Packaged Equipment
An assembly of individual pieces or stages of equipment, complete with
inter-connecting piping and connections for external piping. The assembly
may be mounted on a skid or other structure prior to delivery.
Packaging
All operations, including filling and labeling, which a bulk product has to
undergo in order to become a finished product.
Packaging Material
Any material intended to protect an intermediate or API (Active
Pharmaceutical Ingredient) during storage and transport.
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.
Parenteral Drug (LVP, SVP)
A parenteral drug is defined as one intended for injection through the skin
or other external boundary tissue, rather than through the alimentary canal,
so that active substances they contain are administered, using gravity or
force, directly into a blood vessel, organ, tissue, or lesion. They are
infused when administered intravenously (IV), or injected when administered
intramuscularly (IM), or subcutaneously into the human body. A large volume
parenteral (LVP) is a unit dose container of greater than 100ml that is
terminally sterilized by heat. Small volume parenteral (SVP) is a "catch-all"
for all non-LVP parenterals products except biologicals.
Particle
Solid or liquid object which for purposes of classification of air
cleanliness, falls within a cumulative distribution that is based upon a
threshold (lower limit) size in the range from 0,1 µm to 5 µm. ISO
14644-1
Particle Size
The apparent maximum linear dimension of a particle in the plane of
observation as seen with a microscope or the equivalent diameter of a
particle detected by automatic instrumentation. The equivalent diameter is
the diameter of a reference sphere having known properties and producing the
same response in the sensing instrument as the particle being measured. ISO
14644-1
Particle Concentration
Number of individual particles per unit volume of air. ISO 14644-1
- Particulate Usually a solid particle large enough to be removed by
filtration. Nonfilterable solids are usually referred to as colloids.
- Parts Per Billion (PPB)
(also see: PPB)
Parts Per Million (PPM)
(also see: PPM)
Passive Immunity
Temporary immunity produced by administration of gamma globulin.
Passivity
The state in which a stainless steel exhibits a very low corrosion rate.
Also known as passivity, is the loss (or minimizing) of chemical
reactivity exhibited by certain metals and alloys under special
environmental conditions.
Passivation
A final chemical treatment/cleaning process that removes exogenous iron
or iron compounds from the surface of stainless steel piping and equipment
by the use of a mild oxidant, such as a nitric acid solution, or by "in-situ
electropolishing. The purpose of passivation is to restore and/or enhance
the spontaneous formation of the chemically inert surface or protective
passive film.
Passive Layer
A passive oxidized film that forms naturally on a stainless steel surface
when exposed to air or similar oxidizing environment thus protecting the
underlying base metal from corrosion. Welding disturbs the passive layer
by reducing the chromium and increasing the iron, thus altering the
chromium/iron ratio (measure of corrosion resistance). Upon completion and
approval of the weld, the weld surface and adjacent boundary area must be
brought back to a passive state. Additionally, normal operating conditions
in typical Water For Injection, reverse osmosis, deionized water, clean
steam, Clean In Place, and process piping often lead to formation of the
most prevalent form of self catalyzing corrosion called "rouge"
(French for red), which is a colloidal form of rust containing iron oxide,
chromium and nickel in various forms. This problem is further accentuated
by high temperature. The rouge layer acts as a passive layer until it
becomes so thick that it "sloughs off" into the process or water
stream.
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.
Pathogen
Any microbiological or eukaryotic cell containing sufficient genetic
information, which upon expression of such information is capable of
producing disease in healthy people, plants, or animals.
Pathogenic
Causing or capable of causing disease.
Pathogenic Organisms
Organisms capable of causing disease, either directly (by infecting) or
indirectly (by producing a toxin that causes illness).
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. Low-density polyethylene (LDPE) has a melt point of 221°F
(105°C), specific gravity of 0.91 to 0.925 g/cc, increased toughness,
stress cracking resistance, clarity, flexibility, and elongation. It also
has reduced creep and mold shrinkage. Polyethylene of higher density such
as HDPE has better permeation barrier properties, hardness, abrasion
resistance, chemical resistance, and surface gloss. It is important to
note that photo or light oxidation will occur when natural PE is exposed
to UV radiation, usually from the sun.
Penetrance
A term indicating the likelihood that a given gene will actually result
in disease.
