Safety testing

Adventitious agents (in vitro and in vivo). These assays are designed to detect the presence of infectious viral agents of human or animal origin (serum, trypsin). 

Mycoplasma. The test for the presence of mycoplasma relies on expansion of cells in antibiotic-free conditions and detection of the organism using dye or PCR, as well as growth of mycoplasma on appropriate agar media. 

Endotoxin. Endotoxin can be detected using the LAL or rabbit pyrogen assays. 

Sterility. This assay determines the absence of bacterial or fungal organisms. 

General safety. This assay is designed to determine if there are toxins (chemical or biological) that would induce an acute toxicity in animals. 

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UE 94 Standardfor Safety, Tests for Flammability of Plastic Materials for Parts in Devices and Appliances, Underwriters Laboratories, Inc., Northbrook, lU.,... 

The U.S. standard pertussis vacciae is used to standardize the potency of the whole ceU pertussis vacciae. The number of protective units Hi the vaccine is estimated for each lot from the results of simultaneous intracerebral mouse-protection tests of the vaccine being studied and the U.S. reference standard (14,17). The potency of the aceUular vaccines is estimated by then abUity to produce antibodies to the proteins Hi the vaccine Hi a mouse model. These vaccines also undergo a series of animal safety tests to ensure that the iaactivation and toxoiding steps were carried out correctiy (14,17). 

Standardization and Testing. Potency is determiaed by quantitating the Hepatitis B antigen by an antibody-biading assay combiaed with a determination of the amount of proteia. Safety testing typical for cell culture-derived products is also performed, and iacludes assuting the absence of Hve vims. 

Standardization and Testing. Potency is determined by titrating the amount of Hve vims using a suitable cell substrate. Safety testing is also performed on seed lots to assure proper attenuation and on vaccine to assure absence of unwanted contaminants. 

G. Vettora22i, Handbook of International Food Eegulatory Toxicology, Vol. II, Spectmm Pubhcations, Inc., Jamaica, N.Y., 1981. Lists safety tests performed on... 

Safety testing of a finished cosmetic product should be sufficient to ensure that the product does not cause irritation when used in accordance with directions, neither eUcits sensitization nor includes a sensitizer, and does not cause photoaHergic responses. Some of the methods for determining animal or human responses to cosmetics are noted in Table 3. 

Performance. Consumer acceptance is a criterion on which cosmetic marketers caimot compromise. Whereas the likes and dislikes of consumers are in a state of constant flux, some product features are critical. A deodorant that does not deodorize or a hair coloring that fades in sunlight is unacceptable. Performance is tested by in vitro techniques during formulation, but the ultimate test of a product s performance requires in-use experience with consumers and critical assessment by trained observers. Performance tests can sometimes be combined with in-use safety tests, and protocols for such programs have been developed. 

Edgren carried out a number of studies in which bioassays were used to compare the widely differing potencies of a number of analogues of 17/i-oestradiol that were modified in the 18-position. Commenting on the use of potency ratios, Edgren concluded that they were only valid for specific substances and test systems and useless for product safety testing . These problems could have important consequences for any attempt to establish the potency of specific environmental EDs or environmentally relevant mixtures. 

The accident resulted from a routine safety test of some electrical control equipment at the start of a normal reactor shutdown for routine maintenance. The test was to determine the ability to continue to draw electrical power from a turbine generator during the first minute of coast-down following a station blackout. In a blackout, the reactor automatically scrams and diesel generators start to assume load (about 1 minute required). 

At this stage the interferon preparations were assayed and submitted to safety tests for the absence of contaminating viruses. 

Safety tests at maximum operating conditions - usual on all or a high proportion of production units. 

V2O5-P205 (95 5, molar ratio) cathode and a lithium anode (Li/a-V205 cell) [1]. In this section, we describe safety test results for AA Li/a- V2Os cells. The AA cell we fabricated has a pressure vent, a Polyswitch (PS, Raychem Co., thermal and current fuse) and is composed of a spirally wound cathode sheet, a metallic Li-based anode sheet and a polyethylene (PE) separator [87]. 

Underwriters Laboratories (UL) requires that consumer batteries pass a number of safety tests [3]. UL requires that a battery withstand a short circuit without fire or explosion. A positive temperature coefficient (PTC) device [4] is used for external short-circuit protection. The resistance of a PTC placed in series with the cell increases by orders of magnitude at high currents and resulting high temperatures. However, in the case of an internal short, e.g., if the positive tab comes lose and contacts the interior of the negative metal can, the separator could act as a fuse. That is, the impedance of the separator increases by two to three orders of magnitude due to an increase in cell temperature. 

Na-S system/battery 571,574 nail penetration, safety tests 354 naphthalene 428... 

Where necessary the manufacturer must carry out, or arrange for, safety testing. Many countries operate mandatory premanufacturing and premarketing notification schemes of which safety testing is the cornerstone. Within the European Community under Directive 67/548/EEC and its sixth amendment 79/831/EEC, Competent Authorities must be... 

Vaccine Source materiai Processing Potency assay Safety tests... 

Safety tests. Beeause many vaccines are derived from basic materials of intense pathogenieity— the lethal dose of a tetanus toxin for a mouse is estimated to be 3 x 10 (ig—safety testing is of paramount importance. Effective testing provides a... 

Viral vaccines present problems of safety testing far more complex than those experienced with bacterial vaccines. With killed viral vaccines the potential hazards are those due to incomplete virus inactivation and the consequent presence of residual live virus in the preparation. The tests used to detect such live virus consist of the inoculation of susceptible tissue cultures and of susceptible animals. The cultures are examined for cytopathic effects and the animals for symptoms of disease and histological evidence of infection at autopsy. This test is of particular importance in inactivated poliomyelitis vaccine, the vaccine being injected intraspinally into monkeys. At autopsy, sections of brain and spinal cord are examined microscopically for the histological lesions indicative of proliferating poliovirus. 

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