'Accelerating Microbial Testing in Pharmaceutical Manufacturing' 

Time matters. Everyone in pharmaceutical manufacturing is busy, making it imperative to find better monitoring tools. In particular, bioburden monitoring and bacterial endotoxin testing are areas in need of improvement. These contaminants are high risk in any pharmaceutical manufacturing site and should be monitored as quickly and easily as possible. However, these tests are traditionally time-consuming and require significant hands-on time.

Implementation of new tools such as the Sievers Soleil Rapid Bioburden Analyzer and Eclipse BET Platform can provide efficiency gains from data integrity, ease of use, and fewer human errors to impact the final product.

How can microbial testing be faster and easier?

With the use of rapid micro methods and simplified testing, you can improve control and have a better understanding of your entire process. As described in recent revisions to Annex 1 which went into effect in August 2023, there are benefits of implementing rapid methods to improve contamination control strategies. Faster and more efficient methods for bioburden and endotoxin testing will increase the protection of products and environments, and areas.

Rapid bioburden methods

Traditional methods for microbial testing take days. These tests not only delay the production process but lack the ability to provide real-time information to drive ongoing decision-making. The Sievers Soleil Rapid Bioburden Analyzer provides results that correlate to plate counts in less than 45 minutes. This is achieved using unique viability stains in conjunction with ultra-sensitive optics.

More efficient endotoxin testing

Traditional endotoxin assays are time consuming, error prone and difficult to perform. They also rely heavily on resources. Historical options for BET include traditional 96-well microplate assays that are manual and not ergonomically friendly. Automation with robots can be prone to errors using multiple softwares to control the instruments and still require many liquid handling steps. 

The Sievers Eclipse microfluidic endotoxin testing system enables users to set up fully compliant assays in less than ten minutes with a 90% reduction in Limulus amoebocyte lysate (LAL) reagent and only 55μL of sample. With this technology, BET assays are simple, easy and compendial and can be performed with your choice of commercially available reagent. Assays are remarkably easier, as you don't need to make your own standard curve - it's already preloaded on the microplate along with positive product controls (PPCs). 

What can be gained from greater manufacturing agility?

A combination of rapid micro methods and microfluidic technology can lean out the bioburden and endotoxin testing processes within your facility. This allows you to get results quickly and make faster, actionable decisions to mitigate risks and increase efficiencies throughout manufacturing. The goal is to increase your manufacturing agility and reduce delays in production.

Simplified technologies to make timely, data-driven decisions

For bioburden testing, reducing time to results from days to less than an hour offers significant agility to make important decisions and maximize efficiency and quality. In particular, correlation to plate counts is critical to have the confidence you need to make these decisions. For endotoxin testing, setting up assays in less than ten minutes using a simple platform enables analysts to eliminate the majority of hands-on time, thus reducing errors and retests. Efficiency gains are coupled with improvements in sustainability using 90% less lysate and simplifying reagent use and storage.

Today's pharmaceutical manufacturing environment requires agility, efficiency, flexibility, and quality. To meet these needs, innovative instrumentation and PAT can be implemented to improve process control and increase speed. With faster microbial detection, you can make timely, data-driven decisions and quickly take action to control contamination events and reduce risk.

Visit PMT Benelux N.V. at the WoTS - Booth number 7A065