Penicillin
An antibiotic containing a ß-lactam ring that inhibits an enzyme
responsible for making peptide cross-links in the bacterial cell wall. It
is obtained from cultures of the molds Penicillium Notatum or Penicillium
Chrysogenum.
Penicillium
The genus of mold causing a zone of inhibition in an agar plate of
bacteria. It is the organism, which produces natural penicillin.
- Peptide A secondary protein derivative defined as "a definitely
characterized combination of two or more amino acids, the carboxyl
(COOH) group of one being united with the amino (NH2) group of the
other, with the elimination of a molecule of water". They form a
peptide bond.
- Peptide Hormones
A diverse class of hormones that are synthesized and excreted at various
sites within the body. Examples include: insulin, relaxin, glucagons,
growth hormone, vasopressin, ACTH (Adrenocorticotropic Hormone),
endorphins, and encephalins.
Percent Recovery
In reverse osmosis or ultrafiltration, the ratio of pure water output to
feedwater input.
Percent Rejection
In reverse osmosis or ultrafiltration, the ratio of impurities removed to
total impurities in the incoming feedwater. For example, RO membranes
typically remove (reject) 90% of the dissolved inorganic contaminants in
water.
Peristaltic Pump
A type of positive displacement pump that operates by pulsations of flow
caused by passing rollers over flexible tubing. Operating pressure limited
by tubing tolerance.
Permeability
he ability of a body to pass a fluid under pressure.
- Permeate In reverse osmosis, the water that diffuses through the
membrane, thereby becoming purified water.
- Permissible Exposure Limit (PEL)
The maximum permitted eight-hour time-weighted average concentration of
an airborne contaminant. For Permissible Exposure Limits see CFR 29 -
1910.1000.
Permissions or Privileges
Security codes that define or restrict which users can read, write, and
execute the associated files, directories, or programs. Some departments
need to look only at data, some need to input data or run programs, and
others may not need to look at the data at all.
Peroxisome
Very small membrane-bound particles responsible for photorespiration in
plants. Similar to lysosome in structure, but not in function.
Petrolatum
White petrolatum is a purified mixture of semi-solid hydrocarbons
obtained from petroleum. It is a common base or carrier for ointments. It
can be sterile filtered at elevated temperatures.
pH
The pH value of an aqueous solution is a number describing its acidity or
alkalinity. A pH is the negative logarithm (base 10) of the concentration
of hydrogen ions (equivalent per liter). The pH value of a neutral
solution is 7. An acidic solution has a pH less than 7, while a basic
solution has a pH greater than 7, up to 14.
Phage
A virus for which the natural host is a bacterial cell. (also see:
Bacteriophage)
- Phagocyte A cell that engulfs foreign particles from its surroundings
by a process called phagocytosis. The cell releases hydrolytic enzymes
from intracellular bodies called lysosomes that partially digest the
foreign particle, after which it is further degraded in the phagocyte
cytoplasm.
- Pharmaceutical
A medicinal drug, or relating to or engaged in pharmacy or the
manufacture and sale of pharmaceuticals. A pharmaceutical product is
generally one that is made up using available chemical compounds.
Pharmaceutical Area
A general manufacturing area classification designated by the need for a
change of clothing (e.g., Packing Hall). See ISPE® Sterile Baseline
Guide.
Phenol
An organic acid often used as a disinfectant. Proper strength for a
bacteriocidal preparation is 5%. Sometimes dispersed as an aerosol "fog"
in manufacturing rooms.
Physical Hazard
A classification of a chemical for which there is scientifically valid
evidence that it is a combustible liquid, compressed gas, cryogenic,
explosive, flammable gas, flammable liquid, flammable solid, organic
peroxide, oxidizer, pyrophoric, unstable, (reactive), or water-reactive
material.
Photoautotrophs
Facultative autotrophs that obtain their energy from light.
Photoluminescent
The property of emitting light as the result of absorption of visible or
invisible light, which continues for a length of time after excitation.
Photo Oxidation
The mechanism by which ultraviolet light reduces Total Organic Carbon
(TOC) to Carbon Dioxide. If halogenated organics are present, both CO2 and
mineral acids can be formed.
- Phycomycetes Algalike fungi that do not posses chlorophyll and cannot
photosynthesize. Aquatic and terrestrial molds belong to this category.
