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Pharmaceutical Manufacturing and Packing Sourcer

Screening is Believing


One of the most cost-effective ways to streamline manufacturing processes and unlock revenue is a rapid microbial detection method, which can provide definitive results within 24 hours, while reducing waste and increasing sustainability in the lab

Within a typical pharmaceutical manufacturing facility, a product will meet specification more than 97 per cent of the time. Yet this product will spend many days in quarantine awaiting the results of microbial testing that typically show no growth. In contrast, a microbiological screening that can quickly provide a clear, presence/ absence result is ideal.

There are two applications where the presence/absence screen is most applicable in the pharmaceutical industry: micro limits testing and sterility testing. As a primary screen for pharmacopeia micro limits testing, a rapid detection system can provide results in 24 hours for a full bacteria, yeast and mould assay. All products testing negative can be rapidly released, with no additional testing necessary. The small percentage of product that presents as positive can undergo further evaluation against release criteria.

Rapid screening for sterility testing offers even more dramatic results. A presence/absence test makes sense for sterility products and formulae, as they are either sterile or not. Used in lieu of the typical 14-day pharmacopeia sterility test, a rapid detection system can provide definitive results in half the time or less. A flexible, rapid system will eliminate additional delays caused by testing solid, non-filterable, coloured and/or opaque products via traditional methods, which usually extends testing time to 17 to 21 days. For example, a major European pharmaceutical manufacturer recently adopted a rapid detection system to reduce its time to test sterile, in-process solutions from 14 days to only two days. The company is currently validating the system for end-product release.

A Lean Solution

In lean manufacturing terms, saving time in the production cycle translates into significant, quantifiable savings in reduced inventory requirements, shortened lead-time and faster recovery from contamination events.

The steps in Figure 1 show value-added activities. In the red section, the plateaux represent micro testing hold times.

The first is for raw materials testing, the second is in-process screening and the top horizontal line represents hold time for finished product testing. For each area where micro-hold is applied, three to six days are generally required to detect contamination using traditional microbial limits methods; sterility testing is 14 to 21 days. This time is expensive: it significantly impacts manufacturing efficiency, responsiveness and working capital requirements, all of which ultimately affect a company’s profitability and bottom line. The company in this example was able reduce its total cumulative inventory investment at any given moment in time by approximately €650,000.

However, to benefit from a rapid microbial detection method, the quality department of a company will have to increase its budget for a rapid system. The quality department may be concerned about this as they may not understand the value of such a system, but it will create considerable savings for the company, as shown in Figure 2. It often takes someone looking at the larger, facility-wide picture to see the opportunity.

Quantifying the Value


Pharmaceutical manufacturers can accurately quantify the financial value of implementing a rapid microbial screening system with a financial impact assessment, which enables companies to estimate the value of adopting a rapid detection system using readily available data. For example, a high-throughput rapid system can be purchased and installed for less than €100,000, achieve payback in six to nine months, and realise an average five year net present value in excess of €500,000 for non-sterile testing and well upwards of €1 million for sterility testing at a single plant. In addition, implementing a rapid detection system can contribute to a pharmaceutical company’s profitability by providing the following quantifiable benefits:

Reduces Working Capital Requirements
A rapid detection method can decrease investment in product held in quarantined inventory at any given time. Also, because it takes fewer days to produce the same amount of product, the shortened cycle time also reduces safety stock requirements and its associated working capital investment.

Improves Operational Efficiencies

Shorter cycle times results in a leaner, more responsive manufacturing operation, which improves a company’s financial metrics, including return on invested capital and inventory turns.

Improves Recovery from Contamination Events
Rapid detection means earlier detection of contamination when it does occur. This helps to minimise the amount of product affected, accelerate corrective action and get the manufacturing facility back on track quickly. Also, risk of customer service interruptions or product recalls is minimised.

Saves Warehouse Space
Reduced inventories throughout the supply chain will decrease the physical space required in the manufacturing and distribution facilities for in-process inventories and safety stock. It may also reduce the need for outsourced warehousing, or defer the costs associated with facility expansion.

Shortens the Cash Cycle
With rapid detection methods, finished goods are released to market faster, leading to an accelerated revenue cycle.

Swift Decision-Making
A rapid detection system provides actionable information that allows product to move forward quickly. When contamination is detected, that batch can be isolated and attention focused on remediation and further process improvement.

Contamination Benefit

As significant as it is to take days out of the production cycle, the benefits more than double if there is a contamination event. This is because the sooner a problem is identified, the faster the manufacturing line can be stopped, the problem removed, and production and testing of a replacement batch commenced. A quicker response time minimises the overall economic impact of discarded or reprocessed goods and also increases customer response times, saving money at the same time as protecting the company’s reputation.

Laboratory Sustainability


The savings gained from implementing a rapid detection method do not even include the many environmental benefits it can also provide. Efforts to be greener have already been adopted by many pharmaceutical companies with solar panels, motiondetecting lights, energy monitoring and recyclable packaging measures to reduce a company’s footprint. Until now, though, the laboratory is one area that has yet to see much improvement.

Rapid microbial methods can reduce the amount of material that is generated and then disposed of, compared to traditional methods. Less waste to recycle or dispose of is a big saving. Often, a specialised medium is prepared for each standard organism type, as well as product- and site-specific organisms for various product samples. Yet a rapid method requires only a single broth enrichment be used to screen for all microorganisms, including bacteria, yeast and mould.

A company can quantify its savings using a rapid detection method with an environmental impact assessment, a companion tool to the financial impact assessment which helps companies evaluate their expected reductions in solid and liquid waste, as well as savings from reduced water and energy consumption (see Figure 3).

Conclusion


Controlling costs and operating more efficiently are priorities for everyone in pharmaceutical manufacturing. The company-wide benefits of a rapid method for screening raw materials, work-in-process and finished goods for contamination cannot be ignored. In addition, as pressure builds to improve sustainability, making the laboratory greener is another reason to adopt a rapid detection method.

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Cindy Lieberman joined Celsis International Ltd in 2007 as a Vice President. She brings significant manufacturing supply chain, technology and healthcare industry experience to the role from her previous positions.
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Cindy Lieberman
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