Glossary

Capability for reducing electrostatic charge on work or product surface as a result of conduction or other mechanism to a specific value or to nominal zero charge level. ISO 14644-3.

A culture maintained in the growth chamber with no agitation movement. The antonym is shake culture.

Large equipment that cannot be easily moved. ISO 14644-5.

The plateau of the growth curve after log growth, during which cell number remains constant. New cells are produced at the same rate as older cells die.

A process control method to demonstrate mathematically that a process or system is operating within the limitations established for the parameter(s) in question.

Sexually Transmitted Disease

In a continuous fermentation process, the condition when the number of cells that are removed with the outflow is exactly balanced by newly synthesized cells.

A seal element that is used on a shaft.

Sanitization or sterilization of process piping connections with steam, after the connections are made.

The use of steam to sanitize or sterilize a piece of equipment without the use of an autoclave.

A process using saturated steam to sterilize or reduce bioburden to predefined levels on specified surfaces of assembled, in position, and ready to use (or nearly ready to use) equipment. Sometimes this process is incorrectly referred to as Sterilize-In-Place.

A process using saturated steam to sterilize or reduce bioburden to predefined levels on specified surfaces of portable equipment moved to a steaming station.

Short-Term Exposure Limit

A term used by ACGIH (TLV-STEL), or OSHA (PEL-STEL) to indicate the maximum average concentration allowed for a continuous 15-minute exposure period. Allowed four times a day, with at least 60 minutes between exposures.

Cells with the ability to divide for indefinite periods in culture and to give rise to specialized cells.

System for Thalidomide Education and Prescribing Safety

A structured software design technique; data and processing steps are defined broadly at first, and then further defined with increasing detail.

(USP <1072>) An agent that destroys all forms of microbial life including fungi, viruses, and all forms of bacteria and their spores. Sterilants are liquid or vapor-phase agents.

A sterilizing agent.

Absence of life; usually refers to absence of viable microorganisms.

Free from living organisms.

The application of techniques to prevent contamination of a fermentation process by undesirable organisms. It includes three basic phases relating to the operation of the plant. First, the fermenter with the ancillary equipment, pipework, and valves must be brought to a sterile state. Secondly, the fermenter feed must be sterilized, and finally, sterile barriers at the interface between the fermenter and the outside environment must be maintained.

In biopharmaceuticals, the transfer of material from a vessel to another vessel without contamination from the surrounding environment or from the transfer device.

(USP) A form in which water is distributed in sterile packages. Sterile Water for Injection is intended mainly for use as a solvent for parenteral products such as sterile solids that must be distributed dry because of limited stability of their solutions. It must be packaged only in single-dose containers of not larger than 1-liter size.

This form of water meets most, but not all, of the requirements for Sterile Water for Injection. The exceptions are with respect of container size (i.e., the container may contain a volume of more than 1 liter), container design (i.e., the container may be designed so as to empty rapidly the contents as a single dose), particulate matter requirements (i.e., need not meet the requirement for Large Volume Injections for single-dose infusions), and labeling requirements (e.g., the designation “For Irrigation Only” and “Not For Injection” appear prominently on the label).