- Physical Barrier
Any equipment, facilities, or devices (e.g., fermentors, factories,
filters, thermal oxidizers) that are designed to achieve containment.
Physical Manipulation
A process other than a chemical reaction that may change the purity of
the physical properties of the material, including but not limited to,
crystallization, recrystallization, gel filtration, chromatography,
milling, drying, or blending.
Physical Map
A map of the locations of identifiable landmarks on DNA (e.g.,
restriction enzyme cutting sites, genes), regardless of inheritance.
Distance is measured in base pairs. For the human genome, the
lowest-resolution physical map is the banding patterns on the 24 different
chromosomes; the highest resolution map would be the complete nucleotide
sequence of the chromosomes.
Pickle
An acid or other chemical solution used as a bath to remove scale and
oxides fro the surface of metals before plating or finishing.
Pipe
A pressure-tight cylinder used to convey a fluid or to transmit a fluid
pressure ordinarily designated "pipe" in applicable material
specifications. Materials designated "tube" or "tubing"
in the specifications are treated as pipe when intended for pressure
service. Types of pipe, according to the method of manufacture, are: 1.
Electric resistance-welded pipe (ERW) 2. Furnace butt welded pipe,
continuous welded 3. Electric-fusion welded pipe 4. Double submerged-arc
welded pipe 5. Seamless pipe 6. Spiral welded pipe
Pipe Size
Pipe size is determined by diameter and schedule. For bioprocessing
equipment, pipe does not include tube.
Pit
A small surface void resulting from a localized loss of base metal by
corrosion or etching, or by the removal of surface inclusions during
electropolishing or passivation. A pit may or may not be detectable during
liquid penetrant inspection.
Pitch
To cause to be set at a particular angle or slope. Degree of slope or
elevation.
Placebo
An inert or innocuous substance used in controlled experiments testing
the efficacy of another substance.
Plankton
Those microorganisms that are passively floating or drifting in a body of
water.
- Plaque A clear zone in a bacterial culture grown on an agar plate
caused by localized destruction of bacterial cells by a bacteriophage.
Applying the fluid to a culture and counting the number of plaques
formed can estimate the concentration of infective virus in a fluid.
- Plasma
The liquid portion of blood in which the cellular elements are suspended.
As a fresh liquid obtained by centrifugation, plasma is a clear,
amber-colored solution containing eight to nine percent solids; of these,
85 percent are proteins while the other components are the lipids, which
include the neutral fats, fatty acids, lecithin, and cholesterol. Also
present are sodium, chloride and bicarbonate, potassium, calcium and
magnesium. A most essential function of plasma is the maintenance of blood
pressure and the exchange with tissue of nutrients for waste. Contains
fibrinogen.
Plasma Cell
A cell derived from a B-lymphocyte and solely responsible for the
production of antibodies. Each plasma cell forms only one type of antibody
and is characterized by an eccentric nucleus, a prominent Golgi zone,
bulky basophilic cytoplasm (due to an extensive endoplasmic reticulum) and
large numbers of mitochondria.
Plasma Membrane
The physical barrier that surrounds the cytoplasm of all cells. It is
composed of lipid, protein, and carbohydrate and is semi-permeable.
Plasma Proteins
The proteins found in plasma, usually divided into albumin, globulin and
fibrinogen fractions.
- Plasma Protein Fraction (PPF)
- Plasmid
Self-replicating, extrachromosomal circular DNA molecules, distinct from
the normal bacterial genome and nonessential for the cell survival under
nonselective conditions. Some plasmids are capable of integrating into the
host genome. A number of artificially constructed plasmids are used as
cloning vectors.
