Law USP study Guide Flashcards
Safety Data Sheet (SDS)
Certificate of Analysis (COA)
Standard Operating Procedures (SOP)
Safety Data Sheet (SDS)
- a detailed informational document prepared by the manufacturer or importer of a hazardous chemical. It describes the physical and chemical properties of the product.
Certificate of Analysis (COA)
- a formal laboratory-prepared document that details the results of one or more laboratory analyses, signed—manually or electronically—by an authorized representative of the entity conducting the analyses
Standard Operating Procedures (SOP)
- provides clear-cut directions and detailed instructions needed to perform a specific task or operation consistently and efficiently.
Personal Protective Equipment (PPE)
Containment Ventilated Enclosure (CVE)
Biological Safety Cabinet (BSC)
Personal Protective Equipment (PPE)
- equipment worn to minimize exposure to a variety of hazards
Containment Ventilated Enclosure (CVE)
- They provide personnel and environmental protection as in biosafety cabinets (BSC) Class I.
Biological Safety Cabinet (BSC)
- an enclosed, ventilated laboratory workspace for safely working with materials contaminated with pathogens requiring a defined biosafety level.
Beyond use date (BUD)
USP
BUD
- After manipulation of a product
– Determined by:
■ Stability (chemical and physical) this can be affected by planned storage conditions
■ Compatibility with storage containers
■ Potential for microbial proliferation
USP
United States Pharmacopeia – National Formulary (USP-NF)
– 5000+ standards for chemical and biologic: active pharmaceutical ingredients (APIs)
and excipients
■ Monographs are available for many compounding recipes and include BUDs
API
Aw
active pharmaceutical ingredients (APIs)
Aw- water activity
High-efficiency particulate air (HEPA)
Primary engineering control (PEC)
Laminar air flow workbench (LAFW)
High-efficiency particulate air (HEPA)
- a type of pleated mechanical air filter
PEC (ISO 5)
- controls airborne contamination from the point of filtration to the critical site and beyond so that airborne contamination is virtually eliminated from the working environment.
- 4 types of PEC: laminar airflow workbench, biological safety cabinet, compounding aseptic isolator, compounding aseptic containment isolator
LAFW
- used to control airborne contamination of sterile products during their extemporaneous preparation.
Vertical and Horizontal
Compounding aseptic isolator (CAI)
Compounding aseptic containment isolator (CACI)
These as well as BSC are types of PECs
International organization of standards (ISO)
Compounded sterile products (CSPs)
American society for testing and materials (ASTM)
Closed system transfer device (CSTD)
Hazardous drug (HD)
Define
USP 795
USP 797
USP 800
Garbing
Master formulation record
Compounding record
Quality Assurance
Quality Control
Aseptic technique
Primary control
Secondary control
Positive Pressure Air Flow
Negative Pressure Air Flow
Secondary buffer rooms
- the ante and buffer rooms
- Have a higher ISO
- Buffer room (ISO 7) houses the PEC (ISO 5)
Ante area - prep area before compounding, GARB up, hand hygiene
- ISO 8 or better
Positive Pressure Air Flow:
- used in a typical non-hazardous, increased room pressure in the buffer room and pushes out into ANTE area
- pushes particulates and microbes to the ANTE area
Negative Pressure Air Flow
- used for hazardous materials
- hood ventilation is also pulling outside and through filters away from the compounder
Air and Surface Monitoring
Genotoxicity
Organ Toxicity
Teratogenicity
Reproductive Toxicity
Carcinogenicity
Yellow Disposal Bin
Black Disposal Bin
Expiration vs BUD
Cleaning steps for 797
Cleaning steps for 800 (HD)
USP 797 factors that affect BUD determination
797
Cleaning
* Contains surfactant to remove dirt and debris
disinfectant
* Destroys fungi, viruses, and bacteria
Sporicidal
* Destroys bacterial and fungal spores
minimum do these steps at least once a day
if working with level 3 organisms then do step 3 more often
800
Deactivation/Decontamination
*2% sterile bleach or peroxide
*Reduces toxicity and removes HD residue
- break down the chemical structure
Cleaning
*Germicidal Detergent
*Removes dirt and microbe contamination
Disinfection
*70% Sterile Isopropyl alcohol (IPA)
*Inhibits or destroys microbes.
USP 797 factors that affect BUD
category 1
- environment
Storage conditions (e.g. controlled room, refrigerator)
category 2
- Environment
Storage conditions (e.g. controlled room, refrigerator)
Compounding method
Sterility testing is being done
Starting compounding components (sterile vs nonsterile)
category 3
- Environment
Storage conditions (e.g. controlled room, refrigerator)
Compounding method
Sterility testing is being done
Starting compounding components (sterile vs nonsterile)
Factors that can help extend BUD (also under category 3)
- Increase the use of sporicidal disinfectants
Increase in environmental monitoring
Stability determination data
Personnel training and qualifications
