Cleaning Validation Glossary

A dose that is unlikely to cause an adverse effect if an individual is exposed at or below this dose every day for a lifetime

How close an experimental value is to the known value

Core components in medications that produce therapeutic effects

A pre-cautionary limit set below the acceptance criteria but still an indication that a procedure is trending out of specification

An analytical technique to determine a specific propterty of a sample

A mechanized process requiring little human interaction

Microbial communities on surfaces

Ensures an instrument is able to perform adequately

Corrective and Preventive Actions addressing process issues

Device using rotation to separate materials based on density

The steps taken for switching multi-product equipment from manufacture of one product to another

Technique separating compounds

Duration for maintaining cleanliness

Chemical agent or solution used for cleaning

Documented evidence of consistent residue removal during cleaning

The gathering of evidence to show that residues or cleaning agents have been reduced below the scientfically set maximum allowable carryover level

Electrical ion-concentration gauge

Foreign matter that may contaminate the next product

Using continous monitoring to verify the performance of a manufacturing process

A process that enables you to confirm that the spray pattern created by the cleaning head has achieved 100% coverage across all internal surfaces of the vessel.

Unintended substance transfer leading to impurity introduction

The documented verification that the proposed design of the facilities, systems, and equipment is suitable for the intended purpose

Fluid-level extraction pipes

Concentration of active components in medications

Protein detection method

A test run at full scale

The sequence of equipment through which a product is produced or processed

A cleaning failure that is not necessarily due to the process itself

Fluid movement routes

Analyzing gas mixtures

Damaging to DNA

Oversight and control

Limit established based on health risks to patients

High-Performance Liquid Chromatography

Unwanted substances in a product

Equipment shared among multiple products

Test variation in diverse conditions

Lowest detectable quantity

Reduced ability of substances to dissolve

Human-operated process

Physical object manipulation

Simulated contamination

Equipment not in direct contact with the process

Circular welding device

Measures for patient wellbeing

Scheduled testing to ensure a process functions consistently

Mixing blade design

Actions taken to prevent an incident

Equipment directly interacting with products

Maintenance of product properties

Compliance checker

Reasoning behind decisions

Performed when a validated system undergoes a change

Resilience to variations

Mechanism for removing residues

Ratio of contaminants to solvent

Documented steps for consistent task execution

Leftover steroid compounds, impacting safety and effectiveness

A tool used to collect adhered residue from a surface

Gas introduction devices

Measure of organic impurities

Enables tracking of manufacturing of products

Validation process outline

Physically clean to the naked eye

Most challenging scenarios

An intake level that poses negligble cancer risk, or for serious life threatening indications where risk and benefit are appropriately balanced

Solutions below 7 on the pH scale used for scale removal

Using vibration or stirring within a solution bath to improve cleaning

Causes allergies

A type of blade that rotates to mix materials in a reactor

Product rejection due to quality issues

Devices for biological reactions

The production of multiple batches of the same product without major cleaning

Unintentional transfer of substances between processes or products

Current Good Manufacturing Practices

A process which changes the molecular structure of a chemical or compound

Cleaning equipment without disassembly

Cleaning equipment with disassembly

Extent of residue removal during cleaning processes

Phases of cleaning validation

The manufacturing processs that produces a commercial product

Devices measuring conductivity

The undesired introduction of impurities into a material or product

Actions taken to rectify an incident or deficiency

Key cleaning conditions

Equipment used exclusively for one product

A multidimensional combination and interacton of input variables and process parameters that have been demonstrated to provide quality assurance

Equipment that is in direct contact with the product during its normal flow through the unit.

The dosage form in the final immediate packaging intended for marketing.

A combination of two liquids that are stablized by an agent

Records the major cleaning of equipment

An unexpected result or event during validation

Pre-installation equipment testing

Speed of substance movement

Introduction of gases

Meeting international regulations

Measurement by weight

Thick fluid property

Design of equipment and piping that can be easily cleaned

Amount of unwanted substances

Documented verification that the facilities, systems, and equipment comply with the approved design and the manufacturer's recommendations

A cleaning failure that may be a result of the process itself

Lowest quantifiable amount

Friction-reducing substances

Identifying compounds based on mass

Pertaining to microorganisms like bacteria

Systems overseeing processes

Analysis of sample without interrupting the process

Carbon-containing solvents

Measureable value to assess condition or status

Daily dose limit

Strength or effectiveness of a substance

Pre-requisite of cleaning validation

Altered product component

Tolerance range of a parameter

Integral characteristics

A laboratory study combining the sampling method and analytical method to determine the quantitative recovery of a residue

Step to remove residues or agents

Duration of process operation

Materials used once then disposed of

Capacity of a substance to dissolve in a solvent

Precise substance detection

Hormone-like organic compounds

Validation of system functionality

Temperature-induced force

Harmful effects of a substance on organisms

Leave no room for doubt or misunderstanding

Flow control device

Water of high purity

Most difficult to clean soil

The threshold that determines if a test passes or fails

A pre-cautionary limit set below the acceptance criteria but still an indication that a procedure is trending out of specification and action must be taken

Clean compressed air forces dislodged debris and liquids to drains

A substance for which an analysis is being performed on

water-based cleaning agents

Refers to the amount of microogranisms present

A validation scheme where only batches on the extremes of certain justified design factors are tested during process validation

Duration of production cycle

Strong stain removers

Management of changes to the cleaning process the ensure the process remains in a state of control

Traces of chemicals used during manufacturing or cleaing remaining on equipment surfaces influencing quality

Any residue remaining is within an acceptable level

Ease of effectively cleaning surfaces

Agents for dissolving residues during cleaning

Cleaning process specifics

Material's electrical conduction ability

Duration of substance contact

Plan to prevent impurities

A small, flat portion of material of construction typically used for laboratory cleaning evaluations

Key quality factors

The breakdown of material during a manufacture

Departures from standards

Duration before cleaning

Active components of drug product

Fever inducing cell wall component of bacteria

The material used to construct an equipment surface

A substance that aids in the manufacture of pharmaceutical ingredients

Flexible fluid conduits

Fundamental basis

Sealing materials

Quality guidelines

A strategy for establishing cleaning processes & validation methods for items that share similar properties

Duration a substance can remain before processing

Process of cleaning solution striking a surface

Measurement where the sample is analyzed within the process stream and not removed from it

A material produced during manufacturing that undergoes further molecular change or purification before it becomes an API

Full product cycle planning

Proportional measurement results

Hand-performed cleaning

Highest tolerated transfer

Traces of microorganisms left post-process, affecting safety

Carcinogenic impurity

Documentation that equipment functions after installation

Substances promoting oxidation reactions

Documentation that equipment works as intended

Measure of solution acidity or alkalinity

Measurement consistency

Procedure of changing between product manufacturing on a single equipment train.

Measures ensuring product meets standards

Highly purified water

Valid measurement span

Precision in repeated analytical results

Evaluating potential hazards

Mechanical cleaning

Unwanted substances on equipment surface

Substances dissolving other substances

Ensures a process consistently functions as intended

Tool for residue collection from surfaces

Cleaning parameters

Genotoxic impurity exposure level associated with theoretical risk

Study of harmful effects

Analyzing light absorption

Direct observation assessment

Length of a wave