Preservation Efficacy Testing
|
|
- Elvin Atkins
- 6 years ago
- Views:
Transcription
1 Preservation Efficacy Testing Scott Sutton, Ph.D Material in this presentation is copyright 2011 Microbiology Network Inc. All rights reserved 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 data 2 1
2 Antimicrobial Efficacy Test USP <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 survivors 3 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 products 4 2
3 Consensus Antimicrobial Effectiveness Test Effort of the European Pharmacopoeia, Japanese Pharmacopeia, and United States Pharmacopeia to come to a harmonized assay. Sutton, SVW and D Porter Development of the Antimicrobial Effectiveness Test As USP Chapter <51>. PDA J Pharm Sci Tech. 56(6): Matthews, BR Preservation and Preservative Efficacy Testing: European Perspectives. Eur J Parent Pharm Sci. 8(4): Proposed Cosmetics AET ISO 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 analysis. 6 3
4 CTFA 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 Methodology o 20. M-3 A Method for Preservation Testing of Water-Miscible Personal Care Products o 21. M-4 Method for Preservation Testing of Eye Area Cosmetics o 22. M-5 Methods for Preservation Testing of Nonwoven Substrate Personal Care Products o 23. M-6 A Method for Preservation Testing of Atypical Personal o Care Products o 24. M-7 A Rapid Method for Preservation Testing of Water-Miscible Personal Care Products 7 AET - Validation Comparisons Test Group Peptone Control Group Viability Group Neutralizer Efficacy Neutralizer Toxicity 8 4
5 Method Suitability Acceptance Criteria ISO Performed in duplicate must be within 50% USP <1227> 5-6 plates in replicate must exceed 70% between populations USP <51> Pharm Eur Standard Antimicrobial Efficacy Test ISO & USP <51> 6 10 CFU/mL Each of five challenge microorganisms - 3 bacteria, 2 fungi 10-fold serial dilutions Incubate microbial suspension Plate in growth agar to count survivors Sample at 7 days, 14 days, *21 days, 28 days Determine Log Reduction (log value of inoculum) - (log value of survivors at the time point) 10 5
6 Challenge Organisms Challenge Organism ISO USP Pharm Eur Pseudomonas aeruginosa ATCC 9027 ATCC 9027 ATCC 9027; NCIMB 8626; CIP Staphylococcus aureus ATCC 6538 ATCC 6538 ATCC 6538; NCTC 10788; MCIMB 9518; CIP 4.83 Escherichia coli ATCC 8739 ATCC 8739 N/A Candida albicans ATCC ATCC ATCC 10231; NCPF 3179; IP Aspergillus brasiliensis ATCC ATCC ATCC 16404; IMI ; IP CTFA PET Challenge Organisms Water- Miscible Non- Woven Eye Area* Atypical Gram (+) Cocci Staphylococcus aureus (6538) NLT One NLT One NLT One NLT One** Gram (+) Cocci S. epidermidis (12228) NLT One NLT One NLT One NLT One Fermentative Gram(-) Bacilli Klebsiella pneumoniae (10031) NLT One NLT One NLT One NLT One Fermentative Gram(-) Bacilli Enterobacter cloacae (13047)) NLT One NLT One NLT One NLT One Fermentative Gram(-) Bacilli Escherichia coli (8739) NLT One NLT One NLT One NLT One Fermentative Gram(-) Bacilli Enterobacter gergoviae (33028) NLT One NLT One NLT One NLT One Fermentative Gram(-) Bacilli Proteus spp N/A NLT One N/A N/A Non-fermentative Gram(-) Bacilli Pseudomonas aeruginosa (9027) NLT One NLT One NLT One NLT One Non-fermentative Gram(-) Bacilli Burkholderia cepacia (25416) NLT One NLT One NLT One NLT One Non-fermentative Gram(-) Bacilli Pseudomonas fluorescens (13525) NLT One NLT One NLT One NLT One Non-fermentative Gram(-) Bacilli Pseudomonas putida (31483) NLT One NLT One NLT One NLT One Non-fermentative Gram(-) Bacilli Flavobacterium spp N/A NLT One N/A N/A Non-fermentative Gram(-) Bacilli Acinetobacter spp N/A NLT One N/A N/A Yeast Candida albicans (10231) Recommended NLT One NLT One Recommended Yeast Candida parapsilosis (22019) N/A NLT One NLT One N/A Mold Aspergillus niger (16404) NLT One NLT One NLT One NLT One Mold Penicillium species NLT One N/A NLT One NLT One Mold Chaetomium globosum (6205) N/A N/A NLT One N/A Mold Trichoderma reesei (13631) N/A N/A NLT One N/A Mold Cladosporium oxysporum (76499) N/A N/A NLT One N/A Mold Penicillium luteum N/A NLT One N/A N/A Spore-Forming Bacilli Bacillus subtilis (6051) Optional Optional Optional Optional Other organisms. Optional NLT One Optional Optional *No ATCC strain designations listed for this method ** Read as "Not Less Than One" or "Select at least one" 12 6
7 CTFA Preparation of Inocula All CTFA methods except eyecosmetics which does not allow Malt Extract Agar for growth of molds 13 Criteria for Passage USP/Pharm Eur Log 10 Reduction 6 Hr 24 Hr 7 Day 14 Day 21 Day 28 Day USP: Bacteria NI EP-A: Bacteria NR EP-B: Bacteria NI USP: Fungi NI NI -- NI EP-A: Fungi NI EP-B: Fungi NI 7
8 USP Categories Category 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 Acceptance Criteria 16 8
9 Proposed ISO Risk Analysis 17 CTFA Criteria for Passage Bacteria Fungi Cosmetics 99.9% in 7 days 90% in 7 days Eye-Area Cosmetics 99.9% in 7 days 90% in 7 days Nonwovens Determined by risk assessment Determined by risk assessment Note that the challenges can be individual or pooled inocula, and that the test may, or may not, incorporate a rechallenge. 18 9
