Glossary of Terms - F

Face Velocity
The velocity obtained by dividing the air quantity by the component face area (NEBB).

Facility Flexibility
A qualitative measure of the number of different products that can be produced in a facility or area of a facility.

Facility User
The end user of a facility, often called the Owner, represented by operating, maintenance, and quality control personnel.

Factor VIII (Hemophilia Factor)
Also known as antihemophilic factor or AHF (Brinkhous) in the clotting of blood, Factor VIII is a labile protein of the blood-clotting system that assists in the conversion of Factor IX into plasma factor X (Stuart factor). Deficiency of factor VIII is associated with classic hemophilia A, a hereditary, sex-linked, hemorrhagic tendency that occurs almost exclusively in men; clotting time is prolonged, less thromboplastin is formed, and the conversion of prothrombin is diminished.

Factor IX (Hemophilia Factor)
In the clotting of blood, also known as Christmas factor (Biggs and Macfarlane). Deficiency of factor IX causes hemophilia B or Christmas disease that resembles hemophilia A, and is an inherited defect that leads to a severe hemorrhagic disorder. Factor IX is required for the formation of intrinsic blood thromboplastin and affects the amount formed (rather than the rate).


After Gabriel Daniel Fahrenheit (1686-1736). Of or pertaining to a temperature scale that registers the freezing point of water as 32°F. and the boiling point as 212°F. under standard atmospheric pressure (29.921 inches of mercury). Fahrenheit temperatures are related to Centigrade temperatures by the equation F = 1.8C + 32 (

FDA Form 483
The official form of notification prepared at the conclusion of an inspection (without review by FDA management) listing observations of perceived violations of Good Manufacturing Practices that may constitute violations of law in the opinion of an inspector. Originally intended to inform companies of possible product adulteration, they must be replied to satisfactorily and/or corrective action taken in order to alleviate any offensive notification and avoid action from the FDA (i.e., plant shut-down). Accessible through the Freedom of Information Act to competitors, potential customers, and the media; 483s can lead to withholding of product approvals, may come into play in due diligence phases of acquisitions and mergers, and can potentially cost companies money.

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.

Federal Standard 209E
The document that established standard classes of air cleanliness for airborne particulate levels in cleanrooms and clean zones. It prescribed methods for classes of air cleanliness for airborne particulate levels in cleanrooms and clean zones. It prescribed methods for class verification and monitoring of air cleanliness. It also addressed certain other factors but only as they affected control of airborne particulate contamination. Federal Standard 209E is in the process of being replaced by ISO 14644-1.

Feedback Loop
A central concept in industrial controls in which the value of a process variable is compared with the desired value (setpoint), and any discrepancy (error) is converted into a modified output signal.

Feedwater
The water entering a treatment process.

Fermentation
The process of growing microorganisms within an enclosed tank (fermenter) under controlled conditions of aeration, agitation, temperature, and pH. The different types organisms used as a basis for fermentation are:

1. Bacteria (E. coli)

2. Yeasts

3. Molds

4. Chinese Hamster Ovary (CHO) cells

5. Kidney cells

6. Vaccines to viruses

Fermentation
The biochemical synthesis of organic compounds by microorganisms.

Fermenter
A tank or vessel used for carrying out fermentation. There are various choices of fermenters, depending on whether cells are suspended in the medium or attached to some type of support:

1. In suspension reactors

2. Attached growth reactors

3. Stirred-tank reactors

4. Airlift fermenters

5. Packed bed reactors

6. Two-chamber reactors

7. Hollow-fiber reactors

Fetal Calf Serum
The liquid portion remaining after natural coagulation of blood drawn from the heart of an unborn calf. Because of the absence of gamma globulin, fetal calf serum is a good tissue culture serum.

Fever
Also known as pyrexia, a human body temperature above the normal 98.6°F (37°C).

