Glossary

(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).

The absence of all life forms.

Free from all living microorganisms.

Inability to produce offspring.

The act or process, physical or chemical, that destroys or eliminates all forms of life (e.g., microorganisms). Despite being stated as an absolute, the action of sterilization is stated in terms of probability.

The act or process, physical or chemical that destroys or eliminates living microorganisms. Despite being stated as an absolute, the action of sterilization is usually stated in terms of probability of survival of a known quantity of a specific microorganism (Fo). Equipment is most often sterilized using clean steam.

Refers to the killing of microorganisms in the distribution system. This is normally done periodically by flushing a sterilizing solution, such as hydrogen peroxide or ozone, through the distribution piping system. In some systems, ozone is continuously injected at low levels for continuous sterilization.

The act or process, physical or chemical, that destroys or eliminates all viable microbes including resistant bacterial spores from a fluid or a solid. Despite being stated as an absolute, the action of sterilization is usually stated in terms of probability of survival of a known quantity of a specific microorganism. Examples of sterilization methods are: steam treatment at 121ºC, dry heat at 450ºF, flushing with a sterilizing solution such as Hydrogen Peroxide (H2O2) or ozone (O3), irradiation, and filtration.

A filter that, when challenged with the microorganisms Brevundimonas diminuta, at a minimum concentration of 107 organisms per square centimeter of filter surface, produces a sterile effluent.

Classified as lipids, naturally occurring steroids are hormones that are important regulators of animal development and metabolism at very low concentrations. A well known steroid, cholesterol, is present in membranes of animal tissues. Other steroids include testosterone (a male sex hormone), cortisone (an adrenocortical hormone), estrone (a female sex hormone), and progesterone.

The single-stranded nucleotide sequence left on a restriction fragment by type II restriction enzymes that cut each strand at a separate location. These unpaired regions are available for hybridization with complementary ends on other fragments during the creation of recombinant DNA. Also known as Protruding End; Overhang; Cohesive End.

Safety Toxic Level

A “top down” estimate approach based on rough cost capacity benchmarks – example cost per square foot (sf) or cost per ton of a product produced from a plant.

Pre-prepared solutions of individual components and used to prepare many different types of media. Certain substances, including Ca and Mg sulphates and phosphates must not be combined until actual medium preparation because insoluble combinations are formed and precipitate.

A Stokesian (or non-Newtonian) fluid is a viscous fluid whose shear stresses are a non-linear function of the fluid strain rate.

A set of three nulecotides for which there is no corresponding tRNA molecule to insert an amino acid into the polypeptide chain. Protein synthesis is hence terminated and the completed polypeptide released from the ribosome. Three stop codons are found: UAA (ochre), UAG (amber) and UGA (opal). Mutations which generate any of these three codons in a position which normally contains a codon specifying an amino acid are known as nonsense mutations. Stop codons can also be called nonsense codons.

The recording of an electronic record on a given medium, e.g., magnetic tape, CD, hard disk.