10 Scope of AET It can Provide relative estimates of the biological activity of a preservative system in a particular formulation at a particular time. It cannot Predict the preservative efficacy of the multidose finished product in all patients hands under all conditions. 19 AET General Reviews Machtiger, N., et al Determination of the Efficacy of Preservation of Non-Eye Area Water-Miscible Cosmetic and Toiletry Formulations: Collaborative Study. J AOAC Intl. 84(1): Farrington, J.K, et al Ability of Lab Methods to Predict In-Use Efficacy Antimicrobial Preservatives In an Experimental Cosmetic. Appl Envir Microbiol. 60(12): Geis, P.A Preservation of Cosmetics and Consumer Products: Rationale and Application. J Ind Microbiol. 29(Suppl 3):
11 Overview 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 data 21 Formulation Effects Cyclodextrins Simpson, W.J Neutralization of the Antibacterial Action of Quaternary Ammonium Compounds with Cyclodextrins. Fed Eur Microbiol Soc. pp Colorants Sakamoto, T.,et al Effects of Some Cosmetic Pigments On the Bactericidal Activities of Preservatives. J Soc Cosmet Chem. 38: Emulsions Rieger, M.M Current Aspects of Cosmetic Science:The Inactivation of Phenolic Preservatives In Emulsions. Cosmet Toilet 96: Myburgh, J.A. et al The Influence of Suspending Agents On Preservative Activity In Aqueous Solid/Liquid Dispersions. Pharm Weekblad Sci Ed 2: Myburgh, J.A. et al Inactivation of Preservatives In the Presence of Particulate Solids Pharm Weekblad Sci Ed. 2:
12 Formulation Effects Excellent Review Geis, P Fundamental Elements of Cosmetic and OTC Drug Microbiological Quality. Amer Pharm Rev. 10(4): Also: Geis, P. and T Rook Microbiological Quality Of Consumer Products HAPPI May, Formulation Effects - Physical Anhydrous Bases No need for preservation Low Water Activity May not require preservation, technically challenging to test Buffer Effects Example: Phosphate buffer base vs Borate ph Halotolerant/halophilic growth in alkaline shampoos 24 12
13 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, D.S Putting the Phoenix Phenomenon Into Perspective. Cosmet Toilet 114(Apr):61-66) Requires product to have sufficient nutrients for growth 25 Fungal Growth Apparent growth of fungal spores in a preservative efficacy test Most commonly seen with products containing surfactants Dissociation of spore aggregates? 26 13
14 Linear Regression Model Linear Regression Model Orth, D.S Linear Regression Method for Rapid Determination of Cosmetic Preservative Efficacy. J Soc Cosmet Chem. 30: Orth, D.S. et al Establishing Cosmetic Preservative Efficacy by Use of D-Values. J Soc Cosmet Chem. 31: Orth, DS and LR Brueggen Preservative Efficacy Testing of Cosmetic Products: Rechallenge Testing and Reliability of the Linear Regression Method. Cosmet Toilet. 97(May): Linear Regression Good Screen Many (most?) preservative systems are not linear except in approximate terms Sutton, SVW. et al D-Value Determinations Are an Inappropriate Measure of Disinfecting Activity of Common Contact Lens Disinfecting Solutions. Appl Envir Microbiol. 57(7): All chemical preservative systems are consumed in the reaction 28 14
15 Linear Regression Good Screen Bou-Chacra, NA et al Evaluation of Preservative Systems in a Sunscreen Formula by the Linear Regression Method. J Cosmet Sci. 54: Unique Microorganisms FDA regulatory focus in recent years Bacillus cereus Gram-positive, facultatively aerobic sporeformer. -hemolytic and may be an emerging pathogen. Burkholderia cepacia Pseudomonad, clearly pathogenic to cystic fibrosis patients who can develop pneumonia. THE CONCERN IS THAT CF PATIENTS ARE EXPOSED TO PRODUCTS THAT MAY LEAD TO PNEUMONIA
16 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 data 31 FDA Role Auditable GMP GMP Topic Good Manufacturing Practice (GMP) Guidelines/Inspection Checklist ISO Buildings and Facilities X X Equipment X X Personnel X X Raw Materials X X Production X X Records X X Labeling X X Complaints X X QC Lab Operation X Subcontractor QA X 32 16
17 ISO Topics 1. Scope 2. Terms and definitions 3. Personnel 4. Premises 5. Equipment 6. Raw materials and packaging materials 7. Production 8. Finished products 9. Quality control laboratory 10.Treatment of product that is out of specification 11. Wastes 12. Subcontracting 13. Deviations 14. Complaints and recalls 15. Change control 16. Internal audit 17. Documentation 33 FDA Actions Recalls Warning Letters Halting Transport 34 17
18 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 data 35 Contract Lab Relationship Must meet your quality standards Sutton, S Successful Use of a Contract Microbiology Laboratory. J GXP Compliance. 15(1): You are responsible for data generated on your products Diebel Labs Warning Letter Micro issues: No Method Suitability Testing Poor investigations Inadequate control of microbiological growth media Poor control of water Poor documentation practices
19 Summary 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 data 37 Thank you for your attention Scott Sutton, Ph.D. scott.sutton@microbiol.org Twitter Material in this presentation is copyright 2011 Microbiology Network Inc. All rights reserved 19
Microbiological Quality Control as Described in the Compendia. Scott Sutton, Ph.D.
