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Preservation Efficacy Testing

10/21/20111 Preservation Efficacy TestingScott Sutton, in this presentation is copyright 2011 Microbiology Network Inc. All rights reserved38 Overview of Presentation What is the Antimicrobial Effectiveness Test? What it can do What it can t do AET (PET) Topics Packaging Effects Formulation Effects Phoenix Phenomenon Linear Regression Unique Microorganisms FDA s Role in this Use of contract labs for generation of PET data210/21/20112 Antimicrobial Efficacy TestUSP <51>/ISO11930 Designed to demonstrate the ability of a multidose product to withstand microbial challenge. High-level challenge, frequent sampling of the challenge suspension for survivors3 USP Antimicrobial Efficacy Test Finished product test in US, development test in Europe Required for multi-dose presentations, anhydrous ointments that contain preservative Method basically harmonized, criteria not Different criteria for different categories of products410/21/20113 Consensus Antimicrobial Effectiveness TestEffort of the European Pharmacopoeia, Japanese pharmacopeia , and united states pharmacopeia to come to a harmonized , SVW and D Porter.

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Transcription of Preservation Efficacy Testing

1 10/21/20111 Preservation Efficacy TestingScott Sutton, in this presentation is copyright 2011 Microbiology Network Inc. All rights reserved38 Overview of Presentation What is the Antimicrobial Effectiveness Test? What it can do What it can t do AET (PET) Topics Packaging Effects Formulation Effects Phoenix Phenomenon Linear Regression Unique Microorganisms FDA s Role in this Use of contract labs for generation of PET data210/21/20112 Antimicrobial Efficacy TestUSP <51>/ISO11930 Designed to demonstrate the ability of a multidose product to withstand microbial challenge. High-level challenge, frequent sampling of the challenge suspension for survivors3 USP Antimicrobial Efficacy Test Finished product test in US, development test in Europe Required for multi-dose presentations, anhydrous ointments that contain preservative Method basically harmonized, criteria not Different criteria for different categories of products410/21/20113 Consensus Antimicrobial Effectiveness TestEffort of the European Pharmacopoeia, Japanese pharmacopeia , and united states pharmacopeia to come to a harmonized , SVW and D Porter.

2 2002. Development of the Antimicrobial Effectiveness Test As USP Chapter <51>. PDA J Pharm Sci Tech. 56(6):300-311 Matthews, BR. 2003. Preservation and Preservative Efficacy Testing : European Perspectives. Eur J Parent Pharm Sci. 8(4) Cosmetics AET ISO 11930 Cosmetics Microbiology Evaluation of the antimicrobial protection of a cosmetic product (DRAFT) Critical Features Requires Method Suitability Test Describes standard test Provides two levels of acceptance criteria based on risk Guidelines 13. Determination of Preservative Adequacy in Cosmetic Formulations 14. Preservation Testing of Eye Area Cosmetics 17. Determination of Preservation Efficacy in Nonwoven Substrate Products Product Type Methodologyo20. M-3 A Method for Preservation Testing of Water-Miscible Personal Care Productso21. M-4 Method for Preservation Testing of Eye Area Cosmetics o22. M-5 Methods for Preservation Testing of Nonwoven Substrate Personal Care Productso23.

3 M-6 A Method for Preservation Testing of Atypical PersonaloCare Productso24. M-7 A Rapid Method for Preservation Testing of Water-Miscible Personal Care Products7 AET - Validation ComparisonsViability GroupTest GroupPeptone Control GroupNeutralizer EfficacyNeutralizer Toxicity810/21/20115 Method Suitability Acceptance Criteria ISO 11930 Performed in duplicate must be within 50% USP <1227>5-6 plates in replicate must exceed 70% between populations USP <51> Pharm Eur Antimicrobial Efficacy TestISO 11930 & USP <51>10 CFU/mL6 Sample at 7 days, 14 days, *21 days, 28 daysIncubate microbial suspensionEach of five challenge microorganisms - 3 bacteria, 2 fungi10-fold serial dilutionsPlate in growth agar to count survivorsDetermine Log Reduction(log value of inoculum) -(log value of survivors at the time point)1010/21/20116 Challenge OrganismsChallenge OrganismISO 11930 USPP harm EurPseudomonas aeruginosaATCC 9027 ATCC 9027 ATCC 9027; NCIMB 8626; CIP aureusATCC 6538 ATCC 6538 ATCC 6538; NCTC 10788; MCIMB 9518.