Plastics
High molecular weight polymers or copolymers. The wide range in physical
properties of polymeric materials allows for utilization as elastomers,
fibers, adhesives, rigid castings, composites, and laminates. ASTM D883
defines a plastic as a material that contains as an essential ingredient,
one or more organic polymeric substances of large molecular weight, is
solid in its finished state, and, at some stage in its manufacture into
finished articles, can be shaped by flow. Plastics, or more appropriately
polymers, are composed primarily of carbon, hydrogen, oxygen, silicon,
chlorine, fluorine, and nitrogen, in various combinations and
permutations. Plastics are grouped into two categories: 1. Thermoplastics:
can be melted, cooled and remelted without destroying the physical or
mechanical characteristics of the polymer. This property permits
components to be molded or extruded. Thermoplastic polymers include:
Chlorinated Vinyls, Fluorinated plastics, Ketone, Nitrile, Nylon,
Polyamide-imide, Polyolefin, Polycarbonate, and Acrylonitrile butadiene
styrene (ABS). (also see: Chlorinated Vinyls, Fluorinated Plastics,
Polyolefin) 2. Thermosets: begin as a liquid or powder that through
chemical reaction with a second reactant or through catalyzed
polymerization result in anew product with characteristics different from
either starting material. Thermoset resins include: Epoxy, Phenolic,
Polyurethane, Silicone, Urea and Melamine, Polyester, Vinyl ester, Furan,
Bisphenol A fumarate.
Plastics, U.S.P. Classification
(also see: Biological Reactivity Tests, In Vivo)
Pleuropneumonia
A specific infectious disease in cattle characterized by inflammation of
the lung and pleura, generally called contagious pleuropneumonia. It is
due to a virus.
Plena
The plural of plenum.
Plenum
An enclosure in which air or other gas is at a pressure greater than that
outside the enclosure.
PLC (Programmable Logic Controller)
An automated system with analog capability as well as binary (discrete).
PLCs must be equipped with a digital interface to a "front end"
computer for data collection and for programmer interface.
PLC Controlled Automated System
Any automated system using a Programmable Logic Controller as its primary
controller.
- Plumbing Code
- Poison
Any substance which when taken into the body in a single dose of 1.0 gm.
or less, is injurious to health or dangerous to life.
Polyalphaolefin (PAO)
A synthetic oil used in lieu of DOP for HEPA filter testing.
Polygenic Disorder
Genetic disorder resulting from the combined action of alleles of more
than one gene (e.g., heart disease, diabetes, and some cancers). Although
such disorders are inherited, they depend on the simultaneous presence of
several alleles; thus the hereditary patterns are usually more complex
than those of single gene disorders.
Polyolefin
The polyolefin polymer is probably one of the most economical and widely
used classes of thermoplastics, including such materials as PB, PP, and
PE. PB is a semicrystalline polymer based on polybutene, homopolymers, and
either polybutene or polyethylene copolymers. The primary use of PB is
pipe with hydrostatic pressure rating of 1,000 psi at 73°F. PP is a
crystalline polymer that has good resistance to caustics, solvents, acids,
and other organic chemicals, but is not resistant to oxidizing-type acids,
detergents, alcohols, or chlorinated organic materials. It is suitable for
pipe applications. The largest group of polyolefins is linear PE. It
includes ULDPE, LLDPE, LDPE, HDPE, HMW-HDPE, and UHMWPE. These density
descriptions generally refer to ASTM designations based on unmodified
polymers. PE types of higher density have better permeation barrier
properties, hardness, abrasion resistance, chemical resistance, and higher
surface gloss.
Polished Water
High purity water after it has undergone a second treatment step.
Ultrapure water usually undergoes two or more treatment steps. More
economical pretreatment processes (e. g., reverse osmosis) are used to
remove all but a very small fraction of the impurities. Highly efficient
polishing processes (e. g., mixed-bed deionization) are used to remove the
impurities that remain.
Polymer
A macromolecule (long chain) consisting of five or more repeating units
called monomers. Examples include polyethylene, polystyrene, and PTFE
(polytetrafluoroethylene).
Polymerase
An enzyme that catalyzes production of nucleic acid molecules.
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. Because the newly synthesized DNA strands can
subsequently serve as additional templates for the same primer sequences,
successive rounds of primer annealing, strand elongation, and dissociation
produce rapid and highly specific amplification of the desired sequence.
PCR also can be used to detect the existence of the defined sequence in a
DNA sample.
Polymorphism
Difference in DNA sequence among individuals. Genetic variations
occurring in more than 1% of a population would be considered useful
polymorphisms for genetic linkage analysis. (also see: Mutation
Polypeptide
A long chain of amino acids covalently bound by peptide.
Porcine
Of, relating to, or from swine (pigs) such as porcine growth hormone.
