The 4 Benefits to Implementing Single Temperature Incubation in Environmental Monitoring of Pharmaceutical Manufacturing
Environmental Monitoring (EM) is essential in the pharmaceutical industry to ensure product safety and efficacy. Traditional EM methods remain manual and error-prone.
Growing regulatory demands for data integrity and traceability are driving efforts to improve process efficiency and productivity, prompting a reevaluation of traditional practices such as incubation periods for EM samples.
Two experts share their insights on implementing single temperature incubation.
Dual or Single Temperature Incubation?
Dual temperature incubation (20-25°C followed by 30-35°C) has traditionally been used to cover the main flora, with a survey showing that 73% of pharmaceutical companies used this method1. However, this practice is rarely revalidated, despite evolving microbial flora.
Today, many industries are considering single temperature incubation, with 70.8% open to this change due to its benefits2, such as reduced manual handling and errors. Recent studies3 indicate that single temperature incubation is at least as effective, if not better, at detecting flora, providing the conditions that match the microorganisms' growth criteria.
4 benefits of implementing single temperature incubation
“Because you only have one incubator, you avoid manipulations that add risks of secondary contaminations, at the end of the day, contributing to reducing costs.”
Pharma Quality Control Experts Mónica Pereira and Gilberto Dalmaso have made the shift and they agree: single temperature has transformed the way labs approach incubation and brings many benefits. They highlight:
- Improved Quality Control: Single temperature incubation allows faster times to result for quicker identification and mitigation of negative trends in Environmental Monitoring data, resulting in potential quality improvements in batches manufactured afterwards.
- Cost Reduction: That benefit is actually two-fold:
- Simplifying the process reduces the need for multiple incubators and the risk of secondary contamination that results in costly and unnecessary investigations. According to a bioMérieux internal analysis, investigation costs could add up to more than €400,000 with more than 10% linked to data integrity issues1.
- A simplified process allows for an earlier start to investigations, potentially resulting in reduced product scrapping.
- Streamlined automated Process: Using a single incubation temperature simplifies laboratory processes, making them more efficient and easier for successful automation and digitalization.
- Validation by Regulatory Bodies: Both experts have been audited by many regulatory authorities and were able to provide robust data that support their Single Temperature Strategy.
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IN SHORT...
The shift to single temperature incubation in Environmental Monitoring offers significant benefits, including improved quality control, cost reduction, and opens the door to streamlined automated processes. The positive feedback and regulatory acceptance experienced by companies like Fresenius Kabi highlight the potential of this approach to enhance pharmaceutical manufacturing processes.
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1 bioMérieux internal analysis based on market survey (n=40 customers; 66% traditional pharma products, 17% Cell & Gene therapy, 17% Bioproducts
2 Efficiency gains evaluated internally and with pharmaceutical industries with 3P ENTERPRISE solution