Test O Pac Industries Inc.: Where Safety Meets Successful Packaging
Ajay Sohal, Quality Manager and Sam Sohal, President Packaging is an essential component to the overall marketability and durability of a product. When it comes to the medical device manufacturing industry, packaging is no longer a mere vessel to contain and transport medical devices, but an integral part that maintains product’s efficacy, prolongs its shelf-life, and even plays a vital role in enhancing its usability. In fact, unscientific and below-par packaging of medical devices pose a high risk of infection to patients and has the potential to affect their well-being adversely. As such, the medical device manufacturing has become one of the most regulated industries for packaging. The U.S. Food and Drug Administration (FDA) has put forward several strict requirements to maintain packaging sterility and demonstrate safe and effective use of a product for all intended users. Manufacturers have to comply with regulations such as ISO 11607 parts 1 and 2 as well as the ASTM (American Society of Testing Material) and International Safe Transit Association (ISTA) test standards to meet these packaging requirements. Unfortunately, we have witnessed several incidents of infection in patients as enterprises have undermined the significance of efficient packaging and failed to comply with regulatory mandates.
Further, effective packaging is a significant contributor to a company’s overall success. Reports from the FDA state that packaging issues that occur due to the lack of sterility assurance are one of the key reasons for most device recalls. Such recalls could result in enormous amounts of money wasted for manufacturers while affecting their overall reputation.
“We are pioneers in the medical device packaging industry. Our efforts to continually grow and improve our quality make us confident in working toward establishing a healthier community and play a vital role in protecting our people, along with our future”
With decades-long experience and in-depth know-how in the packaging industry, Sam Sohal, the President of Test-O-Pac Industries, better understands the impacts of ineffective packaging on medical device manufacturers. He has been in the packaging industries since 1987, with hands-on experiences, designing packaging with polyethylene foam, thermoforming trays, corrugated, pulp, and retail packaging. Envisioning to help enterprises ensure effective package design and guide them toward an accelerated success, he established Test-O-Pac Industries, an environmental and package testing laboratory. “Medical device package validation testing has been one of our main focuses here at Test-O-Pac Industries,” says Sam. As an independent testing laboratory, Test-O-Pac Industries’ goal is to serve customers by providing the climatic, dynamic, and mechanical stimuli necessary to exercise their products, to ensure that there is no breach of sterility.
Revamping Medical Device Packaging
Test-O-Pac Industries is an ISO17025-17 accredited, and International Safe Transit Association (ISTA) certified test facility that strives to fulfill its clients’ package validation needs. By delivering medical device manufacturers with superior testing solutions, the company helps achieve their varying testing requirements in an efficient, systematic, and reliable manner that’s certain to yield accurate, dependable results. Test-O-Pac Industries effectuates this by leveraging its exceptional in-house testing capabilities to conduct a wide range of tests, including accelerated aging, low-pressure test, tensile test, gross leak, and all types of distribution testing.
Further, the company provides free consulting for packaging design, testing, test protocols, and test validation to accelerate the packaging design and testing duration to a minimum. With such a powerful value proposition, they have successfully assisted several medical device companies in their journey to meet their FDA requirement for packaging.
Medical device package validation testing has been one of our main focuses here at Test-O-Pac Industries
For many client’s projects that required conditioning for 72 hours as well as distribution testing, Test-O-Pac Industries had significantly reduced the time consumed for package validation testing and successfully completed all testing within 5-6 days even with a large amount of samples. With a primary focus to help many such medical device startups, Test-O-Pac Industries serves as a reliable partner delivering high-quality service at an affordable price with minimum turnaround time. In fact, a representative from a client company, Santiago Beltran, Director of Packaging, Johnson and Johnson, testifies, “Since I started working at Auris Health (Johnson & Johnson) I’ve been working with Test-O-Pac Industries as they are very accommodating with all of my testing needs. I can always rely on them to execute and prioritize my projects accordingly. I consider Test-O-Pac Industries as an extension of my team.”
