In general, how have evolving disease treatments and delivery systems affected the pharmaceutical packaging industry over the last 20 years?
Compared with 20 years ago there are more complex molecules and means to deliver those treatments. In developing more effective drug types the industry has shifted from small molecule oral dose and parenteral products to more complex biologics. These complex treatments change many aspects to how quality is managed. While a treatment may have been more stable in a prior compound, the newer more effective treatment may be more susceptible to oxidation, moisture or other environmental contaminants. As drug products evolve the requirements surrounding the product quality may also evolve. Delivery systems have also adjusted for ease of administering treatments to the point that patients are self-administering parenteral treatments more than ever before. These parenteral treatments are not only in the highest risk category, but are often in an auto injector format or a delivery system requiring reconstitution of the drug. The complexity of the delivery system and active components falling under the device category introduce added quality related challenges.
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Over this same time period what has been PTI’s mission? How has the company helped the industry bring safe and effective pharmaceuticals to market over the last 20 years?
Over the last two decades PTI has focused heavily on the reliability of our inspection system test results. Without a reliable test method it simply is not a test method. Our inspection systems have evolved over the years, developing unique patented technologies to address high risk package integrity applications. The technologies are focused only on high risk package formats, and the developments within PTI continue to drive to faster, more reliable and more sensitive detection of micro leaks in pharmaceutical packaging. The non-destructive and quantitative inspection solutions provide a leading advantage when assuring container closure integrity for our clients’ products.
What products and services does PTI currently offer to assist their clients in bringing high-quality pharmaceuticals to market?
PTI manufactures CCI test systems based on one of our five quantitative and non-destructive inspection technologies. Unlike standard equipment manufacturers, PTI is highly involved in the scientific process of developing a test method. Our experience and dedication to CCI as it relates to patient safety and the practical implementation required at client sites puts PTI in a position to empower our clients and the quality they deliver. CCI is an interdisciplinary study that requires the understanding of chemistry, physics, statistics, practical implementation, and a deep understanding of the product lifecycle. Without a multifaceted approach to CCI, delivering a robust quality control solution is simply not feasible.
Since its inception almost two decades ago, PTI’s VeriPac line of vacuum decay systems has always been regarded as one of the most reliable vacuum decay test systems on the market. Recent innovations have just positioned the technology to be one of the most sensitive vacuum based leak testing solutions ever, rivalling the Helium leak test with a faster and simpler operation.
PTI has also developed the MicroCurrent High Voltage Leak Detection (HVLD) technology that uses the principles of capacitance to detect leaks in packaging. The technology has established a capability of detecting extremely small leaks in in a wide range parenteral products. PTI’s MicroCurrent technology is recognized for its ability to inspect the broad range of biological parenteral products for CCI.
Looking ahead, are there any new packaging designs, materials, or testing technologies being developed now that will help pharma companies bring innovative products to the market? How is PTI meeting this challenge for its current and future clients?
The pharmaceutical market is never short of new and unique treatment molecules as well as means to deliver those treatments. As treatments become more integrated and provide easier administering, there are often new container challenges that arise. Container material and closure systems continue to evolve. New approaches to applying PTI’s inspection systems have provided our clients with deep insights into identifying the most robust closure designs. An example of this was a multi-dose cartridge that would apply portioned doses of the treatment over an extended period of time. Using PTI’s MicroCurrent HVLD and an innovative inspection fixture the client was able to correlate the appropriate crimping forces for the cartridge to assure CCI performance during the effective life of the treatment. Above all PTI aims to provide accurate information that improves our clients insight into container closure performance.