Medications + Components
17%of exam
Facilities + Equipment
22%of exam
Sterile Compounding Procedures
53%of exam
Handling + Disposal
8%of exam
LabelingStoragePackagingSharpsWaste
Quick Facts
- Exam
- PTCB CSPT
- Questions
- 75 MCQ
- Scored
- 60 scored
- Time
- 1h 50m
- Pass
- 1400 scaled
- Score range
- 1000-1600
- Fees
- $199 total
- Eligibility
- Active PTCB CPhT
- Renewal
- Annual
BUD Rule
BUD follows sterility, stability, and storage.
SterilityStabilityTemperatureContainer
BUD vs Expiration
BUD
- Assigned after compounding
- Sterility plus stability
Expiration
- Manufacturer dating
- Original container
Compounded vs manufactured
High Alert
- Insulin
- Unit-dose danger
- Heparin
- Bleeding risk
- KCl
- Concentrated electrolyte
- Chemotherapy
- Hazardous antineoplastic
- Opioids
- Respiratory depression
- Neuromuscular blockers
- Paralysis risk
- NTI
- Small dose margin
- Double check
- Independent verification
Physical vs Chemical
Physical
- Visible incompatibility
- Precipitate or haze
Chemical
- Molecular degradation
- May look normal
Seen vs unseen
BUD Factors
- BUD
- Use-by limit
- Stability
- Chemical integrity
- Sterility
- Microbial control
- Category 1
- Shortest dating
- Category 2
- Longer dating
- Category 3
- Extra QA dating
- Immediate-use
- Urgent administration
- Container
- Compatibility factor
Compatibility
- Physical
- Visible change
- Chemical
- Molecular degradation
- Precipitate
- Insoluble solid
- Turbidity
- Cloudy solution
- pH
- Acid/base effect
- Sorption
- Drug sticks
- Leaching
- Container releases
- Filter
- Particle removal
Routes + Forms
- IV
- Direct bloodstream
- IM
- Muscle injection
- SC
- Subcutaneous tissue
- Intrathecal
- Spinal canal
- Epidural
- Epidural space
- Ophthalmic
- Eye sterile
- Irrigation
- Rinse solution
- PN
- Sterile nutrition
Hazardous Rule
HD work needs containment, not clean airflow.
BSCCACIC-PECNegative
LAFW vs BSC
LAFW
- Product protection
- No HD containment
BSC
- Product plus personnel
- HD containment
Clean vs contain
PEC Picker
- Nonhazardous CSP→LAFW(Product protection)
- Need containment→BSC(HD work)
- Closed aseptic device→CAI(Non-HD)
- Closed containment→CACI(HD work)
- Critical sites exposed→DCA(ISO 5)
- PEC moved→Recertify(Before use)
PECs
- PEC
- ISO 5 device
- DCA
- Critical work area
- LAFW
- Product protection
- BSC
- Containment airflow
- CAI
- Aseptic isolator
- CACI
- Containment isolator
- HEPA
- 99.97% filtration
- Certification
- Every 6 months
Positive vs Negative
Positive
- Air flows outward
- Nonhazardous CSPs
Negative
- Air flows inward
- Hazardous containment
Protect product vs people
SEC Picker
- PEC sits inside→Buffer room
- Garb transition→Anteroom
- Short Category 1→SCA
- Hazardous segregation→C-SCA
- Nonhazardous pressure→Positive
- Hazardous pressure→Negative
SECs
- SEC
- Cleanroom support
- Buffer room
- PEC location
- Anteroom
- Transition space
- SCA
- Segregated area
- C-SCA
- Containment area
- Positive pressure
- Nonhazardous flow
- Negative pressure
- HD containment
- ACPH
- Air changes
ISO + Monitoring
- ISO 5
- PEC/DCA air
- ISO 7
- Buffer room
- ISO 8
- Ante room
- Viable air
- Microbial sampling
- Nonviable air
- Particle counting
- Surface sample
- Contact plates
- Action level
- Investigate result
- Trend report
- Pattern review
Domain Weights
Procedures dominate; handling is smallest.
