CONTAMINATION - Risk Management | Manage Contamination Risk with a Lean Approach

Judy Madden

How existing products can benefit from examining the true cost of quality

In an ideal manufacturing world, we would always purchase pure ingredients, consistently formulate products within the parameters of aseptic technique, and reliably ship sterile goods to market. Quality by Design (QbD) and process analytical technology (PAT) initiative adherents alike support an approach that makes certain that product quality is part of the production process from the start.
In the real world, even with the best intentions and plans, our products and processes are at risk of contamination. As a result, and with the exception of parametric release, products and processes are tested to ensure their quality prior to releasing product to market. This is a necessary step, but—for companies using traditional microbial testing methods—it is extremely time consuming and costly.
A lean quality approach using rapid testing methods will reduce the cost and impact of contamination events and accelerate your production cycle. Best of all, it can be applied readily to an existing manufacturing process.

The True and Total Cost of Quality

To find the right balance between risk and safety, it can be helpful to compare the costs of not having a quality control process with the costs of a good quality system (see Figure 1).

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Figure 1. The True Cost of Quality

Without quality control processes, products are manufactured and shipped into distribution quickly. While this is not an option for pharmaceutical products, the risk is, of course, that pallets of finished products will be contaminated. In the plant, that means expensive rework, scrap, and overtime. For goods that have left the company bound for pharmacies or retail stores or, worse yet, have already been sold to patients or consumers, the liability and brand impact are significant and potentially catastrophic.
To minimize this risk, companies will often test their products at several stages: when raw materials arrive; potentially at the bulk or prepackaging stage; and always as packaged products ready to leave the facility (see Figure 2).
At each step in situations where traditional test methods are used, materials and products sit idle for multiple days awaiting results. In addition to the cost of the testing itself, warehouse space and invested capital are tied up. Despite these disadvantages, traditional testing is widely accepted as a cost of having good quality. Yet there is an alternative.

Lean Quality Advantage

In lean manufacturing terms, even minutes during which value is not added to the product are considered waste. Imagine the field day your lean team would have if they learned you could free up several days of waiting time by using a rapid method.

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Figure 2. Traditional Quality Testing

A lean quality approach does just that by allowing you to remove many days of “waste” or waiting time from the manufacturing process and still release safe products to market (see Figure 3).
In terms of risk management, the lean quality approach has a significant advantage. A faster production cycle means faster problem detection. Corrective action can be initiated sooner and, therefore, more effectively.
After all, it is far easier to isolate and identify events that may have led to a contamination event yesterday than to try and troubleshoot those same events four, five, or more days later. I can easily remember what I had for breakfast yesterday, but recalling the precise details of a meal I ate last week is a lot trickier.

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Figure 3. Lean Quality Testing

The same is true of contamination events. Additionally, by the time a problem is detected with traditional methods, the company has five or more days of additional, potentially contaminated inventory to deal with. Beyond the cost of the goods themselves, this can have a significant impact on your ability to meet customer demands.

Rapid Methods Manage Risk

The benefits of a rapid detection method are made clear in this simplified contamination event timeline (see Figure 4).
Assume it takes this company one to two days to formulate and package a product and then, using traditional microbiological methods, an additional three to seven days to test finished product for microbiological quality. In this example, contamination is identified after five days of micro-hold and the seventh day of overall production. An investigation and corrective action are initiated.

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Figure 4. Contamination Recovery Timeline

Several days later, replacement product needs to be produced to replace the original contaminated batch. That product is also subject to microbiological testing. The 17-day point in our production timeline arrives before the product is available for distribution—a full 10 days beyond the planned seven-day production schedule.
On the second timeline, we see that using a rapid detection assay reduces the microbiological testing time to 18 to 24 hours. Detection of the problem and initiation of corrective action now happen within 24 hours of production.
The benefits of rapid detection also extend to the release of replacement product. In the example above, replacement product is released at the nine-day point. This is a full eight days faster than in the scenario in which the manufacturer uses traditional methods and is still in crisis mode at day nine.

Costs Are One Thing, Savings Are Another

Many discussions of rapid methods begin and end with the cost per test. “It’s too high,” say the lab managers who appreciate the lab efficiencies generated by rapid methods but feel constrained by their budgets and pressure to keep expenses low.
The biggest obstacle to the adoption of rapid methods is the fact that 100% of the cost of the method is charged to the labs, while 90% of the financial benefits are in manufacturing.
For successful adoption, Operations and Finance need to get involved to help everyone see that the overall benefit to the company is well worth a modest increase in the lab’s testing budget.
Rapid detection may be the best-kept secret outside the microbiological laboratory. Yet some of the largest and most successful companies in the pharmaceutical and consumer product industries benefit from the efficiencies offered by rapid testing systems. The company discussed below implemented their first Celsis rapid detection system in 1996 and now uses the technology at its facilities worldwide.
The company, a manufacturer of pharmaceutical products, was experiencing issues with inventory and periodic in-house contamination events. It was following traditional microbial testing methods for screening raw materials and finished goods with a five-day hold at each step. The value of the company’s daily finished goods production at the time was roughly $75,000.
Celsis worked with the company to complete a financial impact assessment to determine the value of implementing a rapid system.
Readily available data, including the value of daily finished goods, the reduction in micro-hold days, the frequency of contamination events, and instrument and reagent costs, were incorporated into the impact assessment. The model calculated a five-year net present value (NPV) of over $677,000, payback of less than nine months, and savings from faster contamination containment annualized at $64,000 per year.
Projecting these savings over the company’s five facilities with an 18-month rollout program increased the five-year NPV to almost $2.5 million, with a payback of just 15 months. The later rollouts were financed through the working capital efficiencies generated from the earlier placements. Annualized contamination savings alone rose to almost half a million dollars.
Further, with results available in 24 hours, the company was able to introduce some in-process testing at a critical point in production to detect contamination even earlier and reduce the potential impact of a contamination event even further. Total micro-hold was reduced from 10 days to only three days and was redistributed to better manage risk as it occurs in the operation.

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Figure 5. Impact Report

The impact report (see Figure 5) shows a typical output graph with the projected savings for adopting rapid methods at a single plant. The report identifies the economic impact by six-month periods, along with the cumulative discounted cash flow.
The average company’s investment is shown in red. The initial outflow represents the initial system investment followed by an implementation period and the ongoing cost of reagents.
The blue bars represent the positive impact of the reduction in working capital requirements driven by a reduction in inventory held in quarantine and safety stock. This includes the initial release of inventory upon validation and the ongoing value of redeploying that capital into productive investments.
The green bars are the estimated savings from the reduced impact of contamination events. In many cases, these savings alone pay for the program: The green bars are larger than the red bars in each period.
Celsis also offers an environmental impact report documenting sustainability improvements resulting from implementation—from reducing water and energy consumption to minimizing the amounts of liquid, solid, and hazardous waste requiring disposal..