Tuesday 26 December 2023

How to Optimize Workflow in Microbial Identification for Quality Control


Succeeding in microbiological quality control is essential for pharmaceutical industry companies to keep the public safe, protect their reputations and stay profitable. However, microbial identification can be challenging, and it often necessitates workflow improvements. Following best practices can result in lasting improvements. 


By Emily Newton

Take Baseline Readings and Set Goals


Achieving better microbiological quality control does not always mean creating a sterile environment. Instead, lab operators must balance factors such as cost and safety while deciding if there’s an acceptable level of contamination.


Lab operators can start improving their processes by establishing a baseline, and then using the associated data to make challenging but reachable goals. Any readings taken should ideally identify the type and quantity of contaminant.


It’s also wise to determine if certain processes or areas of a factory are more likely to have issues than others. If so, people may focus on those when pursuing improvements.

Review Existing Procedures and Identify Shortcomings


One reason pharmaceutical leaders cannot necessarily aim to eliminate contamination is because humans are a major source of it. Experts stress how people are the biggest aseptic processing risks. Some leaders are reducing humans’ influence by automating manufacturing processes when possible. Although this is an option, people still need to supervise what happens within a plant.


Decision-makers should get feedback from people at all levels of the organization to learn more about what challenges they encounter while trying to adhere to microbiological quality control standards. Valuable data can also come from examining microbial levels over the past few months or years. Have those statistics significantly worsened over time? If so, they could pinpoint where and how people could work toward lasting improvements.

Collect and Study Relevant Data


Most pharmaceutical processes require precise repeatability. That’s especially true when dealing with injectable substances since nearly all are sterile. For example, manufacturers often use vapor compression distillation to produce water suitable for injection. This process reaches a maximum temperature of about 224 degrees Fahrenheit and includes multiple steps.


Maintaining oversight and tight control over all processes significantly reduces the chances of contamination. Suppose pharmaceutical leaders collect data about all internal processes and study that information. In that case, they’re more likely to catch issues that could lead to problems with microbiological quality control if not addressed.

Understand the Various Contamination Sources


Microbial contamination can come from various sources, including:






     Production rooms


Complications can also arise from things outside a manufacturer’s direct control, such as contamination of raw goods sourced from elsewhere. However, they can reduce such instances by holding all suppliers accountable to strict quality control measures.


Decisions to not include certain ingredients in products could also make contamination more likely. In October 2023, United States regulators warned about issues with 26 over-the-counter eye drops that could cause blindness due to contamination. Manufacturing issues were partially to blame, but investigations also indicated some of the affected products did not contain preservatives, making contamination more likely.


Optimizing workflows to reduce microbial contamination requires knowing which steps are most problematic. After that, people can determine the best ways to minimize errors and omissions that could lead to quality failures.

Consider Investing in New Technologies


Pharmaceutical leaders often prioritize emerging technologies to increase their companies’ competitive advantage in a challenging industry that typically requires substantial research and development costs.


High-tech processes can also elevate quality control. In one example, a team from Baylor College of Medicine developed a contamination detection system based on computer analysis. It can find the shared aspects between the mammalian microbiome and that of a lab environment or sample. Experiments showed this approach had a very low false-positive rate.


Some pharmaceutical companies also use next-generation sequencing to expedite microbial identification. Since this option does not require long culturing periods, it allows finding and dealing with problems faster.

Prioritize Employee Education


The pharmaceutical industry requires following many rules and processes. However, even someone who knows them well could contribute to microbiological quality control by making mistakes.


Fortunately, thorough and ongoing education can reduce such instances and emphasize the company’s commitment to high-quality results. Training specialists, safety managers and others should give employees ample time to learn and provide feedback about new processes.


When workers feel their bosses will listen to and care about their input, they’ll be honest and open about providing it. Employees can also give valuable details about education or training gaps they believe their companies should fill.

Microbiological Quality Control Is an Ongoing Effort


Following all these steps will get operators off to an excellent start as they work to manage contamination in their facilities. However, they can improve the outcomes even more by committing to periodic process reviews. Contamination sources can change when companies begin making new products, hire more people or buy new equipment.


Decision-makers should always assume there’s room for further improvement in their processes. Staying on top of what’s working and what’s not establishes the foundation for continuous improvement. This approach also increases preparedness for adopting strategies to meet new regulations or emerging needs.


Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)

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