Pharma & Medical
Increasing Productivity and helping meet Compliance standards and Quality requirements in Pharma
INFICON's Smart PAT sensors and software capabilities can be utilized to affect the three critical aspects in Pharma - Compliance, Quality, and Productivity.
Our Sensors allow for collecting real-time process data, therefore, capturing critical process parameters that affect critical quality attributes. Our software solutions enable the collecting of real-time data for monitoring and reporting, including providing SPC charts and process capability data. The combination of Smart sensors and software solutions ultimately results in not just effectively meeting compliance standards, but also reducing scrap and increasing overall OEE.
Our solutions are utilized in various parts of the value chain in both Pharma and Biopharma. Our holistic approach in surrounding the pharmaceutical value chain is shown from our sensors' applications. Residual gas analyzers and optical emission spectroscopy sensors are utilized for process and contamination monitoring in lyophyilization (freeze-drying) processes in manufacturing. QCM sensors are used for monitoring surface interaction and performing thin film formation studies in R&D and manufacturing. Leak detectors of various technologies are used to validate packaging integrity.
Our innovative manufacturing software for Smart factories helps improve overall factory process efficiency. Ultimately, our combined sensors and software solutions affect product and process efficiency, increasing product quality and process uptime.
Applications
Growing Need
The requirement to provide medications and inoculations for contagious diseases, provide rapid point-of-care analysis and support the trend towards personalized health, have created a need for new analytical tools. The development of new techniques has been further fueled by the ASSURED (affordable, sensitive, specific, user-friendly, rapid, equipment-free, and delivered) Program, an international initiative by the World Health Organizations to create medical tests to meet the needs of the developing world. Biosensors have immerged as one possible solution to these problems.
The Biosensor Platform
The biosensor platform has high sensitivity, is matrix independent, provides fast response (real-time), has limited or no pretreatment steps, is reusable, inexpensive and allows for a wide variety of parameters to be detected. INFICON’s research quartz crystal microbalance (QCM) provides an ideal substrate to create a biosensor. A QCM is a time-tested technology that has increased in usefulness with the maturation of nanoscience and microelectronics, specifically the functional coatings and electronic drive circuitry.
Solution
When a functionalized coating is applied to an INFICON QCM and then combined with the appropriate measurement electronics, the ensuing biosensor has the ability to provide measurements in a wide variety of pharmaceutical applications. The steps to designing the biosensor are extensive, including selecting the appropriate quartz substrate, designing the electrodes and mechanical housing, choosing and applying functionalized coating and finally picking the specific QCM mode of operation to acquire pertinent information for the application. INFICON’s expertise in surface science, via thin film measurement using QCM technology, make us a valued partner in developing your pharmaceutical based biosensor.
Lyophilization is the practice in the pharmaceutical manufacturing industry of removing solvents and water from aqueous solutions and liquid pharmaceuticals using a freeze drying process, to remove non-desired contamination to increase quality, extend shelf life and improve transportability of the pharma products.
INFICON products are used in lyophilization applications to detect contamination from cooling lines, monitor process vacuum conditions and identify air leak into production systems much better than traditional vacuum gauge methods.
INFICON offers a series of self-contained system that includes residual gas analyzer (RGAs), complete pumping package and inlet system. This provides an all-in-one process monitoring solution ideal for primary drying end-point detection practices with a quicker specie-specific response, contamination detection and product collapse or melt back monitoring. In addition, RGAs provide in situ air leak detection and chamber gas monitoring, providing analysis of other gases in the system such as oxygen, nitrogen, carbon dioxide, and argon.
Other INFICON technologies can also be used in this application such as Optical Emission Spectrometers and Photo Ionization Detection (PID) based process gauges.
Appropriate packaging in the pharma manufacturing industry is a requirement to keep drugs from deteriorating due to unintended exposure to oxygen, water and biological contamination that can leak into the product container.
Testing the integrity of the packaging container closure is critical to assure the quality, effectiveness and shelf life of the pharmaceuticals by keeping a sterile atmosphere in the package and verifying the barrier capability to keep out water, oxygen and contamination.
INFICON products like our leak detectors and optical emission spectroscopy sensors, can be used to test on line container closure in the pharma industry to ensure patient safety by verifying container quality in a non-destructive way. These sensors offer greater benefits when compared to current standard methods such as dye ingress testing.
Regulators and pharmacopeias are looking for more improved and reliable methods to substitute standard CCIT destructive methods as a path to move towards more reliable and accurate test procedures as established by the FDA guidance, EU Annex 1, ASTM F2391 and USP <1207>.
