Aseptic handling antineoplastics

Aseptic handling of antineoplastic medicines, such as injections prepared with cyclophosphamide. 

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). 

In many respects the hazards of many antineoplastics and radiopharmaceuticals for staff are similar. Also the required skills for aseptic handling are similar. This may lead to the consideration of designing a standard layout for all premises for handling with extremely hazardous substances. However, for antineoplastics no formal requirement for pressure applies (see Sect. 26.8). Therefore, the viewpoint that overpressure warrants a better microbiological air quality usually will prevail. In addition the validity of negative pressure premises may be impaired as a result of almost unavoidable air leakages. 

Aseptic handling Aseptic processing GMP Annex 1 < Antineoplastics Microbiological controls Monitoring < Validation Qualification... 

Aseptic Handling of Antineoplastics Attaching an infusion system, partly filled with Sodium Chloride 0.9 %, to the infusion bag with antineoplastics ... 

A relevant therapeutic group of active substances, handled aseptically, are parenteral antineoplastics. Many are classified as very toxic for the operator, mainly because of carcinogenicity and reprotoxicity [17], see also Sect. 26.3.3. Therefore, if antineoplastics are involved in aseptic handling, requirements are not only to protect the product against contamination of micro-organisms, but also to protect the operator and the environment from the product. The first measure however is a working procedure to minimise exposure to antineoplastics. This involves... 

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