Parenteral preparations aseptic handling

Some European countries have developed national guidelines for the preparation of ready to administer products in hospital pharmacy (German Society of Hospital Pharmacists Guideline for the aseptic preparation of ready to use-/administer parenterals) or at the hospital ward (Dutch Society of Hospital Pharmacist Guideline for the preparation prior to use on the ward) [49, 50]. For further information on aseptic handling see Chap. 31. 

Sterile medicines, and parenterals in particular, often require reconstitution (sometimes in excess of the SmPC) to make them ready to administer. Reconstitution of parenteral products requires aseptic handling (see Sect. 31.1). This handling can be simple (drawing up of a solution in a syringe for direct injection) or complex (preparation of a cassette reservoir with a number of substances for continuous... 

Handling and filling of aseptically prepared products, including small and large volume parenterals, should be done in a Grade A environment with a Grade background. 

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