Microbiological Quality Control as Described in the Compendia Scott Sutton, Ph.D. Microbiological Quality Control as Described in the Compendia Antimicrobial Effectiveness Test , ,
More informationThe Microbiological Requirements of a Stability Study. Ngoc Anh-Thu Phan 19 th June 2012
The Microbiological Requirements of a Stability Study Ngoc Anh-Thu Phan 19 th June 2012 Contents Introduction Harmonized Tests Acceptance Criteria Selection of Tests Why PE Testing? Selection of Category
More informationPRESERVATIVE EFFICACY TEST FOR COSMETIC PRODUCT
1 SCOPE AND FIELD OF APPLICATION To determine the efficacy of the antimicrobial activity of preservatives used in cosmetic products. The method covers the determination of the suitability of preservation
More informationPreservative Testing Choice of Challenge Isolates
Preservative Testing Choice of Challenge Isolates By Dr. Philip Geis "What you see is that the most outstanding feature of life's history is a constant domination by bacteria."~stephen Jay Gould An effective
More informationDisinfection Qualification Testing
Disinfection Qualification Testing Considerations for Aseptic & Cleanroom Manufacturing Environments White Paper Considerations for Aseptic and Cleanroom Manufacturing Environments Obtaining the highest
More informationToday s Topics. General Quality Control Best Practices. Practices Antimicrobial Effectiveness Testing(AET) Best Practices Environmental Isolates
Laboratory Best Practices in QC Microbiology Today s Topics General Quality Control Best Practices Growth Promotion Testing (GPT) Best Practices Antimicrobial Effectiveness Testing(AET) Best Practices
More informationDISINFECTION QUALIFI CATION TESTING CONSIDERATIONS FOR THE ASEPTIC AND CLEANROOM MANUFACTURING ENVIRONMENT
DISINFECTION QUALIFI CATION TESTING CONSIDERATIONS FOR THE ASEPTIC AND CLEANROOM MANUFACTURING ENVIRONMENT by Dave Rottjakob, M.T. (ASCP) December, 2013 INTRODUCTION Obtaining the highest confidence that
More informationPublished Standards ISO General instructions for microbiological examination ISO Enumeration and detection of aerobic mesophilic bacteri
ISO Standards Cosmetics Microbiology TC 217 WG1 Joyce Beauchamp L OREAL USA Products, Inc. 2010 PCPC Microbiology Workshop ISO TC 217 WG1 Microbiological standards and limits Secretariat IRISI Secretary
More informationá61ñ MICROBIOLOGICAL EXAMINATION OF NONSTERILE PRODUCTS: MICROBIAL ENUMERATION TESTS
USP 40 Microbiological Tests / á61ñ Microbiological Examination 1 á61ñ MICROBIOLOGICAL EXAMINATION OF NONSTERILE PRODUCTS: MICROBIAL ENUMERATION TESTS INTRODUCTION The tests described hereafter will allow
More informationFinal text for addition to The International Pharmacopoeia
March 2012 3.3.1 MICROBIOLOGICAL EXAMINATION OF NON-STERILE PRODUCTS: MICROBIAL ENUMERATION TESTS Final text for addition to The International Pharmacopoeia This monograph was adopted at the Forty-sixth
More informationSpecifications, Methods and precedence of source with particular reference to microbiological requirements in TGOs.
Specifications, Methods and precedence of source with particular reference to microbiological requirements in TGOs. Fergus O Connell RACI Pharmaceutical Science Group (NSW) 10/08/2015 Currently there are
More information3.2 Test for sterility
This text is based on the internationally-harmonized texts developed by the Pharmacopoeial Discussion Group (PDG). Some editorial modifications have been made in order to be in line with the style used
More informationKORALONE C-204 Preservative for Household and Industrial & Institutional Products
Preservative KORALONE C-204 Preservative for Household and Industrial & Institutional Products Description For decades Rohm and Haas has driven the progress of isothiazolinone chemistry to meet your evolving
More informationTechnical Report: (6616) December 05, 2016 Date Received: December 05, 2016 Page 1 of 6
CONSUMER PRODUCTS SERVICES DIVISION NGBO MERRYART GLOWTECH CO., LTD Technical Report: (6616)3371148 Date Received: Page 1 of 6 TANG NGBO MERRYART GLOWTECH CO., LTD NO.8 LIXIN RD, XIAOGANG DUTOUDONG IND.
