Aseptic handling procedure

The verihcation of aseptic processes entails the use of media to assess the suitability of the handling procedures. 

Instmction on the basic principles of aseptic processing and the relationship of manufacturing and handling procedures to potential sources of product contamination... 

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. 

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... 

Several limitations on the synthetic techniques that can be employed are imposed by the need for rapidity and minimization of handling because of the radiation hazard, and the low concentration and small physical quantities of the compounds. Purification steps should be eliminated if possible by optimizing yields. Where purification is unavoidable, simple procedures are employed such as use of anion exchange columns to remove perrhenate (the most common contaminant in the final product). A variety of disposable sample preparation columns are well suited to this purpose and are available containing small quantities of anion or cation exchange materials (0.1 to 0.5 g typically) such as quaternary ammonium-, primary ammonium-, or sulfonate-derivatized silica. Reversed phase columns are also often used (C8 or C18-derivatized silica). The purification is often thus reduced to a simple filtration step which can be performed aseptically. 

A laboratory must provide adequate and, if necessary, separate space for the performance of routine and specialized procedures. Examples of specialized procedures include aseptic surgery, necropsy, histology, radiography, handling of biohazardous materials, and cleaning and sterilizing of equipment and supplies. 

Careful use of aseptic techniques of carrying out procedures, including simple procedures, such as handling central venous catheters. 

Addition, deletion, or substitution of sterilization steps or procedures for handling sterile materials in an aseptic processing operation. 

One of the more common differences between products is the closure system. Closure systems are selected for compatibility with the formulation, and in some cases differences in formulation may be create differences in handling difficulty. A stopper that is more prone to clumping or jamming in the tracks of the stopper bowl will necessitate additional interventions not present with other stoppers of similar size and thus would be considered worst case situations. There are a number of specialized closure systems designed to facilitate the delivery of an aseptically filled product. As these systems have sealed interstitial spaces where product contact can occur during administration of the drug product, the simulation procedure for these... 

Each capsule is aseptically added as a whole to a jar containing the enrichment broth. The broth must be between 20°C and 38°C before a capsule is added. The jars are handled further according to the IDF procedure. 

Clean and aseptic area clothing should be laundered or cleaned and thereafter handled in such a way that it does not gather contaminants which can later be shed. Separate laundry facilities for such clothing are desirable. It should be noted that some methods of sterilisation may damage fibres and reduce effective garments. Washing and sterilisation operation should follow a dearly displayed written procedure. 

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