Pharmaceutical Manufacturers Streamline Operations with Rapid Microbial Methods

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Pharmaceutical Manufacturers Streamline Operations with Rapid Microbial Methods

November 2010

European Pharmaceutical Manufacturer Magazine

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Microbial contamination occurs in many pharmaceutical products, from antacids to infant formula. Fortunately for consumers, all regulated companies are required to test their goods for bacteria, yeast or mould prior to releasing to market.

From the supply chain management perspective, however, this comes at an enormous cost. At every stage where microbial testing is done – in raw materials, work in process or finished goods – each batch is held in quarantine for an average of five days before it is ready to advance. This ties up working capital and incurs storage expenses.

Faced with the challenge of balancing demanding customer expectations with profitability, forwardthinking pharmaceutical companies are increasingly adopting rapid microbial detection methods. The faster companies can identify a contamination and implement corrective actions, the more successfully they can minimise costs and avoid product recalls. Today’s rapid microbiological testing methods (RMM) deliver time-to-results 80% faster, from the five-day average to just one day, helping companies contain outbreaks, streamline operations and capitalise on manufacturing process improvement. RMMs also contribute to corporate sustainability initiatives by reducing waste, water and energy consumption in the laboratory.

Advanced Methods Save Time
Microbial testing is a critical but time-consuming phase of the manufacturing process. The majority of companies continue to depend on inefficient agar plate growth methods that remain essentially unchanged since the 1800s. This traditional method relies on visual identification of microbial growth and averages five days for non-sterile and a minimum of 14 days for sterile products. During this wait time, raw materials, inprocess batch or finished goods can be quarantined, adding days to manufacturing lead times, tying up working capital and ultimately leaving the facility far from fiscally fit.

RMM solutions using newer enzyme and molecular-based technologies that significantly compress testing times can dramatically reduce the amount of time products must be held in micro-hold and drive new efficiencies throughout the supply chain. Easy-to-use, reliable bioluminescence-based systems with ATP (Adenosine Triphosphate) yield definitive results within 24–48 hours, while even more sensitive, amplified bioluminescence assays are accurate and reliable within 18–24 hours, even for slow-growing mould. Similarly, rapid methods can also be used for sterility testing; providing results in less than half the time of traditional methods, thereby cutting a week or more from production. These methods rely on amplifying the growth of microorganisms for faster detection; therefore their protocol is the most similar to classical growth-based methods, making validation and regulatory submissions easier than other types of RMMs.

Reducing the time materials and products spend in quality assurance testing leads to a better utilisation of working capital for a number of reasons. Since fewer days are required to produce the same amount of product, goods are released to distribution faster and sales revenues can be realised more quickly. The shorter manufacturing cycle reduces the amount of product quarantined in micro-hold, in addition to minimising safety stock requirements. As a result, less capital is tied up in finished goods inventory and less warehouse space is required for storage.

The financial savings can be tremendous. For example, one major pharmaceutical company was waiting 14 days for results from an in-process sterility test. During this past year, said company validated and switched to a microbial screening system that enables it to release batches within two days, saving 12 days from its production cycle time and reducing this in-process wait time by 85%.

RMM Benefits Multiply if Contamination Occurs
Although a controlled manufacturing environment will produce contamination-free products more than 99% of the time, pharmaceutical companies must be prepared for the worst. Identifying and isolating contamination as quickly as possible when it does occur enables manufacturers to initiate corrective action sooner, minimising both the negative economic and public relations impact of the contamination. Clearly, the faster manufacturers can produce, test and release safe products following a contamination occurrence; the better for their bottom line and their reputation in the marketplace.

Corrective action can be expensive and time-consuming. The contaminated product must be discarded or reprocessed and recovery is further delayed by the micro-hold required on the replacement product, which must be retested. Therefore, RMM solutions double a company’s savings by reducing the time required for both the initial screening and the testing of the replacement batch to a small fraction of what was needed with traditional methods. The ‘Traditional vs Amplified Method’ graphic shows a timeline illustrating this.

With testing results available within hours instead of days, the amount of product that needs to be scrapped can be significantly reduced and, if a recall is necessary, it can be initiated — and ended — sooner. Even better, if the contamination is discovered quickly enough, the product never gets into the customers’ hands, avoiding the need for a recall altogether and further minimising waste.

RMM processes not only accelerate recovery time, but can also play a valuable role in building consumer confidence in the continued quality and safety of a company’s products. For example, whilst implementing RMMs, a company in the pharmaceutical industry chose to calibrate its amplified-ATP-based testing method to be more sensitive than the microbial detection standards required by its FDA submission in order to minimise downstream risk. This voluntary decision bolstered internal confidence in its testing procedures and consumer confidence in the safety of its products.

Redefining Quality Control Best Practices
Reducing by more than half the waiting time for contamination testing results, RMM solutions define a new ‘best practice’ for pharmaceutical manufacturers seeking cost-effective approaches to boost supply chain responsiveness and reinforce consumer confidence.

Already accepted by global regulatory bodies, including the EMEA (European Medicines Agency), RMM technology also supports efforts to achieve certification with ISO 9001 standards, CGMP compliance, Lean and other manufacturing best practices. Yet fewer than one in four pharmaceutical manufacturers are using rapid microbial methods. The companies that have demonstrated leadership in the adoption of this innovative technology have streamlined their operations, enhanced their ability to quickly contain contaminations and fortified consumer confidence in the quality and safety of their released products. The fast payback and long-term advantages make RMM a good investment for pharmaceutical manufacturers in today’s economy.

 

Cindy Lieberman joined Celsis Rapid Detection in 2007 as a Vice President. She has brought significant manufacturing supply chain, technology and healthcare industry experience to the role from her previous positions. She can be reached at Tel: +44 20 7152 4022, Email: clieberman@celsis.com.

 

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