Aseptic preparation

Aseptically prepared products Terminally sterilized products (TSP) ... 

Aseptically prepared collection plates are placed in the sampling apparatus. Petri dishes used must be sterilized prior to filling. Verify the adequacy of petri dish dimensions so that the operational characteristics are maintained according to the manufacturers specifications. Plastic petri dishes are not recommended because static changes are likely to be present in plastic that will reduce the collection efficiency. 

In another study carried out in fasted ponies, the oral administration of a flunixin meglumine paste (l.lmg/kg) resulted in peak plasma concentrations >2 jLg/ml less than 1 h after administration (Welsh et al 1992). In ponies with free access to hay, the peak plasma concentration decreased to approximately 1.3 j,g/ml and the peak concentration was not reached until 7.6 h after administration (Welsh et al 1992). Nevertheless, the mean area under the plasma concentration-time curve (AUC) was not significantly different whether the ponies had been fasted or fed. The parenteral preparation of flunixin meglumine can be administered i.m. however, necrotizing soft-tissue infections have been reported following i.m. administration (Kahn Styrt 1997) and so aseptic preparation of the injection site is advisable. 

A Aseptic preparation and filling in a protective work unit Filling of products at particular microbiological risk 3... 

Health Care Products (Sharp, 2000) and Quality Assurance of Aseptic Preparation Services (Beaney, 2001), which discusses manufacturing in hospitals. 

Beaney, A. M. (2001) Quality Assurance of Aseptic Preparation Services, 3rd edn. Pharmaceutical Press, London. British Pharmacopoeia (2003) HMSO, London. 

The authors found that over 15 different aseptically prepared lysine-rich proteinoids 18 Table XII) each had about the same level of activity, that the pH optimum was near 7, and that Michaelis-Menten kinetics were obeyed. CMC (carboxymethyl cellulose) column chromatography of one polymer yielded nine fractions, four of which showed activity. Control experiments lacking one or more of polymer, Cu2+, urea, or KGA did not produce detectable amounts of glutamic acid. 

Resuspend the formulation-stimulated dendritic cells with staining buffer and aseptically prepare a single-cell suspension. 

Grade B In case of aseptic preparation and filling the background environment for grade A zone. 

Handling and filling of aseptically prepared products should be done in a grade A environment with a grade background. 

In cleanroom suites in which both terminally sterilised and aseptically prepared products are made, it is preferable for both types of product to be processed in accordance with the standards required for aseptically prepared products. 

A Aseptic preparation and filling. Filling of products to be terminally sterilised when products are unusually at risk. 

The preparation of sterile ophthalmic suspensions, as required by all official compendia, presents some difficulties since filtration as a sterilization method cannot be used. Even if heat sterilization is possible in some cases, it is to be avoided since it might cause partial dissolution of the drug at high temperature and separation of larger crystals on cooling. Therefore, aseptic methods are preferable. In some cases, final sterilization by y irradiation is possible. A detailed picture of different techniques for aseptic preparation of suspensions is given in Refs. 4.1 and 44. 

Determine virus titer by measuring the absorbance at 540 nm of the 10-times-diluted supernatant using a photometer. An optical density at 540 nm corresponds to 15,000 hemagglutinating units (HAU), which is well correlated with fusion activity. The supernatant prepared as described usually contain 30,000 HAU/ml. An aseptically prepared virus solution maintains the fusion activity for 3 weeks. Note that the virus should never be frozen. 

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