Press release BoxID: 406809 (Microrite Inc)
  • Microrite Inc
  • CA 95136
  • 5019 New Trier Avenue

Cleanroom Monitoring, Disinfection & Microbial Contamination Control; A Risk Based Approach

(PresseBox) (San Jose CA USA, ) Microrite Inc announced further details for its latest training course, "Cleanroom Monitoring, Disinfection & Microbial Contamination Control; A Risk Based Approach, to be held on March 2-3 2011 in St Joseph MO USA.

Why You Should Attend:

Using a risk based approach, learn how to establish a compliant, yet cost effective, environmental monitoring program that will enable you to determine contamination sources during investigations and help predict product contamination.

Learn how contamination can be controlled by evaluating environmental monitoring data to choose right disinfectants, perform a defendable and scientifically sound disinfectant qualification study and establish an effective cleaning program.

Who Should Attend:

Quality Assurance, QC Microbiology, Manufacturing, Cleanroom Operators, Cleanroom Cleaning & Facilities Personnel.

Day 1: Environmental Monitoring-A Risk Based Approach

Correct use of environmental monitoring data will help you maintain control of your facility. This data will provide information on the condition of the cleanroom, cleanroom practices and efficacy of your disinfection program. This seminar will provide the tools to establish compliant and practical environmental monitoring programs and the keys to using the data to control contamination.

- Discussion on the various cleanroom classification schemes, & environment monitoring regulations & guidances
- Qualification of cleanrooms-important points to consider & common errors
- Using a risk based approach, how to establish meaningful environmental monitoring program

-- Number of sites using regulatory guidance & risk based approach
-- Discussion on choice & evaluation of equipment for environmental monitoring
-- Frequency of monitoring

- Microbial Identification, when it is necessary & why - how to identify objectionable microorganisms
- Challenges in establishing validity of microbial identification
- Importance of trending data to assess risk to product
- Establishing User Requirements for Electronic Environmental Monitoring systems
- Discussion on phenotypic & genotypic microbial identification systems
- Overview of the key components of EM Summary Reports
- Environmental Monitoring related investigations; what & where to look for?
- Case studies & discussion on HACCP principles to investigate excursions & assess risk
- Discussion on current FDA 483 observations on environmental monitoring & data trending

Day 2: Qualification of Disinfectants & Cleanroom Cleaning Challenges

- Cleaning & Disinfecting a Cleanroom is a science, not an exercise. Learn about the disinfectants used in the industry, understand the in-house microbial contaminants. Use this information to develop effective disinfectant efficacy studies, plus implement robust cleaning procedures to prevent contamination.

- Common bacterial and fungal contaminants in cleanrooms, their source & quantities - how this information can be used to develop or change your disinfection program
- Disinfectants commonly used in the industry

-- Modes of action, efficacy, & toxicity
-- Advantages/Disadvantages
-- Governing Bodies/Regulations for Disinfectants
-- Testing for Manufacturers
-- Disinfectant Qualification

- Discussion on current industry trend for qualifying disinfectants -- what is expected from regulatory agencies & who is required to perform such studies
- Tools to develop an effective disinfectant qualification program

-- Discussion on different methods - advantages & disadvantages
-- Planning & scheduling
-- Protocol details
-- Choice of organisms, hard surfaces & materials
-- Calculations
-- Report format

- Common challenges in drafting & executing Disinfectant Qualification protocols
- Commonly observed deficiencies in Disinfectant Qualification studies that may lead to contamination or FDA observations
- Cleaning procedures-points to consider when choosing disinfectants, establishing rotation of disinfectants, frequency of cleaning, flow of cleaning, & choosing right cleaning supplies, considering the criticality of the surfaces to be cleaned
- Challenges in Cleaning - Understand the natures of surfaces & the role of supplies
- Know the importance of chemical kill & physical removal of contamination
- Discussion of FDA 483s related to disinfection & disinfectant qualification

To view the complete brochure please visit: Brochure
To register visit: Registration


Sterilization Strategies For Pharmaceuticals Medical Devices & Combination Products
Dedham MA USA | April 21-22 2011

Advance Course in Identification of Fungi
Raleigh NC USA | May 4-6 2011

Investigating Microbial Contaminations
Princeton NJ USA | May 19-20 2011