Glossary

DNA molecule originating from a virus, a plasmid, or the cell of a higher organism into which another DNA fragment of appropriate size can be integrated without loss of the vectors capacity for self-replication; vectors introduce foreign DNA into host cells, where it can be reproduced in large quantities. Examples are plasmids, cosmids, and yeast artificial chromosomes; vectors are often recombinant molecules containing DNA sequences from several sources.

Not exposed to the environment.

Not exposed to the room, capable of holding some pressure or purge. PDA TR-28 provides a rigid definition of closed.NOTE: PDA Technical Report 28 Revised, (TR-28) Process Simulation Testing for Sterile Bulk Pharmaceutical Chemicals

A continuous culture in which inflow of fresh medium is balanced by outflow of corresponding volumes of spent medium. Cells are separated mechanically from outflowing medium and added back to the culture.

For orbital GTAW, a welding head that encapsulates the entire circumference of the tube/pipe during welding and that contains the shielding gas.

A process condition when the product, materials, critical components or container/closure surfaces are contained and separated from the immediate process environment within closed/sealed process equipment. A process step (or system) in which the product and product contact surfaces are not exposes to the immediate room environment.

A process step (or system) that utilizes processing equipment in which the product is not exposed to the immediate room environment. It is the manufacturer’s responsibility to define and prove closure for a process step.

A process step (or system) where the product is not exposed to the immediate room environment (and vice versa). It is the manufacturer’s responsibility to define and prove closure for a process step.

One in which by its design and proper operation, prevents release of a microbiological agent or eukaryotic cell contained therein.

System sterilized-in-place or sterilized while closed prior to use, is pressure or vacuum tight to some predefined leak rate, can be utilized for its intended purpose without breach to the integrity of the system, can be adapted for fluid transfers in or out while maintaining asepsis, and is connectable to other closed systems while maintaining integrity of all closed systems.

Located right or left from the cover page of the booklet label, area where label is opened and closed.

A genus of bacteria, most are obligate anaerobes and form endospores.

The appearance of a milky white hue across some portion of a surface resulting from the electropolishing process.

Clinical and Laboratory Standards Institute

Two or more pits the closest distance between each being less than the diameter of any one pit.

Porosity that occurs in clumps or clusters.

Case Management

Chemistry and Manufacturing (Canada)

Configuration Management

Construction Management

Chemical Manufacturers Association

Cancer Molecular Analysis Project (NCI)

Carboxymethyl Cellulose

Chemistry, Manufacturing, and Control