Micro-hold: The Last Great Frontier for Reducing Process Time and Waste

Adopting Rapid Microbial Methods (RMM) can greatly reduce cycle time.

Manufacturers who regularly test for microbiological contamination in raw materials, in-process or finished goods can literally cut days out of their cycle times by adopting rapid microbial methods (RMM). At the same time, RMM ensures equal or better raw materials and product quality standards, and is a widely accepted method of regulatory compliance.

Within Lean manufacturing practices, one of the biggest culprits of waste is production delays based on inefficient processes or movement of goods. Manufacturing companies have invested millions of dollars on supply chain software and other costly initiatives to streamline the flow of goods. Saving 30 minutes a shift, multiplied by the number of working days and the number of plants or warehouse facilities, can add up to significant annual savings.

The micro hold area is truly the last great frontier for reducing process time and waste. Here's why: process manufacturers of pharmaceuticals, cosmetics, cleansers and other consumer products regularly sample and test their raw materials or finished goods for microbiological contamination. The majority of them are using an outdated and inefficient process dating back to the 1800s that takes three, five, seven or more days to get results. During this waiting period, the full lots of raw materials or finished goods being tested are often quarantined in micro-hold. It's easy to see how reducing the time spent in micro-hold can save a fortune in supply chain efficiency. Holding inventory for several days stymies customer responsiveness. It creates waste on the production floor. It ties up valuable resources and liquidity that could otherwise be contributing to profitability. When inventory isn't getting off the floor and out the door fast enough, revenue is lost.

Consider how much manufacturing companies spend to relocate processes on the manufacturing floor 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 crystal clear.

Next-generation RMM systems from companies such as Celsis feature newer enzyme and molecular-based technologies that significantly compress testing times to 18-24 hours 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, 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.

Today's New RMM Solutions Come to Light

Why Adopt Advanced RMM?

  • Supports lean manufacturing with reduced waste
  • Reduces manufacturing cycle times
  • Decreases the amount of capital tied up in finished goods inventory
  • Reduces the cost and impact of contamination events
  • Shrinks warehouse space requirements
  • Boosts operational efficiency while lowering manufacturing costs
  • Meets just-in-time (JIT) demands
Compared to traditional detection systems using agar plates, today's RMM technology is a great opportunity to reduce manufacturing cycle times and increase throughput. With agar plates, manufacturers wait for results from incubations of three to seven days in the micro-hold area. A rapid detection system using AK-enhanced bioluminescence assays will cut this waiting time by half or more.

The following diagrams compare traditional micro-testing methods to newer rapid detection methods in the manufacturing production process. By compressing the time required for micro-testing at various stages of production, 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 new RMM technology are now available to manufacturers in just hours -- not days. This represents a new "best practice" for pharmaceutical and consumer goods 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 they can release their held stock or batches. This enables companies to bring products to market faster, which is a critical competitive benefit. Since a controlled manufacturing environment will have uncontaminated products 95-99% of the time, a presence/absence screen is an efficient and fast testing method. Yet if there is a contamination event, the sooner it is known the sooner it can be contained. Manufacturers using RMM can initiate faster corrective action, reduce production recovery time, and provide for more rapid release of replacement product. In the end, quicker response time minimizes the overall negative economic impact of discarded or reprocessed goods -- saving companies not only money, but reputation.

RMM Creates Measurable Value

Implementing rapid microbial testing in a typical single plant operation costs less than $100k in capital, achieves payback in six to nine months; and realizes a net present value (NPV) of $500k to $750k in approximately 5 years Following are some examples of operational areas where savings can be quantified:

  • Reduces working capital requirements -- RMM can help lower the cost of capital by decreasing your investment in product manufacturing, since it takes fewer days to produce the same amount of product. The shortened cycle time also reduces safety stock requirements as well as the amount of product held in quarantined inventory at a given time.
  • Decreases stock carrying costs -- What's your interest rate for finished goods capital? RMM helps reduce the amount of capital tied up in finished goods inventory, and therefore shaves costs for carrying excess stock.
  • Saves warehouse space -- How much physical space is required in your warehouse or distribution center to store one day's production of finished goods? To store inventory and safety stock? Calculate the cost per cubic foot of a single production day's worth of warehouse space, then multiply that number by how many fewer days your product will spend in storage. Add this space-savings number to your product savings.
  • Streamlines the supply chain -- RMM drives finished goods to market faster, leading to quicker sales. This helps accelerate your revenue cycle.
  • Improves recovery from contamination events -- Rapid detection not only accelerates recovery time, but helps reduce the amount of contaminated product that must be scrapped or, worse yet, recalled from customers.

To quantify the value of implementing rapid methods, a global consumer products company, in conjunction with Arthur D. Little management consultants and Celsis, Inc., developed a financial model that estimates the payback period and five-year net present value (NPV) using the company's specific manufacturing and testing data. While results will vary based on company specifics --such as cost of capital and average daily output of finished goods -- the typical single plant operation will achieve payback in six-to-nine months and realize an NPV of $500,000 - $750,000.

In Conclusion

Faced with ever-increasing pressures to drive costs out of the supply chain while meeting customer demands, pharmaceutical and personal care product manufacturers can tap into additional savings by using rapid micro methods in the quality control/quality testing area. Rapid detection helps speed products to market while ensuring quality and safety standards are met. Companies that have yet to incorporate value-add rapid micro technology into their quality testing process are overlooking a significant opportunity -- perhaps the last great frontier of process improvement -- for a leaner manufacturing facility.

Nick Nichols is Vice President and General Manager of Celsis Rapid Detection. Celsis International plc is a leading provider of innovative life science products and laboratory services to the global pharmaceutical, biopharmaceutical, and consumer products industries through its three business areas: Rapid Detection systems for industry, Analytical Services' accredited testing labs, and drug discovery products and services from In Vitro Technologies. www.celsis.com/lean.

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