Glossary

Inability to produce offspring.

Free from all living microorganisms.

The absence of all life forms.

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.

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 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.

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.

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.

The process of managing media upon which information is stored.

(ICH Q1A (R2)) The acceptable variations in temperature and relative humidity of storage facilities for formal stability studies. The equipment should be capable of controlling the storage condition within the ranges defined in this guideline. The actual temperature and humidity (when controlled) should be monitored during stability storage. Short term spikes due to opening of doors of the storage facility are accepted as unavoidable. The effect of excursions due to equipment failure should be addressed, and reported if judged to affect stability results. Excursions that exceed the defined tolerances for more than 24 hours should be described in the study report and their effect assessed.

A unit into which data or programs can be placed, retained and retrieved.

This is a determination of whether or not certain processing conditions use more storage (memory) than estimated.

Shielded Twisted Pair

A population of cells all descended from a single cell.

Tactical relationships between an owner and its suppliers, service providers, or equipment manufacturers which benefit both parties by an agreement based on volume and price.

A path in a steady flow field along which a given fluid particle travels.