Glossary

This term refers to the dewpoint temperature (PDP) of a gas under full line pressure; it is usually found when measuring the dewpoint temperature of gases at pressure higher than atmospheric pressure.(also see: Atmospheric Dewpoint)

Capability of providing a quantifiable pressure leakage rate repeatable under test conditions.

Pressure at which a system is designed to operate, allowing for applicable safety factors.

(ASME) A device designed to prevent pressure or vacuum from exceeding a predetermined value in a pressure vessel by the transfer of fluid during emergency or abnormal conditions.

(ASME) A pressure relief device which is designed to recluse and prevent the further flow of fluid after normal conditions have been restored.

A closed vessel designed to operate at pressures above 15 psig (103.4 kPa).

An automatic relief device actuated by the static pressure upstream of the valve or by the temperature of the fluid. The maximum temperature setting is usually 210°F (99°C). It is used primarily for liquid service. (also see: Pressure Relief Valve)

Initial water treatment steps performed prior to final processing to prolong the life of cartridges and filters and to protect downstream elements from premature failure.

(ICH Q10) Action to eliminate the cause of a potential non-conformity or other undesirable potential situation. NOTE: Preventive action is taken to prevent occurrence whereas corrective action is taken to prevent recurrence. (ISO 9000:2005)

(ISO 8402) Action taken to eliminate the cause of a potential non-conformity, defect, or other undesirable situation in order to prevent occurrence.

Typically based on calendar time or run time. The intent is to perform the maintenance activity on a regular basis so as to ensure the equipment is operating within tolerances, minimizing wear and/or preventing failures.

Air circulating through HEPA filters used to produce unidirectional flow in critical zones.

In an ELISA or other immunological assay, the antibody that binds to the target molecule.

(ICH Q1A (R2)) A batch of a drug substance or drug product used in a formal stability study, from which stability data are submitted in a registration application for the purpose of establishing a re-test period or shelf life, respectively. A primary batch of a drug substance should be at least a pilot scale batch. For a drug product, two of the three batches should be at least pilot scale batch, and the third batch can be smaller if it is representative with regard to the critical manufacturing steps. However, a primary batch may be a production batch.

A cell or cell line taken directly from a living organism, which is not immortalized.

Cultures of cells obtained by trypsination of a suitable tissue or organ. The cells are essentially identical to those of the tissue of origin and are no more than 5 in vitro passages from the initial preparation from the animal tissue.

The first level of containment, consisting of the inside portion of that container which comes into immediate contact on its inner surface with the material being contained.

Device used to convert the process parameter into a measured signal.

A group of rare inherited disorders of the immune system, including adenosine deaminase deficiency, severe combined immunodeficiency (SCID), and ataxia-telangectasia.

(FDA) The single mode of action (drug, device or biological) of a combination product that provides the most important therapeutic action of the combination product.

Immediate container with IMP.

The early steps in separation and purification of a biopharmaceutical, in which a complex biological solution containing the protein of interest is concentrated and clarified, usually by means of filtration, centrifugation, or precipitation/extraction.

The RNA molecule produced by transcription prior to any post-transcriptional modifications; also called a premRNA in eukaryotes.

Total of direct material cost, labor cost and expenses costs.