4 CIP coliATCC 8739 ATCC 8739N/ACandida albicansATCC 10231 ATCC 10231 ATCC 10231;NCPF 3179; IP brasiliensisATCC 16404 ATCC 16404 ATCC 16404; IMI 149007; IP PET Challenge OrganismsWater-MiscibleEye Area*Non-WovenAtypicalGram (+) CocciStaphylococcus aureus (6538)NLT OneNLT One NLT OneNLT One**Gram (+) CocciS. epidermidis(12228)NLT OneNLT One NLT OneNLT OneFermentative Gram(-) BacilliKlebsiella pneumoniae(10031)NLT OneNLT One NLT OneNLT OneFermentative Gram(-) BacilliEnterobacter cloacae(13047))NLT OneNLT One NLT OneNLT OneFermentative Gram(-) BacilliEscherichia coli(8739)NLT OneNLT One NLT OneNLT OneFermentative Gram(-) BacilliEnterobacter gergoviae(33028)NLT OneNLT One NLT OneNLT OneFermentative Gram(-) BacilliProteussppN/ANLT One N/AN/ANon-fermentative Gram(-) BacilliPseudomonas aeruginosa(9027)NLT OneNLT One NLT OneNLT OneNon-fermentative Gram(-) BacilliBurkholderia cepacia(25416)NLT OneNLT One NLT OneNLT OneNon-fermentative Gram(-) BacilliPseudomonas fluorescens(13525)NLT OneNLT One NLT OneNLT OneNon-fermentative Gram(-) BacilliPseudomonas putida(31483)NLT OneNLT One NLT OneNLT OneNon-fermentative Gram(-) BacilliFlavobacteriumsppN/ANLT One N/AN/ANon-fermentative Gram(-)

5 BacilliAcinetobactersppN/ANLT One N/AN/AYeastCandida albicans(10231)Recommended NLT One NLT OneRecommendedYeastCandida parapsilosis(22019)N/ANLT One NLT OneN/AMoldAspergillus niger(16404)NLT OneNLT One NLT OneNLT OneMoldPenicilliumspeciesNLT OneN/ANLT OneNLT OneMoldChaetomium globosum(6205)N/AN/ANLT OneN/AMoldTrichoderma reesei(13631)N/AN/ANLT OneN/AMoldCladosporium oxysporum(76499)N/AN/ANLT OneN/AMoldPenicillium luteumN/ANLT One N/AN/ASpore-Forming BacilliBacillus subtilis(6051)OptionalOptionalOptionalOp tionalOther One OptionalOptional12*No ATCC strain designations listed for this method** Read as "Not Less Than One" or "Select at least one"10/21/20117 CTFA Preparation of InoculaAll CTFA methods except eye-cosmetics which does not allow Malt Extract Agar for growth of molds13 Criteria for Passage USP/Pharm EurLog10 Reduction6 Hr 24 Hr 7 Day14 Day21 Day28 DayUSP: : Bacteria23------NREP-B: Bacteria--13----NIUSP: Fungi----NINI--NIEP-A: Fungi----2----NIEP-B: Fungi------1--NI10/21/20118 USP CategoriesCategory Product Description 1 Injections and other parenterals, otic, sterile nasal products, and opthalmics 2 Topical Products 3 Oral Products 4 Liquid Antacids 15 Proposed ISO 11930 Acceptance Criteria1610/21/20119 Proposed ISO 11930 Risk Analysis17 CTFA Criteria for in 7 days90% in 7 daysEye-Area in 7 days90% in 7 daysNonwovensDetermined by risk assessmentDetermined by risk assessment18 Note that the challenges can be individual or pooled inocula, and that the test may, or may not, incorporate a It can Provide relative estimates of the biological activity of a preservative system in a particular formulation at a particular time.

6 It cannot Predict the preservative Efficacy of the multidose finished product in all patients hands under all of AET19 AET General Reviews Machtiger, N., et al. 2001. Determination of the Efficacy of Preservation of Non-Eye Area Water-Miscible Cosmetic and Toiletry Formulations: Collaborative Study. J AOAC (1):101 110. Farrington, , et al. 1994. Ability of Lab Methods to Predict In-Use Efficacy Antimicrobial Preservatives In an Experimental Cosmetic. Appl Envir Microbiol. 60(12):4553-4558. Geis, 1988. Preservation of Cosmetics and Consumer Products: Rationale and Application. J Ind Microbiol. 29(Suppl 3) of Presentation What is the Antimicrobial Effectiveness Test? What it can do What it can t do AET (PET) Topics Packaging Effects covered in the excellent presentation of Dr. Machtiger Formulation Effects Phoenix Phenomenon Linear Regression Unique Microorganisms FDA s Role in this Use of Contract Labs for generation of data21 Formulation Effects CyclodextrinsSimpson, 1992.

