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Basic requirements of gmp soft dosage forms

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СATALOGUE / EQUIPMENT WITH REVIEWS / PHARMA / OINTMENT PRODUCTION / ANTIBACTERIAL OINTMENT / Basic requirements of gmp soft dosage forms

Basic requirements of gmp soft dosage forms

In the manufacture of ointments, creams and other soft dosage forms, there is a particularly high risk of microbial and other contamination. Consequently, special measures are required to prevent any contamination. Soft dosage forms have specific rheological properties and are in most cases heterogeneous dispersed systems. Therefore, in order to avoid product heterogeneity due to uneven distribution of components, formation of gas emulsions and destabilization of disperse systems, special attention should be paid to the correct conduct of the technological process, the equipment used and the temperature conditions of product storage.
Requirements to production premises and equipment. The environment of the premises, taking into account all measures to protect production, should present the lowest possible risk of contamination of materials and products.

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  • Information updated : 10 / 03 / 2025
  • In stock
  • Manufacturer : 1 year for Basic requirements of gmp soft dosage forms

Model: Soft dosage forms

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Materials (cardboard, wood chips, etc.) from which fibers or other contaminants may be separated must not be located in areas where products or clean containers are not protected from the environment. During packaging, it must be ensured that the homogeneity of mixtures, suspensions, etc. is maintained. Mixing and filling processes must be validated. To ensure that the homogeneity of the product is maintained, special care must be taken at the beginning and 6 end of the filling process, as well as after interruptions. If bulk products are not immediately packed and finished products are not immediately packaged, the maximum storage times and conditions for these products must be established and strictly observed.

Pharmaceutical Glossary

Articles  — A genre of journalism in which the author sets the task of analyzing social situations, processes, phenomena, primarily from the point of view of the regularities underlying them.
Blog Business Business plan Buy a business Classification of ointments Commerce Company Cream packaging Cream production Dosage forms Equipment catalog Equipment for production of soft dosage forms Innovation Investments Medications Medicinal substances Novelty Ointment packaging Ointment production Pharmaceutical equipment Production Production of soft dosage forms Soft dosage forms Startup Technology of production of soft dosage forms

Technical specifications

Closed systems are recommended for the manufacture and transportation of products to protect them from contamination. Production areas where products or open containers are not protected from the environment should generally be effectively ventilated with filtered air. Tanks, containers, piping and pumps should be designed and installed so that they can be easily cleaned and sanitized if necessary. In particular, equipment should be designed to minimize “dead” areas or areas where product residues could accumulate, creating a breeding ground for microorganisms. Where possible, the use of glass equipment should be avoided. Parts of the equipment that come into contact with the product should generally be made of high quality stainless steel.

Additional information

Process requirements. The quality of the water used should be established and monitored with respect to chemical and microbiological purity. Care should be taken when maintaining water supply systems to prevent the risk of microbial growth. Any chemical sanitation of water systems should be followed by flushing according to a validated methodology that ensures effective disinfectant removal. The quality of substances received in angro containers should be checked before they are placed in storage tanks. When materials are transported via pipelines, it must be ensured that they are delivered strictly to their destination.

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Roman Tsibulsky pharmaceutical equipment supplier www.Minipress.ru

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