Positional Cloning
A technique used to identify genes, usually those that are associated
with diseases, based on their location on a chromosome. This is contrast
to the older, "functional cloning" technique that relies on some
knowledge of a gene protein product. For most diseases, researchers have
no such knowledge.
Positive Pressure Personnel Suit
Personnel protection equivalent to that provided by Class III (BSCs). It
is a one-piece, ventilated suit worn by the laboratory worker when working
with Biosafety Level 3 (BL-3) or Biosafety Level 4 (BL-4) in a "suit
area" and using Class I or II Biological Safety Cabinets (BSCs). The
personnel suit is maintained under positive pressure with a life-support
system to prevent leakage into the suit. In this containment system, the
worker is isolated from the work materials. The personnel suit area must
be entered through an airlock fitted with airtight doors. A chemical
shower is provided as a "dunk tank" to decontaminate the
surfaces of the suit as the worker leaves the area. The exhaust air from
the suit area is filtered through two HEPA filters installed in series.
The entire area must be under negative pressure.
Potable
Suitable for drinking.
Potent
A substance that is "active" in relatively low doses or
concentrations.
PP (Polypropylene)
A crystalline polymer with a melting point of 330°F (165°C),
and heat deflection temperature ranging from 195°F (91°C) to 240°F
(116°C) which is higher than other common plastics. Its key
properties are high heat resistance (for piping an upper limit of 212°F
(100°C)), a specific gravity of 0.91 if unmodified (the lightest of
the most common thermoplastics), stiffness, and chemical resistance with
respect to handling caustics, solvents, acids, and other organic
chemicals. It is not recommended for use with oxidizing type acids,
detergents, low boiling hydrocarbons, alcohols, and some chlorinated
organic materials. Polypropylene is a relatively inert material and
contributes little in the way of contamination to pharmaceutical water.
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.
PPF
A blood plasma fraction. Identical to NHSA (also see: NHSA, ISG) but
containing no more than 15% w/w A and ß globulins. Dispensed as a 5%
solution.
PPLO
Pleuropneumonia Like Organism.
PPM (Parts Per Million)
Abbreviation for parts per million, used to describe concentration in
liquids or gases, e.g., 10,000 ppm is approximately equivalent to 10
g/liter or a 1% W/V solution.
PPM (Parts Per Million)
The most common measure of dissolved ionized impurities in water. It is
the same as milligrams per liter. For discussion of ppm as a measure of
Total Ionized Solids see Milliequivalent.
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.
Precipitate
An insoluble reaction product. When a solution reaches saturation, solute
will begin to come out of solution, as when water precipitates from the
air as rain, or calcium carbonate precipitates out of water to form scale,
the chalky white substance deposited on the inside of tea kettles.
Precommission
Preparing the plant for commissioning (start-up). This includes briefly
starting (bumping) all pieces of equipment, verifying their shaft rotation
is correct, verifying that valves, gauges, and other inline devices are
installed in the correct orientation, and performing functionality runs on
all equipment and material. This also includes leak tests.
Predicate Rules
A previously published set of rules (such as GLPs, GCP, or cGMPs) that
mandate what records must be maintained, the required contents of those
records, whether signatures are necessary, and how long the record must be
maintained.
Prefilter
A filter to trap gross particulates located upstream before a HEPA
filter. The efficiency of initial prefilters is usually in the 20% to 30%
range by the ASHRAE Atmospheric Dust Spot Efficiency, while intermediate
prefilters usually have a collection efficiency of 80% to 90% by the same
test.
Preservative
A bacteriostatic or bacteriocidal agent added to some multiple dose
parenterals and most cosmetics. Examples are benzalkonium chloride (BAC),
formaldehyde, and thimerosol (merthiolate).
Pressure Rating
Pressure at which a system is designed to operate, allowing for
applicable safety factors.
Pressure Vessel
A closed vessel designed to operate at pressures above 15 psig (103.4
kPa).
Pretreatment
Initial water treatment steps performed prior to final processing to
prolong the life of cartridges and filters and to protect downstream
elements from premature failure.
Primary Air
Air circulating through HEPA filters used to produce unidirectional flow
in critical zones.
Primary Containment The first level of containment, consisting of the
inside portion of that container which comes into immediate contact on
its inner surface with the material being contained.
