Aseptic handling complexity

II. Extemporaneous preparations involving specific risks, such as complex aseptic handling and preparation with hazardous substances. Involved in this category is aseptic handling with most antineoplastics, medication cartridges, radiopharmaceuticals, biological or advanced therapy medicinal products (ATMP s). 

Aseptic handling varies in complexity from drawing up the contents of a vial or ampoule into a syringe, to compounding a parenteral nutrition mixture from several separate starting materials. Complexity of aseptic activity has been defined in several texts [6, 10, 11]. 

Medicines produced by aseptic handling are sometimes administered for more than one day (medication cassette, parenteral nutrition etc.). During the administration the product temperarnre is higher than the storage temperatitte, which influences the shelf life. Therefore a second period has to be used, the administration period, which is defined as the maximum time from start to the end of the administration. Both, shelf life and administration period for simple and complex aseptic handling at maximum level of product protection as used in the Netherlands are summarised in Table 31.3 [8]. 

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... 

A natural extension from the simple handling of potent compounds is to use barrier technology to provide highly secure mechanisms for processing and more complex manipulation of powders. Isolators of this type and configuration have the objectives of operator and environmental protection as well as the provision of a secure clean and aseptic environment around the process. 

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