More information3.3.1 Microbial enumeration tests
This text is based on the internationally-harmonized texts developed by the Pharmacopoeial Discussion Group (PDG). Some editorial modifications have been made in order to be in line with the style used
More informationEC-type approval protocol No. 2 Microbiological safety of toys containing aqueous media REV 2
Co-ordination of the Notified Bodies NB-TOYS under the Safety of Toys Directive NB- TOYS/2014/071 10 June 2014 EC-type approval protocol No. 2 Microbiological safety of toys containing aqueous media REV
More informationPreservation is a critical element in protecting consumer, TABLE 1. SIMILARITIES AND VARIATIONS REPORTED IN THE PET SURVEY RESPONSES
PRESERVATIVE EFFICACY TESTING Representatives from finished product companies and suppliers provide insight on methods ensuring preservation of consumer, household and industrial products. Vidya Ananth
More informationEC-type approval protocol No. 2 Microbiological safety of toys containing aqueous media REV 3
Ref. Ares(2016)1375473-18/03/2016 Co-ordination of the Notified Bodies NB-TOYS under the Safety of Toys Directive NB-TOYS 2016/014 18 Febuary 2016 EC-type approval protocol No. 2 Microbiological safety
More informationICH Topic Q4B Annex 8 Sterility Test General Chapter. Step 3
European Medicines Agency December 2008 EMEA/CHMP/ICH/645592/2008 ICH Topic Q4B Annex 8 Sterility Test General Chapter Step 3 ANNEX 6 TO NOTE FOR EVALUATION AND RECOMMENDATION OF PHARMACOPOEIAL TEXTS FOR
More informationPrinciples of Preservation
From ISP/Sutton Laboratories Principles of Preservation What is preservation? When we speak as formulators about preservation, we are referring to the protection of our products from contamination by bacteria,
More informationMethod Suitability Report Membrane Filtration Sterility Test with QTMicro Apparatus
Method Suitability Report Membrane Filtration Sterility Test with QTMicro Apparatus Bevacizumab (Avastin) 1.25 mg/0.05ml This report provides details on the specifics of a Membrane Filtration Sterility
More informationPreservative Challenge Testing and Compendia: Efficient Efficacy
Preservative Challenge Testing and Compendia: Efficient Efficacy October 28, 2014 Leon Nepomniashy Energizer Personal Care Presentation Agenda I. Preservative Efficacy overview The What, The When and The
More informationMicrobiology for Oral and Topical Products - The basics Scott Colbourne Business Manager NSW ALS Food & Pharmaceutical
Microbiology for Oral and Topical Products - The basics Scott Colbourne Business Manager NSW ALS Food & Pharmaceutical RIGHT S O L U T I O N S RIGHT PARTNER Contents TGO 77 - Introduction Tests Performed
More informationWorking document QAS/ June 2011 RESTRICTED DRAFT FOR COMMENT
June 2011 RESTRICTED DRAFT PROPOSAL FOR Revision of General method in the 4th Edition of The International Pharmacopoeia 3.3 MICROBIAL PURITY OF PHARMACEUTICAL PREPARATIONS (June 2011) DRAFT FOR COMMENT
More informationIN THIS SECTION MICROBIOLOGY TESTING EXPERT SOLUTIONS FOR PRODUCT DEVELOPMENT. Bacterial Endotoxin (LAL) Testing
EXPERT SOLUTIONS FOR PRODUCT DEVELOPMENT IN THIS SECTION MICROBIOLOGY TESTING Microbial assays involve a variety of tests, from the determination of the numbers and types of organisms naturally present
More informationIndustry Case Study: A Microbial Investigation of Contamination by Burkholderia multivorans. Jim Klein and Geert Verdonk Merck & Co., Inc.
Industry Case Study: A Microbial Investigation of Contamination by Burkholderia multivorans Jim Klein and Geert Verdonk Merck & Co., Inc. Messages The role of microbiological analysis The role of subject
More informationONAMER M. PRESERVATIVE and ANTIMICROBIAL ONAMER
ONAMER M PRESERVATIVE and ANTIMICROBIAL ONAMER M Stepan Lipid Nutrition is a division of Stepan Company which manufactures lipid and polymer based ingredients. HO OH SUMMARY Our quaternary ammonium polymer
More informationThe International Harmonization of the Compendial Microbial Limits Tests A Cautionary Tale of Compendial Participation
MI C R O BI O L O GY T O PIC S The International Harmonization of the Compendial Microbial Limits Tests A Cautionary Tale of Compendial Participation Scott Sutton image source, medicalrf.com/getty images
More informationWorking document QAS/11.415/Rev. 1 August 2011 RESTRICTED DRAFT FOR COMMENT
/Rev. 1 August 2011 RESTRICTED DRAFT PROPOSAL FOR Revision of General method in the 4th Edition of The International Pharmacopoeia 3.3 MICROBIAL Quality PURITY OF PHARMACEUTICAL PREPARATIONS (August 2011)
More informationGrowth Promotion Test Guide for Media Used in Sterility Tests
Growth Promotion Test Guide for Media Used in Sterility Tests The Sterility Test The purpose of the Sterility Test is to determine if a sample of a pharmaceutical product or component is sterile. A satisfactory
More informationCurrent Industry Trends -Including Cleaning and Disinfection trends, Disinfectant Validation Trends, and Current Warning Letter Activity.
