Aseptic handling pharmacies

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) ... 

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. 

Controlled environments also regard to aseptic handling in pharmacies, where they are achieved using laminar flow cabinets, biological safety cabinets or isolators (see Sect. 28.4). 

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). 

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... 

In pharmacies a laminar flow unit is used to protect the product against microbiological contamination from the operator. With a cross flow LAF cabinet the HEPA filtered air is directed over the working area to the operator. This type of LAF bench thus cannot be used for operations with hazardous substances (hazardous being defined as any substance with a H statement, so with a hazard class higher than one, see Sect. 26.3.1). It can be used for aseptic preparation processes with closed systems, such as aseptic handling, see Chap. 31. 

A safety cabinet is a laminar down flow cabinet, which is constructed specifically for protection of both the sterile product and the operator. It is frequently used in (hospital) pharmacies for aseptic preparation (when products are not fully closed) and for aseptic handling of class 4 or 5 substances (see Sects. 26.5.2 and 26.8). Laminar down flow has the advantage compared to cross flow that the operator does not feel the continuous flow in his direction. Other names for a safety cabinet are biosafety cabinet, biosafety bench, biohazard bench, biohazard cabinet, biological safety cabinet etc. 

Within pharmacy, aseptic handling is carried out in a controlled environment by trained staff. In any hospital, however, aseptic handling also takes place in clinical areas such as wards and operating theatres [4, 5]. This chapter only discusses aseptic handling in pharmacy. Aseptic handling in clinical areas is described in Sect. 13.8. 

In 2008 the Pharmaceutical Inspection Convention published the PIC/S guide to good practices for the preparation of medicinal products in healthcare establishments [2]. Although this document is a stand-alone document and should be used for PIC/S related inspections, it is used more and more as a reference for preparation including aseptic handling in pharmacies in Europe. 

USP Chapter <797> Pharmaceutical compounding -Sterile preparations describes the conditions and practices for all sterile preparations in compounding pharmacies in the United States [6]. The so-called compounded sterile preparations (CSPs) are divided into low-risk level, medium-risk level and high-risk level. Low- and medium-risk levels use closed systems and cover aseptic handling in controlled environments. 

In 1996, the Dutch Association of Hospital Pharmacists wrote, in close cooperation with the Dutch Healthcare Inspectorate, a GMP guide for hospital pharmacy. The Chapter Aseptic Handling in this guide has been reviewed in 2005 and 2013 and covers aseptic handling in the hospital pharmacy as well as in clinical areas [8]. Different levels of product protection are defined. 

Fig. 31.3 Monitoring results over 1 year during/after aseptic handling in a Dutch hospital pharmacy. Every bar is a positive, the continuous line is the mean values over the last 100 samples...

GMP-H(ospital pharmacy) from the Dutch Society of Hospital Pharmacists NVZA, The Netherlands (in Dutch), contains the interpretation of GMP guidelines and Addenda on Formulation and Preparation method design, Extemporaneous preparation. Aseptic handling and Occupational Health and Safety [11]. 

Needlestick and sharps injuries (NSI) are a common occupational hazard for healthcare workers. Although nurses are most at risk fi om needlestick and sharps injuries, it may also affect pharmacy staff, for instance at the collection and handling of patients waste (i.e. insulin syringes) and at aseptic processes. 

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