Intro to Sterility
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35 Terms
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What is the US Pharmacopeia
A drug reference that serves as a standard for pharmacy related topics
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USP 797
The chapter overseeing sterile compounding
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USP 800
The chapter overseeing hazardous drug handling
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CSP
Compounded Sterile Preparations
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How are CSPs categorized?
\-Category 1,2,3
\-Based on condition in which they are compounded, storage conditions, probability for microbial growth, and the time in which they must be used (BUD)
\-Based on condition in which they are compounded, storage conditions, probability for microbial growth, and the time in which they must be used (BUD)
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Immediate-Use CSPs
\-ONLY compounded CSPs that would put patient at risk due to delay in therapy (ie Code Blue)
\-Involves not more than 3 different sterile products
\-Must begin administration within 4 hours following the start of preparation (BUD=4 hours)
\-Must not be stored for later use
\-Involves not more than 3 different sterile products
\-Must begin administration within 4 hours following the start of preparation (BUD=4 hours)
\-Must not be stored for later use
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Category 1 CSPs
\-Compounded under least controlled environment
\-Must be prepared in ISO 5 or better PEC
\-BUD: 12 hours in 20-25 degrees celsius or 24 hours in 2-8 degrees celsius
\-Must be prepared in ISO 5 or better PEC
\-BUD: 12 hours in 20-25 degrees celsius or 24 hours in 2-8 degrees celsius
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Category 2 CSPs
\-Require more environmental controls and testing than Category 1 CSPs
\-Must be compounded in cleanroom and ISO 5 or better PEC
\-Longer BUDs than Category 1 CSPs
\-Aseptically processed using only sterile starting components
\-Must be compounded in cleanroom and ISO 5 or better PEC
\-Longer BUDs than Category 1 CSPs
\-Aseptically processed using only sterile starting components
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Category 3 CSPs
\-Requires sterility testing
\-More requirements for personnel qualification, use of sterile garb, use of sporicidal disinfectants, environmental monitoring frequency, and stability determination
\-May have longer BUDs than Category 2
\-More requirements for personnel qualification, use of sterile garb, use of sporicidal disinfectants, environmental monitoring frequency, and stability determination
\-May have longer BUDs than Category 2
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Why is sterility important?
Contamination from many different things
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What is the #1 source of contamination?
Human physical touch
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How can we avoid contamination?
\-Compounding in an environment that utilizes various measures to prevent any microbial contamination
\-Primary Engineering Controls (PECs): hoods
\-Secondary Engineering Controls (SECs): Cleanroom
\-Gowning/Garbing procedures
\-Disinfectants and cleaning supplies
\-Primary Engineering Controls (PECs): hoods
\-Secondary Engineering Controls (SECs): Cleanroom
\-Gowning/Garbing procedures
\-Disinfectants and cleaning supplies
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What kind of training is required for sterile compounding?
\-Hand hygiene
\-Cleaning and disinfecting
\-Antiseptic technique
\-Measuring and mixing
\-Use of equipment
\-Methods of sterilization
\-Cleaning and disinfecting
\-Antiseptic technique
\-Measuring and mixing
\-Use of equipment
\-Methods of sterilization
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USP 797 guidelines indicate that personnel involved in compounding of sterile products (Category 1&2) should be evaluated initially and every ____ months thereafter.
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Hygiene Requirements
\-Remove any unnecessary items (cosmetics, jewelry, jackets, phones, etc)
\-Fingernails must be kept short, clean, and natural
\-No food or drinks
\-Personnel with cuts, rashes, communicable diseases are excluded
\-Fingernails must be kept short, clean, and natural
\-No food or drinks
\-Personnel with cuts, rashes, communicable diseases are excluded
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PPE
\-Gowns or coveralls (low-lint and disposable)
\-Shoe covers (low-lint and disposable)
\-Hair covers (low-lint and disposable)
\-Sterile gloves (powder free)
\-Masks
\-Eye shields
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\-Shoe covers (low-lint and disposable)
\-Hair covers (low-lint and disposable)
\-Sterile gloves (powder free)
\-Masks
\-Eye shields
\
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What is the cleanest ISO?
ISO 3- cleanest
ISO 8- least clean
ISO 8- least clean
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Hoods should be ISO
5
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Cleanrooms should be ISO
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Ante rooms should be ISO
7 or 8
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Ante-Area
\-ISO 8
\-Hand hygiene, garbing, CSP handling
\-No compounding in this area
\-Hand hygiene, garbing, CSP handling
\-No compounding in this area
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Buffer Area (Clean Room)
\-ISO 7
\-Contains PEC for compounding
\-Only authorized personnel and materials required for compounding and cleaning are allowed
\-Contains PEC for compounding
\-Only authorized personnel and materials required for compounding and cleaning are allowed
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Segregated Compounding Area
\-PEC is placed in a separated space that is away from unsealed windows or doors
\-Only CSP 1 can be compounded here
\-Only CSP 1 can be compounded here
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Primary Engineering Control (PEC)
\-A device that provides ISO 5 environment for exposure of critical sites when compounding CSPs
\-All CSPs must be compounded in a PEC
\-Maintain air quality by unidirectional air flow and high efficiency particulate air (HEPA) filters
\-All CSPs must be compounded in a PEC
\-Maintain air quality by unidirectional air flow and high efficiency particulate air (HEPA) filters
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What are the two types of PECs?
1. Laminar Airflow Workbenches
2. Biologic Safety Cabinets
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Standard Operating Procedure
A set of procedures for all aspects of compounding activities; every compounding facility must have one
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Master Formulation Record
A form to document all activities and products utilized in the compounding process
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Before release and dispensing
Each injectable CSP unit must go through a physical inspection and sterility testing, which must be done on category 3 CSPs
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Expiration Date
Time during which a conventionally manufactured drug product may be expected to maintain its labeled identity, strength, quality, and purity, provided it is kept under the labeled storage conditions assigned by manufacturer
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Beyond Use Date
Indicates the date or date and hour after which the CSP must not be used, stored, or transported because its required characteristics cannot be insured
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Establishing a BUD
Minimize timing between compounding CSP and administration to patient; consider both sterility and stability
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What is quality assurance?
Set of written processes that, at a minimum, verifies, monitors, and reviews the adequacy of the compounding process
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What must quality assurance include?
\-Personnel qualifications and training
\-Component selection and handling
\-Design and maintenance of the building, facility, and equipment
\-Compounding process
\-Final CSP release
\-Documentation
\-Component selection and handling
\-Design and maintenance of the building, facility, and equipment
\-Compounding process
\-Final CSP release
\-Documentation
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Quality Control
The observation of techniques and activities that demonstrate that requirements are met
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How long should records and documentation be kept for?
3 years
Note 
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