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VALIDATION OF MICROBIAL RECOVERY FROM …

Printed on: Mon Mar 30 2020, 16:40:04 pmPrinted by: Deborah NishikawaOfficial Status: Currently Official on 30-Mar-2020 Official Date: Official as of 1-Dec-2019 Document Type: GENERAL CHAPTERDocId: 1_GUID-48912B84-F603-4473-8250-EEE8533D3 9FF_3_en-USPrinted from: 2020 USPC 1227 VALIDATION OF MICROBIAL RECOVERY FROM PHARMACOPEIAL ARTICLES Change to read:INTRODUCTION This chapter provides guidelines for the VALIDATION of RECOVERY methods for the estimation of the number of viable microorganisms, the detection of indicators or specified microorganisms, and the sterility testing of pharmacopeial articles. The test procedures in Antimicrobial Effectiveness Testing 51 , Sterility Tests 71 , MICROBIAL Enumeration Tests 61 , and Tests for Specified Microorganisms 62 are considered validated.

〈〈〈〈1227 〉〉〉〉VALIDATION OF MICROBIAL RECOVERY FROM PHARMACOPEIAL ARTICLES Change to read: INTRODUCTION This chapter provides guidelines for the validation of recovery methods for the estimation of the number of viable microorganisms, the detection of indicators or specified microorganisms, and the sterility testing of ...

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Transcription of VALIDATION OF MICROBIAL RECOVERY FROM …

1 Printed on: Mon Mar 30 2020, 16:40:04 pmPrinted by: Deborah NishikawaOfficial Status: Currently Official on 30-Mar-2020 Official Date: Official as of 1-Dec-2019 Document Type: GENERAL CHAPTERDocId: 1_GUID-48912B84-F603-4473-8250-EEE8533D3 9FF_3_en-USPrinted from: 2020 USPC 1227 VALIDATION OF MICROBIAL RECOVERY FROM PHARMACOPEIAL ARTICLES Change to read:INTRODUCTION This chapter provides guidelines for the VALIDATION of RECOVERY methods for the estimation of the number of viable microorganisms, the detection of indicators or specified microorganisms, and the sterility testing of pharmacopeial articles. The test procedures in Antimicrobial Effectiveness Testing 51 , Sterility Tests 71 , MICROBIAL Enumeration Tests 61 , and Tests for Specified Microorganisms 62 are considered validated.

2 However, use of compendial methods requires establishment of suitability of the method demonstrating RECOVERY of the challenge organisms in the presence of the product. Alternatives/modifications to these RECOVERY procedures beyond what are described in these chapters (such as dilution, chemical or enzymatic neutralization, and membrane filtration) require VALIDATION . (USP 1-Dec-2019)It is generally understood that if a product possesses antimicrobial properties because of the presence of a specific preservative or because of its formulation, this antimicrobial property must be neutralized to recover viable microorganisms. This neutralization may be achieved by the use of a specific neutralizer, by dilution, by a combination of (USP 1-Dec-2019)dilution, filtration, and rinsing, (USP 1-Dec-2019)or by any combination of these methods.

3 Activity, the risk of (USP 1-Dec-2019)Change to read:these factors in mind. negative bacteria, anaerobic the VALIDATION . The specific conditions of the test, including buffers used, water, light conditions, and temperature, must be reproduced in the VALIDATION study. All test conditions also should be standardized and performed in the VALIDATION study exactly as performed in the test. The conditions of MICROBIAL RECOVERY are among the most crucial in accurately estimating the number of microorganisms present in a test solution. The first consideration is the RECOVERY medium used to support the growth of survivors. This concern is discussed in detail below. The second consideration is the incubation conditions.

4 Optimal conditions for growth must be present to ensure complete growth and reproducible results. Change to read:METHODS OF NEUTRALIZING ANTIMICROBIAL PROPERTIEST hree common methods are used to neutralize antimicrobial properties of a product: 1) chemical inhibition, 2) dilution, and 3) filtration and rinsing. (USP 1-Dec-2019)Chemical Neutralization (USP 1-Dec-2019)Page 1 of 6 USP-NF30/03/2020 1shows known neutralizers for a variety of chemical antimicrobial agents and the reported toxicity of some chemical neutralizers to specific microorganisms. However, despite potential toxicity, the convenience and quick action of chemical inhibitors encourage their use. Chemical neutralization of antimicrobial agents (USP 1-Dec-2019)is the preferred method for the antimicrobial efficacy test.

