Dear Pharma leader, as the saying goes, “A stitch in time saves nine,” the QRM/QRS approach helps prevent potential disasters.
Today, we aim to empower you by providing all you need to know about the QRM/QRS approach to designing Biopharma vessels. Beyond meeting the regulatory standards, the vessels designed with the QRM/QRS approach offer valuable benefits you won’t want to miss. Finally, we have included a few FAQs at the end of the blog. Keep reading and Keep learning!
What is QRM?
QRM refers to the quality risk management process that identifies, assesses, and controls risks related to product quality. The QRM approach to designing a biopharma vessel emphasizes understanding potential failures in vessel construction or usage, which could impact the final product’s safety, efficacy, and purity.
The Key Steps in the QRM process for designing a vessel are:
- Risk Identification: Identify the potential risks, such as product contamination, material incompatibility, temperature inconsistencies, over-pressurization or under-pressurization during fermentation or storage, leading to product loss or degradation.
- Risk Assessment: After identifying the potential risks, evaluate the probability and severity of the possible dangers. Each risk’s severity, likelihood and detectability are calculated to plan mitigation steps.
- Risk Control: Incorporate design features like sterilizable surfaces, pressure control valves, and sensors to mitigate the identified risks.
- Risk Communication: Inform all the stakeholders, engineering and production teams about the risks and measures in place to address them. Regular reviews confirm that the risks are continually monitored as vessel designs evolve or new risks emerge during operations.
What is QRS?
QRS refers to Quality by Design (QbD) via Risk-Screening, which involves designing the process vessels with built-in quality. This approach to developing the vessels is more cost-effective than following the traditional way of testing the quality of the products at the end.
The Risk Screening component ensures efficiency by proactively screening for potential risk factors during the design phase, allowing teams to address these risks before they become issues.
The QRS approach involves:
- Material Selection: Choosing a suitable material that meets the regulatory standards and is durable and corrosion-resistant is paramount. Also, these materials must not react with or degrade the biological product that is being processed.
Typically, vessels made from stainless steel are preferred as they can tolerate acidic or alkaline solutions used for processing, in addition to harsh chemicals used as cleaning agents.
- Vessel Geometry: The vessel’s shape and size are the critical parameters to be optimized for enhancing the mixing efficiency, heat transfer and ease of cleaning to prevent cross-contamination.
These vessels are designed to have smooth, rounded surfaces that are easy to clean with no sharp corners where contaminants could accumulate.
- Automation and Monitoring: Integration of sensors and automation processes leveraging AI technology to monitor critical factors like temperature, pressure, and pH levels to ensure consistent conditions during production.
Advantages of choosing vessels designed using the QRM/QRS approach
The QRM/QRS approach to biopharma vessel design is an essential strategy to imbibe at the production stage. In an industry like the biopharmaceutical industry, where the stakes for product quality, safety, and efficiency are incredibly high, investing in vessels designed applying the QRM/QRS approach is a smart move.
In addition to enhanced Product Quality and Consistency across batches, here are the other advantages:
1. Small batches for clinical trials
Since the biopharma products are susceptible to contamination, the vessels designed using the QRM/QRS approach consider every possible risk of contamination. Not only must the choice of material be correct, but the surface finish of the vessel holds significance as well.
Other risk control measures, such as seamless welding, easy-to-clean geometry, and sterilizable designs, reduce the chances of contamination, thereby safeguarding both the products and the patients.
As the picture shows, TSA offers premium-quality Fermenters, Bioreactors, and Process Vessels for bipharma. The parts of the vessels are orbitally welded to prevent any risk of contamination. At TSA, the team of multidisciplinary experts custom-design the vessels to suit your requirements. These vessels are intelligently engineered to seamlessly deliver upstream and downstream processes while complying with the most stringent regulatory standards.