Current Industry Trends -Including Cleaning and Disinfection trends, Disinfectant Validation Trends, and Current Warning Letter Activity. Jim Polarine Jr. MA. Technical Service Manager Steris Corp. Copyright
More informationGUIDE TO INSPECTIONS OF MICROBIOLOGICAL PHARMACEUTICAL QUALITY CONTROL LABORATORIES
GUIDE TO INSPECTIONS OF MICROBIOLOGICAL PHARMACEUTICAL QUALITY CONTROL LABORATORIES Note: This document is reference material for investigators and other FDA personnel. The document does not bind FDA,
More informationCompounding Pharmacies and the USP <71> Sterility Tests
Compounding Pharmacies and the USP Sterility Tests Scott Sutton, Ph.D. scott.sutton@microbiol.org 49 41 Disclaimer I am making this presentation as an independent agent I am not making this presentation
More informationBIO & PHARMA ANALYTICAL TECHNIQUES
BIO & PHARMA ANALYTICAL TECHNIQUES Chapter 11 by Dr. Siti Umairah Mokhtar Faculty of Engineering Technology umairah@ump.edu.my Chapter Description Aims Discuss theory, principles and application of analytical
More informationValidating the microbiological integrity of cosmetic products through consumer-use testing
j. Soc. Cosmet. Chem., 37, 481-488 (November/December 1986) Validating the microbiological integrity of cosmetic products through consumer-use testing SUSAN M. LINDSTROM and JOYCE D. HAWTHORNE, Avon Products,
More informationFinal text for addition to The International Pharmacopoeia
March 2012 3.3.2 MICROBIOLOGICAL EXAMINATION OF NON-STERILE PRODUCTS: TESTS FOR SPECIFIED MICROORGANISMS Final text for addition to The International Pharmacopoeia This monograph was adopted at the Forty-sixth
More informationANALYTICAL REPORT: Comparison of the Microbial Recovery Efficacy of QI Medical EnviroTest Paddles versus a Conventional Contact Plate
FOCUS Scientific Services LLC ANALYTICAL REPORT: Comparison of the Microbial Recovery Efficacy of QI Medical EnviroTest Paddles versus a Conventional Contact Plate REPORT: FS-QI-GM-003 Study Manager: Anthony
More informationMicrobiological Analysis of Pharmaceutical Preparations
Microbiological Analysis of Pharmaceutical Preparations Drug Production Facility; GMP (Good Manufacturing Process) Causes of Microbiological Contaminations of Pharmaceutical Preparations Microorganisms
More information2.6. BIOLOGICAL TESTS
2.6.1. Sterility 2.6. BIOLOGICAL TESTS 2.6.1. STERILITY 01/2005:20601 The test is applied to substances, preparations or articles which, according to the Pharmacopoeia, are required to be sterile. However,
More informationManaging Your Environmental Isolates
Managing Your Environmental Isolates The Controversy Good practice includes the periodic challenge of prepared media with low levels of organisms. This includes USP indicator organisms as well as normal
More informationá62ñ MICROBIOLOGICAL EXAMINATION OF NONSTERILE PRODUCTS: TESTS FOR SPECIFIED MICROORGANISMS
USP 40 Microbiological Tests / á62ñ Microbiological Examination 1 á62ñ MICROBIOLOGICAL EXAMINATION OF NONSTERILE PRODUCTS: TESTS FOR SPECIFIED MICROORGANISMS INTRODUCTION The tests described hereafter
More information2.6. BIOLOGICAL TESTS
2.6.1. Sterility 2.6. BIOLOGICAL TESTS 2.6.1. STERILITY 01/2008:20601 The test is applied to substances, preparations or articles which, according to the Pharmacopoeia, are required to be sterile. However,
More informationGuidelines for Laboratory Verification of Performance of the FilmArray Blood Culture Identification (BCID) Panel
Guidelines for Laboratory Verification of Performance of the FilmArray Blood Culture Identification (BCID) Panel Purpose The Clinical Laboratory Improvement Amendments (CLIA), passed in 1988, establishes
More informationProtocols for Laboratory Verification of Performance of the FilmArray Blood Culture Identification (BCID) Panel
Protocols for Laboratory Verification of Performance of the FilmArray Blood Culture Identification (BCID) Panel Purpose The Clinical Laboratory Improvement Amendments (CLIA), passed in 1988, establishes
More informationIntroduction. Michael J. Miller, Ph.D. RMM»
RMM» Case Study of a New Growth-based Rapid Microbiological Method (RMM) that Detects the Presence of Specific Organisms and Provides an Estimation of Viable Cell Count Michael J. Miller, Ph.D. President
More informationUSP <1116> and Contamination
USP and Contamination Recovery Rates Scott Sutton ABSTRACT United States Pharmacopeia (USP) "Microbiological Control and Monitoring of Aseptic Processing Environments" approaches analysis
More informationINTRODUCTION water-soluble Figure 1.
