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| There are 25 entries in the glossary. |
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| Face Velocity | The velocity obtained by dividing the air quantity by the component face area (NEBB). |
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| Facility Flexibility | A qualitative measure of the number of different products that can be produced in a facility or area of a facility.
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| Facility User | The end user of a facility, often called the Owner, represented by operating, maintenance, and quality control personnel. |
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| 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).
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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 ( |
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| 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. |
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| 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. |
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| 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. |
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| 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. |
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| 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. |
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| Feedwater | The water entering a treatment process. |
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| 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
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| 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
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| 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. |
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| 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
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| 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. |
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| 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. |
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| 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 |
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| 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. |
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| 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. |
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| Finished Product | A medicinal product that has undergone all stages of production, including packaging in its final container. |
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Glossary V2.0 |
