Glossary

Division of Immunology and Hematology Devices (CDRH)

Lowering the concentration of a solution by adding more solvent.

The ratio of solvent to solute by volume.

System wherein aerosol is mixed with particle-free dilution gas in a known volumetric ratio to reduce concentration. ISO 14644-3.

A polymer made up of two identical molecules. When three monomers link up, the resultant polymer is called a trimer. Placing a number before the “-mer” suffix usually refers to larger polymers: 4-mer, 5-mer, 6-mer, and so on.

(C2H6OS) A highly hygroscopic liquid and powerful solvent with little odor or color. It is an organic co-solvent used in small quantities to dissolve neutral organic substances in tissue culture media preparation. DMSO also has uses as a cryoprotectant.

Data Information Management Staff (CFSAN

Division of Infrastructure Management and Services (OC)

Drug Identification Number (Canada)

Deutsches Institut für Normung eV (German Institute for Standardization; similar to US ANSI)

Division of Information Operations (CBER)

Division of Infrastructure Operations (OC)

Division of Import Operations and Policy (ORA)

Dissemination Information Package

1. The status of having two complete sets of chromosomes, most commonly one set of paternal origin and the other of maternal origin.2. An organism or cell with a double set (2n) of chromosomes (most commonly one of paternal origin, and the other of maternal origin), or referring to an individual containing a double set of chromosomes per cell. Somatic tissues of higher plants and animals are ordinarily diploid in chromosome constitution, in contrast with the haploid gametes.

(ICH Q5D) A cell line having a finite in vitro lifespan in which the chromosomes are paired (euploid) and are structurally identical to those of the species from which they were derived.

A phase in the lifecycle of an organism where the organism has two copies of each gene. The organism is said to be diploid.

A series of processes including coagulation and filtration but excluding sedimentation resulting in substantial particulate removal.

A system that is expected to have a direct impact on product quality. These systems are designed and commissioned in line with Good Engineering Practice, and in addition, are subject to Qualification Practices that incorporate the enhanced review, control, and testing against specifications or other requirements necessary for cGMP compliance.

An engineering system that may have a direct impact on product quality.

A system or facility expected to have a direct impact on product quality.

A system that is expected to have a direct impact on product quality. These systems are designed and commissioned in line with Good Engineering Practice, and in addition, are subject to Qualification Practices that incorporate the enhanced review, control, and testing against specifications or other requirements necessary for cGMP compliance.

A system, which is expected to have a direct impact on final water or steam quality. These systems are designed and commissioned in line with Good Engineering Practice, and in addition, are subject to Qualification Practices that incorporate the enhanced review, control, and testing against specifications or other requirements necessary for cGMP compliance.

Specialized circuitry or a dedicated microprocessor that transfers data from memory to memory without using the CPU.

A laboratory process used on isolated molecules or microbes to cause mutations and identify subsequent adaptations to novel environments.