Glossary

Particle that consists of, or supports, one or more live microorganisms. ISO 14698-1, ISO 14698-2.

Particle that consists of, or supports, one or more live microorganisms.

One or more viable particles which are enumerated as a single unit. ISO 14698-1, ISO 14698-2NOTE: When viable units are enumerated as colonies on agar media, it is common usage to name them colony forming units (CFU). One CFU might consist of one or more VU.

A final container for a parenteral or diagnostic product. Sealed with a rubber closure and over-seal. Generally required to be class I borosilicate glass.

Standard method for measuring the hardness of metals, particularly those with extremely hard surfaces; the surface is subjected to a standard pressure for a standard length of time by means of a pyramid shaped diamond. The diagonal of the resulting indention is measured under a microscope and the Vickers Hardness value read from a conversion table.

Vocabulaire International de Metrologie/International Vocabulary of Metrology

Vacuum Insulated Panel

Verified Internet Pharmacy Practice Sites (Canada)

Specific proteins on the capsid of a virus that can act as inducers of antibody formation.

(ICH Q5A (R1)) Elimination of target virus by removal of viral particles or inactivation of viral infectivity.

Removal and/or inactivation of viruses from a biopharmaceutical product. Sometimes methods are a combination or removal and inactivation.

Process step which separates a given class of virus, if any are present, from the desired product. A clearance factor may be estimated by performing scale-down experiments using a model virus, to determine process capability.

The act of inactivating viral activity/infectivity (differs from removal). Use of low pH is a common method for viral inactivation.

Process step, which inactivates the activity of a given class of virus, in order to provide assurance of safety. An inactivation factor may be estimated by performing scale-down experiments using a model virus, to determine process capability.

Vaccines consisting of live viruses rather than dead ones or separated parts of viruses. However, as the virus itself cannot be used, because that would simply give the patient the disease, the virus is genetically engineered so that it elicits the immune response to the viral pathogen without causing the disease itself.Two genetic engineering methods can be used. The first is to make the disease virus harmless, but still able to replicate in cultured animal cells. This is similar to producing an ‘attenuated’ virus, i.e., one which has been grown in the laboratory until it loses its ability to cause disease. However, the genetic engineering route seeks to make sure that the attenuated virus has no chance of mutating back to a wild type, pathogenic virus, by deleting whole genes or replacing key regions of genes with completely different genetic material.The second approach is to clone the gene for a protein from the pathogenic virus into another, harmless virus, so that the result ‘looks’ like the pathogenic virus but does not cause disease.

A plastic material that has not been subjected to use or processing other than that required for its initial manufacture. It can be in the form of pellets, granules, powder, floc, or liquid.

An infectious virus particle. A plant pathogen that consists of a naked RNA molecule of approximately 250-350 nucleotides, whose extensive base pairing results in a nearly correct double helix.

An infectious entity similar to a virus but smaller, consisting only of a strand of nucleic acid without the protein coat characteristic of a virus.

Study of viruses.

Identifies Digital Equipment Corporation's VAX family of computers, ranging from a desktop workstation to a large scale cluster of multiprocessors supporting thousands of simultaneous users.

Instrument to separate the particle sizing by inertial force to collide with the hypothetical (virtual) surface.NOTE: Large particles pass through the surface into a stagnant volume and small particles deflected with the bulk of the original airflow.

Digital Equipment Corporation's multiprocessing, interactive operating system for the VAX computers.

An agent that destroys or inactivates viruses.

The degree of ability of an organism to cause disease. The relative infectiousness of a bacterium or virus, or its ability to overcome the resistance of the host metabolism.

Generic term for all the various types of malicious code that has been designed to breach a company’s security requirements/measures.