Glossary

Steam that is generated from treated water (deionized water or distilled water) that is free of volatile additives such as amines and hydrazines. It is raised in a clean stem generator or taken from the first effect of a multi-effect still. Clean steam may be supplied to autoclaves used for sterilizing product, product containers or components of aseptic equipment. Also, it may be used where equipment or piping systems are subjected to thermal disinfection or sterilization-in-place (SIP). Clean steam is sometimes used for humidification of pharmaceutical clean rooms.Clean steam also must be free of pyrogenic endotoxins (lipopolysaccharides) if it is to be condensed to make Water For Injection (WFI). Clean steam that is free of pyrogens is termed “pure steam”.

Steam free from boiler additives that may be purified, filtered, or separated. Usually used for incidental heating in pharmaceutical applications.

Water vapor under pressure and free from boiler additives. When condensed, clean steam meets the specification for WFI, and is usually used to sterilize process equipment.

Water vapor under pressure and free from boiler additives. When condensed, clean or pure steam meets the specification for WFI.

Water vapor under pressure and free from boiler additives. When condensed, clean steam meets the specification for WFI.

An area defined environmental control of particulate and microbial contamination, constructed and used in such a way as to reduce the introduction, generation, and retention of contaminants within the area.

Dedicated space in which the concentration of airborne particles is controlled, and which is constructed and used in a manner to minimize the introduction, generation, and retention of particles inside the zone, and in which other relevant parameters, e.g. temperature, humidity, and pressure, are controlled as necessary.NOTE: This zone may be open or enclosed and may or may not be located within a cleanroom. ISO 14644-1, ISO 14644-3.

Internally cleaning a piece of equipment without relocation or disassembly. The equipment is cleaned but not necessarily sterilized. The cleaning is normally done by acid, caustic, or a combination of both, with water-for-injection (WFI) rinse.

Action of removing, and dissolving or dispersing, soiling from a surface.NOTE: Cleaning may be effected by one or more of the following means: physico-chemical (detergent action); chemical (e.g. sodium hydroxide); biochemical (e.g. enzymes); physical (e.g. shear forces caused by brushing or hosing). Cleaning efficiency is also dependent on the length of time and temperature of application, etc.

All operations necessary or the removal of surface contaminants from metal to ensure maximum corrosion resistance of the metal, prevention of product contamination, and achievement of desired appearance.

(ASTM A 380) Cleaning includes all operations necessary for the removal of surface contaminants from metals to ensure maximum corrosion resistance of the metal; prevention of product contamination; and achievement of desired appearance.

(USP <1072>) An agent for the removal from facility and equipment surfaces of product residues that may inactivate sanitizing agents or harbor microorganisms.

Condition of a product, surface, device, gas, fluid, etc. with a defined level of contamination.NOTE: Contamination can be particulate, non-particulate, biological, molecular or of other consistency. ISO 14644-4.

(1996 Edition) A room in which the concentration of airborne particle is controlled to specified limits.

Room in which the concentration of airborne particles is controlled, and which is constructed and used in a manner to minimize the introduction, generation, and retention of particles inside the room, and in which other relevant parameters, e.g. temperature, humidity and pressure, are controlled as necessary.

A specially constructed space environmentally controlled with respect to airborne particles (size and count), temperature, humidity, air pressure, airflow patterns, air motion, and lighting.

The maximum number of particles greater than or equal to 0.5µm in diameter that may be present in a cubic foot of room air.

Demonstrated removal according to specified parameters.

The splitting up of a complex molecule into two or more simpler molecules. The series of cell divisions occurring in the ovum immediately following its fertilization.

Cross-Linked Enzyme Crystals

Clinical Laboratory improvement Amendments of 1998

(In context of Client/Server) The networked computing device enabling the user to access a client/server system; this encompasses desktops, laptops, palmtops, etc.NOTE: A thick client performs the bulk of data processing operations locally using software stored on the client, in contrast to a thin client, which has greater reliance on the server. In both cases, data is typically stored on the server.

A term used in a broad sense to describe the relationship between the receiver and the provider of a service. In the world of microcomputers, the term client-server describes a networked system where front-end applications, as the client, make service requests upon another networked system. Client-server relationships are defined primarily by software. In a local area network (LAN), the workstation is the client and the file server is the server. However, client-server systems are inherently more complex than file server systems. Two disparate programs must work in tandem, and there are many more decisions to make about separating data and processing between the client workstations and the database server. The database server encapsulates database files and indexes, restricts access, enforces security, and provides applications with a consistent interface to data via a data dictionary.