Pharmaceutical Compounding—Sterile Preparations

These flashcards cover key terms and definitions related to Pharmaceutical Compounding—Sterile Preparations, focusing on standards, processes, and personnel competencies necessary for safe and effective compounding.

Compounded Sterile Preparation (CSP)

A preparation intended to be sterile created by combining, admixing, diluting, pooling, reconstituting, repackaging, or otherwise altering a drug product or bulk drug substance.

Aseptic Techniques

Procedures used to prevent microbial contamination by maintaining sterility during the preparation of CSPs.

Beyond-Use Date (BUD)

The date or hour after which a compounded sterile preparation must not be used.

Primary Engineering Control (PEC)

A device or zone that provides an ISO Class 5 air quality environment for sterile compounding.

Gloved Fingertip and Thumb Sampling (GFT)

A method for assessing the microbial contamination of compounding personnel's gloves after garbing.

Master Formulation Record (MFR)

A detailed document outlining the procedures and components used to prepare a CSP.

Compounding Record (CR)

A document that records each step of the compounding process for a specific CSP.

Category 1 CSP

CSPs that are compounded under less controlled environmental conditions, assigned a BUD of 12 hours or less at controlled room temperature.

Category 2 CSP

CSPs requiring more environmental controls than Category 1 and may have a BUD greater than 12 hours at room temperature.

Category 3 CSP

CSPs that may be assigned a BUD exceeding the limits for Category 2, subject to stringent preparation requirements.

Cleaning Agent

An agent used for the removal of substances from surfaces, typically containing surfactants.

Sporicidal Disinfectant

A disinfectant effective in destroying bacterial and fungal spores.

Personal Protective Equipment (PPE)

Clothing and equipment worn by personnel to minimize exposure to hazards that can cause injury or illness.

Air Quality Standards

Standards established for controlled environments outlining allowable particulate matter concentrations.

Sterilization by Filtration

The process of passing a drug solution through a sterilizing-grade membrane to achieve sterility by removing contaminants.

Endotoxin

A toxin that is a structural component of the cell wall of certain bacteria, released upon cell rupture and can cause severe reactions in humans.

Visual Inspection

A physical evaluation of a CSP's appearance and labeling to ensure they meet quality standards.

Microbial Contamination

The presence of undesired microorganisms which can compromise the sterility and safety of CSPs.

Quality Assurance (QA)

A systematic approach to ensure processes meet quality standards in compounding pharmacy.

Quality Control (QC)

The testing and documentation process that assures physical and chemical properties meet specified requirements.