Aseptic definition

CDC Case Definition Arboviral infections may be asymptomatic or may result in illnesses of variable severity sometimes associated with central nervous system (CNS) involvement. When the CNS is affected, clinical syndromes ranging from febrile headache to aseptic meningitis to encephalitis may occur, and these are usually indistinguishable from similar syndromes caused by other viruses. Arboviral meningitis is characterized by fever, headache, stiff neck, and pleocytosis. Arboviral encephalitis is characterized by fever, headache, and altered mental status ranging... 

It should be noted that aseptic assembly of a sterile product becomes difficult with large volume containers and the Food and Drug Administration, for example, would be unlikely to approve an aseptic process for container volumes in excess of 100 mL, i.e., by definition only small volume injectables are acceptable for aseptic assembly. 

ISPE (2005), Restricted access barrier systems (RABS) for aseptic processing, ISPE definition, Aug. 16. 

The bulk production of sterile drug products such as antibiotics, corticosteroids, insulin, and certain biotechnology products requires that a number of processes be carried out under aseptic conditions. These processes can be evaluated in a manner adapted from those employed for aseptic filling processes. A joint PDA/PhRMA task force has developed the definitive guidance document on this subject. ... 

The most recent industry survey on aseptic processing was published by PDA in 1997. It attempted to address the statistical nature of the limits as actually practiced, however the response to questions in that area are inconclusive. It did include evidence that several firms had adopted acceptance criteria tighter than 0.1%, suggesting that another round of acceptance criterion definition might be in the offing. The most recent commentary on acceptance criteria is that provided by USP in draft chapter, 1116. The USP expanded upon PDA s 1996 position, and established ever tighter requirements, The goal is zero contamination. In an individual run not more than one positive unit in 5000 filled units. In a series of three media fills, two of the three media fills should have no contamination present. ... 

A definition of the aseptic techniques and work practices of operative personnel, and a report of findings based upon videotaped observation of the actual work stream during prequalification runs for identification and elimination of personnel-generated contamination sources, identification of susceptible areas including critical sites and steps, and indicator sites ... 

Closed systems provide for complete separation between the environment in which personnel (uniformly accepted as the primary source of contamination in aseptic environments) are located from that in the materials are processed. Theoretically, if a sterile BPC could be processed in its entirety within closed systems, there would no possibility of microbial contamination. In marked contrast to the closed system is the open system , perhaps best defined by what it is not. Essentially, an open system lacks one or more of the features of a closed system, thus leaving it vulnerable to the potential ingress of contamination. One substantial issue associated with these definitions is establishing that a system remains closed over the length of the production campaign. 

Not all researchers use the same definition of osteolysis in their radiographic analyses, complicating the comparison of results between smdies. Some researchers identily radiolucencies around the margin of an implant as a linear lytic defect [52], whereas in other smdies, only a focal lesion or cyst is classified as osteolysis [46]. Of greatest clinical concern are unstable or expansile lesions (so-called balloon lesions ) that grow over time and lead to aseptic loosening of a prosthetic component. 

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