USER QUALITY CONTROL PROCEDURES
The selection of these two principal QC procedures is based on the critical need for the inner test vial to be free from contamination. This could cause interferences with the performance characteristics of the test and the medium performing in an appropriate manner. In performing these QC procedures, it is assumed that the person undertaking this procedure has an adequate understanding of basic aseptic procedures and the necessary skills to safely culture bacteria.
Confirmation of the sterility of the BART Biodetectors
Sterility QC on the Inner Test Vial
Aseptically add 15 ml of sterile distilled or deionized water (which has been kept at room temperature) to the vial. Do not use non-sterilized distilled or deionized water for these tests since the incumbent bacterial population may be sufficient to trigger a reaction in the test vial. Stand the test vial up at room temperature (22 to 24oC) and observe for twelve days. If the test vial is sterile there should be no evidence of bacterial activity or reactions. If evidence is found that the test vial was contaminated, this could have been an isolated event. Repeat the procedure in triplicate. Should a duplicate result suggesting contamination, please contact the QC dept. at (306) 585-1762 or by fax at (306) 585-3000.
Below is a description of the typical events that occur as the dried medium pellet dissolves and diffuses up into the water column. It is based upon the standard QC procedures discussed above. There are two events to determine. First, the form in which the medium pellet diffuses up into the water. This gives a good indication as to the acceptability of the medium. Second, the clarity with which this happens indicates whether or not there has been some microbial contamination. If contamination has occurred from whatever source, clouding, slime formation, abnormal color shifts and gasses are possible consequences and the test vial would be deemed to have failed the test. It should be remembered that if the water used for this test contained a high concentration of various salts, it is possible for some of these reactions to occur. It must therefore be remembered that only sterile (distilled or deionized) water should be used in these QC tests. Additional tables are used to describe the initial diffusion patterns that should occur in these QC tests and also the most common form of expression of bacterial contamination.
A successful QC test would have the typical characteristics reported for the basal zone and the column. There should be no evidence of microbial contamination that would usually be seen in the form described in the "contamination" column. Every effort is made by Droycon Bioconcepts Inc. to produce a sterile product and routine QC practices are undertaken to ensure that the product has a satisfactory quality. Users may request the "Certificate of Analysis" issued for every batch of BART produced.
Assurance of Status of Crystallized Medium by Visual Inspection
It is recommended that, to view the base of the test vial, the tube be held with the basal cone facing directly towards the observer. It is best to view this using diffuse light against a neutral background. After viewing the base, examine the lower walls just above the basal cone for any medium deposits. Some of the media will coat the lower walls up to a height of 5mm above the cone. All BART products are examined for splattering of dried medium on the sidewalls of the inner test vial. If there are any splatter particles of greater than 1 mm diameter or a number positioned to disturb the view through the test vials, the tube is rejected (second grade). These seconds are still effective for conducting the tests. Tubes are rejected where there is an acceptably large amount of splatter (>1% of wall area) which affects the viewing of any reaction, or there are fractures in the polystyrene wall of the vials exceeding 5 mm in length and/or have penetrated through the vial wall.
EXPIRY DATE QC
1. Assurance of the status of crystallized medium by visual inspection.
All of the BART test products are subjected to this QC procedure to be assured that there has not been any deterioration of the products over time.
QC Information for Individual BARTs:
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