ROI and automated rapid detection – What’s growing in your micro QC lab?

The financial success of a new or existing drug can be directly tied to the manufacturing process. Issues in the process with scrap, extended quarantine time, lost capacity, or brand issues, such as the rising number of recalls, can directly impact the bottom line for a drug manufacturer. One overlooked area of improvement is Micro quality control.

For over 100 years, the traditional culture method has been the accepted technique for routine pharmaceutical and biological quality control testing.  The test is inexpensive, but requires time for the contaminating organism to grow to a level to be seen by the human eye.  During this time, product could be waiting in quarantine, or production could be stopped, waiting for a component to pass inspection.  This idle time in manufacturing can cost millions of dollars. 

New technologies for rapid detection of microbial contamination in the pharmaceutical micro QC lab are playing a strategic role in improving the time to results of an inspection, allowing product to pass quality control sooner. While rapid detection alone can solve- part of the problem, it still leaves the QC lab with a labor intensive process that, because of the human element, is still prone to errors.  The manual process drives highly educated microbiologists to become bogged down with running tests versus focusing their data analysis and problem solving skills on more value added activities to drive business productivity.

Automation of the micro QC lab takes rapid detection to the next level, allowing the lab to benefit from automation much like their counterparts in the analytical chemistry QC labs and in manufacturing.  Automated rapid detection removes  cumbersome steps in the testing process driving efficiency and productivity.

Did you realize that automated rapid detection in the micro QC lab can deliver a compelling ROI to your business?  Automated rapid detection offers benefits in the following areas:

Faster Product Testing -- as a result of products coming out of quality control faster, the business can realize a reduction in inventory in the first year.

Quicker detection of contamination in raw materials, in-process batches or finished drug products- because contamination is uncovered faster, less product is contaminated resulting in less scrap. 

Plant Start Ups - automated rapid detection reduces the number of days required to restart a plant after shutdown or line change.  This allows faster return to service and results in increased manufacturing days.

Process Automation - because the process is automated, the time spent on the LIMS data input, and reporting and auditing of test results is significantly reduced.

An Example ROI

Consider the example of a biologics manufacturing site producing an injectable pharmaceutical. This example site manufacturers over $1B worth of product, and struggled with contamination issues, specifically in bioreactors, resulting in  multiple shut downs and investigations.

In this example, savings comes from earlier detection of in-process contamination resulting in increased production capacity utilization, reduced product scrap, and reduced labor costs. The estimated annual savings is $2.9 Million.

This savings comes from a combination of areas, including:

• Faster detection of raw material contamination
• More rapid facility changeovers
• Rapid detection of in-process failures
• Labor savings from automation of steps

Of course savings can vary from facility to facility and from business to business, but these numbers create a compelling reason to research automated rapid microbial detection for the micro QC lab.

Summary:

One area that has been overlooked for process improvements and ROI is the micro quality control (QC) process, which still operates using 19^th century principals of inspection and detection, a labor intensive and error-prone process that creates an unnecessary risk to the pharmaceutical manufacturer.  Automated rapid micro methods provide real, quantifiable results to the manufacturing process.