7 Neutralization of the Antibacterial Action of Quaternary Ammonium Compounds with Cyclodextrins. Fed Eur Microbiol Soc. ColorantsSakamoto, T.,et al. 1987. Effects of Some Cosmetic Pigments On the Bactericidal Activities of Preservatives. J Soc Cosmet Chem. 38:83-98. Emulsions Rieger, 1981. Current Aspects of Cosmetic Science:The Inactivation of Phenolic Preservatives In Emulsions. Cosmet Toilet96:39-43. Myburgh, et al. 1980. The Influence of Suspending Agents On Preservative Activity In Aqueous Solid/Liquid Dispersions. Pharm Weekblad Sci Ed2:1411-1416. Myburgh, et al. 1980. Inactivation of Preservatives In the Presence of Particulate Solids Pharm Weekblad Sci Ed. 2 Effects Excellent Review Geis, P. 2007. Fundamental Elements of Cosmetic and OTC Drug Microbiological Quality. Amer Pharm Rev. 10(4) : Geis, P. and T Rook. 2011. Microbiological Quality Of Consumer Products HAPPIMay, Effects - Physical Anhydrous BasesNo need for Preservation Low Water ActivityMay not require Preservation , technically challenging to test Buffer EffectsExample: Phosphate buffer base vs Borate pHHalotolerant/halophilic growth in alkaline shampoos2410/21/201113 Phoenix Phenomenon The apparent regrowth (rebound) of microorganisms after initial Testing revealing an aerobic plate count (APC) of <10 cfu/g, is known as the Phoenix Phenomenon (Orth, 1999.)

8 Putting the Phoenix Phenomenon Into Perspective. Cosmet Toilet 114(Apr):61-66) Requires product to have sufficient nutrients for growth25 Fungal Growth Apparent growth of fungal spores in a preservative Efficacy test Most commonly seen with products containing surfactants Dissociation of spore aggregates?2610/21/201114 Linear Regression ModelLinear Regression Model Orth, 1979. Linear Regression Method for Rapid Determination of Cosmetic Preservative Efficacy . J SocCosmet Chem. 30:321-332. Orth, et al. 1980. Establishing Cosmetic Preservative Efficacy by Use of D-Values. J Soc Cosmet Chem. 31:165-172. Orth, DS and LR Brueggen. 1982. Preservative Efficacy Testing of Cosmetic Products: Rechallenge Testing and Reliability of the Linear Regression Method. Cosmet Toilet. 97(May) Regression Good Screen Many (most?) preservative systems are not linear except in approximate termsSutton, SVW. et al. 1991. D-Value Determinations Are an Inappropriate Measure of Disinfecting Activity of Common Contact Lens Disinfecting Solutions.

9 Appl Envir Microbiol. 57(7):2021-2026. All chemical preservative systems are consumed in the reaction2810/21/201115 Linear Regression Good ScreenBou-Chacra, NA et al. 2003. Evaluation of Preservative Systems in a Sunscreen Formula by the Linear Regression Method. J Cosmet Sci. 54 MicroorganismsFDA regulatory focus in recent years Bacillus cereusGram-positive, facultatively aerobic sporeformer. -hemolytic and may be an emerging pathogen. Burkholderia cepaciaPseudomonad, clearly pathogenic to cystic fibrosis patients who can develop pneumonia. THE CONCERN IS THATCF PATIENTS ARE EXPOSED TOPRODUCTS THAT MAY LEAD TO of Presentation What is the Antimicrobial Effectiveness Test? What it can do What it can t do AET (PET) Topics Packaging Effects Formulation Effects Phoenix Phenomenon Linear Regression Unique Microorganisms FDA s Role in this Use of Contract Labs for generation of data31 FDA Role Auditable GMPGMP TopicGood Manufacturing Practice (GMP) Guidelines/InspectionChecklistISO 22716 Buildings and FacilitiesXXEquipmentXXPersonnelXXRaw MaterialsXXProductionXXRecordsXXLabeling XXComplaintsXXQC Lab OperationXSubcontractor QAX3210/21/201117 ISO 22716 Topics1.

10 Scope2. Terms and definitions3. Personnel4. Premises5. Equipment6. Raw materials and packaging materials7. Production8. Finished products9. Quality control laboratory3310. Treatment of product that is out of specification11. Wastes12. Subcontracting13. Deviations14. Complaints and recalls15. Change control16. Internal audit17. DocumentationFDA Actions Recalls Warning Letters Halting Transport3410/21/201118 Overview of Presentation What is the Antimicrobial Effectiveness Test? What it can do What it can t do AET (PET) Topics Packaging Effects Formulation Effects Phoenix Phenomenon Linear Regression Unique Microorganisms FDA s Role in this Use of Contract Labs for generation of data35 Contract Lab Relationship Must meet your quality standardsSutton, S. 2011. Successful Use of a Contract Microbiology Laboratory. J GXP Compliance. 15(1):54-64. You are responsible for data generated on your productsDiebel Labs Warning Letter Micro issues: No Method Suitability Testing Poor investigations Inadequate control of microbiological growth media Poor control of water Poor documentation What is the Antimicrobial Effectiveness Test?


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