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Standard Operating Procedure (SOP)
A written, approved set of instructions on the correct and safe way to perform a task.
Environmental Monitoring (EM)
The planned sampling and measurement of facility conditions to ensure suitability for work, focusing on air quality, temperature, humidity, and microbial contamination.
Compressed gas cylinders
High-pressure containers that require strict handling procedures due to hazards such as flammability and toxicity.
Safety Data Sheet (SDS)
A standardized document that communicates a chemical’s hazards and the necessary controls for safe use.
Neutralization
The chemical process of bringing an acidic or basic solution closer to neutral pH for safer handling or disposal.
Hazard identification
The section of an SDS that describes what type of harm a chemical can cause.
Particle count
A measure of non-living particles of various sizes in the air, used as an indicator of cleanliness in controlled environments.
Viable monitoring
Monitoring that assesses living microorganisms using methods like active air sampling and settle plates.
Pressure control
Managing pressure differentials in clean rooms to ensure proper airflow direction and maintain integrity.
Out-of-range pressure differential
An indicator that can signal a loss of clean room integrity when pressure readings are not within acceptable limits.
Precautionary statements
Instructions on how to prevent harm associated with use of a chemical, as found on labels and SDS.
Personal Protective Equipment (PPE)
Gear worn to reduce exposure to hazards and ensure safety when handling chemicals or materials.
Gowning procedures
SOPs that dictate how personnel should dress to minimize contamination risks in clean rooms.
Calibration checks
Verifications made to ensure measurements from instruments like pipettes and balances are accurate and consistent.
Controlled environment
An environment maintained at specific conditions, such as temperature, humidity, and cleanliness, to support safe work.
Chemical incompatibilities
Situations where chemicals should not be mixed due to potential dangerous reactions.
Air quality monitoring
Assessing the cleanliness of air in controlled settings by measuring non-viable particles.
Documentation
The process of recording operational details, necessary for compliance and traceability in regulated environments.
Cleaning/decontamination procedures
SOPs that ensure surfaces are free from contaminants and properly disinfected in controlled environments.
GHS label elements
Components like product identifiers, signal words, hazard statements, and pictograms used in chemical labeling for hazard communication.
Emergency response procedures
Steps defined in SOPs for actions to take when an unexpected event or hazard occurs.
Temperature excursion
A situation in which temperature readings surpass permitted ranges, requiring documentation and investigation.
Sampling frequency
The predetermined rate at which environmental conditions are sampled to ensure ongoing control.
Heat release
Energy emitted during a chemical reaction, which can cause hazards like splashing or boiling during neutralization.
Spill response measures
Procedures outlined in SDS for safely managing accidental releases of chemicals or biologicals.
Audit trail
The documentation of all steps taken in a process, necessary for compliance in laboratory settings.
Secondary container labeling
Labels on containers used to hold transferred materials, which must clearly indicate the contents and associated hazards.
Alarms and deviations
Signals indicating a potential issue that requires immediate investigation and response according to SOP.