Screening is Believing: Streamline the manufacturing supply chain and increase sustainability in the lab

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Screening is Believing: Streamline the manufacturing supply chain and increase sustainability in the lab

February 2013

PMPS Magazine

Download a PDF version of this article or view it on the PMPS site.

How a rapid microbial detection method can streamline the manufacturing supply chain as well as increase sustainability in the laboratory.
 
One of the most cost-effective ways to both streamline your manufacturing process and make your company more profitable is a rapid microbial detection method. Today’s rapid detection systems can provide definitive results within 24 hours, but they can also reduce waste and increase sustainability in the laboratory.
 
Streamlining the manufacturing supply chain
In a typical pharmaceutical manufacturing facility, product is within specification more than 97% of the time. Yet product spends 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, absence/presence 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 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 17–21 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 2 days. The company is currently validating the system for end-product release.
 
A lean solution that saves days in the production cycle
In lean manufacturing terms, saving days in the production cycle translates into significant, quantifiable savings in reduced inventory requirements, shortened lead-time and faster recovery from contamination events. 
 
The steps on the graph below show value added activities. In the red section, the plateaus 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, 3-6 days are generally required to detect contamination using traditional microbial limits methods; sterility testing is 14-21 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.
Figure 1. Adopting a rapid microbial detection method reduces the number of days needed to complete testing.
 
The company in this example was able reduce their total cumulative inventory investment at any given moment in time by approximately €650,000.00.  
 
Spending to Save
However, to benefit from a rapid microbial detection method, the Quality department 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 a rapid detection system, but it will save a company much more, as shown in figure 2. It often takes someone looking at the larger, facility-wide picture to see the opportunity.
 
Cost per test comparison shows Celsis saves companies money overall
 
Figure 2. Operational savings for a company with a rapid detection system far outweigh the increase in direct costs in the laboratory when changing from the traditional method.
 
Quantifying the value of a rapid detection method
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.
 
* Improved 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.
 
Added benefit in the event of a contamination
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. The 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.
 
Contributing to sustainability in the laboratory
The savings gained from implementing a rapid detection method, as outlined above, 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, motion-detecting 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 their 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. 
 
 
 
Figure 3. An Environmental Impact Assessment used to project ‘green’ savings from implementing a rapid detection system.
 
A leaner and more sustainable future
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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