GB/T 50902-2013Standard for fundamental terms of pharmaceutical engineering (English PDF)

1 General provisions

1.0.1 The standard was drawn up in order to unify the fundamental terms of pharmaceutical engineering and their definitions, to standardise the professional vocabulary, to help technical exchange in pharmaceutical engineering and to advance pharmaceutical engineering technology.

1.0.2 The standard applies to the planning, design, construction, acceptance, quality inspection and qualification of newly built, rebuilt and extended pharmaceutical works.

1.0.3 Besides the provisions of this standard, the fundamental terms of pharmaceutical engineering shall also meet the relevant current national standards.

2.1 Production

The clause is divided into five groups, printed with the headings I active pharmaceutical ingredient production, II preparation production, III traditional Chinese medicine production, IV biological fermentation and V others.

2.1.1 Active pharmaceutical ingredient (API): any substance or mixture of substances used in the manufacture of a medicinal product which, when so used, becomes an active ingredient of that product; such a substance has pharmacological activity or another direct effect in the diagnosis, treatment, relief of symptoms, handling or prevention of disease, or can affect the function or structure of the body.

2.1.2 Bulk pharmaceutical chemicals (BPC): a pharmacologically active ingredient produced by a one step or multi step chemical reaction route.

2.1.3 API intermediates: chemical raw materials or chemical products used during the synthesis of a medicinal product in order to carry the process forward, so as to reach the final synthesised drug, that is intermediate products.

2.1.4 API starting materials: a raw material, intermediate or active pharmaceutical ingredient used in the production of a given active pharmaceutical ingredient and becoming an important structural part of it; the starting material may be an article of commerce, bought from one or several suppliers under contract or commercial agreement, or made in house, and it normally has a well defined chemical nature and structure.

2.1.5 Critical steps: the one or more steps at which failure of the process or contamination would make it impossible to obtain a drug active ingredient of the intended properties and impurity content, or to obtain the intended therapeutic effect.

2.1.6 Dedicated facility: a facility used solely for the production of one active pharmaceutical ingredient or one intermediate.

2.1.7 Multi-use facility: a facility usable for the production of several active pharmaceutical ingredients or intermediates, in which each drug or intermediate is nevertheless handled on a defined production equipment line.

2.1.8 Multi-purpose facility: a facility holding several non dedicated production lines for active pharmaceutical ingredients, on which several products can be made at the same time or in turn.

2.1.9 Dangerous chemicals: highly toxic chemicals and other chemicals that are poisonous, corrosive, explosive, combustible or combustion supporting and are harmful to people, installations and the environment.

2.1.10 Major hazardous resources for dangerous chemicals: a unit, including its site and its facilities, in which dangerous chemicals are produced, stored, used or transported and in which the quantity of dangerous chemicals equals or exceeds the threshold quantity.

2.1.11 Dangerous chemicals production: the production of final products or intermediates listed in the Catalogue of Dangerous Chemicals.

2.1.12 Mother liquid: the residual liquid left after crystallisation or separation.

2.1.13 Preparation, formulation: a medicinal form of the stated specification made from an active pharmaceutical ingredient by a defined preparation process, according to the pharmacopoeia, a drug standard or another suitable prescription.

2.1.14 Liquid preparation: a liquid medicinal form for internal or external use, made by dispersing the drug in a liquid medium.

2.1.15 Oral solid dosage, solid preparation: a solid medicinal form obtained from the active ingredient by a defined preparation process, such as tablets, capsules, granules, pills and films.

2.1.16 Oral dosage: a medicinal form given by mouth and absorbed through the digestive tract to produce its therapeutic effect.

2.1.17 External preparation: a drug preparation applied to the body surface so as to produce a local or a systemic effect.

2.1.18 Injection, parenteral dosage: a sterile preparation made of the drug with a suitable solvent or dispersing medium, as a solution, emulsion or suspension for injection into the body, or as a powder or concentrated solution to be made up or diluted into a solution or suspension before use; it covers injection solutions, sterile powders for injection and concentrated solutions for injection.

