Technical Jargon: Terms used, which you should know (Part 2)

Dear friends, continued from last post I am again giving here some more technical terms.

D5W (5 D/W)
One of the most prevalent of LVPs (also see: LVP (Large Volume Parenteral)). Five percent dextrose in water. Presence of dextrose presents significant filtration problems. Usually requires activated charcoal pretreatment.Dalton
The unit of molecular weight, equal to the weight of a hydrogen atom.
The time under a stated set of exposure conditions (temperature in an autoclave) required to reduce a microbial population by a factor of 90% (e.g. from 10,000 to 1,000).

Decontamination
A process that reduces contaminating substances to a defined acceptance level.

Deflagration
An exothermic reaction, such as the extremely rapid oxidation of a combustible dust or flammable vapor in air, in which the reaction progresses through the unburned material at a rate less than the velocity of sound. A deflagration can have an explosive effect.

Depyrogenation
The removal or destruction of endotoxins.

Dialysis
The separation of low-molecular weight compounds from high molecular weight components by diffusion through a semipermeable membrane. Frequently utilized to remove salts, introduce salts, remove biological effectors such as nicotinamide adenine dinucleotides, nucleotides phosphates, etc. from polymeric molecules such as protein, DNA, RNA, etc. Commonly used membranes have a molecular weight cutoff around 10,000 but other membrane pore sizes are available.

Dilution
Lowering the concentration of a solution by adding more solvent.

Dilution Factor
The ratio of solvent to solute by volume.

Disinfection
Process by which viable microbiological agents or eukaryotic cells are reduced to a level unlikely to produce disease in healthy people, plants, or animals. These processes may use chemical agents, heat, ultraviolet light, etc. to destroy most (but not necessarily all) of the harmful or objectionable microorganisms, pathogens, and potential pathogens. Disinfection does not necessarily result in sterilization.

1. "High level disinfection" inactivates fungi, viruses, and bacteria. High-level chemical disinfectants maybe ineffective against bacterial spores if they are present in large numbers. Extended exposure times may be required.

2. "Intermediate level disinfection" destroys fungi, some viruses (lipid and most non-lipid medium-size and small viruses), mycobacteria, and bacteria.

3. "Low level disinfection" kills vegetative forms of bacteria, some fungi, and some medium-size and lipid-containing viruses. Low-level disinfectants do not reliably kill bacterial spores, mycobacteria, or small or non-lipid viruses.

DOP (Dioctyl Phthalate)
A mono-dispersed test aerosol of sub-micron particles, generated to challenge (evaluate integrity) of HEPA filters for HVAC.

Dry Air
Air from which all water vapor and contaminants have been removed. Its composition by volume is: 1. Nitrogen 78.08% 2. Oxygen 20.95% 3. Argon 0.93% 4. Carbon Dioxide 0.03 5. Other gases 0.00003

Efficacy
The ability of a substance to produce a desired effect.

Effluent
The output or discharge from a process, such as a wastewater treatment process.

Elastomer
Long chain co-polymers or terpolymers (two or three different monomers in one chain) that contain adequate crosslinks among individual chains. Fluorinated elastomers are more stable than hydrocarbon or silicon elastomers because C-F bonds are approximately 30% stronger than C-H bonds. There are five major FDA compliant elastomers used in the pharmaceutical and biopharmaceutical industries: EPDM (ethylene-propylene-diene rubber), fluororelastomers (FKM), platinum-cured silicon (pt-Si), and finally Kalrez® parts using compounds KLR-6221 and KLR-6230, which are perfluoroelastomers.

Eutectic
Of, pertaining to, or formed at the lowest possible temperature of solidification for any mixture of specified constituents. A common term used to describe metal alloys.

Exergonic reaction
Referring to a chemical reaction that takes place with release of negative standard energy to its surroundings, a "downhill" reaction.

