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Chapter 15: Compounding I Basics Flashcards

1
Q

Non-sterile and hazardous USP

A

795 and 800

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2
Q

non-sterile and non-hazardous USP

A

795

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3
Q

Sterile and non-hazardous

A

797

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4
Q

Sterile and hazardous

A

797 and 800

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5
Q

BSC

A

biologic safety cabinet

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6
Q

CACI

A

compounding aseptic containment isolator

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7
Q

CAI

A

compounding aseptic isolator

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8
Q

C-PEC

A

containment primary engineering control

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9
Q

C-SCA

A

containment segregated compounding area

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10
Q

C-SEC

A

containment secondary engineering control

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11
Q

CSPs

A

compounded sterile products

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12
Q

CSTD

A

closed system transfer device

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13
Q

CVE

A

containment ventilated enclosure

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14
Q

LAFW

A

laminar airflow workbench

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15
Q

LVP

A

large volume parenteral

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16
Q

PEC

A

primary engineering control

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17
Q

PPE

A

personal protective equipment

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18
Q

RABS

A

restricted access barrier system

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19
Q

SCA

A

segregated compounding area

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20
Q

SEC

A

secondary engineering control

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21
Q

SVP

A

small volume parenteral

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22
Q

Critical areas ISO requirement

USP 797

A

Critical areas are those that are closest to exposed sterile drugs (hood, PEC) and container, are quality must be at least ISO 5.
This means that there are no more than 3,520 particle per cubic meter. Particles are included in this count if they are 0.5 microns (micrometer) or larger

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23
Q

Buffer area ISO requirement

USP 797

A

ISO 7

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24
Q

Anteroom ISO requirement

USP 797

A

ISO 8 if it opens to a positive pressure buffer area and ISO 7 if it opens into a negative pressure buffer area
Anteroom is where hand washing and garbing occurs

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25
Q

High-Efficiency Particulate Air Filters

A

HEPA filters are >99.97% efficient in removing particles as small as 0.3 microns wide or larger

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26
Q

Vertical Airflow biologic safety cabinet (BSC) or C-PEC

A

the HEPA filter is at the top of the sterile hood

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27
Q

Laminar Airflow Workbench (LAFW) or PEC

A

Also called a horizontal airflow hood the HEPA filter is at the back of the hood

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28
Q

Air pressure for non-hazardous compounding

A

Positive air pressure in the PEC and SEC because the air will not cause toxicity if it moves into adjacent spaces

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29
Q

Air pressure for hazardous compounding

A

C-PEC and C-SEC must have negative pressure to contain and exhaust the toxic air in the space.
The negative air pressure protects the compounding staff

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30
Q

Cleanroom Suite

A

One or more sterile hoods (ISO 5 PECsO inside an ISO 7 buffer room (SEC) that is entered through an adjacent anteroom

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31
Q

Segregated Compounding Area

A

SCA
With and ISO 5 PEC: a sterile hood, often and isolator (glovebox) with a closed front, located in a segregated space with unclassified air

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32
Q

Primary Engineering Control

A

PEC
IS a device or room that provides ISO 5 environment for sterile compounding. The most common way to achieve ISO 5 is by using a sterile hood.

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33
Q

PECs for non-hazardous sterile preparations

A
  • Laminar airflow workbench

- A compounding aseptic isolator

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34
Q

Secondary Engineering Control

A

SEC
Is the room that contains the PEC, it is commonly called the buffer area. Provides a “buffer” of clean air (ISO 7) around the PEC

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35
Q

Anteroom

A

Connects the rest of the pharmacy to the buffer room. It has a sink, cabinets, and benches to facilitate garbing.
Running down the center of the room is the line of demarcation which separates clean from dirty sections (shoe covers must be applied one at a time while stepping over the line)

36
Q

Segregated Compounding Area

A

A designated area with unclassified airflow, does not have a buffer area or ante room and can only be used for certain low-risk CSPs. The max BUD for compounds made here is 12 hours

37
Q

A drug is considered hazardous if it is:

A
  • carcinogenic
  • teratogenic
  • genotoxic
  • toxic to organs
  • labeled by the manufacturer with special handling instructions
38
Q

