Usp 71 sterility pdf

Oils and oily solutions of suffi- ciently low viscosity may be filtered without dilution through a dry membrane. Viscous oils may be diluted as necessary with a suitable sterile diluent such as isopropyl myristate shown not to have antimicrobial activity in the conditions of the test. Allow the oil to penetrate the membrane by its own weight, and then filter, applying the pressure or suction gradually. Transfer the membrane or membranes to the culture medium or media, or vice versa, as described above for Aqueous Solutions, and incu- bate at the same temperatures and for the same times.

Filter as rapidly as possible, and proceed as described above for Oils and Oily Solutions. If a separate sterile needle is attached, directly expel the syringe contents as indicated above, and proceed as directed for Aqueous Solutions. Proceed as directed for Aqueous Solutions. Dissolve in about mL of Fluid A, and mix. If feasible, allow the propellant to escape before aseptically opening the container, and transfer the contents to a sterile pooling vessel.

Add mL of Fluid D to the pooling vessel, and mix gently. Collect the fluids in an appropriate sterile vessel, and proceed as directed for Aqueous Solutions or Oils and Oily Solutions, whichever applies. In the case of sterile, empty syringes, draw sterile diluent into the barrel through the sterile needle, if attached, or through a sterile needle attached for the purpose of the test, and express the contents into a sterile pooling vessel.

Proceed as directed above. If the product to be examined has antimicrobial activity, carry out the test after neutralizing this with a suitable neutralizing substance or by dilution in a sufficient quantity of culture medium. When it is necessary to use a large volume of the product, it may be preferable to use a concentrated culture medium prepared in such a way that it takes into account the subsequent dilution. Where appropriate, the concentrated medium may be added directly to the product in its container.

Incubate the inoculated media for not less than 14 days. Observe the cultures several times during the incubation period. Shake cultures containing oily products gently each day. However, when Fluid Thioglycollate Medium is used for the detection of anaerobic microorganisms, keep shaking or mixing to a minimum in order to maintain anaerobic conditions.

Open the sealed package using aseptic precautions, and remove three sections of the strand for each culture medium. Carry out the test on three sec- tions, each cm long, which have been cut off from the beginning, the center, and the end of the strand. Use whole strands from freshly opened cassette packs. Transfer each section of the strand to the selected medium. Use sufficient medium to cov- er adequately the material to be tested 20 mL to mL.

Transfer the material so obtained to mL of Fluid Thioglycollate Medium, and mix. From individually packaged, single-use materi- als, aseptically remove the entire article. Immerse the portions or article in each medium, and proceed as directed above.

To ensure that device pathways are also in contact with the media, im- merse the appropriate number of units per medium in a volume of medium sufficient to immerse the device completely, and proceed as directed above.

For extremely large devices, immerse those portions of the device that are to come into contact with the patient in a volume of medium sufficient to achieve complete immersion of those portions. For catheters where the inside lumen and outside are required to be sterile, either cut them into pieces such that the medi- um is in contact with the entire lumen or fill the lumen with medium, and then immerse the intact unit.

If the material being tested renders the medium turbid so that the presence or absence of microbial growth cannot be readily determined by visual examination, 14 days after the beginning of incubation transfer portions each not less than 1 mL of the medium to fresh vessels of the same medium, and then incubate the original and transfer vessels for not less than 4 days. If no evidence of microbial growth is found, the product to be examined complies with the test for sterility.

If evidence of microbial growth is found, the product to be examined does not comply with the test for sterility, unless it can be clearly dem- onstrated that the test was invalid for causes unrelated to the product to be examined.

The test may be considered invalid only if one or more of the following conditions are fulfilled: a. The data of the microbiological monitoring of the sterility testing facility show a fault. A review of the testing procedure used during the test in question reveals a fault. Microbial growth is found in the negative controls. After determination of the identity of the microorganisms isolated from the test, the growth of this species or these spe- cies may be ascribed unequivocally to faults with respect to the material and or the technique used in conducting the sterility test procedure.