5 The potential of chemical neutralizers (USP 1-Dec-2019)should be considered in the membrane filtration and the direct inoculation (USP 1-Dec-2019)sterility tests. Antibiotics may not be susceptible to neutralization by chemical means, but rather by enzymatic treatment ( , penicillinase). These enzymes may be used where required. Table 1. Some Common Neutralizers for Chemical Antimicrobial Agents (USP 1-Dec-2019)Neutralizer Antimicrobial (USP 1-Dec-2019)Class Potential Action of Antimicrobial Agents (USP 1-Dec-2019)BisulfateGlutaraldehyde, mercurials Non-sporing bacteria DilutionPhenolics, alcohol, aldehydes, sorbate GlycineAldehydesGrowing cells LecithinQuaternary ammonium compounds (QACs), parabens, bis-biguanides BacteriaMg or Ca ions EDTA Polysorbate ThioglycollateThiosulfate antimicrobial agent (USP 1-concentration and antimicrobial with the general formula: C= concentration tversus log Ctk= a constant values are not good Table 2.)

6 Concentration Exponents for Some Common Antimicrobial AgentsRepresentative Antimicrobial Agent ValuesIncreased Time Factor (x) to Kill Microorganisms When the Concentration Is Reduced to:One-HalfOne-ThirdPhenolics664729 Alcohol10102459, +2+2 Page 2 of 6 USP-NF30/03/2020 Antimicrobial Agent ValuesIncreased Time Factor (x) to Kill Microorganisms When the Concentration Is Reduced to:One-HalfOne-ThirdMercury compounds123 Quaternary ammonium com-pounds123 Formaldehyde123 (USP 1-Dec-2019)Membrane FiltrationAn approach that is often used, especially in sterility testing, is neutralization by membrane filtration. This approach relies upon the physical retention of the microorganism on the membrane filter, with the antimicrobial agent passing through the filter into the filtrate.

7 The filter is then incubated for RECOVERY of viable microorganisms. However, filtration alone may not remove sufficient quantities of the antimicrobial (USP 1-Dec-2019)agent to allow growth of surviving microorganisms. Adherence of residual antimicrobial agents to the filter membrane may cause growth inhibition. Filtration through a low-binding filter material, such as polyvinylidene difluoride, helps to minimize this growth inhibition. Additionally, the preservative may be diluted or flushed from the filter by rinsing with a non-toxic (USP 1-Dec-2019)fluid, such as diluting Fluid A(see Sterility Tests 71 , Diluting and Rinsing Fluids for Membrane Filtrationfor diluting fluid compositions).

8 Chemical neutralizers in the rinsing fluid can ensure that any antimicrobial residue on the membrane does not interfere with the RECOVERY of viable microorganisms. Change to read:neutralizer non-toxicity. employed is effective in ( lack of (USP 1-Dec-2019) RECOVERY results for treatment groups. Membrane Filtrationis used without exposure to non-toxicity. (USP 1-Dec-2019)In the tests under 51 and 61 , (USP 1-Dec-2019)the number of viable challenge microorganisms in the product is estimated (USP 1-Dec-2019)by calculating the concentration of cfu per milliliter by the plate count method. A design for validating neutralization would incorporate the treatment groups as described under VALIDATION of Neutralization Methods RECOVERY Comparisons.)

9 At least three independent replicates of the experiment should be performed, and each should demonstrate a mean count of any of the test organisms not differing by a factor greater than 2, , 50% 200% RECOVERY , from the value of the control in the absence of product. If it is necessary to solubilize the test sample, (ERR 1-Dec-2019)the effects of the solubilization method on viable microorganisms must be determined. This situation can occur when testing ointments, suspensions, or other articles. (USP 1-Dec-2019)If a greater number of replicates is required in the VALIDATION study, the comparisons may be evaluated by transforming the numbers of cfu to their logarithmic values and analyzing the data statistically by the Student ttest (pairwise comparisons) or by analysis of variance (ANOVA) (for comparing all groups).

10 If ANOVA is used, and significant differences among the populations are determined, a test such as Dunnett's test may be used, with the peptone group used as the control group. RECOVERY by Membrane FiltrationPage 3 of 6 USP-NF30/03/2020 VALIDATION follows the procedure described in Sterility Tests 71 , Method Suitability Test, (USP 1-Dec-2019)with the exception of plating on solid medium to quantitate RECOVERY . It should be emphasized that quantitative RECOVERY is not required to demonstrate sterility test suitability. It only requires a qualitative assessment (visual turbidity). (USP 1-Dec-2019)Three 100-mL rinses are assumed, but the volume and number of rinses are subject to VALIDATION .


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