Fiber Any particulate contaminant having an aspect (length to width) ratio of 10 or more. ISO 14644-1

Fibrin
A plasma protein that, in its aggregated state, is the major component of a blood clot. It is produced from fibrinogen, a soluble precursor, by the action of the proteolytic enzyme, thrombin.

Fibrinogen
In the clotting of blood it is known as Factor I. The plasma protein that becomes converted to a clot at the end of the coagulation process. Present in plasma; absent in serum.

Filtration
Removal of suspended matter from a fluid by passing it through a porous matrix that prevents particles from getting through, usually by entrapment on or in the filter matrix.

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. The processing of raw materials into finished dosage forms must comply at all times with cGMPs and must be able to support process validation. Mechanical design should include HVAC Classifications considered essential to attain global regulatory acceptance. For classifications, see the ISPE® Guide for Sterile Manufacturing Facilities. The desire for increased levels of sterility assurance has led the FDA to promote the use of terminal sterilization for aseptically filled products. The FDA has stated that terminal sterilization processing is the method of choice unless the manufacturer can show that it is detrimental to the product. Terminal sterilization may be accomplished using autoclaves that apply overpressure to balance the pressures that are developed across the inside and outside of the containers. Because of product sensitivities, biologics, and blood products are not appropriate applications for terminal sterilization (also see:

Final Bulk Product
The final drug product after chemical or biological processing and purification, ready for concentration, drying, and filling into containers prior to dispensing and final filling.

Finished Product
A medicinal product that has undergone all stages of production, including packaging in its final container.

Fire Code
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Firmware
A combination of hardware and software with the programming written directly into read-only memory (ROM).

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.

Fissile Material
A radioisotope that could undergo a nuclear fission reaction and is usually found at reactor sites or as part of a nuclear weapon.

Flaggelae
Thin, helical filaments attached to the surface of bacterial and eukaryotic (e.g. sperm, protozoa) cells. They are motile structures containing microtubules (composed of proteins called tubulin) that enable cells possessing them to move.

Flammable Liquid
A liquid having a closed cup flash point below 100°F (37.8°C). Flammable liquids do not include compressed gases or cryogenic fluids. Flammable liquids are subdivided as follows: 1. Class I-A - Liquids having a closed cup flash point below 73°F (22.8°C) and having a boiling point below 100°F (37.8°C). 2. Class I-B - liquids having a closed cup flash point below 73°F (22.8°C) and having a boiling point at or above 100°F (37.8°C). 3. Class I-C - liquids having a closed cup flash point at or above 73°F (22.8°C) and below 100°F (37.8°C).

Flammable Solid
A solid substance, other than one which is defined as a blasting agent or explosive, that is liable to cause fire through friction or as a result of retained heat from manufacture, which has an ignition temperature below 212°F (100°C), or which burns so vigorously or persistently when ignited that it creates a serious hazard. Flammable solids include finely divided solid materials which when dispersed in air as a cloud could be ignited and cause an explosion.

Flaws
Metallic flaws are unintentional irregularities that occur at one place or at relatively infrequent or widely varying intervals on the surface. Flaws include such defects such as cracks, blowholes, inclusions, pits, checks, ridges, scratches, and other surface abnormalities.

Floc
Mass having a fluffy or wooly appearance.

Flocculation
A technique for liquid/solids separation. Cationic or anionic polyelectrolytes (e.g. polyacrylamides) are added to highly colloidal water causing coagulation and subsequent settling. The phenomena could be charge neutralization or a bridging effect between separate particles.

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.

Flow Decay
Measuring the decline in flow rate through a filter to establish a Silt Index for the water being filtered. The Silt Index is a measure of suspended solids and their ability to clog the filter.

Flow Restrictor
A flow-limiting orifice used to control flow rate or pressure drop in a liquid stream.

Fluid Service (piping)
As defined in ASME B31.3, fluid service is a general term concerning the application of a piping system, considering the combination of fluid properties, operating conditions, and other factors, which establish the basis for design of the piping system.