INTRODUCTION Natural waters contain bacteria. The aerobic gram negative bacillus of the genera Psedomonas, Alcalignes, and Flavobacterium are common in natural waters. Many of these bacteria are able to
More informationStandard Operating Procedure Title: Stock Suspensions of Micro-Organisms
2. Correct Aseptic technique must be used when performing all Microbiological procedures. 3. All work must be carried out in the Biohazard Cabinet. Table of Contents 2. Positive Identification of Reference
More informationTests to Support Sterility Claim. Imtiaz Ahmed
Tests to Support Sterility Claim Imtiaz Ahmed Sterile Product As per TGO 77, a sterile product must comply with the requirements of the following tests: Sterility Test Bacterial Endotoxins Test Appendix
More informationProtocols for Laboratory Verification of Performance of the BioFire FilmArray Blood Culture Identification (BCID) Panel
Protocols for Laboratory Verification of Performance of the BioFire FilmArray Blood Culture Identification (BCID) Panel A Laboratory Protocol for Use with Live s Purpose The Clinical Laboratory Improvement
More information11/1/2010. Key Points to Remember
A Review of Microbial Limits and Objectionable Organisms Steven Schnittger, The Estee Lauder Companies, Inc. Key Points to Remember Cosmetic products are not required to be sterile It is the aim of all
More informationMICROBIOLOGICAL EXAMINATION OF NON-STERILE PRODUCTS: TEST FOR SPECIFIED MICRO-ORGANISMS Test for specified micro-organisms
5-2-3. Most-probable-number method Prepare and dilute the sample using a method that has been shown to be suitable as described in section 4. Incubate all tubes at 30-35 C for 3-5 days. Subculture if necessary,
More informationDetermination of Inoculum for Microbiological Testing
Determination of Inoculum for Microbiological Testing IMAGE SOURCE, MEDICALRF.COM/GETTY IMAGES Microbiology Topics discusses various topics in microbiology of practical use in validation and compliance.
More informationManaging Your Environmental Isolates
Managing Your Environmental Isolates Good Testing Practices Good practice includes the periodic challenge of media with low levels of organisms. This includes USP indicator organisms as well as normal
More informationValidation of the BacT/Alert as an Alternative Sterility Test for Dendreon s Autologous Cell Therapy Product Timothy Wood QC Scientist
Validation of the BacT/Alert as an Alternative Sterility Test for Dendreon s Autologous Cell Therapy Product Timothy Wood QC Scientist Somatic Cell Therapy Symposium, Bethesda MD September 28, 2007 1 Overview
More informationTechnical Data Sheet. Clariant In-can Biocides. Nipacide BIT 10W. Chemical name:1,2-benzisothiazolin-3-one
Technical Data Sheet Clariant In-can Biocides Nipacide BIT 10W. Chemical name:1,2-benzisothiazolin-3-one Description; Nipacide BIT10W is a light colour, 10% active VOC free water based solution of 1,2-
More informationCase study Microbiological excursion during a phase I PQ of a WFI system. Walid El Azab Technical Service Manager STERIS Life Science
Case study Microbiological excursion during a phase I PQ of a WFI system Walid El Azab Technical Service Manager STERIS Life Science Agenda Agenda Case study Microbiological excursion Description of the
More informationISO INTERNATIONAL STANDARD
INTERNATIONAL STANDARD ISO 14729 First edition 2001-04-15 Ophthalmic optics Contact lens care products Microbiological requirements and test methods for products and regimens for hygienic management of
More informationProtocol Reference: Verification Protocol
Protocol Reference: Verification Protocol Contents 1. About BioBall Multishot 550 3 2. About This Protocol 4 3. Safety Precautions 4 4. Protocol Pre-approval 4 5. Protocol Scope 5 5.1. Intended Location
More informationAnalytical Service Code
Mycometrics, LLC. 9 Deer Park Dr. Suite K-18 Monmouth Junction, NJ 08852 Tel: 732-355-9018 Fax: 732-658-5185 Email: quest@mycometrics.com URL: www.mycometrics.com Analytical Service Code Microbial Identification
More informationStudy Title Antibacterial Activity and Efficacy of KHG FiteBac Technology Test Substance Using a Suspension Time-Kill Procedure
Study Title Antibacterial Activity and Efficacy of KHG FiteBac Technology Test Substance Using a Suspension Time-Kill Procedure Test Method ASTM International Method E2315 Assessment of Antimicrobial Activity
More informationAvoid recurrent microbial contamination using trending of historical data. El Azab Walid Technical Service Manager STERIS
Avoid recurrent microbial contamination using trending of historical data El Azab Walid Technical Service Manager STERIS Agenda Factors influencing the cleaning and disinfection performance Recurring microbial
More informationAntimicrobial effectiveness evaluation of Isocide powder coating versus stainless steel plate
Antimicrobial effectiveness evaluation of Isocide powder coating versus stainless steel plate By: Dian Susanti and Alexander Atmadi Abstract Undesirable bioburdens can cause contamination on equipment
