Wednesday August 22, 2018
12:00 pm – 1:30 pm EDT
Instructor: Barry A. Friedman, Ph.D.
Sanitization, Disinfection and Sterilization are required for controlled and classified environments in the manufacture of pharmaceutical and biotechnology products to prevent contamination in a Gene Therapy/Cell Therapy environment. Both non-sterile and sterile products may become contaminated from in-coming components and raw materials, purified and water for injection, the manufacturing environment and personnel. Good Manufacturing Practices emphasize size, design, construction, and location of buildings and construction materials, and the appropriate material flow to facilitate low levels of microorganisms within the facilities.
Sanitizers, disinfectants and sterilants are inherently toxic and must be used carefully to prevent the components, intermediates, API and final product from becoming contaminated with the chemicals. The requirements within an Aseptic Processing Area (APA) include the ability to clean all surfaces.
They may require removal following use to minimize damage to equipment and surfaces. Temperature and humidity control are also important in assuring that the various chemicals work as intended. The cleaning and disinfection should achieve specified cleanliness standards, control microbial contamination of products and assure no contamination of the product with the various chemicals. A chemical sterilant is somewhat a misnomer because one cannot assure that a chemical sterilant will leave the surface sterile as would steam or dry heat where a Sterility Assurance Level (SAL) can be validated.
Key considerations in the development of a Cleaning, Disinfection and Sterilization Program include:
- Purified Water (PW) and Water for Injection (WFI)
- Airborne viable particulate and non-viable particulate
- Gowning
- Cleaning/Sanitization/Disinfection
- Identification of Microorganisms
- Planned and Unplanned Facility Shutdowns
- Equipment DQ/IQ/OQ/PQ
- Data Capture, Analysis and Storage
These elements will be reviewed during the course of the webinar.
During the development of any Environmental Program, microorganisms must be considered as a key element to control. ISO CLASS 5 controlled environments should be absent of microorganisms, while ISO CLASS 7/8 will be expected to have finite numbers. Unclassified, but controlled environments, generally will contain both Gram positive and Gram negative microbes and should be controlled through a Risk Assessment (ICH Q9).
As the facility is being commissioned, tentative Acceptance Criteria should be developed based upon regulatory requirements, historical data or a combination of both. The Plan should consider these criteria to control these microorganisms as well as to isolate and identify them.
This live, interactive Executive Conference Corp. webinar will conclude with a discussion of Cleanroom shutdowns during planned and unplanned activities. A Plan should be in place to manage both the removal of the cleanroom from as well as its return to activity. Planned activities may include shutdowns for maintenance, extended holidays, non-use of or renovation of an area. Unplanned activities may include equipment malfunctions, utility outages, other utility problems, fire drills, etc. and may last from a few seconds to weeks. The Plan should minimize a “what do we do” attitude and permit a planned, well thought out series of activities well in advance.
Please plan to bring a cross sectional group to attend this webinar.
Learning Benefits will include:
- Learn how to Develop a Cleaning and Disinfection Program
- Determine the Implementation Aspects of a Cleaning and Disinfection Program
- Monitoring and Interpretation of the Results of the Cleaning and Disinfection Program
- Understand Resistance and Rotation of Disinfectants and Its Meaning to the Facilities
- The Use of USP<1072>, <1227> and <51> within the Development of Disinfectant Efficacy Programs
- A Review of Form FDA 483 and Selected Warning Letters
Fee:
$385 for one person
$700 2-5 people
$999 6-10 people
Questions? support@eccwebinars.com
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