In the pharmaceutical industry, Biocell provides professional solutions for purified water system, water for injection system, pure steam system, storage and distribution system in terms of water demand for medical infusion, injection, freeze-dried powder injection, oral liquid, solid preparation and other dosage forms.
They are individually customized based on the feed water quality and the production requirements. A variety of optional equipments are available with all units and the instrumentation can be adapted to clients' in-hose standards. The software programs are developed to follow the GAMP guidelines.
Oral liquid is a clear liquid preparation for oral use, which uses purified water as the solvent and contains one or more drug components. The drug is dissolved in a suitable solvent.
Purified water is the process water used in the production of solid preparations, usually used for ingredients or cleaning. The quality of purified water is directly related to the quality of drugs produced.
Large volume injection is commonly known as large infusion, which usually refers to liquid sterilization preparations with a capacity of 50 ml or more that are directly injected into the body by intravenous drip. Water for injection is the most widely used process raw material in the production of large infusion and participates in the entire production process, including the dissolution of raw and auxiliary materials, volume determination and preparation with finished products, equipment and system cleaning, etc.
The freeze-dried powder injection is a preparation made by dissolving the medicinal ingredients with water for injection, preparing a solution of a certain concentration, sub packaging it in containers such as ampoules or vials, freezing it under low temperature in a sterile and closed environment, and then sublimating the water for injection in the product by reducing the ambient pressure and slowly increasing the product temperature, leaving a solid form of loose blocky or powder drugs. When using, it is necessary to add water for injection to dissolve the drug into solution and then use it for injection or infusion to treat diseases.
Pure steam sterilization can kill all microorganisms and is a very thorough sterilization method. For high-temperature resistant individuals that cannot be effectively killed by conventional disinfection and sterilization methods, such as bacterial spores, fungal spores or dormant bodies, pure steam sterilization can completely kill these organisms. The steam temperature of sterilization increases with the increase of steam pressure. When the steam pressure is increased, the sterilization time can be greatly shortened. At present, for the water system, the pure steam sterilization parameters are usually set to 121 ℃ and 30 min sterilization time.
The pure steam used for humidification of HVAC system in key process posts can prevent amine and hydrazine impurities in the steam, which will seriously pollute drugs.
Water is the most widely used raw material in the pharmaceutical industry.
Pharmaceutical water mainly includes purified water, water for injection and pure steam.
Water for injection and pure steam are used in many areas of the pharmaceutical industry. Pure steam is mainly used to disinfect products in process tanks, filters, piping systems and sterilizers, and also for air humidification in clean room systems. Water for injection is used for the production of drugs and intermediates, as well as the final cleaning of equipment.
The purified water system based on reverse osmosis and EDI module adopts the latest technology, such as thermal disinfection. According to the raw water quality and production requirements, the most suitable purified water preparation process and equipment are customized for different working conditions.
All devices have a variety of optional components, instruments and meters can be adjusted according to the specific needs of customers, and equipment control software programs are designed and developed according to GAMP validation guidelines.
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