Balancing Powder Recovery Efficiency with Regulatory Compliance
March 5, 2025 | ChargePoint Technology
Recent advancements in pharmaceuticals, particularly in cell and gene therapies (C>s), monoclonal antibody (mAb) treatments, and advanced therapy medicinal products (ATMPs), have greatly enhanced patient care.
However, the substantial costs involved in developing and manufacturing these cutting-edge treatments limit their availability to a broader population.
To overcome this challenge, the industry must prioritize production efficiency by intensifying processes.
One effective approach is to optimize the recovery of powdered active pharmaceutical ingredients (APIs) and other critical materials used in drug manufacturing. Improved recovery rates lead to higher yields and reduced costs. At the same time, pharmaceutical manufacturers must ensure strict adherence to regulatory standards to protect both patients and workers.
In this article, ChargePoint examines the complexities of maximizing powdered product recovery while maintaining full regulatory compliance.
Minimizing Waste in Powder Handling
Single-use technology (SUT) bags play a vital role in powder handling, providing a safe and efficient means of transferring powdered APIs and other essential substances within pharmaceutical production.
A major challenge lies in optimizing powder recovery from these bags to boost production efficiency and minimize waste. Although many SUT bags are designed to maximize yield, their performance can be affected by design factors such as crevices and indentations where material can become trapped.
Enhancing powder recovery requires thoughtful bag design. Features such as a funnel shape with a minimum 45-degree angle, seamless joints, and welded components help improve powder flow and reduce residual product.
Another effective method for maximizing product retrieval is liquid rinsing, enabled by a fully welded liquid entry connection. However, when implementing this technique, manufacturers must assess the compatibility of the bag’s material with the chosen liquid, as well as potential extractables and overall process suitability.
Navigating Regulatory Requirements
While optimizing powder recovery improves production efficiency, it must also align with stringent regulatory requirements. The latest updates to Annex 1 of the Good Manufacturing Practice (GMP) guidelines reinforce the need for strict protocols in sterile drug production while recognizing the benefits of single-use equipment like SUT bags.
A fundamental aspect of these guidelines is the requirement for a comprehensive contamination control strategy. This strategy should cover cleanroom design, operational procedures, equipment maintenance, and personnel training, ensuring robust contamination prevention throughout drug manufacturing.
For compliance with Annex 1, the use of SUT bags and related powder recovery methods must be integrated into the broader contamination control framework. The bags should be manufactured in controlled environments and sterilized using gamma irradiation before use. Additionally, they must meet biocompatibility and cytotoxicity standards to ensure safety and effectiveness.
Expert Guidance for Achieving Compliance and Efficiency
Striking the right balance between regulatory compliance and operational efficiency in powder transfer processes can be complex. Pharmaceutical manufacturers can benefit from consulting specialists in powder transfer technology—especially those with expertise in SUT solutions—to help achieve both objectives.
To navigate these challenges effectively, manufacturers should engage with powder transfer experts who can offer tailored guidance on SUT bag design, maximum yield recovery, and regulatory compliance. ChargePoint’s eBook, Powderful Impact: An Engineer’s Guide to Solving the Containment Conundrum with Single-Use Technology, provides essential insights into the key considerations for ensuring efficiency and compliance in powder handling processes.
