제약 및 의료
생산성 향상 및 제약 분야의 규정 준수 표준 및 품질 요구 사항 충족 지원
INFICON의 Smart PAT 센서 및 소프트웨어 기능에서 생산성을 높이고 규정 준수 표준 및 품질 요구 사항을 충족하도록 지원하여 제약의 세 가지 중요한 측면인 규정 준수, 품질 및 생산성에 영향을 미칠 수 있습니다.
당사의 센서를 사용하면 실시간 프로세스 데이터를 수집할 수 있으므로 중요한 품질 특성에 영향을 미치는 중요한 프로세스 매개변수를 캡처할 수 있습니다. 당사의 소프트웨어 솔루션은 SPC 차트 및 프로세스 기능 데이터 제공을 포함하여 모니터링 및 보고를 위한 실시간 데이터 수집을 가능하게 합니다. 스마트 센서와 소프트웨어 솔루션의 조합은 궁극적으로 규정 준수 표준을 효과적으로 충족할 뿐만 아니라 스크랩을 줄이고 전체 OEE를 증가시킵니다.
당사의 솔루션은 제약 및 바이오 제약 분야의 가치 사슬의 다양한 부분에서 활용됩니다. 제약 가치 사슬을 둘러싼 우리의 전체적인 접근 방식은 센서의 응용 프로그램에서 보여집니다. 잔류 가스 분석기 및 광학 방출 분광법 센서는 제조의 동결 건조(동결 건조) 공정에서 공정 및 오염 모니터링에 활용됩니다. QCM 센서는 R&D 및 제조에서 표면 상호 작용을 모니터링하고 박막 형성 연구를 수행하는 데 사용됩니다. 다양한 기술의 누출 감지기가 포장 무결성을 검증하는 데 사용됩니다.
스마트 공장을 위한 당사의 혁신적인 제조 소프트웨어는 전체 공장 프로세스 효율성을 개선하는 데 도움이 됩니다. 궁극적으로 당사의 결합된 센서 및 소프트웨어 솔루션은 제품 및 프로세스 효율성에 영향을 미쳐 제품 품질 및 프로세스 가동 시간을 향상시킵니다.
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>.
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