Fed-Batch Fermentation
The most common operating mode for rDNA fermentation. After an initial partial charge of media to the fermenter and seed transfer, sterile media is added at measured rates during the balance of the fermentation cycle. Cell mass and broth are withdrawn only at the end of the cycle.

Fill and Finish (Parenteral Drugs)
Preparation of parenteral drugs, either LVPs or SVPs, demands the highest level of contamination control, because the human body's normal defenses against infection are bypassed when parenteral medications are introduced either intramuscularly (I.M.) or intravenously (I.V.) directly into the body.

FISH (Fluorescent In Situ Hybridization)
A physical mapping approach that uses fluorescein tags to detect hybridization of probes with metaphase chromosomes and with the less condensed somatic interface chromatin.

Flow Cytometry
Analysis of biological material by detection of light-absorbing or fluorescing properties of cells or subcellular fractions (i.e., chromosomes) passing in a narrow stream through a laser beam. An absorbance or fluorescence profile of the sample is produced. Automated sorting devices, used to fractionate samples, sort successive droplets of the analyzed stream into different fractions depending on the fluorescence emitted by each droplet.

Germicidal Lamps
Light sources that emit ultraviolet radiation at a wavelength of 254 nanometers. These lights are commonly found in biological safety cabinets and used to inactivate bacteria, viruses and fungi which are either airborne or on exposed surfaces.

Good Engineering Practice (GEP)
A combination of standards, specifications, codes, regulatory and industrial guidelines as well as accepted engineering and design methods intended to design, construct, operate, and maintain pharmaceutical and/or biotechnology facilities taking into account not only regulatory compliance but also safety, economics, environmental protection and operability.

Haloenzyme
An enzyme that contains a non-protein component.

HeLa Cells
An established line of human cervical carcinoma cells used to study the biochemistry and genetics of human cell growth.

Hold-up Volume
The volume of liquid remaining in a vessel or piping system after it has been allowed to drain

Hydrotest
A pressure test of piping, pressure vessels, or pressure-containing parts, usually performed by pressurizing the internal volume with water at a pressure determined by the applicable code or to test the integrity of a process system.

IBC (Intermediate Bulk Container)
A container for storing, transporting, and handling dry materials. Normally bigger than ½ cubic meter but smaller than 3 cubic meters, dust free, able to receive and discharge a variety of materials, and capable of automation.

IDLH (Immediately Dangerous to Life and Health)
A concentration of airborne contaminants, normally expressed in parts per million (ppm) or milligrams per cubic meter, which represents the maximum level from which one could escape within 30 minutes without any escape-impairing symptoms or irreversible health effects. This level is established by the National Institute of Occupational Safety and Health (NIOSH).

Impurity Profile
A description of the identified and unidentified impurities present in a typical batch of API (Active Pharmaceutical Ingredient) produced by a specific controlled production process. It includes the identity or some qualitative analytical designation (e.g. retention time), the range of each impurity observed, and type of each identified impurity. For each API there should be an impurity profile describing the identified and unidentified impurities present in a typical batch. The impurity profile is normally dependent upon the process or origin of the API.

LAL (Limulus Amoebocyte Lysate)
A material obtained by rupturing the cellular components of the blood of a horseshoe crab (Limulus Poliphemus). This material coagulates in the presence of LPS (lypopolysaccharides) and is a test used to quantitate bacterial endotoxins (pyrogens).

Langelier Index
A measure of the degree of saturation of calcium carbonate in water that is based on pH, alkalinity and hardness. If the Langelier Index is negative, the water is corrosive (pH value below 7 or acidic). If the Langelier Index is positive, calcium carbonate can precipitate out of solution to form scale (pH value above 7 or basic). The Langelier Index will vary for cold water and for warm water.

Lower Flammability Level (LFL)
The minimum concentration of vapor in air at which propagation of flame will occur in the presence of an ignition source. LFL is sometimes referred to as LEL or Lower Explosive Limit.

To be continued.........................