Nanjing Biocell Environmental Technology Co., Ltd.
Nanjing Biocell Environmental Technology Co., Ltd.

A Detailed Explanation Of Pharmaceutical Water System Validation

For the pharmaceutical industry, the reason why the pharmaceutical water purification system is so important is not only the requirements of the pharmaceutical industry regulations and product quality, but also the inevitable development of science and technology, and the result of people's understanding of the law of drug quality improvement and risk control.


Validation Of Steam System For Pharmaceutical Use


Steam is an important public project in pharmaceutical enterprises. It mainly provides heat sources for the preparation of pharmaceutical water and temperature control of process equipment and is used for the sterilization of sterile process equipment, appliances, and final sterilized products. Steam can be roughly divided into industrial steam, process steam, and pure steam.


(1) Industrial steam -- used for heating non-direct contact products, for non-direct impact systems, and can be subdivided into ordinary industrial steam and no chemical added steam.

  • Ordinary industrial steam. The steam prepared by the municipal water softening belongs to the indirect impact system, used for the heating of the production process that does not directly contact, generally as long as the system how prevents corrosion.

  • No chemical added steam. Steam prepared from purified municipal water with flocculant added does not directly affect the system. It is mainly used for air humidification, heating of non-direct contact products, sterilization of non-direct contact product process equipment, inactivation of waste liquid, and so on. The vapor should not contain volatile compounds such as ammonia and hydrazine.


(2) Process steam -- generally a direct impact system, mainly used for heating and sterilization of the final sterilized product, condensate should at least meet the standards of urban drinking water.


(3) Pure steam -- directly affecting the pharmaceutical water purification system. It is prepared by distillation of purified water or water for injection. The condensate shall meet the requirements of water for injection. Mainly used for sterilization of sterile production equipment, pipes, etc. Eu and FDA require that non-condensable gas, dryness and superheat must be confirmed for pure steam sterilization.


Pharmaceutical Water System Design Confirmation

Before construction, the design documents of the pure steam generation system (URS, FDS, DDS, etc.) shall be checked one by one to ensure that they can fully meet all requirements of URS and GMP. Design validation should continue throughout the design phase, from conceptual design to the start of procurement construction, and should be a dynamic process. The design verification of a pure steam generation system should contain at least the following contents.


Review of design documents. All design documents (URS, FDS, P&ID, calculation, equipment list, instrument list, etc.) of the preparation and distribution system are complete, available, and approved.


The quality standard of pure steam. Whether the quality of steam prepared and distributed meets the requirements of the process.


Confirm The Pharmaceutical Water System Installation

The installation of pure steam systems can usually follow the verification requirements of purified water and water for injection systems, but pure steam systems also have their own special verification items.


  • Install the required files for confirmation.

  • Items included in installation confirmation.

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