Tuesday October 8, 2019
12:00 pm – 1:30 pm EDT
Instructor: Barry A. Friedman, Ph.D
Nonsterile dosage products often use preservatives in their formulations to minimize the growth of microorganisms inadvertently introduced during or subsequent to the manufacturing process. Sterile products packaged in multiple-dose containers contain antimicrobial preservatives to inhibit the growth of microorganisms that may be introduced from the repeated withdrawal of individual doses.
Antimicrobial preservatives should not be considered as a substitute for good manufacturing practices (GMP), solely to reduce the viable microbial population of a nonsterile product or control the presterilization bioburden of a multidose formulation during manufacturing.
Antimicrobial effectiveness, whether natural within the product or produced because of the addition of an antimicrobial preservative, must be demonstrated for all injections packaged in multiple-dose containers or for other products containing antimicrobial preservatives. Antimicrobial effectiveness must be demonstrated for aqueous-based, multiple-dose topical and oral dosage forms and for other dosage forms such as ophthalmic, otic, nasal, irrigation, and dialysis fluids,
Challenge organisms are generally based on likely contaminants to a drug product while considering its physical attributes, formulation, and intended use. The standard battery of challenge organisms (ATCC) described in this test need not prevent the inclusion of other species of microorganisms if deemed useful to measure the biological activity of the preservative system for a specific product.
The revision of this document providesthe user with greater clarity in preparation and use of test microorganisms, which test microorganisms should be used and when, how to perform growth promotion testing, and method suitability (bacteriostasis/fungistasis).
The revision also clarifies the definition of “no increase” and method execution. As part of this webinar, the revised USP<51> will also be compared and contracted to the European Pharmacopeia, EU 5.1.3 Efficacy of Antimicrobial Preservation.
The objective of this live, interactive Executive Conference Corp. training webinar is to explore the role of antimicrobial effectiveness testing and assuring that manufactured product will retain its effectiveness of maintaining either low number or the absence of microorganisms within product as prescribed by GMPs. It will review the issues regarding standardized and in-house microorganisms, management of Type 1 through Type 4 products and the interactions that occur between USP and EU testing. Because of the sensitivity of the antimicrobials with nonsterile and sterile product, this live, interactive training webinar is a MUST for anyone in your organization that is involved with nonsterile and sterile product.
Learning Benefits will Include:
- Understand why Antimicrobial Preservatives are often Required for Aqueous Pharmaceutical Products.
- Learn about Controls to include Growth Promotion and Method Suitability (bacteriostasis/fungistasis).
- Understand the Growth Promotion and Suitability of the Recovery Methods Studies.
- Determine the Concentration of Each Microorganism and Its Conditions for Growth.
- Learn about the Four Product Categories.
- Learn of the Criteria for Antimicrobial Effectiveness.
- Compare the USP Revised Method vs. the Current EU Method.
- Learn why USP<51> may not Meet European Pharmacopeia Standards.
$385 for one person
$700 2-5 people
$999 6-10 people
Questions? support@eccwebinars.com
ECC-139