Can you give us some background on the company and an overview of the products and services it provides to the pharmaceutical industry?
PTI is a solutions provider for high-risk container closure integrity applications. We utilize a variety of sensory technologies in our equipment that finds itself anywhere from a packaging laboratory to right into a production setting to assure the quality and performance of the primary container. PTI provides a range of services to support our clients’ pursuit of quality including feasibility studies, transferable test method development, and full validation support. We are a global company with specialists guiding client CCI needs at all stages of the pharmaceutical life cycle process, from the R&D lab through manufacturing.
What are some general industry issues pharmaceutical companies are facing regarding equipment validation? How has the COVID-19 pandemic exacerbated this situation?
Validating any pharmaceutical solution can be a challenging task that requires coordination of materials, personnel and equipment. During the COVID environment on-site resources can be limited while time is of the essence to bring treatments to market. To successfully navigate these challenges, it requires coordination and preparation ahead of performing any onsite work. Installations and validations are reviewed thoroughly with all stakeholders during FAT’s to build consensus ahead of the work. Aligning all stakeholders ahead of the installation is critical to reducing time onsite and bringing projects to the finish line.
The industry is under intense pressure to deliver therapies and vaccines to fight COVID-19. Some equipment needed to produce these products can be classified as “high risk”. What are “high risk” equipment – and how is their maintenance and validation handled compared to other equipment?
Fundamentally container closure integrity for parenterals is a high-risk application. Even in the non-COVID era CCI test equipment is considered ‘high-risk’. The validation and continued performance challenge testing of this type of equipment must be robust and simple. System performance and reliability is a core characteristic of what we deliver, and a CCI test system must always be able to produce reliable and accurate test results. Maintaining CCI test equipment involves standard annual calibrations and intermittent challenge testing. COVID has not changed anything about system performance requirements and has simply forced us to be creative in offering different ways those services can be offered.
Regarding the validation of container closure integrity for vaccines; what processes, tools, and analytics can pharmaceutical companies employ to ensure their products are in compliance and get to market as quickly and efficiently as possible?
Parenterals are a high-risk product class and require the highest level of container performance assurance. CCI is a foundational requirement for product release. The more reliable and robust the test method is the more likely our clients can avoid an adverse quality event. Legacy test methods take longer to produce test results and lack the reliability of modern quantitative test methods. Accurate and timely information related to product quality can only support the compliance of pharmaceutical containers and advance the ability of manufacturers to deploy vaccines quickly and safely.
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Looking ahead, what are the company’s goals regarding its products and technologies to aid pharma companies with their equipment validation needs?
PTI has a strong legacy of producing the most reliable and sensitive CCI test equipment for high-risk applications. We have developed and refined multiple sensory technologies to bring accurate information to our clients with challenging applications. PTI’s mission continues to evolve to support our clients across the entire value stream for container performance. PTI will be moving further upstream to support container design and development, and further downstream to provide more automated inspection solutions. Our goal is to transpose that same level of performance and sensitivity into 100% on-line inspection solutions for our clients. PTI has always been more than an equipment manufacturer, and our expertise and consultative support in the field of CCI will continue to assure that pharmaceuticals reach their patients safely.