Aseptic handling

For processing under aseptic conditions, the spray drier must be connected to a filling hne that allows aseptic handling of the product. 

A very important aspect of dressings production is packaging. The packaging material must allow correct sterilization conditions (e.g. permeation of moisture or ethylene oxide), retain the dressing in a sterile condition and allow for its removal without contamination prior to use. All dressings intended for aseptic handling and application must be double wrapped. For steam sterilization they may be individually wrapped in fabric, paper or nylon and sterilized in metal drums, cardboard boxes or bleached Kraft paper. The choice of method also determines... 

The production of drugs under GMP conditions is costly, especially for protein-based drugs, which require aseptic handling. Manufacturers have looked to transgenic animals and plants as possible factories for the production of cost-effective protein-based drugs. 

It is prone to false piositive results due to the high precision necessary for lab technicians to aseptically handle and manipulate packages and products. 

Raw materials Containers Human resources Occupational safety and health Premises Equipment Basic operations Sterilisation methods Aseptic handling Quality requirements and analysis... 

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. 

Aseptic handling Membrane filtration <0.2 pm, if possible Sterile solution of excipients Sterile solution of excipients Sterile solution of excipients... 

As to the shelf life from a microbiological viewpoint reference is made to chapter Aseptic handling (Sect. 31.3.6). A system is given for determination of microbiological shelf life in relation to the risk of microbiological contamination at aseptic handling. 

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. 

Industrially-manufactured standard multichamber bags usually have a shelf life of more than 12 months before mixing. Admixtures for the individual needs of a patient must be prepared in accordance with aseptic handling (see Sect. 31.3). The admixtures are prepared in general on a daily or weekly basis. The shelf life of standard admixtures is maximum 7 days when stored under refrigerated conditions at 2-8 °C, provided that physico-chemical stability is sufficient. 

The industrially manufactured two and three chambers are mixed just prior to infusion, by breaking the separation seals between the bag chambers. The content is mixed in the closed system and vitamins and trace elements can be added via an injection port prior to administration or administered as separate infusion solutions. Nutrition admixtures (all-in-one, all-in-two system) for the specific need of patients are prepared using industrially manufactured lipid emulsions and aqueous solutions containing amino acids, carbohydrates, electrolytes, vitamins and eventually trace elements. AU components are admixed in sterile empty infusion bags under conditions of aseptic handling (see Sect. 31.3). 

Aseptic handling National Elution in class A background at At the start of every Microbiological No validation... 

Aseptic handling National Elution in class A background at guideline least class D At each elution (extent depending on risk assessment) Microbiological monitoring of the eluate endotoxins Product dossitn with validation data on elution and QC supplier assessment... 

Aseptic handling National Aliquoting in clean environment, if Not applicable Not applicable No validation... 

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). 

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 ... 

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

In chapter Aseptic handling (see Sect. 31.5) product protection results in single gloving and change after 30 min or earlier when damaged. 

The investigations considered small-scale preparation of capsules, cutaneous preparations, aseptic handling in a safety cabinet with laminar down flow. The inhalation exposure was measured by filtration of the air in the breathing zone, see Fig. 26.5a and b. 

Aseptic handling of solutions with class 5 substances in a safety cabinet or an isolator is safe for inhalation exposure. 

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. 

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). 

---