Glossary

Self-Emulsified Drug Delivery System

The gravitational settling of solid particles in a liquid system. A primary step in municipal water treatment where water is allowed to stand long enough for solids to settle by gravity.

Gravitational settling of solid particles in a liquid system.

The initial inoculum, or the cells placed in growth medium from which other cells will grow.

Industrial fermentations are generally started in tanks smaller than a 1,000 to 50,000 gallon main fermentor. This small “seed” tank may be up to 100 gallons and propagate enough organisms to “kick-off” the main fermentation. Often, a seed tank may be large enough to require its own seed tank.

A seed-lot system is a system according to which successive batches of a product are derived from the same master seed lot at a given passage level. For routine production, a working seed lot is prepared from the master seed lot. The final product is derived from the working seed lot and has not undergone more passages from the master seed lot than the vaccine shown in clinical studies to be satisfactory with respect to safety and efficacy. The origin and the passage history of the master seed lot and the working seed lot are recorded.

Soft Elastic Gelatin Capsule

Storage in the same room or inside area, but physically separated by distance from incompatible materials.

The separation of the two members of a chromosome pair from each other at meiosis; the result is seen as the separation of alleles from each other in the gametes of heterozygotes; the occurrence of different phenotypes among offspring, resulting from chromosome or allele separation in their heterozygous parents. Mendel's first principle of inheritance (the Law of Segregation) predicts that heterozygotes will produce equal numbers of gametes containing each allele.

The provision of facilities which, although dedicated to a particular use, can be within the same building as other operations. A fully segregated area within a common building is one where there is a continuous floor-to-roof wall (a floor-to-ceiling, non-segregated roof space, is not acceptable). The wall should be sealed at all break points where common services breach the wall.

The use of physical facility design elements to define the basic organization of the biopharmaceutical plant design and establish environmentally controlled work areas around specific steps of the process, e.g., the establishment of classified areas. It provides distinct environmental protection for the process/product from contamination, and is traditionally accomplished by the designation of dedicated areas, staff, and supporting mechanical systems. FDA CBER suggests discussion of segregation concepts more specifically, addressing physical segregation or procedural segregation.

The use of procedural or chronological controls to minimize potential interactions or contamination. It is usually applied in instances where supporting components, equipment, or product are closed and adequately protected from the surrounding environment. Such secondary separation mechanisms can vary widely and include storage of raw materials in different stages of quarantine; clean/dirty equipment areas; and general access paths/process areas. Whereas primary segregation controls the immediate quality of the process, secondary segregation measures are traditionally implemented to minimize the potential for human error. FDA CBER suggests discussion of segregation concepts more specifically, addressing physical segregation or procedural segregation.

Structural Engineering Institute

Nutrient material constituted such that it will support the growth of specific organisms while inhibiting the growth of others.

The elimination of all fluid from the system due to the force of gravity alone.

Action of an instrument to automatically adjust its characteristics to compensate for changes in operational parameters (sometimes referred to as self-calibration).

Premises which provide complete and total separation of all aspects of an operation, including personnel and equipment movement with well established procedures, controls and monitoring. This includes physical barriers as well as separate air-handling systems, but does not necessarily imply two distinct and separate buildings.

Scanning Electron Microscopy

Utilizes an electron beam to produce images over a very broad magnification range of 10X to 105X. The technique is somewhat limited by the conductivity of the material but works very well to inspect 316L stainless steel. Typical magnification levels for surface defect evaluation are from 100 to 4,000.

Semiconductor Manufacturing Technology

Arc welding with equipment that controls only the filler metal feed. The advance of the welding is manually controlled.

Membranes that do not have measurable pores but through which smaller molecules can pass.