Technical Jargon: Terms used, which you should know (Part 3)

Dear friends, continued from my last two posts I am again giving here some more technical terms 

MAb
Monoclonal Antibody

Macroreticular Resin
An ion exchange resin with a reticular porous matrix that makes it effective for removing colloids and bacteria from process streams, as well as dissolved anions. It is especially useful for preventing colloidal and organic fouling of mixed-bed resins and premature clogging of final filters.

Mean Kinetic Temperature (MKT)
The single calculated temperature at which the degradation of an article would be equivalent to the actual degradation that results from actual temperature fluctuations during the storage period. It is not a simple arithmetical mean. The MKT is calculated from average storage temperatures recorded over a one-year period, with a minimum of 12 equally spaced storage temperatures being recorded.

Microinch
A unit of length equal to one millionth of an inch (0.000001 inches).

Micron or Micrometer
A unit of length equal to one millionth of a meter (µm) or thousandth of a millimeter (25µm are approximately 0.001 inch.). Bacteria range in size from 0.5µm to 20µm.

Moist Air
A binary mixture of dry air and water vapor. Each component behaves as if the other is not present and each occupies the complete volume of the mixture.

MSDS (Material Safety Data Sheet)
Document describing the chemical and physical properties of a substance as related to its safe handling and storage. The substance manufacturer originates it.

Nephelometer
Any apparatus used to measure the size and concentration of particles in a liquid by analysis of light transmitted through or reflected by the liquid.

New Drug Application (NDA)
The New Drug Application contains most of the information included in the IND. Only after FDA approval of the NDA, can distribution and marketing of a new drug begin.

NHSA (Normal Human Serum Albumin)
A blood plasma fraction usually prepared by Cohn cold ethanol precipitation. Dispensed as a 5% to 25% protein solution.

Oncogene
A gene that when expressed as a protein can lead cells to become cancerous, usually by removing the normal constraints on growth.

OQ (Operational Qualification)
Documented verification that aspects of a facility system that can affect product quality perform as intended throughout anticipated operating ranges.

Orphan Drug
The FDA grants Orphan Drug status to one company for a drug that is believed to substantially increase the life expectancy of the treated patient for a particular disease. This excludes other companies from receiving an FDA license to produce a similar drug for a finite period (usually 7 years), thereby allowing the company producing the drug to recuperate their R&D expenses.

Pandemic Disease
An epidemic over an especially wide geographic area.

PAR (Proven Acceptable Range)
A range for a critical parameter that has been determined to be achievable and appropriate for the process or processes with which it is associated. It is established by knowledge gained through relevant documentation and actual testing. A process should perform consistently and as intended when all critical parameters are held within the established PARs.

Pasteurization
The heating of milk, wines, fruit juices, etc., for about thirty minutes at 68°C (154.4°F) whereby the living bacteria are destroyed, but the flavor or bouquet is preserved; the spores are unaffected, but are kept from developing by immediately cooling the liquid to 10°C (50°F) or lower.

PE (Polyethylene)
A thermoplastic material that varies from type to type according to the particular molecular structure of each type, i.e. its crystallinity, molecular weight, and molecular weight distribution. These variations are possible through changes in polymerization conditions used during manufacturing.

Percent Recovery
In reverse osmosis or ultrafiltration, the ratio of pure water output to feedwater input.

Permissible Exposure Limit (PEL)
The maximum permitted eight-hour time-weighted average concentration of an airborne contaminant.Peroxisome
Very small membrane-bound particles responsible for photorespiration in plants. Similar to lysosome in structure, but not in function.

Polyalphaolefin (PAO)
A synthetic oil used in lieu of DOP for HEPA filter testing.

Polymerase Chain Reaction (PCR)
A method for amplifying a DNA base sequence using a heatstable polymerase and two 20-base primers, one complementary to the (+) strand at one end of the sequence to be amplified and the other complementary to the (-) strand at the other end.

PPB (Parts Per Billion)
Parts per billion (abbreviated ppb only in the U.S.), or micrograms per liter. One part per billion is like seeing a bottle cap on the earth's equator from an orbiting satellite.
PQ (Performance Qualification)
Documented evidence that a process or system consistently and reproducibly performs as intended and does what it purports to do. This accomplished through extended time studies or process runs with simulated products or conditions.

Psychrometry
Determination of the properties of gas-vapor mixtures. The air-water vapor system is by far the one most commonly encountered.

