In general, what are some current issues facing pharmaceutical companies in regards to parenteral product inspection?
Parenteral final product inspection is challenging for a variety of reasons. The end use initiates the highest level of quality testing for product safety, with even the smallest of sterile barrier defects posing a risk to the patient. The multitude of delivery systems and the types of products creates a more technical challenge. Some product classes are not ideal for use with certain inspection methods. Different package formats and product classes will create different physical and chemical responses to the test methods that are used.
Currently, what are some of the technologies used for parenteral product inspection? What are their shortcomings?
Dye ingress is one of the most common and simple methods used in the pharmaceutical industry. While the method seems simple, there are many variables that contribute to whether a defect can be detected, including defect location, liquid viscosity, and package headspace. The process and variables have led to these methods being generally categorized as probabilistic. Vacuum Decay is a common method used across the packaging industry for package inspection. However, large molecule and proteinaceous products that are common to the parenteral industry can leave solutes and residues inside the defect during the test cycle that would lead to a false negative (a worst case situation in pharma). Some methods, have simple limitations in terms of the product that can be tested. What is certain is that there is not a single method to rule them all.
Can you describe the latest technologies for parenteral product inspection? What benefits do these technologies offer?
The next generation of technologies focuses on capturing reliable data. There are more sensory solutions becoming available that can measure package and product characteristics that were not attainable through non-destructive and quantitative methods before. The field of physics is broad and there are many tools available to get us closer to the information that we actually need.
What product(s) has PTI introduced that implement the latest technologies in parenteral product inspection? Can you provide us with details? Benefits?
High Voltage Leak Detection (HVLD) has been common to pharma package testing for decades. Recent developments by PTI have led to HVLD systems that are far more versatile and sensitive. PTI’s MicroCurrent HVLD technology is capable of detecting leaks below 1 micron in diameter, and exposes the product to very limited voltages. The most advantageous aspect of the new MicroCurrent HVLD developments is that they can test parenteral products with a wide range of conductivities using the same test method. Developing a single method for multiple products will greatly reduce development and validation time for products.
In addition to the instruments, does PTI offer other services/expertise to assist pharmaceutical companies with parenteral product inspection? Can you describe them?
PTI offers in-depth application support from the outset. Clients with challenging applications may need data to better evaluate a test method, and we offer this through feasibility studies on a client’s specific products. Feasibility studies are a great way to provide a broad overview of two or three test methods rather than channeling a single technology that may not yield the best results. The data is then processed and a full report is typically issued with summary findings. While we do manufacture equipment, PTI is able to draw on the multitude of technologies to select the right solution for the client.
Looking ahead, how will PTI continue to offer its current and future customers the best available technology and expertise for parenteral product inspection?
PTI employs two methods of innovation: uninhibited thinking and thorough listening. The uninhibited thinking yields unique and disruptive ideas that can change the game. Several of our technologies have been developed not by asking “what does the market need?” but by asking, “what is actually possible?”. Other solutions have developed after intently listening to our client’s dreams. There is enough material in the pharmaceutical space for dreams, and there is still a broad spectrum for what is possible.