Glossary

Substance or microorganism used to measure the quantitative development of soiling. ISO 14698-3.NOTE 1: In order to measure the efficiency of a process, the microorganisms which have developed within soiling, with or without formation of a biofilm, may be used as a tracer.NOTE 2: Activities such as cleaning, rinsing, and biochemical or mechanical action eliminate soiling and biofilm by removal. The aim of disinfection is, by definition, to destroy or inactivate microorganisms. Consequently, it may be desirable to measure, in the overall efficiency of a process, that which may be attributed to the eliminative action, in order to distinguish this from the effect of the killing (destructive) action. To this end, one or more additional tracers may be chosen, whether naturally present in the soiling or to be added to it, that ere not liable to be destroyed.

Tool for the Reduction and Assessment of Chemical and Other Environmental Impacts

The HIPAA Privacy Rule gives individuals the right to request an accounting of disclosures of protected health information over the previous six years. If an individual authorizes uses or disclosures for research, the disclosures do not need to be tracked, but disclosures must be tracked if the researcher receives an IRB-approved waiver of authorization. The accounting of disclosures generally must include: the date of the disclosure, the name of the entity or person (and address if known) who received the protected health information, a brief description of the information disclosed, and a brief statement of the purpose of the disclosure. An alternative tracking option is available for research involving 50 or more people.

Designates an assembly of connected equipment, which as a unit, serves to process and deliver a product. A train is not an architectural entity, and does not equate to a room or processing space. Trains can and often do transcend several "Suites" in their implementation.

In a database management system, a unit of processing activity that accomplishes a specific purpose such as a retrieval, an update, a modification, or a deletion of one or more data elements of a storage structure.

(ANSI) A command, message, or input record that explicitly or implicitly calls for a processing action, such as updating a file.

An exchange between and end user and an interactive system.

A structured software design technique, deriving the structure of a system from analyzing the transactions that the system is required to process.

A model of the structure of the system's [program's] behavior, i.e., functionality.

(IEEE) A matrix that identifies possible requests for database access and relates each request to information categories or elements in the database.

An RNA molecule that has been synthesized from a specific DNA template. In eukaryotes, the primary transcript produced by RNA polymerase must often be processed or modified in order to form the mature, functional mRNA, rRNA or tRNA.

The process by which the genetic information encoded in the gene, represented as a linear sequence of DNA (deoxyribonucleotides), is copied into an exactly complementary sequence of ribonucleotides known as mRNA (messenger RNA).

A protein that binds to regulatory regions and controls gene expression.

A cloning vector that allows the foreign gene or DNA sequence to be transcribed in vitro.

The full complement of activated genes, or mRNAs or transcripts, in a particular tissue at a particular time.

The process whereby a specialized cell de-differentiates and re-differentiates into a different cell type; or the process whereby and adult stem cell from a specific tissue type becomes a cell type from a very different tissue (for example a nerve stem cell differentiates into a kidney cell).

The transfer of DNA sequences from one bacterium to another via lysogenic infection by a bacteriophage (transducing phage). Genetic recombination in bacteria mediated by bacteriophage. Abortive t: Bacterial DNA is injected by a phage into a bacterium, but unable to replicate.

The acquisition of new genetic markers by addition of viral DNA to cells.

A small portable vessel used to facilitate closed transfer of a process fluid without exposure to the room environment. Typical applications are seed/inoculum transfer, small volume additions to bioreactors and other closed process systems, chromatography fraction collectors, and bulk purified product storage containers. Also know as seed canisters, pressure cans, addition cans, coke cans, “Kelly” cans.

Mechanism to effect movement of material into or out of separative enclosures while minimizing ingress or egress of unwanted matter. ISO 14644-7.

A panel to which process and utilities are piped, allowing cross connections between different use points. A jumper spool is used to connect the desired process/utility users and mechanically preclude erroneous connections to other lines.

A panel to which process and/or utilities are piped that mechanically precludes erroneous cross-connections.

A class of RNA having structures with triplet nucleotide sequences that are complementary to the triplet nucleotide coding sequences of mRNA. The role of tRNAs in protein synthesis is to bond with amino acids and transfer them to the ribosomes, where proteins are assembled according to the genetic code carried by mRNA.

Equipment allowing the introduction and removal of material, toxic and/or sterile, with continuous protection to both operator and product.

Engineering Controls used to transfer materials from equipment to equipment, equipment to container or container to equipment in a controlled manner while minimizing dust emissions.