More informationDisinfectant Qualification A Multifaceted Study
Disinfectant Qualification A Multifaceted Study In this article, Ziva Abraham, Microrite, Inc., gives us a brief overview of the disinfectant qualification study process. An effective cleaning and disinfection
More informationTECHNICAL LEAFLET. MEDI-MEDIA-FILL KIT SUPPLY PACKAGE (Code: MR-25/S)
TECHNICAL LEAFLET MEDI-MEDIA-FILL KIT SUPPLY PACKAGE (Code: MR-25/S) TEST AGAR PLATES FOR PERSONNEL AND ENVIRONMENTAL MICROBIOLOGICAL MONITORING COMPONENTS: Test Agar Plates Data Log Sheet Technical Leaflet
More informationDecontamination Effectiveness of Esco Celsafe CO2 Incubator Sterilization Feature using High Heat Temperature By Bekti Tri Sumaryati
Decontamination Effectiveness of Esco Celsafe CO2 Incubator Sterilization Feature using High Heat Temperature By Bekti Tri Sumaryati 1. Summary Esco Celsafe CO 2 Incubator sterilization feature, which
More informationSTS Directory Accreditation number: STS 0268
International standard: ISO/IEC 17025:2005 Swiss standard: SN EN ISO/IEC 17025:2005 Bioexam AG Maihofstrasse 95a P.O.B. 6858 CH-6000 Lucerne 6 Head: Candid Bucher Responsible for MS: Nathalie Amstein Telephone:
More informationErin Patton, MS Senior Product Specialist Charles River Labs, Microbial Solutions
Validation of a Rapid Microbial Method Approach to Validation Case Studies: Equivalence Verification of an Alternate Assay for Microbial Limits Screening and Sterility Testing of Pharmaceutical Products
More informationStudy Title Antibacterial Efficacy of Bio-Care Technology's Non-Porous Test Substance
Study Title Antibacterial Efficacy of Bio-Care Technology's Non-Porous Test Substance Test Method Japanese Industrial Standard Z 2801 Antibacterial Products Test for Antibacterial Activity and Efficacy
More informationEfficacy Report Summarization for SoClean 2
Efficacy Report Summarization for SoClean 2 October 2017 SoClean Inc 36 Town Forest Road Oxford, Massachusetts 01540 USA Tel. 508-363-0418 Email info@soclean.com SoClean 2 is USA FDA Registered 3009534409
More informationThe Most Probable Number Method and Its Use in QC Microbiology
MICROBIOLOGY TOPICS The Most Probable Number Method and Its Use in QC Microbiology Scott Sutton IMAGE SOURCE, MEDICALRF.COM/GETTY IMAGES Microbiology Topics discusses various topics in microbiology of
More informationVINKOCIDE CMI 14 -Broad spectrum preservative-
PRODUCT FEATURES Vinkocide CMI 14 is a formulation of 5-Chloro-2-methyl-2H-isothiazol-3-one (CIT) with 2-Methyl-2H-isothiazol-3-one (MIT). Synonyms of 5-Chloro-2-methyl-2H-isothiazol-3-one: 5-chloro-2-methyl-4-isothiazolin-3-one,
More informationEuropean Pharmacopoeia
EXAMPLES OF VALIDATION PROTOCOLS OF THE ALTERNATIVE MICROBIOLOGICAL METHODS ACCORDING TO CHAPTER 5.1.6 Alternative methods for control of microbiological quality European Pharmacopoeia EDQM Edition 2018
More informationEnvironmental Surveillance FIDSSA Dr Ben Prinsloo Medical Microbiologist
Environmental Surveillance FIDSSA 2015 Dr Ben Prinsloo Medical Microbiologist The Scientist A scientist, in a broad sense, is a person engaging in a systematic activity to acquire knowledge We require
More informationThis document is a preview generated by EVS
INTERNATIONAL STANDARD ISO 11930 First edition 2012-04-01 Cosmetics Microbiology Evaluation of the antimicrobial protection of a cosmetic product Cosmétiques Microbiologie Évaluation de la protection antimicrobienne
More informationIndigo-Clean White Paper: #1 Bactericidal Performance Testing of Indigo-Clean Upon Bacterial Species. Healthcare
Indigo-Clean White Paper: #1 Bactericidal Performance Testing of Indigo-Clean Upon Bacterial Species Healthcare HC Bactericidal Performance Testing of Indigo-Clean Upon Bacterial Species Clifford J. Yahnke,
More informationAmerican Pharmaceutical
American Pharmaceutical The Review of American Pharmaceutical Business & Technology Volume 15 Issue 1 January/February 2012 www.americanpharmaceuticalreview.com A Review of Reported Recalls Involving Microbiological
More informationProduct Information. Bellacide 350
BioLab Water Additives A Subsidiary of Great Lakes Chemical Corporation Tenax Road Trafford Park Manchester M17 1WT United Kingdom Phone +(44) 161 875 3875 Fax +(44) 161 875 3175 Product Information Bellacide
More informationComparative Study in Preservation Efficiency of Oral Calcium/Vitamin D 3 /Vitamin B 12 Syrup
Columbia International Publishing American Journal of Pharmaceutical Sciences and Nanotechnology doi:10.7726/ajpsn.2017.1001 Short Communication Comparative Study in Preservation Efficiency of Oral Calcium/Vitamin
More informationMicrobiological study of cosmetic products during their use by consumers: health risk and efficacy of preservative systems
Letters in Applied Microbiology ISSN 0266-8254 ORIGINAL ARTICLE Microbiological study of cosmetic products during their use by consumers: health risk and efficacy of preservative systems R. Campana, C.