2. Regulatory Compliance
Regulatory agencies like the FDA and EMA strictly look over the biopharma sector. Therefore, meeting or exceeding every standard set by these authorities is mandatory. By following a systematic risk management process, the manufacturing company demonstrates compliance with the GMP, reducing the chances of any issues and ensuring smoother approval processes.
3. Improved Efficiency and Cost Savings
As someone has rightly said, “Prevention is better than cure.” Implementing the QRM/QRS approach helps mitigate potential risks during the design phase, thereby reducing downtime delays, production halts, and costly recalls due to equipment failure, fines, and penalties. This proves highly cost-effective as the vessels are optimized to avoid common operational issues.
Check the video to see the process vessels designed by TSA performing at par in the industry worldwide.
Propofol Emulsion Manufacturing Plant by TSA Process Equipments
4. Customization for Specific Needs
The manufacturing processes and equipment vary depending on the products developed. The QRS aspect of the approach considers these specific requirements. For instance, to handle highly viscous solutions, the vessel must have a suitable agitator to ensure consistent mixing of the ingredients and have an advanced monitoring system integrated for real-time tracking of critical factors. Such customizations guarantee the vessel is well suited for specific applications, ultimately boosting performance and productivity.
5. Scalability and Flexibility
Another impressive benefit of using vessels designed with the QRM/QRS approach is easy scalability. The vessels that produce small batches for clinical trials can be easily adjusted for large-scale market production, allowing companies to adapt to market demands without compromising quality or performance.
Choose our multi-product system to switch to small-volume parenteral production easily. These systems comply with US FDA 21 CFR part 11 and GAMP 5. Integrated with an inline homogenizer, these vessels can work seamlessly under high pressure for 24-7 hours.
6. Supports Sustainable Development Goals
In July 2023, the United Nations Secretary-General António Guterres highlighted the dire need to support sustainable development at the UN headquarters, stating, “The era of global warming has ended; the era of global boiling has arrived.” Be a trailblazer and set an example by choosing our vessels.
Our Process Vessels help you minimize excess material and resource usage, reducing production, storage, and disposal waste. As these vessels are flexible and can be easily scaled, they help reduce the carbon footprint over time and eliminate the need to manufacture new equipment.
Additionally, the Quality and Risk consideration in vessel design results in lower energy consumption and less frequent maintenance, thereby reducing the environmental impact of production.
Conclusion
The End is just the Beginning. While our discussion on the significance and advantages of choosing a vessel designed using the QRM/QRS approach ends here, the conversation has only just begun!
At TSA, we are ready for your call. Reach out to us today to learn more and ensure contamination-proof process vessels for your operations!
FAQs
- How is QRM/QRS different from traditional vessel design approaches?
Unlike traditional approaches that often address risks after the design phase, QRM/QRS integrates risk management from the start. This proactive method allows for better customization, quality control, and operational efficiency, making it more effective in addressing the complexities of pharmaceutical production.
- What are some challenges of implementing QRM/QRS in pharmaceutical vessel design?
Challenges may include the need for specialized expertise, potential upfront costs for risk assessment and data analysis, and the need to align cross-functional teams on QRM/QRS principles. However, the long-term benefits often outweigh these initial challenges. At TSA, we assure you that we provide the specialized expertise and equipment you need– at affordable prices. Contact us today!
- What industries outside of pharma benefit from QRM/QRS design principles?
Beyond pharmaceuticals, industries like biotechnology, medical devices, food and beverage production, and chemical manufacturing benefit from QRM/QRS due to its focus on quality, compliance, and process safety.
- Does the QRM/QRS approach help with equipment validation?
By integrating quality considerations and risk assessments into the design, QRM/QRS helps ensure that vessels meet validation requirements more efficiently. This approach often simplifies the equipment validation process, making it easier for regulatory approval.
- What types of risk management tools are commonly used in QRM/QRS?
Tools like Failure Mode and Effects Analysis (FMEA), Hazard Analysis and Critical Control Points (HACCP), and Fault Tree Analysis (FTA) are frequently used to identify, evaluate, and mitigate risks in vessel design and production.