If the test is declared to be invalid, it is repeated with the same number of units as in the original test. If no evidence of microbial growth is found in the repeat test, the product examined complies with the test for sterility. If microbial growth is found in the repeat test, the product examined does not comply with the test for sterility. The tests for bacterial and fungal sterility are carried out on the same sample of the product to be examined.

When the volume or the quantity in a single container is insufficient to carry out the tests, the contents of two or more con- tainers are used to inoculate the different media. A reduction in antimicrobial activity may not be adequately demonstrated by chemical methods.

This chapter summari- zes procedures for the antibiotics recognized in the United States Pharmacopeia USP for which the microbiological assay is the standard analytical method.

Two general techniques are employed: the cylinder-plate or plate assay and the turbidimetric or tube assay. Table 1 lists all the antibiotics that contain microbial assays and specifies the type of assay cylinder-plate or turbidimetric. Be the first to like this. Total views. You just clipped your first slide! Clipping is a handy way to collect important slides you want to go back to later. Now customize the name of a clipboard to store your clips.

Visibility Others can see my Clipboard. Cancel Save. Exclusive 60 day trial to the world's largest digital library. Activate your free 60 day trial. Potency — Non-solution capsules, gels, suspensions, creams, animal treats, powder aliquots, suppositories, troche, tablets, etc. We offer additional testing services not listed on this document. Call the Eagle Client Care Team at If testing has been initiated, the full price of the test will be charged. Sterile articles packaged in multi-dose containers must be free of microorganisms throughout their entire shelf-life.

Due to the potential for the introduction of microorganisms through the repeated withdrawal of individual doses, sterile products that are packaged in multi-dose containers should contain an antimicrobial preservative. However, the concentration of an added antimicrobial preservative can be kept to a minimum if the ingredients of the compounded formulation possess an intrinsic antimicrobial activity.

The presence of these objectionable pathogens and microorganisms cannot exceed the acceptance criteria outlined in Table 1. Method Suitability Testing only needs to be completed once for each compounded formulation, and consists of two parts: i a suitability test that confirms that the growth media used for sterility testing supports the growth of certain microorganisms and ii a validation test that demonstrates that no components of the compounded preparation inhibit microbial growth.

For each bacterial endotoxin test, inhibition validation testing is performed. This testing confirms that there are no components of the formulation that will interfere with the bacterial endotoxin test and that the testing used is sensitive enough to provide meaningful, accurate data. Solutions must be essentially free from observable particulate matter. Due to the small amount of material and the heterogenous composition that particulate matter represents, it cannot be quantitated by chemical analysis alone.

As sterility is an event-related occurrence, container-closure integrity testing is performed to support the claim that the sterile containers in which the preparation is packaged are capable of maintaining the sterility of the product throughout its shelf life. Gibraltar Laboratories Follow. Sterility testing Sterility test and modern microbiological methods. Validation of Microbiological Methods. Pyrogen testing Sterilization methods. F sterility failure. Related Books Free with a 30 day trial from Scribd.

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Sterility testing USP 71 1. What is sterility Testing? However, a satisfactory results only indicated that no contaminating microorganism has been found in the sample examined under the conditions of the test. Sodium Chloride 2. Papaic Digest of Soybean Meal 3. Sodium Chloride 5. Inoculate portions of the media with less than cfu of appropriate organisms.

Incubate for not more than 3 days in case of bacteria and not more than 5 days in the case of fungi. The media are suitable if a clearly visible growth of the microorganisms occurs. If microbial growth is present in the sample and control, then the test is valid. Test Methods 1. Membrane Filtration 2. Direct Inoculation Membrane Filtration After transferring the content of the container or containers to be tested to the membrane, add an inoculum of a small number of viable microorganisms not more than cfu to the final portion of sterile diluent used to rinse the filter.