Challenge organisms

Different performanee eriteria are laid down for injeetable and ophthahrtic preparations, topical preparations and oral hquid preparations. Inhibition of the challenge organism is determined by viable coimting teehniques. The British Pharmacopoeia (1993) should be eonsulted for full details of the experimental procedures to be used. 

All disinfection and sterilization processes for equipment should be validated, for preference using a microbiological challenge with an organism of appropriate resistance to the disinfectant, sterilant or sterilizing conditions. Once the required log reduction of the challenge organism has been achieved, physical and/or chemical parameters can be set which form the critical control points for the process. 

Static aerosol challenge Expose sealed containers to periodic challenge by generating aerosol containing the challenge organism... 

Dynamic immersion challenge Expose sealed containers to periodic challenge by immersion in a suspension of challenge organisms, with simultaneous additional stress of pressure/ vacuum if warranted by the normal conditions of product storage... 

Invertebrates (crustacea and molluscs) readily accumulate hydrocarbons when exposed for more than a few hours through surrounding water. In crustacea, thoracic and abdominal sections (21,22), gills (22,23), stomach (22, 23), hepatopancreas (23), muscle (23), gonad (23), and blood (23j are sites of hydrocarbon accumulation. In molluscs, gills (24,25), adductor muscle (24, 25), viscera (25), mantle (24,25), and foot (25) are tissues in which hydrocarbons were identified in challenged organisms. 

The choice of additional challenge organisms used in the formulation development is determined by... 

The possible alternatives to ozone-depleting or otherwise environmentally challenging organic solvents for chemical processes are abundant. We can begin a review by looking at five broad categories aqueous, ionic liquids, supercritical fluids, fluori-nated solvents, or solventless processes (llhnan, 1993). 

In duplicate, pipette 10 ml of each of the dilutions into separate sterile test tubes (changing pipettes after each transfer). Provide 12 tubes for each dilution and time interval, as there are six challenge organisms. Using... 

The test methodology should be validated by inoculation with 10 to 100 CPUs of challenge organism strains to the media/product container at the beginning of the test incubation period. 

Periodically, strains of microorganisms collected from the manufacturing environment should be used as challenge organisms. 

The test is declared invalid if validation challenge organisms do not show clearly visible growth of bacteria within 3 days and fungi within 5 days in the test media-containing product. In most cases, unless the sterile product causes turbidity in the media, visual recovery times should be comparable to those of the growth promotion test. Records of validation and/or revalidation tests should be maintained. 

Stasis test challenge organisms should show clearly visible growth in the test medium within 3 days for bacteria and 5 days for fungi otherwise the test is invalid. Records of stasis tests should be maintained. 

Count of the challenge inoculum STM No. The inoculum count of all challenge organisms in the range between 10 and 100 CPU... 

For each challenge organism, provide appropriate numbers of tubes for each dilution and time intervals. 

This type of testing generally involves inoculation of a coupon (chosen to simulate cleanroom surfaces, e.g., stainless steel, polycarbonate, etc.) with the challenging organism. 

Growth promotion ability of the medium in final filled containers must be demonstrated using ten randomly selected containers for each challenge organism (more than 100 microorganisms per test container). 

Challenge Organic (CH2C12) Diesel O-Cyclohexyl O-methyl 2.B.4... 

The stmctural complexity and diversity of bromopyrrole alkaloids continue to challenge organic chemists, as indicated by the high number of contributions appearing since 2000. 

This new concept for diastereoface differentiation 95 in the osmylation reaction seems quite promising and will undoubtedly challenge organic chemists during the future development of newer methods for cyclic and acyclic stereocontrol. 

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