More informationStudy Title Antimicrobial Activity and Efficacy of Seal Shield's Electroclave. Test Method Custom Device Study. Study Identification Number NG7233
Study Title Antimicrobial Activity and Efficacy of Seal Shield's Electroclave Test Method Custom Device Study Study Identification Number NG7233 Study Sponsor Christian Davis Seal Shield 3105 Riverside
More informationWhy Do I Test, What Do I Test & When Do I Test It? Ross Caputo, PhD Chief Technical Officer Eagle Analytical Services
Why Do I Test, What Do I Test & When Do I Test It? Ross Caputo, PhD Chief Technical Officer Eagle Analytical Services Disclosures I, Ross Caputo, declare no conflicts of interest, real or apparent, and
More informationXylose Lysine Deoxycholate (XLD) Agar LI acc. EP/USP
Technical Data Sheet Xylose Lysine Deoxycholate (XLD) Agar LI acc. EP/USP Ordering number: 1.46073.0020 / 1.46073.0120 Xylose Lysine Deoxycholate (XLD) Agar LI is a selective culture medium for isolation
More informationPuritan Environmental Sampling Kit (ESK )
Puritan Environmental Sampling Kit (ESK ) Table of Contents: Introduction Pg.2 Description..Pg.2 Production Information.... Pg.2-4 Attributes and Intended Uses... Pg.4-5 Common Food and Water Borne Pathogens...Pg.5-6
More informationCompounding Pharmacies and Water
Compounding Pharmacies and Water Scott Sutton, PhD scott.sutton@microbiol.org August 21, 2014 46 Disclaimer I am an independent consultant. I have been involved with USP for many years. I do not represent
More informationTest Method for Efficacy of Copper Alloy Surfaces as a Sanitizer
Test Method for Efficacy of Copper Alloy Surfaces as a Sanitizer Test Organisms: Staphylococcus aureus (ATCC 6538) Enterobacter aerogenes (ATCC 13048) Pseudomonas aeruginosa (ATCC 15442) Methicillin Resistant
More informationThe aim of antimicrobial efficacy testing (AET) performed during
Proposed Method to Evaluate the Microbiological Stability of Cosmetics During Use Nadine Bresciani, Valérie Poulet and Nathalie Collard Anemcoli, Lille, France Raphaél Dugue Laboratoire Midac, Loos, France
More informationAvailable online at Evaluation of microbial content of some sunscreen creams in Iran s market
Original Article Available online at http://pbr.mazums.ac.ir PBR Pharmaceutical and Biomedical Research Evaluation of microbial content of some sunscreen creams in Iran s market Narges Sedghi Sharif-Abad
More informationAvailable online at
Original Article Available online at http://pbr.mazums.ac.ir Pharmaceutical and Biomedical Research Evaluation of microbial content of some sunscreen creams in Iran s market Narges Sedghi Sharif-Abad 1,
More informationTSA + LTHT CSG Contact Plate
TSA + LTHT CSG Contact Plate Article N : 100.0100 CSG Click & Safe gamma Use in Pharmaceutical Industry in clean rooms and isolators Use for detection of aerobic and anaerobic micro-organisms contact sampling,
More informationTest Method for the Continuous Reduction of Bacterial Contamination on Copper Alloy Surfaces
Test Method for the Continuous Reduction of Bacterial Contamination on Copper Alloy Surfaces Test Organisms: Staphylococcus aureus (ATCC 6538) Enterobacter aerogenes (ATCC 13048) Pseudomonas aeruginosa
More informationBioburden Contamination Control: A Holistic Overview
Bioburden Contamination Control: A Holistic Overview Scott Sutton, PhD Microbiology Network, Inc. Scott Sutton, PhD is the Principal of Microbiology Network, Inc (http:// microbiologynetwork.com/) a company
More informationand Product Protection Process
UniFirst Garment Service for Healthcare UniFirst Garment Service for Healthcare and Product Protection Process Workwear Solutions for Healthcare Industry Safety A laboratory study to measure the effectiveness
More informationCHAPTER III SCREENING, ISOLATION AND DETERMINATION OF ANTIMICROBIAL SPECTRA OF ACTINOMYCETES
CHAPTER III SCREENING, ISOLATION AND DETERMINATION OF ANTIMICROBIAL SPECTRA OF ACTINOMYCETES (a) Collection of Samples: A total of nine samples were collected in sterile containers for the systematic screening
More informationCreating a Culture of Data Integrity Using an Automated Detection and Enumeration Method
Creating a Culture of Data Integrity Using an Automated Detection and Enumeration Method Novartis, Schaffhauserstrasse, 4332 Stein AGStein, Switzerland Sanofi Pasteur, Marcy l Etoile, France Leo Pharma,
More informationMicrobiological Quality of Drug Products after Penetration of the Container System for Dose Preparation Prior to Patient Administration
Microbiological Quality of Drug Products after Penetration of the Container System for Dose Preparation Prior to Patient Administration John W. Metcalfe, Ph.D. Senior Review Microbiologist FDA/CDER/OPS/New
More informationBacterial inactivation claims in the context of sterility. Adonis Stassinopoulos, Ph.D V.P. Global Scientific Affairs and Research Cerus Corporation
Bacterial inactivation claims in the context of sterility A follow up on the NBL PI validation study with the INTERCEPT system Adonis Stassinopoulos, Ph.D V.P. Global Scientific Affairs and Research Cerus
More informationUrine Monovette with Boric Acid
with Boric Acid Simulated use - Study showing stabilization of specific microorganisms in urine prepared by: Aktiengesellschaft & Co. SARSTEDT AG & Co. P.O. Box 1220 D-51582 Nümbrecht Phone (+49) 0 22
More informationCosmetics Microbiology Detection of Candida albicans
INTERNATIONAL STANDARD ISO 18416 Second edition 2015-12-01 Corrected version 2016-12-15 Cosmetics Microbiology Detection of Candida albicans Cosmétiques Microbiologie Détection de Candida albicans Reference
More informationResult:COMPLETE Report Date: December 28 th, 2015
Send to: Clean Water Environmental, LLC 1939 Talamore Court Southeast, Grand Rapids, MI 49546 Dr. Dale Williams Result:COMPLETE Report Date: December 28 th, 2015 Customer Name: Clean Water Environmental,
More information