gloved fingertip test and media fill test?

A

Initially
Annually - medium risk CSP
Semiannually - high risk CSP

17
Q

What are the pass results for gloved fingertip test?

A

3 consecutive samples with ZERO CFUs done after garbing

18
Q

What are the pass results for media fill test?

A

The tryptic soy broth filled IV bags stay clear after 14 days of incubation

*testing aseptic technique

19
Q

What is the temperature requirement for refrigerators and freezers?

A

2-8 degreesC for fridge
(-25) - (-10) degreesC for freezer

20
Q

What is the humidity control requirement?

A

Checked at least daily
< 60%

21
Q

What are the surface sampling requirements for different ISO areas?

A

ISO 5 < 3 CFUs
ISO 7 < 5 CFUs
ISO8 < 100 CFUs

22
Q

Steps to clean the Horizontal Laminar Airflow PEC?

A
  1. Ceiling back to front
  2. Grill back to front
  3. Sides back to front
  4. Anything left in the hood
  5. Bottom surface back to front
23
Q

What do you use for disinfection for sterile compounding?

A

70% Isopropul Alcohol

24
Q

What do you use for deactivation and decontamination of hazardous work spaces?

A

2% bleach (sodium hypochlorite)
or peroxide

25
Q

Where should you dispose of clearly visable hazardous material?

A

BLACK container

26
Q

Where should you dispose of trace hazardous waste?

A

YELLOW cantainer

27
Q

When administrating HD drugs what should you use?

A

-2 pairs of chemo gloves (ASTM D6978 rated)
-chemo gown
-fit-tested N95 mask
-head cover
-eye protection
-2 pairsshoe covers
-closed system drug transfer device

28
Q

Garbing for Sterile Hazardous Drugs

A
  1. remove jewelry and makeup
  2. cover face and head
  3. place shoe covers on while stepping over the line of demarcation
  4. wash hands with soap and water
  5. put on non-shedding goqn
  6. put on gloves using sterile technique in the SEC
  7. sanitize gloves before entering into the PEC

Calculations + Compounding (4 decks)

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