Hazardous Drug Handling and Safety Protocols Study Guide
This guide provides comprehensive information on USP <800> standards for handling hazardous drugs. It covers identification of hazardous drugs, risk assessment, facility and engineering controls, personal protective equipment, and procedures for disposal, spills, and exposure.
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Handling and Standards for Hazardous Drugs
USP <800> Hazardous Drug Handling Standards
USP <800> describes practice and quality standards for handling hazardous drugs including receipt, storage, compounding, dispensing, administration, and disposal of sterile and nonsterile products.
- Hazardous drugs handling
- NIOSH list of antineoplastic and other HDs
- Personnel training and garbing
- Facility design
- Carcinogenic, teratogenic, and genotoxic drugs
- Safety Data Sheets (SDS)
- Hazard Communication Plan
- Risk assessment
USP <800> Hazardous Drug Handling Standards
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Micromeritics and Derived Powder Properties
Micromeritics and Flow Properties of Solids
This topic covers micromeritics including porosity, packing arrangements, densities of particles, bulkiness, and flowability measurement.
- Porosity
- Void volume
- Packing arrangements
- True density
- Granule density
- Bulk density
- Tap density
- Bulkiness
- Flowability
- Angle of repose
- Coefficient of friction
- Particle size and distribution
- Particle shape
- Particle surface forces
- Flow activators
Formulation and Manufacturing of Sterile Parenterals
Sterile Dosage Form Testing and Packaging
Methods for pyrogen testing, endotoxin testing, sterility testing, and sterilization method quality control using biological indicators, alongside pharmaceutical packaging and labeling requirements.
- Pyrogen Testing
- Rabbit Testing
- Endotoxin Testing
- Sterility Testing
- Direct Inoculation
- Membrane Filtration Sterility Test
- Biological Indicator
- Bacillus stearothermophilus
- Bacillus subtilis
- Bacillus pumilus
- Pharmaceutical Packaging
- Pharmaceutical Labeling
Pharmaceutical Quality Control: Sterile and Solid Dosage Forms
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Hazardous Drug Compounding and Safety Controls
USP <800> Hazardous Compounding Safety Standards
Guidelines for assessment of risk, space requirements, and primary engineering controls for sterile and nonsterile hazardous drug compounding.
- Assessment of Risk (AoR)
- C-PEC
- C-SEC
- C-SCA
- Class II Biological Safety Cabinet (BSC)
- Compounding Aseptic Containment Isolator (CACI)
- Containment Ventilated Enclosure (CVE)
- Externally vented exhaust air
- Hazardous drug storage
- Personnel protection
- Product protection
- Environmental protection
- Air changes per hour (ACPH)
Solid Dosage Forms: Tablet Formulation and Manufacturing
Solid Dosage Forms: Tablet Formulation and Manufacturing
This lecture covers tablet dosage forms, including various types, advantages, disadvantages, qualities of a good tablet, and quality standards.
- Tablet dosage forms
- Tablet advantages and disadvantages
- Qualities of a good tablet
- Tablet characteristics
- Types of tablets
- Multiple compressed tablets
- Sugar-coated tablets
- Film-coated tablets
- Gelatin-coated tablets
- Enteric-coated tablets
- Buccal and sublingual tablets
- Effervescent tablets
- Immediate-release tablets
- Instantly disintegrating or dissolving tablets
- Extended-release tablets
- USP weight variation test
- Tablet hardness
- Tablet friability
- Tablet disintegration
Introduction to Micromeritics and Particle Analysis
Importance of Particle Size and Distribution
Particle size and distribution influence manufacturing uniformity, storage stability, route of administration, solubility, absorption, and duration of action.
- Manufacturing non-uniformity
- API distribution
- Flow properties of powders
- Storage stability
- Route of administration
- Solubility
- Absorption
- Onset of action
- Duration of action
- Adverse effects
Hazardous Drug Handling, Disposal, and Safety
Hazardous Drug Handling and Disposal Protocols
Procedures for hazardous drug administration, preparation techniques, equipment use, transport labeling, disposal of trace and bulk waste, spill cleanup, and drug exposure response.
- Garb for HD administration and transportation
- Injectable antineoplastics administration
- C-PEC manipulation
- Negative Pressure preparation technique
- Closed-System Transfer Device
- Hazardous CSP Preparation Technique
- HD Disposal (Trace vs Bulk)
- PPE Disposal
- Spill cleanup procedures
- Drug exposure response
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