2.1.19 Large volume parenterals (LVPs): injections with a volume equal to or greater than 50 mL, also called large volume infusions.

2.1.21 Small volume parenterals (SVPs): injections with a volume of less than 50 mL.

2.1.23 Aseptic powder for injection: a sterile powder or sterile block made from the drug, to be made up before clinical use with a suitable sterile solution into a clear solution or an even suspension; it may be obtained by solvent crystallisation, spray drying or freeze drying.

2.1.25 Sustained release preparation: a preparation that releases the drug slowly and at a non constant rate in the stated release medium as required, whose dosing frequency is halved or otherwise reduced compared with the corresponding ordinary preparation and which markedly improves patient compliance.

2.1.26 Controlled release preparation: a preparation that releases the drug slowly and at a constant rate in the stated release medium as required, whose dosing frequency is halved or otherwise reduced compared with the corresponding ordinary preparation, whose blood concentration is steadier than that of a sustained release preparation and which markedly improves patient compliance.

2.1.30 Soft capsule, soft gelatin capsule: a capsule in which a measured quantity of liquid drug is sealed directly, or in which a solid drug is dissolved or dispersed in a suitable vehicle to form a solution, suspension, emulsion or semi solid, sealed in a spherical or oval soft capsule shell.

2.1.34 Paste: a semi solid external preparation in which a large quantity of solid powder, generally more than 25 %, is evenly dispersed in a suitable base.

2.1.73 Herbal medicine granules: a series of pure traditional Chinese medicine products made from traditional Chinese medicine decoction pieces as raw material by modern pharmaceutical techniques of extraction, concentration, separation, drying, granulation and packing; they carry the full therapeutic effect of the original decoction pieces, need no decoction, are safe and hygienic and are convenient to carry and to take.

2.1.81 Medium: an artificially prepared nutrient for the growth and maintenance of micro organisms and of plant and animal tissue, generally containing carbohydrates, nitrogenous substances, inorganic salts including trace elements, growth factors and water.

2.1.83 Biological products: preparations made from micro organisms, cells, animal or human tissue and body fluids as raw material by traditional or modern biotechnology, used for the prevention, treatment and diagnosis of human disease; biological products for human use include bacterial vaccines containing toxoids, viral vaccines, antitoxins and antisera, blood products, cytokines, growth factors, enzymes, in vivo and in vitro diagnostic preparations and other active biological preparations such as toxins, antigens, allergens, monoclonal antibodies, antigen antibody complexes, immunomodulators and micro ecological preparations.

2.1.87 Medicinal gas: a gas or gas mixture given to a patient for the purpose of treating, diagnosing or preventing disease through its pharmacological action, and supplied as a medicinal product.

2.1.88 Oxygen for medical use: oxygen for clinical use meeting the quality standard of the Chinese Pharmacopoeia.

2.2 Process

2.2.1 Inoculation: the process of transferring the target micro organism into the culture medium under aseptic technique requirements.

2.2.2 Cultivation: the process of multiplying animal and plant cells by means of a culture medium.

2.2.3 Fermentation: the process in which organic matter is oxidised and broken down by an organism into oxidation products with release of energy.

2.2.4 Separation: the process of grading and parting a two component or multi component solute or solvent, a liquid solid, gas solid or gas liquid system, or solid particles by size.

2.2.5 Crystallization: the process by which the solute comes out of a supersaturated solution and forms crystals.

2.2.6 Centrifugation: a method that uses differences in density and similar properties, the centrifugal force produced by rotation causing particles or solute to settle, so that they are separated, concentrated, purified and identified.

2.2.7 Filtration: a separation method in which a porous medium, a sieve plate or a filter membrane, holds back the larger particles while matter smaller than the pores passes through; it is used mainly for separating suspensions.

2.2.8 Micro-filtration: a filtration process using as filter medium a membrane whose pore size is of the order of micrometres.

2.2.9 Hyper-micro filtration: a filtration process using as filter medium a microporous membrane whose pore size lies between the micrometre and the nanometre range, from 0,005 µm to 1 µm.