17 meds22 facilities53 procedures8 handling
Clean vs Disinfect
Clean
- Removes soil
- Detergent action
Disinfect
- Kills microbes
- Requires contact time
Remove before kill
Cleaning Picker
- HD residue→Deactivate
- Visible soil→Clean
- Microbial control→Disinfect
- Spore concern→Sporicidal
- Final PEC wipe→Sterile IPA
- Wet surface needed→Contact time
Garbing + Hygiene
- No jewelry
- Remove contamination
- No cosmetics
- Particle control
- No illness
- Protect CSPs
- Hand hygiene
- Wash then sanitize
- Gown
- Low shedding
- Gloves
- Sterile barrier
- GFS
- Fingertip sampling
- Media fill
- Aseptic simulation
Cleaning Order
Deactivate, decontaminate, clean, disinfect.
DeactivateDecontaminateCleanDisinfect
Media Fill vs GFS
Media fill
- Process simulation
- Aseptic technique
GFS
- Glove contamination
- Hand hygiene proof
Process vs gloves
Defect Picker
- Cloudy solution→Quarantine
- Visible particles→Reject
- Leaking container→Reject
- Color change→Investigate
- Failed sterility→Recall
- Failed potency→Do not dispense
Aseptic Technique
- First air
- Unblocked HEPA air
- Critical site
- Sterile exposure
- Turbulence
- Blocked airflow
- Six inches
- Inside PEC
- Swab vial
- Disinfect septum
- Ampule filter
- Glass particle control
- Needle safety
- No recapping
- Final check
- Inspect defects
First Air
Critical sites need uninterrupted first air.
Critical siteNo blockingISO 5
Cleaning Agents
- Deactivation
- Render inactive
- Decontamination
- Remove residue
- Cleaning
- Remove soil
- Disinfection
- Kill microbes
- Sporicidal
- Kills spores
- Sterile IPA
- Final wipe
- Contact time
- Wet dwell
- Top to bottom
- Clean direction
Calculations + QA
- Ratio
- Proportional relation
- Dilution
- Reduce concentration
- Alligation
- Mix strengths
- Flow rate
- Volume over time
- Percent
- Parts per hundred
- Gravimetric
- Weight verification
- MFR
- Master formula
- Compounding record
- Batch evidence
Hazardous Procedures
- USP 800
- HD handling
- NIOSH list
- HD source
- CSTD
- Closed transfer
- C-PEC
- Containment PEC
- C-SEC
- Containment room
- Negative technique
- Pressure control
- Spill kit
- Immediate response
- HD PPE
- Exposure protection
Trace vs Bulk HD
Trace
- Contaminated items
- Empty containers
Bulk
- Usable HD remains
- Spill materials
Residue vs remaining drug
Waste Picker
- Needle or glass→Sharps
- Unused HD→Bulk HD
- Contaminated PPE→Trace chemo
- Nonhazardous CSP→Pharma waste
- Temperature excursion→Quarantine
- Recalled item→Segregate
Handling + Storage
- Label
- Patient plus BUD
- Aux label
- Special warning
- Room temp
- Controlled storage
- Refrigerated
- 2-8 C
- Frozen
- Product specific
- Light protect
- Prevent photolysis
- FEFO
- Earliest expiry first
- Quarantine
- Hold status
Packaging + Disposal
- Primary package
- Drug contact
- Secondary package
- Outer protection
- PVC
- Plastic container
- DEHP-free
- Plasticizer avoided
- Latex-free
- Allergy protection
- Sharps
- Puncture container
- Trace chemo
- Contaminated items
- Bulk HD
- Unused hazardous drug
Common Traps
BUD Is Not Expiration
BUD after compounding ≠ Expiration from manufacturer
LAFW Is Not HD
LAFW protects product ≠ BSC contains HD
Clean Before Disinfect
Soil blocks disinfectant ≠ Wet contact matters
Visible Normal Can Fail
Chemical failure hidden ≠ Testing may reveal
First Air Can Be Blocked
Hands create turbulence ≠ Critical sites exposed
Positive Is Not HD
Positive protects CSP ≠ Negative contains hazard
Trace Is Not Bulk
Trace means residue ≠ Bulk means drug remains
Last Minute
- 1.Procedures are 53%
- 2.BUD means compounded use-by
- 3.PEC DCA is ISO 5
- 4.LAFW not for HD
- 5.HD needs negative containment
- 6.First air stays unblocked
- 7.Clean before disinfecting
- 8.Contact time stays wet
- 9.GFS checks glove contamination
- 10.Media fill simulates process
- 11.Inspect for particles leaks
- 12.Sharps go puncture-resistant
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