In every industry, producing quality products remains the absolute top priority. In the pharmaceutical industry – this is no different – and with the added onus of lives being at stake – the impetus to deliver quality products is even more pressing.
In the pharmaceutical industry to ensure that every product and package leaves your facility with the highest quality and to eliminate any defects you test and test again and then inspect and inspect some more – all to avoid producing one pill or package that might have a problem that could end up causing your worst nightmare – the recall.
While pharmaceutical manufacturers would do their utmost to insure quality through inspections processes – real-life concerns always enter the picture. For example, the cost of inspection and implementing news technologies can be an issue, regulatory concerns are always present, and trying to be ahead of the curve and look “down the road” to see what’s coming is an ever-present challenge.
To get more insight and detail into the world of pharmaceutical inspection technologies and trends we talked to a few vendors of inspection equipment to find out their thoughts on the current state of pharmaceutical inspection technologies, how they are assisting pharmaceutical companies to meet their inspection requirements, and get their views on what the near-future will hold for pharmaceutical inspection technologies and trends.
Current Inspection Issues
We asked our experts to comment on what they see as some of the biggest issues pharmaceutical companies are facing with their inspection operations. According to Louis Roy, President of Optel Vision regulatory issues are at the top of the list. “The biggest issue pharmaceutical companies are facing is the pressure from the regulatory organizations to implement technology to ensure public safety. An example is the current serialization requirements have a big impact on line cost and future improvement. The challenge will be to find the right supplier that can integrate more complex solutions adapted to the line while ensuring a smooth deployment overall.”
Oliver Stauffer, Vice President/COO of PTI Inspection Systems sees the implementation of new equipment and the related validation tasks as one of the key issues currently facing pharmaceutical companies. “The industry has long relied on subjective and variable test methods that do not have the reliability or sensitivity to provide a high level of quality assurance. The wide reliance on manual visual inspection puts critical to quality package assessments at risk. Vial crimp defects are hidden. Human detection of blue die varies between operators. While many sites would jump at the opportunity to introduce a new and improved method to production, revalidation and filing a new method stifles most operations. Validating new methods with cross comparative studies to the method in place to prove “equal to or better” is the most effective approach. With evolving drug delivery systems, new and effective methods are needed to provide accurate inspection of package integrity. Continued reliance on subjective methods will continue to generate critical to quality integrity issues.”
To remain competitive pharmaceutical companies around the globe are all looking to be more flexible. Flexibility in plant operations, processing lines and now inspection technologies is being pushed as a means to heighten efficiency, save money and get products to market faster. Brian Ball, President, Nikka Densok USA, Inc. has seen first hand how pharmaceutical companies are now demanding that inspection equipment be more flexible to meet their production goals. “At Nikka Densok, we are being challenged with various issues of inspection operations. Many inspection lines require the flexibility of the equipment design to inspect a variety of product sizes and at times numerous product shapes with one piece of equipment. This may affect the final output of the line and in many cases the cost of the project. Being more flexible in our design thinking has allowed for a more diverse line of equipment which reduces changeover time for each product and also the reduction of equipment validation costs.”
Our equipment vendors all offer their own unique take on inspection equipment and offer various technologies to accomplish product and package inspection. We asked them about what they were currently working on how their latest product offerings are helping pharmaceutical companies.
“Nikka Densok is focusing on changing the design of equipment from the leak detection of glass ampoules to glass vials as ampoule production in the US has been decreasing for several years,” says Nikka Densok’s Ball. “The concern for Container Closure Integrity Testing (CCIT) throughout the industry has increased the awareness for reliable and faster inspection methods. The High Voltage Method of leak detection historically used on ampoule inspection is now being utilized on high speed vial lines.”
“PTI’s inspection solutions all follow the same core principle, a non-destructive method producing reliable and repeatable quantitative test data,” says Stauffer. “Low headspace packaging has long been a challenge for common package integrity tests, and products can range from a moisture sensitive tablet in a blister package to Class IV transdermal patches in sachets or pouches. All low headspace packaging suffers from the same issue, the challenge of using a test method that can reliably detect integrity failures down to the critical leak sizes of the products. PTI’s VeriPac 410 provides a simple and effective approach to measuring package integrity for all low headspace package formats. A simple measurement platform makes validation straightforward and provides simple changeover from one package format to another.”
“The latest innovation on the electronic counter inspection, CountSafe™, allows a last check on the product before the cap is applied to the bottle,” says Optel Vision’s Roy. “This kind of solution is great for the pharmaceutical industry and very welcome by regulatory agencies for avoiding expensive recalls. Also with the introduction of our new TabletProof technology, this revolutionary inspection will shorten the time to inspect all production. Pill or tablet inspection that would normally take weeks can now be done within a few days.”
Keeping in mind the current state of regulations and inspection technology, we asked our experts to look ahead to the future and give their best outlook on how regulations, technology and the needs of the industry will shape upcoming inspection technologies.
“Lots of new technology will be coming in the near future, especially in optics and mathematics allowing new ways to improve system and inspection performance,” says Roy. “We can also expect to see more and more new inspection equipment using various wavelength technologies.”
“While technology is set to evolve, the landscape of regulatory affairs and package validation will see the greatest adjustments,” says Stauffer. “In industry today, ISO 11607 is used to prove that a package serves its purpose. Also critical in this package development process is to assess what types of defects are critical to product quality. Few operations understand what defect types and sizes affect their products. Package validation will evolve to include critical to quality defect assessments, drawing a baseline for package integrity testing. Notified bodies are well educated on new technology offerings, and approval of subjective and qualitative test methods are coming under greater scrutiny. In the long run, this evolution supports manufacturers the most, providing a solid foundation for package integrity assurance.”
“We understand the necessity of improving and expanding our product line of leak testers as the industry grows and changes,” says Ball. “The industry’s increase of inspection requirements of glass vials, plastic containers which include IV Infusion Bags and BFS products along with inspection of both empty and pre-filled syringes has pushed for improvements in the High Voltage Leak Detection Technology. One of our newest challenges is to manufacture equipment for the inspection of pre-filled syringes at compatible output speeds currently being produced by modern filling machines. Regardless of the application, it is important to deliver a reliable method of inspection that can be easily understood and documented by the end user.”