Glossary

Non-liquefied gases are elements , or combination of elements, that have boiling points lower than -130ºF (-90ºC). Examples of non-liquefied gases include:• nitrogen• oxygen• argonWhen specific elements become liquefied at extremely low temperatures they are reerred to as “cryogenic liquids”.

A high priority interrupt that cannot be disabled by another interrupt. It can be used to report malfunctions such as parity, bus, and math co-processor errors.

Materials that do not emit expel or discharge particulate.

An investigational medical device that does not present significant risk to the patient.

(ICH Q5A (R1)) A virus used for characterization of viral clearance of the process when the purpose is to characterize the capacity of the manufacturing process to remove and/or inactivate viruses in general, i.e., to characterize the robustness of the purification process.

Research that has no likelihood or intent of producing a diagnostic, preventive, or therapeutic benefit to the current subjects, although it may benefit subjects with a similar condition in the future.

Airflow that does not meet the definition of unidirectional airflow; previously referred to as “turbulent” or “non-laminar” airflow.

Air distribution where the supply air entering the clean zone mixes with the internal air by means of induction.

A localized surface polishing pattern that is dissimilar to the surrounding area.

Opposite of viable, not alive.

Opposite of viable, not alive.

Member of an Institutional Review Board who has no ties to the parent institution, its staff, or faculty. This individual is usually from the local community (e.g., minister, business person, attorney, teacher, homemaker).

Hardness in water caused by chlorides, sulfates, and nitrates of calcium and magnesium.

Hardness in water caused by chlorides, sulfates, and nitrates of calcium and magnesium.

When applied to a diagnostic device or procedure, means one that does not by design or intention: (1) Penetrate or pierce the skin or mucous membranes of the body, the ocular cavity, or the urethra, or (2) Enter the ear beyond the external auditory canal, the nose beyond the anterior opening to the nasal cavity, the mouth beyond the pharynx, the anal canal beyond the rectum, or the vagina beyond the cervical bone. For purposes of this part, blood sampling that involves simple venipuncture is considered noninvasive, and the use of surplus samples of body fluids or tissues that are left over from samples taken for noninvestigational purposes is also considered noninvasive.

A solvent for molecules that do not have permanent electric dipoles and consequently may be less soluble in water (lipids, for example).

For an over-the-counter (OTC), or nonprescription medicine, information printed on the medication bottle or package under the heading Drug facts is important for taking care of yourself and your family. The Drug Facts tell you what a medicine suppose to do, who should or should not take it, and how to use it. Safety information and instructions for use are displayed in a uniform and easy-to-read format.

The concentration of organic carbon remaining after sparging a sample to remove inorganic carbon.

A mutation which converts an amino-acid specifying codon into a stop codon, e.g., a change from UAU (tyr) to UAG (amber) would lead to the premature termination of a polypeptide chain at the place where a tyrosine was inserted in the wild-type.

A neonate after delivery that, although living, is not viable.

The actual observed values of the critical parameter during operations, collected over time. This range may be larger than the design tolerance, but should be well within Action Limits.

(CMC-BWG) A defined range, within the Proven Acceptable Range, specified in the manufacturing instructions as the target and range at which a process parameter is controlled, while producing unit operation material or final product meeting release criteria and Critical Quality Attributes.

Values of a parameter that are normally observed while a process is operating. The normal operating condition should be within the alert and action limits.

A very common LVP that has a physiologic (0.9gm%) concentration of sodium chloride.