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设计分析和技术研究确保符合最严格的制药行业监管标准。
基立福工程事业部将设计和设置过程控制（PLC 编程、Scada 系统和触摸屏），确保遵守美国食品药品管理局 (FDA)、cGMP（21CFR 部分 11）要求，并在必要时应用 FDA、cGMP（21CFR 部分 11）和 GAMP4 标准。
通过培训，确保贵组织能够顺利开展生产和遵从法规要求。
基立福工程事业部的专业团队提供以下领域的专业培训：
工程
我们按照欧盟卫生当局和美国食品药品监督管理局 (FDA) 严格的标准开发自己的生物制药项目，以满足生产需求。
机械
我们建造用于改善自动化工艺实施的机械和机器人系统。
Vacuum gauge
A vacuum gauge is a device used to measure the pressure and vacuum in specific spaces.
gmp
Good Manufacturing Practices.
Agglutination technique
Technique for pretransfusion tests based on the Ag-Ab reaction (antigens-antibodies), causing a given agglutination, which can then be observed to determine the blood type. This technique can be performed in a tube, a gel column or on microplates.
ABO blood group system
System used to group human blood into different types depending on the presence or absence of certain markers on the surface of the red blood cells. The four main blood types are A, B, O and AB.
Albumin
Plasma protein fraction commonly used as a macromolecular medium in the incubation of laboratory tests, reducing what is known as the "zeta-potential". As a hemoderivative, it is used as a plasma volume expander and for protein replacement in some cases.
Antibody
Protein synthesized by the body in response to the introduction of an antigen.
Angiography
Exploratory radiological technique in which a contrast fluid is injected into the vascular system to render the blood opaque and thus enable observation of the internal state of blood vessels.
Blood agglutination
Antigens have the capacity to stimulate the immune system, triggering a response in the form of antibodies. This reaction determines compatibility between different blood groups. First, the antigen binds to the antibody. The antibodies then react to the appearance of contrary antigens, causing the red blood cells to form clumps or agglutinate.
Angiogram
X-ray or image of the blood vessels and flow of blood within the body.
Anticoagulant
Substance that prevents or reduces blood coagulation.
Antiglobulin
Antibody that reacts with the plasma globulins.
DNA
Deoxyribonucleic acid: a nucleic acid that contains the genetic instructions used in the development and functioning of all living organisms and some viruses. It is also responsible for hereditary transmission.
Asepsis
Absence of pathogenic micro-organisms.
Antiserum
Serum or reagent that contains specific antibodies (immunoglobulins) against one or more antigens.
Antigen
Foreign body that enters the organism and prompts an immune response.
Artificial vision
This is the process of obtaining, describing and interpreting information from images.
Urea
Crystalline or colorless organic substance found primarily in the blood and urine. It is formed in the liver as an end product of metabolism and excreted in urine and sweat.
Screening
Refers to a preliminary test or study.
Serum
Liquid portion of coagulated blood.
Sulfonamide
Chemical substance derived from colorants, used in the treatment of several infectious diseases.
serology
Biological study of blood serum. Study of the antigen-antibody complexes in serum, to detect the presence of certain diseases.
spectrometer
Device used to study the composition of the light emitted by a source.
Spectrophotometry
Measurement of the relative light intensity of simple emissions.
spectroscope
Optical instrument used to record the spectrum of a given emission.
Spectrophotometer
Instrument combining the properties of a spectrometer and a photometer, used to determine the intensity of any range of wavelengths absorbed by a solution.
spectroscopy
Branch of physics that studies spectrums.
spectrum
Distribution of the intensity of radiation as a function of a given magnitude, such as wavelength, energy or temperature.
Residual transfusion risk
Probability (mathematical or statistical) that the transfusion of a blood component might transmit an infectious agent (virus) after performing tests using direct or indirect detection methods, antigen methods or based on immune response elements.
Rh factor
The Rhesus (Rh) factor is an inherited protein found on the surface of red blood cells. A person is Rh+ if they possess this protein, and Rh– if they don't.
RNA
Ribonucleic acid. This is a nucleic acid formed from a chain of ribonucleotides, present in eukaryotic and prokaryotic cells, which participates in the intermediate stages of protein synthesis, following the program recorded in the genetic code.
Rheostat
Instrument to vary the resistance of an electrical circuit.