2.2.10 Nanofiltration: a filtration process using as filter medium a microporous membrane whose pore size is of the order of nanometres.

2.2.11 Reverse osmosis (RO): a filtration process using as filter medium a reverse osmosis membrane whose pore size is not greater than 1 x 10 to the power minus 10 m.

2.2.12 Extraction: the process of using the different solubilities of substances in a chosen solvent to separate the components of a mixture, or to extract and separate the active constituents of a solid material.

2.2.13 Extraction: the process of leaching the active constituents out of a material with a suitable solvent at a defined temperature and pressure.

2.2.14 Dynamic extraction: an extraction process in which a stirring device or other mechanical means keeps the material in motion.

2.2.15 Reflux extraction: an extraction process in which the secondary vapour is condensed and used again as the circulating solvent.

2.2.16 Continuous reflux extraction: an extraction process in which the solvent flows continuously and counter currently into several charging buckets holding the solid material, the concentration difference bringing the active constituents of the drug quickly into solution.

2.2.17 Microwave extraction: an extraction process in which microwaves are used to penetrate the cells of the medicinal material soaked in a polar solvent, so that the active constituents dissolve quickly.

2.2.18 Ultrasonic extraction: an extraction process in which ultrasound produces an impact force on the medicinal material soaked in a polar solvent, breaking the cell membranes so that the active constituents dissolve quickly.

2.2.19 Supercritical extraction: an extraction process carried out on the material near the critical point, using the properties of a fluid in the supercritical state, in which both its temperature and its pressure are above the critical point.

2.2.20 Heat exchange: the process of exchanging heat between fluids by means of their temperature difference.

2.2.21 Evaporation: the process in which heating vaporises and removes part of the solvent of a solution, so that the solution is concentrated or the solute comes out.

2.2.22 Rising film evaporation: the process in which the solution in the heating tube is carried along by the rising vapour and moves rapidly upward as a film along the tube wall while it evaporates.

2.2.23 Falling film evaporation: the process in which the solution in the heating tube descends as a film along the tube wall under gravity while it evaporates.

2.2.24 Multi-effective evaporation: the process in which the secondary vapour produced by one evaporation is led to the next evaporator as the heat source for a further evaporation.

2.2.25 Thermodynamic evaporation: the process in which the secondary vapour is compressed by a pump, its low temperature heat being taken up so that its temperature is raised and it is then used as the heat source for a further evaporation.

2.2.26 Vacuum evaporation (concentration): the process of evaporating under vacuum, that is under reduced pressure.

2.2.27 Distillation: the process of separating the components of a liquid mixture by their different volatilities.

2.2.28 Rectification: a distillation method in which reflux is used to obtain a high purity separation of a liquid mixture.

2.2.29 Molecular distillation: a distillation process under high vacuum in which the distilling component escapes from the evaporating surface and flies directly to the condensing surface without collision, where it condenses.

2.2.30 Drying: the process of removing the moisture, water or another solvent, from a wet material by vaporising it with heat energy or by low temperature sublimation, so as to obtain a dry material.

2.2.31 Convection drying: the drying process in which a hot gas in convection is in direct contact with the wet material, mass transfer and heat transfer taking place between them.

2.2.32 Air stream drying: the drying process in which a dry hot gas stream of a certain velocity keeps the wet material suspended in it and dries it while conveying it.

2.2.33 Fluid bed drying: the drying process in which the wet material is put into the fluidised state and exchanges heat with the heat carrying gas.

2.2.34 Vibrating fluid bed drying: the process in which vibration and the hot gas stream together bring the wet solid material into the fluidised state for drying.

2.2.35 Flashing drying: the process in which the wet material, under the double action of the hot gas stream and of stirring, is dispersed into fine irregular particles and dried rapidly by full heat exchange with the gas stream.

2.2.36 Spraying drying: the process in which the feed liquid is sprayed by an atomiser into droplets dispersed in a hot gas stream, so that the wet component evaporates rapidly.