Disinfectant Qualification & Cleaning Procedures

הכשרה של חומרי חיטוי ותהליכי ניקוי
מרצה: Mrs Ziva Abraham

תאריך: 24 יוני 2013
מיקום הקורס:  מלון מטרופוליטן, רח' טרומפלדור 11, תל אביב
מידע כללי
משך הפעילות: יום לימודים מלא
שעות:  09:00-17:00
עלות: 2,150 ש"ח + מע"מ
נקודות זכות: 1
מק''ט: 13626
שפת הקורס: אנגלית
על הקורס

Microbial contamination whether by planktonic organisms or biofilms is a matter of concern due the many implications, such as time consuming investigations, process failures, product failures, complaints and recalls. Regulators are increasing looking for healthcare product manufacturers to evaluate their disinfectants and prove that the disinfection program is effective at controlling contamination. Disinfectant qualification studies if not performed adequately could be very costly and yield erroneous data. There are many ways to conduct this study: understanding the pros and cons of each method is extremely critical to avoid costly mistakes

קהל היעד
  • Quality Assurance personnel who perform EM excursion or product failure investigations
  • QC Microbiologists performing environmental monitoring and reviewing data
  • QC Microbiology supervisors who review and approve EM and product testing data
  • Facilities personnel who participate in investigations
  • Manufacturing Supervisors who review cleaning records
  • Cleanroom personnel in charge of disinfection
  • Cleanroom cleaning contractors

Target Industries

  • Medical Device
  • Aseptic and Non Aseptic Drug Manufacturers
  • In-Vitro Diagnostics
  • Herbal Supplements
  • Food and Beverage Manufacturers
  • Biofules
Disinfectant Qualification & Cleaning Procedures
התועלת שתופק
  • Learn about the types of disinfectants used in the industry and their modes of action on various types of microbes
  • Realize how disinfectant label claims are established and why it is necessary to test even though the manufacturer has performed AOAC testing for dilution and contact time
  • Get familiarized with the different methods available to test disinfectants  including USP guidance
  • Step by step, learn how to plan, cost and execute these multi-part studies
  • Know well in advance about the probability and types of errors that will be encountered  during execution of these studies
  • Practice interpreting data for thorough review
  • Learn from numerous case studies and FDA 483s presented at this workshop
השאר פרטים למידע נוסף
  • שם מלא
  • דוא''ל
  • טלפון
  • הערות
  • שלח
תכני הקורס

  • Disinfectants commonly used in the industry, their modes of action, efficacy, and toxicity
  • Understanding the nature of contaminants in the cleanroom and which disinfectants will be effective against them
  • Overview of the many methods and variations used for disinfectant qualifications
    • Tube dilution method
      • Using filtration
      • Using neutralizing broth
    • Representative Hard Surfaces
      • Using contact plates
      • Using Swab Recovery Method
      • Using Rinse Method
      • Using Neutralizing Broth
      • Using Sonication
  • Discussions on the variants of each of the methods and the benefits and shortcomings of each method
  • Discussion on the pitfalls expected when choosing each method available
  • Disinfectant Qualification Protocol
    • Guidance on drafting a Disinfectant Study Protocol for each of the methods discussed
  • Planning the Study-Scheduling and Costs
    • Using planning templates, guidance will be provided for breaking up the study components to manage scheduling, costing and ordering supplies to avoid waste due to expiry of media and buffers
  • Managing personnel
    • Planning each section of protocol for execution
    • Planning of daily activities while maximizing testing
  • Method Validation for Bacteria and Fungi
    • How to validate each method
    • What to look for as acceptance criteria
  • Recovery Study
    • Guidance on how to perform swabbing studies to get maximum recovery
    • How to plan a recovery study for various methods of efficacy testing
    • Understand the facts and myths about recoveries
  • Efficacy Testing
    • Points to consider when planning an efficacy study
    • How to mitigate inoculum count drop
    • Application of inoculum and disinfectants-what to pay attention to
    • Log reduction calculation
  • Time “0” Verification
    • Understand why this additional step gives more confidence in the data generated from the efficacy study
  • Expiry Dating Study for Disinfectants
    • How to review efficacy data to abbreviate expiry study which will generate dependable results for assigning expiry date for pre-diluted disinfectants and concentrated disinfectants that do not have an expiry assigned by the manufacturer
  • Log Reduction Calculation
    • Common errors
    • Detecting false positive or false negative log values
  • Reviewing Data
    • How to identify execution errors when reviewing data. Establish and Implement corrective actions
  • Overview of testing disinfectants using biofilms
  • Translation of disinfectant qualification results to cleaning procedures to prevent contamination
  • Cleaning procedures-what should be addressed
  • How to monitor efficacy of the cleaning program
  • Commonly observed deficiencies in Disinfectant Qualification studies that may lead to contamination or FDA observations
אודות המרצה

Mrs Ziva Abraham

Ziva Abraham a known microbial contamination control expert and a seasoned mycologist has educated industry on fungal identification and investigating mold contaminations for over two decades. Her understanding of the origin and behavior of mold makes her a well respected investigator for mold contaminations. She has over 25 years of academic, research, clinical and industrial experience in Microbiology, and Quality Assurance.
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