Phenotype
The observable characteristics or traits of an organism that are produced by the interaction of the genotype and the environment.
Photometer
Device that measures light intensity.
Pipetting technique
Pipetting involves using a pipette to draw up a given quantity of liquid. The technique allows liquids to be dispensed quickly and accurately.
Photometry
Measurement of light intensity and of corresponding amplitudes.
Plasma
Liquid portion of uncoagulated blood, yellow in color, obtained after separating out the cellular elements. Contains water, electrolytes, proteins, fats and proteins.
Pyrogenic
Fever-inducing.
Lyophilized plasma
Plasma that has undergone lyophilization to extend its shelf life.
Platelets
Platelets, also referred to as thrombocytes, are tiny fragments of cytoplasm from very large cells called megakaryocytes. Platelets are formed from these large cells in the bone marrow and are released into the bloodstream, where they are essential for enabling normal blood coagulation.
Plasmapheresis
Technique by which whole blood is extracted from a donor and processed to separate the white blood cells, red blood cells and platelets from the plasma. The blood cells are then returned to the donor, minus the plasma, which the body can replace rapidly.
Nomogram
Graphic representation that enables rapid approximate numerical calculation (nomography).
nat
Nucleic Acid Testing: RNA and DNA tests to detect infectious viral agents based on the amplification of nucleic acid fragments.
Nephritis
Inflammation of the kidneys.
Microplate technique
Technique to observe agglutination, using plates with multiple wells which are used as small test tubes. This technique enables automation of the process and is used for large series of samples.
Microcentrifuge
Specialized centrifuge used in a clinical laboratory for capillary tubes.
Lyophilizer
A lyophilizer is a device used to perform lyophilization.
Lyophilization
Conservation method that consists of conducting a sublimation process by dehydrating a substance through rapid freezing, and transforming the ice humidity into vapor by means of the application of vacuum.
Immunoglobulin
Plasma protein associated with immune processes. All antibodies are immunoglobulins, but not all immunoglobulins perform the antibody function.
Hematocrit
The volumetric proportion of red blood cells in the blood. This value is obtained by performing a blood test in a laboratory. The normal hematocrit values depend on the references selected by the laboratory. In general, average values are between 41% and 51% for men, and between 36% and 45% for women.
Hemolysis
The process of decomposition of red blood cells.
Hemostasis
Hemostasis is the interruption of hemorrhage either spontaneously or by physical means, such as manual compression or tourniquet, or chemical means, such as the use of drugs.
Inoculate
Introduce into an organism a substance that contains the germ of a disease.
Incubator
Device that regulates the optimum temperature, humidity and ventilation to preserve and grow microbiological and cell cultures in a laboratory. Essential for much experimental work in biology, and in pharmaceutical, hematological and biochemical studies, among others.
Hemogram
Study that makes it possible to identify the composition of blood and which is used as a clinical analysis tool.
Genotype
An individual's set of genes.
Heparin
Heparin is a natural substance in the blood which interferes with the blood clotting process. It acts on a substance called thrombin, which plays an important role in the formation of blood clots.
Heparinization
Treatment with heparin to prevent blood coagulation.
Globulin
Particular class of protein, to which antibodies belong.
Genotyping
Genotyping is the process by which differences in the genetic makeup or genotype of an individual are identified by analysis of their individual DNA sequence. This can be done by comparing the genotype with another individual's sequence or with a reference sequence.
Flebula
Glass tube with vacuum, used to obtain blood samples for clinical analysis under aseptic conditions.
ELISA technique
Enzyme-linked immunosorbent assay: immunological technique where the reaction between antigen and antibody is detected by spectrophotometric determination of the action of an enzyme that is linked to the antigen or antibody. It is cheaper and simpler than radioimmunoassay, with similar effectiveness. It is also called enzyme immunoanalysis or enzyme immunoassay.
edta
Ethylenediaminetetraacetic acid: an anticoagulant used in hematology.
glp
Good Laboratory Practice.
Red blood cell
Red blood cells, also referred to as erythrocytes, are the most common type of blood cell, and are responsible for transporting oxygen from the lungs to the different tissues, organs and systems of the body, a task they perform thanks to a protein called hemoglobin.