Hazardous Key Drugs on the NIOSH List:

Abortifacients

A
  • mifepristone

- misoprostol

39
Q

Hazardous Key Drugs on the NIOSH List:

Antibiotics

A

-chloramphenicol

40
Q

Hazardous Key Drugs on the NIOSH List:

Anticoagulants

41
Q

Hazardous Key Drugs on the NIOSH List:

Antifungals

A
  • fluconazole

- voriconazole

42
Q

Hazardous Key Drugs on the NIOSH List:

Antiretrovirals

A
  • Abacavir
  • Entecavir
  • Zidovudine
43
Q

Hazardous Key Drugs on the NIOSH List:

Antivirals

A
  • Cidofovir
  • Ganiclovir
  • Valganciclovir
44
Q

Hazardous Key Drugs on the NIOSH List:

Acne

A

-Isotretinoin

45
Q

Hazardous Key Drugs on the NIOSH List:

Arrhythmias

A

-Dronedarone

46
Q

Hazardous Key Drugs on the NIOSH List:

Autoimmune

A
  • Acitretin
  • Azathioprine
  • Leflunomide
  • Fingolimod
  • Teriflunomide
47
Q

Hazardous Key Drugs on the NIOSH List:

BPH

A
  • Dutasteride

- Finasteride

48
Q

Hazardous Key Drugs on the NIOSH List:

Bisphosphonates

A
  • Pamidronate

- Zoledronic Acid

49
Q

Hazardous Key Drugs on the NIOSH List:

Chemoprotectant (cardiac)

A

-Dexrazoxane

50
Q

Hazardous Key Drugs on the NIOSH List:

Depression

A

-Paroxetine

51
Q

Hazardous Key Drugs on the NIOSH List:

Diabetes

A
  • Exenatide

- Liraglutide

52
Q

Hazardous Key Drugs on the NIOSH List:

Dyslipidemia

A

-Lomitapide

53
Q

Hazardous Key Drugs on the NIOSH List:

Seizures/Epilepsy

A
  • Clobazam
  • Clonazepam
  • Carbamazepine
  • Oxcarbazepine
  • Eslicarbazepine
  • Divalproex
  • Fosphenytoin
  • Phenytoin
  • Topiramate
  • Vigabatrin
  • Zonisamide
54
Q

Hazardous Key Drugs on the NIOSH List:

Gout

A

-Colchicine

55
Q

Hazardous Key Drugs on the NIOSH List:

HF

A
  • Ivabradine

- Spironolactone

56
Q

Hazardous Key Drugs on the NIOSH List:

Hepatitis

A

-Ribavirin

57
Q

Hazardous Key Drugs on the NIOSH List:

Hormonal Agents

A
  • Androgens
  • Estrogens
  • Oxytocin
  • Dinoprostone
  • Progesterones
  • SERD/SERMs (tamoxifen, fulvestrant)
  • Ulipristal
58
Q

Hazardous Key Drugs on the NIOSH List:

Hyperthyroid

A
  • Methimazole

- Propylthiouracil

59
Q

Hazardous Key Drugs on the NIOSH List:

Insomnia

A
  • Temazepam

- Triazolam

60
Q

Hazardous Key Drugs on the NIOSH List:

Iron Overload

A

-Deferiprone

61
Q

Hazardous Key Drugs on the NIOSH List:

Migraine

A

-Dihydroergotamine

62
Q

Hazardous Key Drugs on the NIOSH List:

Parkinson Disease

A
  • Apomorphine

- Rasagiline

63
Q

Hazardous Key Drugs on the NIOSH List:

PAH

A
  • Ambrisentan
  • Bosentan
  • Macitentan
  • Riociguat
64
Q

Hazardous Key Drugs on the NIOSH List:

Schizophrenia

A

-Ziprasidone

65
Q

Hazardous Key Drugs on the NIOSH List:

Transplant

A
  • Cyclosporine
  • Mycophenolate
  • Tacrolimus
  • Sirolimus
66
Q

C-PECs for hazardous Compounding: BSC

A

Biologic Safety Cabinet: have vertical laminar airflow and negative air pressure
Must be Class II or III for compounding of hazardous drugs

