Aseptic dispensing

Many isolator applications at the clinical trial scale of manufacturing are based on the same scale of technology used for sterility testing. The aseptic dispensing of pharmaceutical products in hospital pharmacies is also carried out on this scale. Such manufacturing is not carried out on a continuous basis, but in relatively small batches that can be transferred from the isolator with the help of one of the more secure transfer systems. In this type of application, one isolator is being used to dispense a variety of products or several isolators are used for separate tasks. 

Aseptically, dispense 0.5 mL aliquots of stock YNB into previously autoclaved capped or cotton-plugged test tubes. 

Aseptically dispense 0.5mL aliquots of lOx stock YCB into sterile capped or cotton-plugged 16 X 125 mm test tubes. 

Aseptic bulk packing has now become a well-established means of packing concentrated or RTD juice. Containers are available from as little as a 5 1 bag-in-a-box to be dispensed from a bar up to a 1 000 1 bin in a 1 m3 pallet box. 

Tor European aseptically produced products with sterile raw materials, where sterile filteration is not carried out, then dispensing and compounding shall be in a grade A area, with a grade B background. 

Ointments, ophthalmic. Sterile ointments designed for application to the eyelids. Petrolatum, petrolatum-mineral oil, and petrolatum-anhydrous lanolin bases are often used in ophthalmic ointments because of their low irritating potential. Finely powdered, sterile active ingredients are aseptically incorporated into a sterile base, using sterile utensils, and dispensed in sterile ophthalmic-tipped tubes to reduce the possibility of contamination. ... 

Before culturing the cells for immunolabeling, prepare glass coverslips cut in a size of about 3x3mm, sterilize them by dryheating, and dispense aseptically into the wells of a 96-well plate handle the cut coverslips with forceps, as used to handle for electron microscope grid. 

Yeast extract Dissolve 7 g of yeast extract in 100 mL distilled water, and autoclave as above. Using aseptic technique dispense into 10-mL aliquots and store at 4°C. 

Pig serum Using aseptic technique, dispense into 10-mL aliquots and heat-inac-tivate by incubation of serum at 56°C for 45 min. Store at 4°C. 

Additionally, 100 mL of a 0.2M phosphate buffer solution at pH7 was prepared under aseptic conditions and sterilized by membrane filtration (0.22 pm, Millipore) 5.0 mL of the solution was dispensed into pre-steriUzed serum vials and stored at 4°C. All vials were tested as sterile and apyrogenic preparations by conventional pharmaceutical procedures. 

The handling of starting materials and the preparation of solutions should be done in a grade C environment These activities could be allowed in a grade D environment if additional measures were taken to minimize contamination, such as the use of dosed vessels prior to filtration. After sterile filtration, the product must be handled and dispensed into containers under aseptic conditions in a grade A or area with a grade or C background respectively. 

FIGURE 33.19 Aseptic open spray drying system (1, drying chamber 2, air dispenser 3, atomizer 4, prefilter 5, filter 6, heater 7, HEPA filter 8, sterile feed filter 9, feed pump 10, cyclone collector 11, packing room). (Courtesy of A/S Niro Atomizer, Soeborg, Denmark.)... 

Radiopharmaceuticals for parenteral administration should be sterile. Preparation under aseptic conditions should ensure this however, conditions and operator dispensing technique can be checked by carrying out sterility testing of products. 

High volume eye lotions prepared in pharmacies may be packed in sterile, clean polypropylene bottles with an appropriate closure. Also type I glass bottles can be used. The volume is a maximum of 200 mL, except if the solution is intended for first-aid treatment where a dispensed volume of 1,000 mL is more appropriate. Aseptically prepared eye lotimis should be packed in sterilised containers. 

A radiopharmacy has dedicated equipment for synthesis, preparation and quality control of radiopharmaceuticals. The workbench for the safe and aseptic preparation of radiopharmaceuticals is often a sufficiently lead shielded radiopharmacy safety cabinet with downflow HEPA filtered laminar air providing a GMP class A working zone. The exhaust air is filtrated and expelled outside the radiopharmacy to the roof on top of the building. The cabinet has built-in radiation protection by installed lead plates in the walls and in the working field, a horizontally movable lead containing glass window, lead shielded instruments for radiation measurement and waste containment and special equipment for automatic preparation and dispensing such as a barcode seamier, printer, screen and mouse pad. 

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