Centrifuge
Laboratory instrument that applies centrifugal force to accelerate the separation of solid particles suspended in a liquid, based on their density. It is used, for example, to separate plasma and blood serum from blood cell components during analysis for blood testing.
Sodium citrate
Sodium citrate is the sodium salt of citric acid. It is used as an anticoagulant in tubes used to extract blood in some laboratory tests that measure blood clotting time, including activated partial thromboplastin time and prothrombin time. The concentration of sodium citrate used as an anticoagulant is an important pre-analytic variable because blood plasma clotting time may vary as the quantity of citrate present affects the concentration of calcium used in these tests.
Coombs test
Diagnostic test that can detect the presence of antibodies in the serum that react with antigens on the surface of the red blood cells. Used to diagnose blood disorders in which the patient produces antibodies against their own red blood cells and platelets. Also used to determine blood type.
Gel column agglutination technique
Agglutination technique to determine blood groups and for transfusion compatibility studies, which uses gel as a reagent. This gel sits in columns on cards of 6 to 8 wells.
Amino acid
Organic chemical substance that is the basic component of proteins. Amino acid solutions are one of the components of parenteral nutrition mixtures and must be administered in combination with appropriate quantities of energy preparations for infusion (solutions of carbohydrates and/or lipid emulsions).
Cross contamination
Microorganism contagion from patient to health professional, from health professional to patient, or from patient to patient. Occurs when microorganisms are transferred to nearby equipment, clothing or furniture.
Chemotherapy
Treatment with drugs to interrupt the formation of cancer cells, whether by destroying them or by preventing them from multiplying. Chemotherapy is administered orally, by injection, by infusion or onto the skin, depending on the type of cancer and the stage of the disease. It is administered alone or combined with other treatments such as surgery, radiation therapy or biological therapy.
Carousel
Revolving cabinets. The contents of the system are transported by a structure that rotates either vertically or at floor level. Both systems facilitate the product selection process by transporting the items to the operatives. Carousels optimize storage space and selection time.
Blister pack
Package consisting of two layers, normally plastic and metal (aluminum), heat-set to form ampoule-shaped cavities which can contain individual doses of the product. This form of presentation facilitates identification of the tablet and protects individual tablets from external agents.
Autoclave
Device that uses water vapor at high pressure and high temperature to destroy microorganisms, in order to achieve asepsis. Used to sterilize non-disposable hospital and surgical material, in the manufacture of parenteral solutions, and with other products that need to be sterilized and can withstand this physical process.
Enteral
Introduced into the organism via the gastrointestinal tract, whether orally or via the nasogastric route.
FDA
Acronym of Food and Drug Administration. The government agency of the US Department of Health and Human Services that is responsible for regulating food, drugs, biological products and blood-derived products.
Industrial filling
In the pharmaceutical industry, the standardized process of aseptic filling of pharmaceutical products, parenteral solutions or plasma-derived products.
Cryoprecipitate
The fraction of plasma proteins that remains insoluble when the fresh frozen plasma is thawed under appropriate temperature conditions. Contains factor VIII (coagulant, 80–120 U), von Willebrand factor VIII, fibrinogen (around 250 mg), factor IX, factor XIII and fibronectin.
Cytostatic
Refers to a drug or therapy used to treat cancer by inhibiting cell proliferation, such as in anti-tumor treatments.
Hemoderivative
Substance or product derived from blood or plasma. Pharmaceutical preparations whose active principle comes from the blood of healthy donors via an appropriate fractionation and purification process, and which cannot be obtained using chemical or biological synthesis methods.
Fractionation
Separation of therapeutic proteins from plasma using physical and chemical processes.
Fluid therapy
Therapy consisting in the parenteral administration of liquids and electrolytes, in order to maintain or reestablish homeostasis in the patient's body. The main objectives are to maintain adequate hydration and tissue perfusion with electrolytic equilibrium.
Gene therapy
Any treatment consisting in introducing specific genes into the patient's cells to combat certain diseases.
Injection
Action and effect of introducing a gas, liquid or drug solution into a blood vessel, body cavity or tissue under pressure using a syringe or suitable instrument.
Intravenous infusion
Technique of introducing a liquid into the bloodstream in order to hydrate the patient or administer a drug.