Primer
Short preexisting polynucleotide chain to which DNA polymerase can add
new deoxyribonucleotides.
Principle of Nonrepudiation
The ability to say with confident assurance that only one user entered
specific data or performed specific actions on a computer system and that
the particular user is identifiable. If more than one user can get into
the system in such a way that the audit trail cannot specify who performed
what action, the principle of nonrepudiation has been violated.
Prions
Virus-like proteinaceous infectious agents. Prions differ from viruses in
that they are not known to contain either DNA or RNA.
Probe
Single stranded DNA or RNA molecules of specific base sequence, labeled
either radioactively or immunologically, that are used to detect the
complementary base sequence by hybridization.
Procedures
A documented description of the operations to be carried out, the
precautions to be taken and measures to be applied directly or indirectly
related to the manufacture of an intermediate or API.
Process Aids
Materials, excluding solvents, used as an aid in the manufacture of an
intermediate or API (Active Pharmaceutical Ingredient) which themselves do
not participate in a chemical or biological reaction (e.g. filter aid,
activated carbon, etc.).
Process Control
Process Limits
Environmental limits that, if exceeded, may affect product quality
adversely.
Process Suitability
The established capacity of the manufacturing process to produce
effective and reproducible results consistently.
Process Support Systems
Systems that do not contact product and are generally engineering
systems.
Process Systems
Systems that may contact the drug substance or could otherwise directly
impact product quality.
Process Validation
Establishing, through documented evidence, a high degree of assurance
that a specific process will consistently produce a product that meets its
predetermined specifications and quality characteristics.
Process Validation Protocol
Documented plan for testing a pharmaceutical product and process to
confirm that the production process used to manufacture the product
performs as intended. This includes a review of process variables and
operational limitations as well as providing the sampling plan under
actual use conditions.
Product Campaign
The production of more than one product in a facility, with strict
adherence to accepted cleaning procedures between these products. The
products may be run in the same equipment, but not at the same time.
Product Contact Surface
A surface that contacts raw materials, process materials, and/or product.
Product Mix
The types and number of different products produced in a facility.
Product Water
The water produced as a result of a treatment process.
Production
All operations involved in the preparation of an API (Active
Pharmaceutical Ingredient), from receipt of materials, through processing
and packaging, to its completion as a finished API.
Prokaryote
A unicellular organism having a less complex structure than a eukaryote.
It is characterized by the absence of a nucleus and by having the genetic
material in the form of simple filaments of DNA. The sizes of most
prokaryotes vary from 0.5µm to 3µm in equivalent radius.
Different species have different shapes such as spherical or Coccus (for
example, Staphylococci), cylindrical or bacillus (E. coli), or spiral or
spirillum (Rhodospirillum).
Promoter
A site on DNA to which RNA polymerase will bind and initiate
transcription.
Prophylactic Surgery
Surgery to remove tissue that is in danger of becoming cancerous, before
cancer has the chance to develop. Surgery to remove the breasts of women
at high risk of developing breast cancer is known as prophylactic
mastectomy.
Prophylaxis
The prevention of, or protective treatment for disease.
Propylene Glycol
A common solvent for antibiotics, particularly the tetracyclines.
Miscible (soluble) in water, but often filtered as pure propylene glycol
prior to combination with the antibiotic. Its high viscosity controls
absorption of the dissolved drug.
Prospective Validation
Establishing documented evidence that a system does what it purports to
do based on a preplanned protocol.
Prosthetic Groups
Organic and/or inorganic components other than amino acids, contained in
proteins.
Protease
A proteolytic enzyme; a protein that can cleave other proteins into
smaller fragments.
Protein
One of a group of substances constituting the greater part of the
nitrogen-containing components of animal and vegetable tissues. They are
of very complex constitution, all containing carbon, hydrogen, nitrogen,
and oxygen and some containing in addition iron, phosphorous, or sulfur;
chemically they are regarded as peptides (polypeptides) or combinations of
amino acids and their derivatives. They are colorless, odorless, generally
tasteless, and of varying degrees of solubility; they are putrefiable and
readily undergo chemical change, hydrolysis, under the influence of
ferments and on boiling with dilute acids or alkalis.
Protein Sequencer
An instrument that will determine the sequence of amino acids, which make
up a particular protein.