PTFE (Polytetrafluoroethylene) Teflon®
A fluoroplastic that is resistant to practically every known chemical or solvent in combination with the highest useful temperature limit of commercially available plastics. PTFE has a melt point of 620°F (327°C), a useful temperature range from -436°F (-260°C) to 500°F (260°C), high impact strength, and exceptionally low coefficient of friction.

Purified Water, U.S.P.
Water rendered suitable for pharmaceutical purposes by processes such as distillation, ion-exchange treatment (deionization or demineralization), or reverse osmosis. It meets rigid specifications for chemical purity, the requirements of the Federal Environmental Protection Agency (EPA) with respect to drinking water, and it contains no added substances. Cannot be used as raw material for parenterals. Common uses are: a rinse for equipment, vials, and ampoules, and as make up for cosmetics, bulk chemicals, and oral products. For FDA acceptance, purified water must contain less than 0.5 mg/l of TOC (Total Organic Carbon), and less than 100 CFU (Colony Forming Units).

PVC (Polyvinyl Chloride)
The largest volume of the vinyl family of plastics. Overall it has excellent basic properties, may be easily processed and welded, and is exceptionally economical in cost. Homopolymers grades of PVC comprise over 80% of all PVC used, and contain 56.8% chlorine by weight. When the chlorine content is increased to about 67% its heat deflection temperature at 264 psi increases from 155°F (68°C) to 218°F (103°C). Because PVC is a thermally sensitive thermoplastic compounding ingredients such as heat stabilizers, lubricants, fillers, plasticizers, impact modifiers, pigments, and processing aids must be added to make it processible.

PVDF (Polyvinylidene Fluoride)
A thermoplastic fluoropolymer with a melt point of 352°F (178°C), and a wide service range from -40°F (-40°C) to 284°F (140°C). It has a very linear chemical structure, and is similar to PTFE with the exception of not being fully fluorinated, i.e. having 3% hydrogen by weight. Its drawbacks in the area of chemical resistance include unsuitability with strong alkalis, fuming acids, polar solvents, amines, ketones, and esters.

QA (Quality Assurance)
The sum total of the organized arrangements made to ensure that all APIs (Active Pharmaceutical Ingredients) are of the quality required for their intended use and that quality systems are maintained.

QC (Quality Control)
Checking or testing, that specifications are met, or the regulatory process through which the industry measures actual quality performance, compares it with standards, and acts on the difference.

Quarantine
The status of materials isolated physically or by other effective means pending a decision on their subsequent approval or rejection.

Radio-Immunoassay (RIA)
A highly sensitive method of detecting and measuring the concentration of biological compounds in vivo.

Recalcification
A technique producing serum from anticoagulated plasma. Citrate and oxalate act as anticoagulants because they are Ca++ (Calcium Ion) chelating agents; Ca++ as calcium chloride is added in excess (1/40 Molar). Ca++ is a coagulation co-factor (catalyst) and promotes clot formation

Refrigerants
Fluids used for heat transfer in a refrigerating system; the refrigerant absorbs heat and transfers it at a higher temperature and higher pressure, usually with a change of state. Refrigerants can be: 1. Primary refrigerants. Liquids with low boiling points that change from a liquid to a gas after absorbing heat. 2. Secondary refrigerants. Substances that act only as heat carriers, such as brine, air, and water.

Relative Humidity (% RH)
The ratio (measured in percent) of actual water vapor pressure in air to the pressure of saturated water vapor in air at the same temperature and pressure.

Reprocessing (ICH API definition)
Introducing an intermediate or API, including that which does not conform to standards or specifications, back into the process and repeating a crystallization step or other appropriate chemical or physical manipulation steps (e.g., distillation, filtration, chromatography, milling, etc.) that are part of the established manufacturing process. Continuation of a chemical reaction after an in-process control test shows the reaction to be incomplete is considered to be part of the normal process, and not reprocessing.

Restriction Fragment Length Polymorphism (RFLP)
Variation between individuals in DNA fragments sizes cut by specific restriction enzymes; polymorphic sequences that result in RFLPs are used as markers on both physical maps and genetic linkage maps. RFLPs are usually caused by mutation at a cutting site.

Reverse Osmosis (RO)
The reversal of osmosis to purify water. In osmosis, water diffuses through a semipermeable membrane from a region of higher concentration (such as pure fresh water) into one of lower concentration (such as a solution of water and salt). The flow of water can be reversed with an opposing pressure that exceeds osmotic pressure. With RO, water is forced out of the lower concentrated solution (such as the salt solution), leaving the solute (impurities) behind.

Rinse
The operation that follows regeneration, a flushing out of excess regenerant solution.