Pharmaceutical Compounding and Sterile Preparations

Vocabulary terms related to pharmaceutical compounding and sterile preparations.

Compounding

The process of combining, admixing, diluting, pooling, reconstituting, repackaging, or otherwise altering a drug product or bulk drug substance to create a sterile preparation.

Sterile Compounding

Combining or preparing medicines in such a way that they are free from living microorganisms.

CSPs

Compounded sterile preparations intended for human or animal use.

BUD

Beyond-use date; the date or time after which a CSP must not be used.

Aseptic Technique

A set of procedures designed to minimize contamination by pathogens.

ISO Class 5

An environment with a maximum allowable particles of 3,520 particles/m3 and is suitable for sterile compounding.

Endotoxins

Toxic substances bound to the bacterial cell wall that are released when the bacteria die.

Validation

The process of proving that a procedure, process, or activity will consistently lead to the expected results.

SOP

Standard Operating Procedure; a set procedure followed for routine operations.

Personal Protective Equipment (PPE)

Clothing or equipment worn by an employee for protection against hazards.

Immediate-Use CSPs

CSPs intended for administration within 4 hours of compounding.

Media-Fill Test

A test conducted to evaluate the ability of compounding personnel to prepare sterile products.

Garbing

The process of dressing in specific attire to minimize contamination risk.

Cleanroom

A controlled environment designed to keep out pollutants like dust, particles, and microorganisms.

HEPA Filter

High-efficiency particulate air filter that removes particles from the air.

Agycocod, a.s. or q.s.

A term used to denote that sufficient quantity of a certain ingredient is prepared or to reach a desired concentration.

Container Closure System

Packaging components that protect the integrity of a drug product.

Pharmaceutical Isolator

A barrier system utilized for the compounding of sterile preparations that creates a controlled environment.

Compounding Allergenic Extracts

The preparation of allergenic extracts for immunotherapy.

Repackaging

The act of transferring a sterile product from one container to another.

Quality Assurance (QA)

A system of procedures to ensure that compounding processes meet specified quality standards.

Quality Control (QC)

The process of testing and inspection to ensure that products meet quality standards.

Visual Inspection

A method to check CSPs for visible defects before release.

Active Pharmaceutical Ingredient (API)

The substance in a drug that produces its effects.

Trypticase Soy Agar (TSA)

A nutrient agar used for culturing bacteria.

Sporicidal Disinfectant

A disinfectant that kills bacterial and fungal spores.

Compounding Record (CR)

A document that captures the details of each compounding process.

Training and Competency Assessment

Evaluating personnel's ability to perform specific tasks related to compounding.

Microbial Monitoring Program

A system used to assess the levels of microorganisms in a sterile compounding environment.

Action Levels

Specified limits for acceptable counts of microorganisms in monitoring programs.

Environmental Monitoring

The process of assessing air and surface quality in sterile compounding areas.

Storage Conditions

The environmental conditions under which CSPs are kept to ensure their stability.

Container Closure Integrity

The ability of a container closure to maintain its sterile status.

Antimicrobial Effectiveness Testing

Testing to confirm that a preservative in a CSP effectively inhibits microbial growth.

CSP Quality

The assessment of compounded pharmaceutical preparations for potency, purity, and sterility.

Compounding Environment

The area where CSPs are prepared, often subject to strict cleanliness and sterility standards.

Personnel Hygiene

Practices followed by compounding personnel to maintain cleanliness and reduce contamination risk.

Compounding Aseptic Containment Isolator (CACI)

A type of isolator that provides protection to the operator when compounding hazardous drugs.

Cleaning and Disinfecting Procedures

Protocols for maintaining cleanliness and reducing microbial contamination in compounding spaces.

Prescription Set

A set of allergenic extracts prepared for individual patient administration.

Biohazard Waste

Waste containing potentially infectious materials.

Container Integrity Testing

Testing to ensure that container closure systems maintain sterility.

Temperature and Humidity Monitoring

Monitoring environmental conditions to ensure they remain within acceptable limits for compounding.

Patient Safety

Practices intended to minimize the risk of harm to patients during compounding operations.

Cross-Contamination

Contamination of a drug product with another substance.

Quality Management System

A system that oversees quality processes and ensures compliance with standards.

Sterility Assurance Level (SAL)

The probability that a process has achieved sterility, usually set at 10^-6.

Component Evaluation

Assessing the quality and suitability of supply components before use.

Multiple-Dose Container

A container designed for multiple uses of a single sterile product.

Adverse Event Reporting

Reporting events that may indicate quality issues or harm related to CSPs.

Primary Engineering Control (PEC)

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

Segregated Compounding Area (SCA)

An area designated for the compounding of Category 1 CSPs.

Category 1 CSP

Compounded sterile preparations with a BUD of 12 hours or less.

Category 3 CSP

Compounded sterile preparations with longer BUDs subject to stringent sterility testing.

Air Changes per Hour (ACPH)

The number of times the entire air volume in a defined space is replaced in one hour.

Quality Control Procedures

Systems used to check CSPs for quality before release.

Sterility Testing

Testing designed to determine whether a compounded preparation is free from viable microorganisms.

Recertification

The process of validating equipment or environments to ensure ongoing compliance with standards.

Compliance Monitoring

The oversight of practices to ensure they meet regulatory requirements.

Handling Instructions

Specific directives for the safe handling of CSPs during transport.

Cleaning Agent

Substance used to remove contaminants from surfaces.

Surgical Asepsis

Techniques to keep sterile field areas free from all microorganisms.

Contamination Control

Methods employed to prevent the introduction of pathogens or unwanted substances into CSPs.

Hazardous Drugs (HDs) Guidelines

Protocols for handling drugs that pose special risks.

Incompatibility

A characteristic of drugs that indicates they should not be mixed.

Quality Assessment

The ongoing evaluation of a process or product to ensure it meets quality standards.

Hazardous Drug Handling

Protocols for safely managing drugs that can be harmful to health.

Segregated-Area Compounding

Compounding performed in a designated area, intended for specific types of preparations.

Automated Compounding Device (ACD)

A device that automates the preparation of CSPs.

Controlled Temperature Environment

A storage area maintaining specific temperature ranges suitable for CSPs.

Fill Volume

The amount of solution contained within a vial or container.

Apyrogenicity

Absence of pyrogens, substances that cause fever in humans.

Action Plans for Quality Control Failures

Procedures implemented in response to quality assessment failures.

Storage Integrity Testing

Verifications conducted to ensure the integrity of storage containers.

Surgical Preps

Procedures for maintaining sterility before surgical operations.

Antineoplastic Drugs

Drugs used to treat cancer that require close safety and handling measures.

Final Quality Assurance Review

A comprehensive examination of CSP quality before release.

Labeling Errors Prevention

Practices aimed at avoiding mistakes in naming or describing CSPs.

Surface Sampling

The act of testing surfaces for microbial contamination within a cleanroom.

Quality Metrics

Data points, indicators, or measurements reflecting quality levels within a process.

Hazardous Waste Disposal

The proper disposal methods for pharmaceuticals that pose potential risks to health and the environment.

Final Yield Validation

Confirmation of expected output from compounding processes.