Rapid Methods and QbD
Rapid Methods and QbD
2011 OCT 06
Quality by Design (QbD) represents a systematic approach to building quality into process development and manufacturing practices right from the start. Rapid microbial methods (RMMs) help manufacturers get their safe products to market as quickly as possible. QbD and RMMs go hand in hand, as they share the same goal — ensure high quality manufacturing process that is lean, efficient and reliable.
Companies that use the traditional agar plating method or pH testing to screen products for microbial contamination are running production cycles that are slower, less efficient and more subject to human error in ways that could compromise product quality. Agar-based methods require a lab technician to correctly interpret and enumerate growth following a secondary incubation period. This can be a subjective process and adds unnecessary micro-hold time to the manufacturing process. pH testing likewise requires an extended micro hold time to allow for contaminating microorganisms to grow and acidify the sample sufficiently to lower the product pH. These slow and unreliable tests not only tie up millions of dollars each year in working capital and excess inventory requirements, they also cause a delayed and, therefore, more expensive response to contamination events when they occur.
By contrast, rapid methods deliver definitive results much faster. ATP bioluminescence technology is the industry standard for the rapid microbial screening of ultra heat treated (UHT) aseptic and extended shelf life (ESL) food and beverage products. ATP bioluminescence is applicable to a wide variety of dairy, foods and beverages, including:
- Soups and broths
- Brewed tea
- Sports and nutritional drinks
- Infant formula
- Condiments and sauces
- Nut milks
- Fruit and vegetable juices
A rapid screening of these products quickly and accurately identifies the occasional batch that carries a bioburden — allowing the majority of your production run to be released to market confidently, rapidly and efficiently — usually within 48 hours.
Leading companies around the world are implementing RMMs as part of their QbD and Lean Manufacturing initiatives. For example, companies that leverage the rapid microbial screening technology offered by leading RMM provider Celsis Rapid Detection to get their safe products to market faster include Procter & Gamble, Unilever Foods, Danone, Pepsi, Morningstar Foods/Dean Foods and FrieslandCampina. These companies have reduced the time required to produce microbial screening results from 4 to 14 days down to as few as 48 hours.
The Value of RMMs
While the time savings achieved by implementing RMMs are significant, the financial savings are even greater. Companies using Celsis Rapid Detection generate an average 5-year Net Present Value (NPV) of $500k at a single plant. Companies are able to estimate these savings in advance using a Financial Impact Assessment available from Celsis. This Impact Assessment is a proprietary financial modeling tool that was co-developed with international management consulting firm, Arthur D Little, and a global Celsis customer. It uses readily available company information — such as the cost of capital, the average value of daily finished goods and the current number of days products are held for microtesting — to calculate a customized projection of that company’s 5-year NPV and time to ROI. The Impact Report is available at no charge to companies interested in learning about the savings they can achieve with Celsis Rapid Detection.
With rapid testing factored into the QbD equation, companies can significantly reduce their inventory and safety stock requirements, as well as dollars lost to costly product recalls or contaminated batches, and get quality products to market days, or even weeks, faster.
Experienced in microbiological testing procedures for the dairy and beverage industry, Mr. Scdoris has been with Celsis for more than 10 years and works closely with Celsis’ business development managers and technical support representatives to help prospective customers successfully implement rapid methods. He helps quantify the value of implementing Celsis Rapid Detection systems, as well as system installation and validation. Prior to joining Celsis, he spent 15 years in quality control for the dairy industry, most recently as Quality Manager for Morningstar Foods, a division of Dean Foods in Gustine, CA. A graduate of Portland State University, Mr. Scdoris holds a bachelor’s degree in biology. Email Mr. Scdoris at firstname.lastname@example.org.