Chapter 15: Compounding I Basics Flashcards
1
Q
Non-sterile and hazardous USP
A
795 and 800
2
Q
non-sterile and non-hazardous USP
A
795
3
Q
Sterile and non-hazardous
A
797
4
Q
Sterile and hazardous
A
797 and 800
5
Q
BSC
A
biologic safety cabinet
6
Q
CACI
A
compounding aseptic containment isolator
7
Q
CAI
A
compounding aseptic isolator
8
Q
C-PEC
A
containment primary engineering control
9
Q
C-SCA
A
containment segregated compounding area
10
Q
C-SEC
A
containment secondary engineering control
11
Q
CSPs
A
compounded sterile products
12
Q
CSTD
A
closed system transfer device
13
Q
CVE
A
containment ventilated enclosure
14
Q
LAFW
A
laminar airflow workbench
15
Q
LVP
A
large volume parenteral
16
Q
PEC
A
primary engineering control
17
Q
PPE
A
personal protective equipment
18
Q
RABS
A
restricted access barrier system
19
Q
SCA
A
segregated compounding area
20
Q
SEC
A
secondary engineering control
21
Q
SVP
A
small volume parenteral
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
23
Q
Buffer area ISO requirement
USP 797
A
ISO 7
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
25
High-Efficiency Particulate Air Filters
HEPA filters are >99.97% efficient in removing particles as small as 0.3 microns wide or larger
26
Vertical Airflow biologic safety cabinet (BSC) or C-PEC
the HEPA filter is at the top of the sterile hood
27
Laminar Airflow Workbench (LAFW) or PEC
Also called a horizontal airflow hood the HEPA filter is at the back of the hood
28
Air pressure for non-hazardous compounding
Positive air pressure in the PEC and SEC because the air will not cause toxicity if it moves into adjacent spaces
29
Air pressure for hazardous compounding
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
30
Cleanroom Suite
One or more sterile hoods (ISO 5 PECsO inside an ISO 7 buffer room (SEC) that is entered through an adjacent anteroom
31
Segregated Compounding Area
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
32
Primary Engineering Control
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.
33
PECs for non-hazardous sterile preparations
- Laminar airflow workbench
| - A compounding aseptic isolator
34
Secondary Engineering Control
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
35
Anteroom
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
Segregated Compounding Area
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
A drug is considered hazardous if it is:
- carcinogenic
- teratogenic
- genotoxic
- toxic to organs
- labeled by the manufacturer with special handling instructions
38
Hazardous Key Drugs on the NIOSH List:
| Abortifacients
- mifepristone
| - misoprostol
39
Hazardous Key Drugs on the NIOSH List:
| Antibiotics
-chloramphenicol
40
Hazardous Key Drugs on the NIOSH List:
| Anticoagulants
-warfarin
41
Hazardous Key Drugs on the NIOSH List:
| Antifungals
- fluconazole
| - voriconazole
42
Hazardous Key Drugs on the NIOSH List:
| Antiretrovirals
- Abacavir
- Entecavir
- Zidovudine
43
Hazardous Key Drugs on the NIOSH List:
| Antivirals
- Cidofovir
- Ganiclovir
- Valganciclovir
44
Hazardous Key Drugs on the NIOSH List:
| Acne
-Isotretinoin
45
Hazardous Key Drugs on the NIOSH List:
| Arrhythmias
-Dronedarone
46
Hazardous Key Drugs on the NIOSH List:
| Autoimmune
- Acitretin
- Azathioprine
- Leflunomide
- Fingolimod
- Teriflunomide
47
Hazardous Key Drugs on the NIOSH List:
| BPH
- Dutasteride
| - Finasteride
48
Hazardous Key Drugs on the NIOSH List:
| Bisphosphonates
- Pamidronate
| - Zoledronic Acid
49
Hazardous Key Drugs on the NIOSH List:
| Chemoprotectant (cardiac)
-Dexrazoxane
50
Hazardous Key Drugs on the NIOSH List:
| Depression
-Paroxetine
51
Hazardous Key Drugs on the NIOSH List:
| Diabetes
- Exenatide
| - Liraglutide
52
Hazardous Key Drugs on the NIOSH List:
| Dyslipidemia
-Lomitapide
53
Hazardous Key Drugs on the NIOSH List:
| Seizures/Epilepsy
- Clobazam
- Clonazepam
- Carbamazepine
- Oxcarbazepine
- Eslicarbazepine
- Divalproex
- Fosphenytoin
- Phenytoin
- Topiramate
- Vigabatrin
- Zonisamide
54
Hazardous Key Drugs on the NIOSH List:
| Gout
-Colchicine
55
Hazardous Key Drugs on the NIOSH List:
| HF
- Ivabradine
| - Spironolactone
56
Hazardous Key Drugs on the NIOSH List:
| Hepatitis
-Ribavirin
57
Hazardous Key Drugs on the NIOSH List:
| Hormonal Agents
- Androgens
- Estrogens
- Oxytocin
- Dinoprostone
- Progesterones
- SERD/SERMs (tamoxifen, fulvestrant)
- Ulipristal
58
Hazardous Key Drugs on the NIOSH List:
| Hyperthyroid
- Methimazole
| - Propylthiouracil
59
Hazardous Key Drugs on the NIOSH List:
| Insomnia
- Temazepam
| - Triazolam
60
Hazardous Key Drugs on the NIOSH List:
| Iron Overload
-Deferiprone
61
Hazardous Key Drugs on the NIOSH List:
| Migraine
-Dihydroergotamine
62
Hazardous Key Drugs on the NIOSH List:
| Parkinson Disease
- Apomorphine
| - Rasagiline
63
Hazardous Key Drugs on the NIOSH List:
| PAH
- Ambrisentan
- Bosentan
- Macitentan
- Riociguat
64
Hazardous Key Drugs on the NIOSH List:
| Schizophrenia
-Ziprasidone
65
Hazardous Key Drugs on the NIOSH List:
| Transplant
- Cyclosporine
- Mycophenolate
- Tacrolimus
- Sirolimus
66
C-PECs for hazardous Compounding: BSC
Biologic Safety Cabinet: have vertical laminar airflow and negative air pressure
Must be Class II or III for compounding of hazardous drugs
67
C-PECs for hazardous Compounding: CVE
Containment Ventilated Enclosures: are powder containment hoods with HEPA filtered air and negative pressure for non-sterile compounding only
68
C-PECs for hazardous Compounding: CACI
Compounding Aseptic Containment Isolators: Closed-front C-PECs (glovebox) that can be located in a buffer room
69
Non-sterile and Sterile HD Compounding in the same space
- 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
ACPH
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
Redundant HEPA Filters
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
HD Storage
Must be stores separately from non-hd in an externally ventilated negative pressure room with at least 12 ACPH
73
Gloved fingertip test
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
Media-fill test
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
Gloved fingertip test procedure
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
Passing a gloved fingertip test
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
Temperatures requirement
- 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
Air Sampling
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
Surface Sampling
- 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
Air Pressure
- check each shift (preferably) or daily (minimally)
| - goals: non-hazardous cleanroom is positive and hazardous cleanroom is negative
81
Humidity
- check daily
| - goal <60%
82
Cleaning: daily
```
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
Cleaning: monthly
- ceiling
- walls
- shelving
- chairs
- bins
- carts
84
HD sanitization steps
1. deactivation and decontamination
2. cleaning
3. disinfection
85
Drug exposure
-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
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