Irrigations preparation method

Method of preparation, release control and quality requirements of sterile vaginal solutions are the same as for irrigation solutions (Preparations for irrigation Ph. Eur., see Sect. 14.7). Preparation method and release controls of non-sterile vaginal solutions are the same as for solutions for cutaneous use (see Sect. 12.6.5). 

Because irrigations are used in or on body areas that are usually sterile or have a low degree of contaminatiOTi, there are strict requirements for their production and quality control. In this chapter the use, the design of formulation and preparation method as well as the on site preparation of irrigations will be discussed. With regard to solutions for various types of dialysis, the use of concentrates, the water quality and the requirements for bacterial endotoxins are fully discussed. 

For irrigatiOTis steam sterilisation in its final container for 15 min at 121 °C (see Sect. 30.5.1) is preferred. These are the same requirements as for parenteral solutions. An aseptic preparation method with bacterial filtration through a 0.2 pm filter, followed by heating at 100 C for 30 min (or another proper combination of temperature and time or validated aseptic conditimis) is an alternative when one of the substances is sensitive to a higher temperature. If an active substance is not heat resistant at all, only an aseptic preparation with bacterial filtration over a 0.2 pm filter is possible. In such cases the starting materials should be sterile or have a low bioburden and the irrigation should be prepared asep-tically. See also Sect. 30.6. 

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