Hemophilia
Hereditary disease, transmitted by autosomal recessive inheritance – the presence of two copies of an abnormal gene – and sex-linked, in which there is a deficit in the production of various plasma factors that are essential to correct blood coagulation: factor VIII (hemophilia A) and factor IX (hemophilia B).
Intravenous therapy
Any treatment consisting in the administration and monitoring of liquids, medicines or both into the general bloodstream by piercing a vein. The aim is to ensure maximum therapeutic impact in comparison to oral therapy, which tends to take longer to act and be less effective.
Intravenous mixture (IVM)
Preparation obtained by adding medicines for intravenous use to containers of solutions for fluid therapy. Can be prepared either by reconstitution (by dissolving a solid medicine in a solvent) or by mixing preparations in an existing watery solution.
Laser
Acronym of Light Amplification by Stimulated Emission of Radiation.
Nosocomial disease
Refers to disease or infection acquired in a hospital or health facility.
Oncology
Branch of medicine that manages the treatment of anomalous cell proliferation (tumor) using cytostatic drugs, radiation therapy, immunosuppression or surgery of cancerous tumors.
Clinical nutrition
Medical discipline that improves the quality of life of patients with a range of pathologies by providing specific nutritional therapy to patients who find it difficult or impossible to ingest food, or provided as a complement to food.
Lipid
Name given to fatty materials and analogous triglycerides. Lipid solutions or emulsions are mixtures created by dissolving lipids in a liquid for intravenous use.
Ranitidine
Drug that inhibits the secretion of gastric acid, used in the treatment of stomach ulcers.
Sensor
In medicine, device that responds to a stimulus, such as heat, light or pressure, and produces a signal that can be measured or interpreted.
Polypropylene
Thermoplastic obtained by polymerizing propylene, a gaseous by-product of petroleum refining. It is an inert material that is suitable for the preparation of some intravenous mixtures that are incompatible with other plastics.
Perfusion
In medicine, the action of introducing a liquid such as blood, serum or antibiotic into the body intravenously in a slow, sustained manner.
Perfusion System
Device used to administer intravenous liquids, consisting of a plastic tube, a regulating clamp, a connection and a syringe.
Parenteral
Introduced into the organism by a pathway other than the digestive tract, such as intravenous, subcutaneous, intramuscular or intradermal. Parenteral solutions are typically constituted with saline solution, gluconate or a combination of these, and may contain amino acids, electrolytes, vitamins or drugs, or they may be lipid emulsions of various products that are not water-soluble.
Sterile
Free of pathogenic germs. Aseptic.
Taurine
Organic compound belonging to the amino acid group, present in some foods of animal origin and also occurring naturally in some of our body tissues. Intervenes in the formation of bile and many other functions. Its name derives from the Latin taurus (meaning bull) because it was first isolated in the bile of a bull in 1827 by the German scientists Friedrich Tiedemann and Leopold Gmelin.
Intravenous
Existing, occurring or administered in one or more veins.
Vial
Small flask containing injectable medicine, from which doses of the medicine are extracted as required.
Clean zone
Room that has been specially designed to ensure low levels of contamination. The cleanliness and environmental parameters such as temperature, humidity, light levels, pressure and flow of particles in the air are strictly controlled to comply with specified parameters.
Jacketed vessel
Tank designed to control the temperature of its contents through the use of an external cavity ("jacket") through which fluid is circulated, permitting heat exchange to produce uniform cooling or heating of the contents.
Diaphragm pump
A diaphragm pump is a type of positive displacement pump, generally alternating, in which pressure is increased through the action of elastic walls – diaphragms or membranes – that vary the volume in the chamber, alternately increasing and reducing it. Retention valves control the movement of fluid from the lower pressure to the higher pressure zone.
Photocolorimeter
Type of colorimeter. Instrument used in chemistry to determine concentration of substances dissolved in liquids or solids so long as they are transparent to visible, ultraviolet or infrared light, measuring and comparing their colors.
Blood typing
Analysis to determine ABO blood group and Rh type. It is always used before transfusion of blood or blood components and when blood is donated. It is also used on pregnant women to determine the risk of Rh incompatibility between mother and fetus.
Capillary tube
Fluid conduit with an interior diameter similar to that of a hair. Can be made from a variety of materials: glass, copper, metal alloys, etc., depending on its use or application.
Antiseptic
Substance that destroys or inhibits the growth of microorganisms.
