Lean Microbiology

Rapid Microbial Testing Methods address micro-hold, the last frontier for reducing process time and waste

By Nick Nichols, Celsis Rapid Detection

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Many pharmaceutical manufacturers are adopting Lean manufacturing practices and investing millions of dollars on supply chain software and other initiatives to streamline and expedite the flow of goods. They’re attempting to cut costly production delays, inefficient processes and slow movement of goods to bring life-saving products to market.

Saving 30 minutes a shift, multiplied by the number of working days and the number of plants, can add up to significant annual savings. Pharmaceutical manufacturers who regularly test for microbiological contamination in raw materials, inprocess or finished goods can literally cut days out of their cycle times by adopting rapid microbial methods (RMM).

At the same time, RMM can ensure equal or better raw materials and product quality standards, and is becoming a more widely accepted method of regulatory compliance. The micro hold area is becoming the last great frontier for reducing process time and waste. Most manufacturers of pharmaceutical products regularly sample and test their raw materials or finished goods for microbiological contamination.

Most of them are using an outdated and inefficient process dating back to the 1800s that takes three, five, seven or more days to yield results. During this waiting period, the full lots of raw materials or finished goods being tested are often quarantined in micro-hold. Reducing the time that any product spends in microhold increases supply chain efficiency and customer responsiveness, freeing valuable resources and liquidity that could otherwise contribute to profitability.

When inventory isn’t getting off the floor and out the door fast enough, revenue is lost – and ultimately patient safety is compromised. Consider how much a company might spend to relocate processes on the manufacturing floor just to save 10 minutes of transport time.

What would it be worth to save three or more days per batch? That’s when the benefits of rapid methods become clear. While the majority of pharmaceutical manufacturers have evaluated RMM, only three percent of production facilities globally have installed rapid micro systems as of 2004. By this year (2008), adoption is expected to grow to 10 percent.

Using RMM for testing raw materials, in-process and finished goods, pharmaceutical manufacturers can better meet or improve upon product quality standards, help satisfy regulatory compliance policies and reap measurable financial gains.

Available Rapid Microbial Methods

Several types of RMM technologies are available to pharmaceutical manufacturers. These include methods which enhance the growth of microorganisms by incubating samples in an enrichment broth so that growth can be detected sooner. The time required to detect depends on the technology used. Impedance is one method that serves as a presence/absence test.

As microorganisms grow in their nutrient broth, they metabolize and therefore change the chemical nature of the broth. This results in a change in electrical current that can be detected by the technology. Most impedance methods can produce a fairly rapid result, but only if the sample is positive and the manufacturer wants to detect bacteria or yeast, not mold.

Another growth-based rapid microbial method is flow cytometry. This technology utilizes a combination of cell labeling and laser excitation to detect living (contaminated) organisms. Flow cytometry is best suited for clear liquid products in water, narrowing the product range of candidates which can be tested. ATP bioluminescence is yet another RMM approach. When the enzymes luciferase and luciferin come in contact with the molecule ATP, which is present in all organisms, the result will be an emission of light directly proportional to the amount of ATP present in a sample.

A luminometer measures the light. An enhanced rapid detection systems use highly sensitive adenylate kinase (AK) bioluminescence assays, which can cut waiting time by half or more. These next-generation RMM systems featuring newer enzyme and molecular-based technologies and significantly compress testing times to 18-24 hours, even for mold, vs. three to seven days with traditional methods.

With greater sensitivity and reproducibility, advanced RMM technology offers a distinct advantage. By reducing the time required to test and release goods, pharmaceutical manufacturing companies can drive new efficiencies throughout the supply chain and realize significant cost savings. This FDA-accepted technology also supports efforts to achieve certification with ISO 9001 standards, cGMP compliance and other manufacturing best practices.

Benefits of RMM vs. Agar Plates

Irrespective of type, RMM technology has a distinct advantage compared to traditional detection methods using agar plates. With RMM, companies can significantly reduce manufacturing cycle times and increase throughput. Users no longer have to wait for results from incubations of three to seven days in the micro-hold area. The diagram (left) summarizes potential savings from RMM compared with traditional methods.

 

ROI,cost and savings data for a typical pharma RMM installation

 

By compressing the time required for micro-testing at various stages of production, pharmaceutical manufacturers can significantly streamline cycle times. The cumulative effect of these cycle time savings is substantial – up to eight days saved in the illustration based on an average five day micro-hold time, and more if testing is performed on in-process work.

Containing Contamination Saves Costs

Put simply, the results of microbial testing with RMM technology are now available to pharmaceutical manufacturers in just hours – not days. This represents a new “best practice” for these manufacturing companies whose livelihood depends on cycle time speed and supply chain efficiency. For example, the sooner a company knows that a batch is free of contaminants, the sooner it can release its held stock or batches. This enables manufacturers to bring products to market faster, which is a critical competitive benefit.

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