1. Category D Fluid Service: A fluid service in which all the following apply: (a) the fluid handled is nonflammable, nontoxic, and not damaging to human tissues (see definition below). (b) The design gage pressure does not exceed 1035 kPA (150 psi). (c) The design temperature is from -29°C (-20°F) through 186°C (366°F).

2. Category M Fluid Service: A fluid service in which the potential for personnel exposure is judged to be significant and in which a single exposure to a very small quantity of a toxic fluid, caused by leakage can produce serious irreversible harm to persons upon breathing or bodily contact, even when prompt restorative measures are taken.

3. High Pressure Fluid Service: A fluid service for which the owner specifies the use of chapter IX (High Pressure Piping) for piping design and construction.

4. Normal Fluid Service: A fluid service pertaining to most piping covered by ASME B31.3, i.e., not subject to the rules for Category D, Category M, or High Pressure Fluid Service, and not subject to severe cyclic conditions.

Damaging to human tissues for the purpose of the Code, describes a fluid service in which exposure to the fluid, caused by leakage under expected operating conditions, can harm skin, eyes, or exposed mucous membranes so that irreversible damage may result unless prompt restorative measures are taken. These measures may include, flushing with water, administration of antidotes, or medication.

Fluidized Bed
A container holding powder coating material which is aerated from below so as to form an air-supported expanded cloud of such material through which the preheated object to be coated is immersed and transported.

Fluorescein
An orange-red compound, C20H12O5, which exhibits intense fluorescence in alkaline solution.

Fluorinated Plastics
Fluorinated plastics are thermoplastic paraffinic polymers where the hydrogen has been replaced by fluorine, and in some cases, chlorine. These materials are some of the more popular in the CPI because of good chemical resistance to a wide variety of aggressive chemicals, and relatively high heat resistance of 400°F to 500°F. They include FEP, PTFE, PFA, PCTFE, ETFE, PVDF, and PVF.

Flux Removers
Chlorinated solvents with alcohols that may be sprayed from aerosol cans to remove welding flux.

Formaldehyde
A colorless, highly irritating, pungent compound used in the pharmaceutical and cosmetic industries as an antimicrobial agent.

Forward Flow Test
An objective and quantitative method of determining filter integrity. A test in which the filter is wetted and a predetermined constant air pressure is applied. A measurement of pure diffusional airflow through the wetted membrane is made. If the diffusional airflow across the membrane is below the maximum allowable value given, then the filter is acceptable.

Fouling
Occurs when gelatinous coatings, colloidal masses, or dense bacterial growth form a compacted crust on membrane or filter surfaces which blocks further flow.

Fume Hoods
Units that collect fumes from chemicals, solvents, acids, and other hazardous materials. Hoods may include HEPA filters if powders are present, or carbon filters to filter fumes from the work surface and return cleaned air to the room. Most fume hoods are 100% exhausted to outdoors. A glass, Plexiglas™ or acrylic front panel may be included for worker safety.

Functional Description A written description of what a system is to do with sequence of operation relating activities to Critical Parameters (Why the system does what it does for GMP reasons). A non-GMP system should also have a functional specification to aid designers and software development.

Functional Gene Tests
Biochemical assays for a specific protein, which indicates that a specific gene is not merely present but active.

Functionality
Suitability for the intended purpose.

Fungi
Plural of fungus. Low forms of plant life unable to form protein and carbohydrates (heterotrophs) that are widespread in nature. Fungal cells are larger than bacterial cells, and their typical internal structures, such as nucleus and vacuoles, can be seen easily with a light microscope. On the basis of their mode of sexual reproduction, fungi are grouped in four classes: Phycomycetes, Ascomycetes, Deuteromycetes (Fungi Imperfectii), and Basidiomycetes. Two major groups of fungi are the yeasts and molds. (also see: Mycelium)

Fungicide An agent that destroys fungi.

Fusion
The melting together of filler metal and base metal, or of base metal only, that results in coalescence.

Fusion Welding
Welding in which the base material is fused together without the addition of filler material to the weld.