Tuesday August 14, 2018
12:00 pm – 1:30 pm EDT
Instructor: Barry A. Friedman, Ph.D.
Cleaning, sanitization and disinfection of all controlled and classified environments is a key consideration in the control of microorganisms in a Gene Therapy/Cell Therapy environment. Surfaces to include ceilings, walls and floors must be cleaned and meet the microbial requirements for the classified area. Simultaneously, the chemicals used should not degrade the facilities. Both the FDA and the EMA require that facilities test the acceptability of the chemicals on coupons, e.g., glass, stainless, plastic, floor and wall materials. They also require that “in-house” microorganisms will be killed when placed on a coupon, dried and then have the specific sanitizer/disinfectant added.
References to the cleaning and disinfecting of manufacturing areas may be found in the Code of Federal Regulations (CFR) and FDA Guidances for Industry.
Examples include:
- 21 CFR 211.42(c) Operations shall be performed within specifically defined areas of adequate size. There shall be separate or defined areas or such other control systems for the firm’s operations as are necessary to prevent contamination or mix-ups during the course of the following procedure.
- 21 CFR 211.42(v) A system for cleaning and disinfecting the room and equipment to produce aseptic conditions.
- FDA’s “Guidance for Industry Sterile Drug Products Produced by Aseptic Processing — Current Good Manufacturing Practice”.
- The EU Guidelines to Good Manufacturing Practice, “Medicinal Products for Human and Veterinary Use”, Annex 1, “Manufacture of Sterile Medicinal Products”.
- The Pharmaceutical Inspection Convention (PIC/S) “Guide to Good Manufacturing Practices for Medicinal Products – Part I.
Qualification and validation testing of sanitizers, disinfectants and sterilants will also be reviewed and include methods to demonstrate efficacy with both suspension and surface carriers (coupons) studies. A total of only three sanitizers/disinfectants/ sterilants are required to be validated within the typical biopharmaceutical/ pharmaceutical facility. While, historically, it was thought that a wide array of different biocides were required to minimize the buildup of facility resistant microorganisms, this is no longer believed to occur because of the lack of selectivity of the biocides (see USP 1072). It remains an “Old Wives Tale” that one must rotate their disinfectants on a weekly or monthly basis to minimize resistance to environmental microorganisms. Rationale for not rotating includes: 1) disinfectants are more powerful biocides than antibiotics, 2) applied in high concentrations against low populations of microorganisms, and 3) micro-organisms are already in a stressed condition.
Please plan to attend this two-part live, Executive Conference Corp interactive webinar. The initial Part I will be offered on Tuesday, August 14 at 12 Noon. Part II will be offered on Wednesday, August 22 at 12 Noon. Please plan to bring an interdisciplinary group to benefit from these discussions.
Learning Benefits will include:
- Learn of the Regulatory Expectations of Sanitizers, Disinfectants and Sterilants within a Gene Therapy/Cell Therapy Environment
- Determine the Vendor Qualification Requirements
- Impact of Product Expiration Dating and Regulatory Implications
- Learn of the Impact of Sanitizers, Disinfectants and Sterilants on Various Common Microorganisms Found within a Pharmaceutical Facility
Fee:
$385 for one person
$700 2-5 people
$999 6-10 people
Questions? support@eccwebinars.com
ECC-049