Quality control is very often perceived as the last step in manufacturing a product. But quality is not a consequence of quality testing; it must be built into the manufacturing process. At the beginning of the 21st century, the FDA Advisory Committee for Pharmaceutical Science (ACPS) began to address this problem, calling for consistent regulations in designing, analyzing, and controlling pharmaceutical manufacturing processes. As a result, process analytical technology (PAT) was developed providing a framework for innovative pharmaceutical manufacturing and quality assurance.
The goal of PAT is to understand and control the manufacturing process in real time (“in-process-control”). This includes the reduction of production time, the prevention of batch rejections, real-time release, and the increase of automation. Important for achieving these goals is primarily the identification of variables affecting the process, followed by the implementation of appropriate process measurements.
PAA Laboratories followed the FDA’s PAT initiative and has designed a multipurpose powder production facility applying the most modern quality by design (QbD) concepts to fulfill the stringent requirements of the biopharmaceutical industry.
Part of this facility is a modern air classification mill, combining an impact mill with an air classifier to ensure a highly consistent particle size distribution with a defined cut-off. This leads to a well controlled dissolving time for cell culture powder, which is most important in biopharmaceutical production processes. In addition, temperature-controlled air flow prevents the degradation of heat-sensitive components.
Four different sizes of screw-cone blenders guarantee a consistent blending process from small- to large-volume batch sizes. Fourier-transform infrared spectroscopy (FTIR) sensors monitor online the homogenizing process, particle size distribution, and moisture during blending, thus guaranteeing constant high quality of the powder products. Furthermore, a validated cleaning-in-place (CIP) system prevents cross contamination between production batches.
Finally, this closed manufacturing process is implemented in a state-of-the-art GMP facility with classified zones; moisture, particle, and temperature control; and complete with a temperature- and humidity-controlled warehouse.
As a result, PAA provides its customers in the biopharmaceutical industry with the highest standard of powder products on the market today.
-
Raw material identification by near infrared (NIR) spectroscopy
-
In-process control of milling and blending
-
FTIR sensors monitoring the homogenizing process, particle size distribution, and moisture online
-
Validated CIP and DIP systems
-
Classified zone D environment
-
Temperature and moisture controlled production area and dry stores