A Comprehensive Customer-Focused Model
Test-O-Pac Industries is unique in its modus operandi when it comes to packaging validation testing. Unlike its competitors who conduct end-to-end packaging validation tests in a single step and then deliver the results, Test-O-Pac Industries adopts a step-by-step approach. The company always keeps clients updated on test progress and any abnormalities or defects identified at any point in the test. With this, they can stop the test at any point on-demand, allowing clients to figure out issues internally, rectify them, and then restart testing, instead of wasting valuable time going through the entire process.
Also, to align well with clients’ ever-changing requirements, Test-O-Pac Industries’ quality testing solutions are designed and developed according to the specific requirements of each client. The company’s dedicated team of engineers pride themselves in their ability to respond to a customer’s varied needs by virtue of their technical skills and the advanced equipment and technology know-how. By combining the team’s responsiveness and ability to design, develop, and customize quality solutions in quick turnaround time, Test-O-Pac Industries is today able to take part in the defense against the COVID-19 pandemic by remaining open as an essential company. “We have been contacted by medical device companies who consider us essential in fighting this pandemic,” says Ajay Sohal, Quality Manager at Test-O-Pac Industries.
What makes Test-O-Pac Industries the most sought-after partner for medical device manufacturers is its commitment to deliver high-quality packaging testing validation evidence reports that offer enhanced visibility through a comprehensive test cycle layout and actionable information with evidence—pictures and graphs. “There is no room for generic boilerplate results in medical device testing. Therefore, we develop customized reports that summarize detailed evidence,” says Sam. With the capability to deliver easy-to-read test evidence report, the company has gained credibility for being a go-to laboratory for medical device companies to achieve their FDA approvals.
Customer Satisfaction: The Ultimate Goal
“As a nimble and responsive company, we are always dedicated to leading our customers toward success by maintaining a healthy and mutually beneficial relationship with them,” says Sam. The team at Test-O-Pac Industries is always willing to stay in-tune with the company’s commitments to go above and beyond for customers, even if the scenario demands them to train their clients about the fundamentals of the package validation process. Sam recalls an instance when Test-O-Pac Industries worked with a client who—despite being in the industry for the last 10 years—was oblivious to the concept of compression testing and struggled to find ways to attain compressive strength for their packages. Understanding the client’s plight, Test-O-Pac Industries served as an educator alongside a service provider to help them break down the entire protocol associated with compression testing. “We quickly realized that the situation demanded us to take a granular approach to solve the task. Our team not only helped the client learn the basics of compression testing but taught them ways to improve their skills to ensure that they would never have to face this plight again,” adds Sam.
“Medical Device companies expect quality results, and that is always our first priority.”
Test-O-Pac Industries goes the extra mile to assist its clients when they are in need by providing them with studies from its testing experiences. To this end, Test O Pac is working on creating tutorial videos to help clients understand the procedures to fold a pouch before putting it into the shipper carton. The company has also conducted studies on tensile strength to show the different pound-force (lbf)—a non-SI (non-System International) measurement unit of force—values under different circumstances.
Facilitating a Healthy Evolution
Identifying that providing systematic education for the next generation will add value to the packaging industry, Test-O-Pac Industries is now working with San José State University to provide internship and scholarship programs for graduating packaging engineers. The company aims to provide them with expertise and experience in testing, test validation, and a complete understanding of medical device companies requirements for packaging validation. This helps them contribute to the healthy evolution of the packaging industry.
As an agile startup continually looking to scale, Test-O-Pac Industries is driving to expand its workforce by hiring experts from the medical device space. Recently, the company has added a new board member, Dr. Anokh Singh—who also serves as the acting Chairman—with significant experience working with UC Davis medical center. Test-O-Pac Industries secured a new CEO, who is a Senior Environmental Scientist at the California Department of Food and Agriculture, to review and support its accelerated growth and commitment for funders. Additionally, the company onboarded a new Quality Manager who has got longstanding experience in the medical device space to assist the team at Test-O-Pac Industries to facilitate their operations.
On the technological side, Test-O-Pac Industries has recently added several equipment to its in-house resources, which enhanced its operational capabilities. Intended to serve more medical device manufacturers, the company is planning to procure more equipment. “We are pioneers in the medical device packaging industry. Our efforts to continually grow and improve our quality make us confident in working toward establishing a healthier community and play a vital role in protecting our people, along with our future,” concludes Ajay.