Biological product means a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, protein other than a chemically synthesized polypeptide, or analogous product, or arsphenamine or any derivative of arsphenamine or any other trivalent organic arsenic compound, applicable to the prevention, treatment, or cure of a disease or condition of human beings.
Surgical procedure means a procedure that is performed
Chemical agent shall mean any compound which, when suitably disseminated, produces incapacitating, damaging or lethal effects on people, animals, plants or material property.
Manufacturing Process means any process for—
Pharmaceutical Product shall have the meaning ascribed to such term in Section 3.1(hh).
Exfiltration means any unauthorized release of data from within an information system. This includes copying the data through covert network channels or the copying of data to unauthorized media.
Interchangeable biological product means a biological product that the U.S. Food and Drug Administration has:
Filtration means a process for removing particulate matter from water by passage through porous media.
Chemicals means substances applied to forest lands or timber including pesticides, fertilizers, and other forest chemicals.
Biological Samples means any physical samples obtained from Study Participants in accordance with the Protocol for the purposes of the Study.
Manufacturing means all activities related to the manufacture of a Compound, including planning, purchasing, manufacture, processing, compounding, storage, filling, packaging, waste disposal, labeling, leafleting, testing, quality assurance, sample retention, stability testing, release, dispatch and supply, as applicable.
Injection tool means a device used for controlled subsurface injection of radioactive tracer material.
Reference biological product means the single biological product licensed pursuant to 42 U.S.C.
Pathogen means an organism that is capable of producing an infection or disease in a susceptible host.
Diagnostic clinical procedures manual means a collection of written procedures that describes each method (and other instructions and precautions) by which the licensee performs diagnostic clinical procedures; where each diagnostic clinical procedure has been approved by the authorized user and includes the radiopharmaceutical, dosage, and route of administration.
Membrane filtration means a pressure or vacuum driven separation process in which particulate matter larger than 1 micrometer is rejected by an engineered barrier, primarily through a size-exclusion mechanism, and which has a measurable removal efficiency of a target organism that can be verified through the application of a direct integrity test. This definition includes the common membrane technologies of microfiltration, ultrafiltration, nanofiltration, and reverse osmosis.
In-stream Waste Concentration or "(IWC)" means the concentration of a discharge in the receiving water after mixing has occurred in the allocated zone of influence.
Chemical Storage Facility means a building, portion of a building, or exterior area adjacent to a building used for the storage of any chemical or chemically reactive products.
Process Gas means gas used for which alternate fuels, other than another gaseous fuel, are not technically feasible such as in applications requiring precise temperature controls and precise flame characteristics.
Drug Substance means an active ingredient that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure or any function of the human body, but does not include intermediates used in the synthesis of such ingredient.
Direct filtration means a series of processes including coagulation and filtration but excluding sedimentation resulting in substantial particulate removal.
Biomethane means biogas that meets pipeline quality natural gas standards.
Process Wastewater means any water which, during manufacturing or processing, comes into direct contact with or results from the production or use of any raw material, intermediate product, finished product, by-product, or waste product.
Bulk drug substance means any substance that is represented for use, and that, when used in the
Collaborative law process means a procedure intended to resolve a collaborative matter without intervention by a tribunal in which persons sign a collaborative law participation agreement and are represented by collaborative lawyers.
Infiltration means water other than wastewater that enters a sewer system (including sewer system and foundation drains) from the ground through such means as defective pipes, pipe joints, connections, or manholes. Infiltration does not include, and is distinguished from, inflow.