Proteolysis
Protein hydrolysis, the decomposition of protein.
Proteolytic Enzyme (Protease)
Any enzyme that takes part in the breaking down of proteins. A system of
several such enzymes is necessary to break down proteins to their
constituent amino acids.
Proteomics
A concept more than a defined technology, it refers to any protein-based
approach that has the capacity to provide new information about proteins
on a genomewide scale. 75% of the predicted proteins in multicellular
organisms have no known cellular function.
Protocol
A prospective plan, that when executed as intended, produces documented
evidence that a Process or System has been properly qualified.
Protoplasm
A semifluid, viscous, translucent mixture of water, proteins, lipids,
carbohydrates, and inorganic salts found in all plant and animal cells.
Protozoa
Nucleated microorganisms, some of which are large enough to be detected
with the naked eye. They consist of a single cell and or an aggregation of
nondifferentiated cells loosely held together and not forming tissues. The
protozoa are divided into four classes: Sarcodina, Mastigophora, Sporozoa,
and Infusoria (Ciliata).
Proven Acceptable Range
Psychrophile
An organism that requires temperatures below 20°C (68°F) for
growth.
Psychrometer
A hygrometer that uses the difference in readings between two
thermometers, one having a wet bulb ventilated to cause evaporation and
the other having a dry bulb, as a measure of atmospheric moisture.
Psychrometry
Determination of the properties of gas-vapor mixtures. The air-water
vapor system is by far the one most commonly encountered.
Pseudonomas Diminuta
The bacterium used for validation of sterilizing filters. Recognized as
the challenge organism for 0.2µm filters, its size is 0.3 x 0.8µm
approximately. According to the HIMA (Health Industries Manufacturers
Association) standard, filters must be successfully challenged to a titre
of 107 per cm² to be validated as sterilizing grade 0.2µm rated.
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. Usual processing techniques like injection molding are not
possible with PTFE due to a very high molecular weight which results in a
melt viscosity about 1 million times higher than is acceptable for
conventional thermoplastics. PTFE resin is pressed into shapes under high
pressure at room temperature and then heated to 700°F (371°C) to
complete the molding (sintering process) and adjust the crystalline
content.
Public Key Certificate (PKC)
A data file issued by a certified authority to a person or company that
acquires a digital signature service. The certificate includes information
identifying the subject, the issuing authority, and the period of
validity, and it provides the related public key. The certified authority
signs the PKC digitally.
Pure Culture
A culture containing only one species of microorganism.
Pure Steam
Steam that is produced by a steam generator which, when condensed, meets
requirements for WFI.
Purification
The removal of impurities of concern. The term has one meaning when
applied to the preparation of drinking water, another when applied to
reagent grade water for the laboratory, and still another when applied to
water used to rinse ICs (Integrated Circuit devices).
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).
Purine
A nitrogen-containing, double-ring, basic compound that occurs in nucleic
acids. The purines in DNA and RNA are adenine and guanine.
Purity
The ratio of desirable to undesirable components in a liquid as
determined on a weight basis per unit volume of sample.
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. PVC is prone to produce extractables during start-up in high
purity water.
PVDF (Polyvinylidene Fluoride) Kynar®, Sygef®,
Solef®
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. It has a high tensile strength as well as a high heat
deflection temperature. It is readily weldable, offers high purity
qualities, and is resistant to permeation of gases. PVDF is a relatively
inert material and contributes little in the way of contamination to
pharmaceutical water.
Pyrimidine
A nitrogen-containing, single ring, basic compound that occurs in nucleic
acids. The pyrimidines in DNA are cytosine and thymine, in RNA, cytosine,
and uracil. (also see: Purine)
Pyrogen A foreign substance that produces a fever response in humans
and animals, hence the name pyrogen (heat producing). Chemically, the
lipopolysaccharide outer layer of gram-negative bacteria. Bacterial
pyrogens were at one time believed to be toxic substances released when
bacterial cells disintegrate and are therefore still referred to as
endotoxins. Parenteral drugs must be essentially pyrogen free. (also
see; Lipopolysaccharide (LPS), Endotoxin) Pyrophoric A chemical that
will spontaneously ignite in air at or below a temperature of 130°F
(54.5°C).