Reconstitution aseptic handling

The reconstitution of parenteral medicines in the strict sense as well in the extended sense (see Sect. 1.2.1) is very frequently performed in hospital pharmacies. The right performance of this process requires extensive precautions on procedures, premises, validation and control. However these differ considerably, due to working with closed systems, from the generally accepted precautions for aseptic processing from raw materials. The use of the term aseptic handling therefore was felt justified. 

Reconstitution of parenterals is commonly performed on hospital wards by physicians or nurses. The risk of erroneous preparatimi and microbiological contamination during handling, can be reduced if the hospital pharmacy performs recOTistitution under specific precautions (see also Sect. 31.3 Aseptic handling). These reconstituted medicines are supplied to the wards either labelled for individual patients or as a batch as ward stock. Common products that are reconstituted in the pharmacy instead of on the wards (see also Sect. 31.3.2) ... 

Hygienic handling is the most important factor for good aseptic handling, both in the pharmacy and during reconstitution on hospital wards (see Sect. 31.3.3). 

Very short shelf lives limit the time frame for reconstitution, aseptic handling, transport and administration of the medicine or do not allow for the preparation in advance for the weekend. Using specific information sources [68-71] can be very helpful to find justification for longer shelf lives. Some examples ... 

I. Extemporaneous sterile and non-sterile preparations Examples of this kind of preparations are Aseptic handling, i.e. uncomplicated operations with sterile medicines in closed containers after which they get a very short usage period, reconstitution of sterile and non-sterile authorised medicines and extemporaneous non-sterile preparations from raw materials. 

The underlying principles for premises for non-sterile stock preparations should be used for extemporaneous preparations as well. Preparation activities in a community pharmacy usually are confined to reconstitution, aseptic handling, manipulation of licensed medical products and non-sterile preparation firom raw materials. The avoidance of crossing process lines in small-scale situations is a... 

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... 

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