67
Q

C-PECs for hazardous Compounding: CVE

A

Containment Ventilated Enclosures: are powder containment hoods with HEPA filtered air and negative pressure for non-sterile compounding only

68
Q

C-PECs for hazardous Compounding: CACI

A

Compounding Aseptic Containment Isolators: Closed-front C-PECs (glovebox) that can be located in a buffer room

69
Q

Non-sterile and Sterile HD Compounding in the same space

A
  • C-SEC must maintain ISO 7 even when it is being use for non-sterile compounding
  • If there are separate sterile and non-sterile C-PECs in the same C-SEC they must be at least 1 meter apart
70
Q

ACPH

A

Air changes per hour is the number of times per hour that the air is replaced in the room.

  • Non-sterile HDs must have at least 12 ACPH
  • Sterile HD C-SEC must be at lest 30 ACPH
  • C-SCA must be at least 12 ACPH
71
Q

Redundant HEPA Filters

A

Alternative to external exhaust (for non-sterile HD compounding only) is to use redundant HEPA filters. Air passes through two or more HEPA filters before being released.

72
Q

HD Storage

A

Must be stores separately from non-hd in an externally ventilated negative pressure room with at least 12 ACPH

73
Q

Gloved fingertip test

A

Demonstrates adequate aseptic technique in hand washing, garbing, and gloving

  • required initially and then annually if compounding low and medium risk CSPs
  • required semi-annually if compounding high-risk CSP
74
Q

Media-fill test

A

Demonstrates adequate aseptic technique in sterile drug preparation

  • must be performed initially and a least annually for low and medium risk level
  • Tryptic soy broth takes place of drug in the preparation
  • Turbidity=contamination
  • Passing =clear liquid after 14 days of incubation
75
Q

Gloved fingertip test procedure

A

Evaluator collects a gloved sample from each hand of the compounder by rolling the pads of the fingers and thumb over a surface that has tryptic soy agair (TSA)

  • plates are incubated
  • spots that form are called colony forming units (CFUs) and indicate contaminationg
76
Q

Passing a gloved fingertip test

A

Initial: requires 3 consecutive tests taken after garbing with zero CFUs for both hands
Ongoing: one sample from each hand after completion of media fill test with goal of <=3CFU total for both hands

77
Q

Temperatures requirement

A
  • SEC (buffer room) 20C or 68F or cooler (monitor once daily)
  • Fridge 2-8C and Freezer -25 and -10, if freezer contains vaccines it must be -50 to -15 (monitor both twice daily)
78
Q

Air Sampling

A

Should be performed at least every 6 months by a person certified in air sampling or by a qualified compounding staff member
-goals vary base on ISO; immediate action for highly pathogenic organisms (gram-neg rods, molds, yeasts)

79
Q

Surface Sampling

A
  • periodically
  • goal is 0 CFU; action must be taken if:
  • > 3 CFU in ISO 5
  • > 5 CFU in ISO 7 or >100 CUF in ISO 8
  • any growths of highly pathogenic organisms
80
Q

Air Pressure

A
  • check each shift (preferably) or daily (minimally)

- goals: non-hazardous cleanroom is positive and hazardous cleanroom is negative

81
Q

Humidity

A
  • check daily

- goal <60%

82
Q

Cleaning: daily

A 
all sterile work
-counters, floors, and carts first with germicidal cleaner then 70% isopropyl alcohol 
HD work
-always sanitize work area at end of shift
ISO 5 PECs
-before each shift
-Q30min while working
-before and after each batch of CSPs
-whenever needed
83
Q

Cleaning: monthly

A
  • ceiling
  • walls
  • shelving
  • chairs
  • bins
  • carts
84
Q

HD sanitization steps

A
  1. deactivation and decontamination
  2. cleaning
  3. disinfection
85
Q

Drug exposure

A

-get the drug or chemical off the person ASAP
minimal actions to take
-removed contaminated garb
-immediately cleanse affected skin
-for eyes, eyewash for at least 15 minutes
-obtain medical attention when warranted
-document

NAPLEX (45 decks)

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