Collectively, the CS Analytical Team has been at the forefront of Container Closure Integrity Testing dating back to the early 2000s. Under the leadership of CEO Brian Mulhall, the CSA Team can boast of envisioning and building the first FDA regulated, cCMP contact laboratory providing the full spectrum of USP <1207> technologies prior to the modern USP <1207> chapter (and some of the technologies themselves) even being in draft form. In fact, much of the work and experience leading to the creation of the modern USP <1207> and its subparts was performed at Mr. Mulhall’s company. This was aided through an appreciation and focus on collaboration between those on the cutting edge of CCI developments: instrument manufacturers, renowned researchers, and importantly, client companies; a spirit that continues in CS Analyical. Mr. Mulhall is a published author on a number of critical, peer-reviewed studies that helped to shape the guidelines we are working under today, including:
High-voltage leak detection of a parenteral proteinaceous solution product packaged in form-fill-seal plastic laminate bags. Part 1. Method development and validation
High-voltage leak detection of a parenteral proteinaceous solution product packaged in form-fill-seal plastic laminate bags. Part 2. Method performance as a function of heat seal defects, product-package refrigeration, and package plastic laminate lot
Vacuum decay container closure integrity leak test method development and validation for a lyophilized product-package system
Jayshree Patel , Brian Mulhall, Heinz Wolf, Steven Klohr, Dana Morton Guazzo
PDA J Pharm Sci Technol Sep-Oct 2011
Vacuum decay container/closure integrity testing technology. Part 1. ASTM F2338-09 precision and bias studies
Heinz Wolf 1, Tony Stauffer, Shu-Chen Y Chen, Yoojin Lee, Ronald Forster, Miron Ludzinski, Madhav Kamat, Phillip Godorov, Dana Morton Guazzo
PDA J Pharm Sci Technol Sep-Oct 2009
Vacuum decay container/closure integrity testing technology. Part 2. Comparison to dye ingress tests
Heinz Wolf 1, Tony Stauffer, Shu-Chen Y Chen, Yoojin Lee, Ronald Forster, Miron Ludzinski, Madhav Kamat, Brian Mulhall, Dana Morton Guazzo
PDA J Pharm Sci Technol Sep-Oct 2009
Starting in 2010, CS Analytical Chief Scientific Officer Brandon Zurawlow worked as part of this team, gaining hands-on experience with novel technologies, unique package system applications, and development of best practices now encapsulated in USP <1207>, including some studies listed above. Based upon their experience and expertise in the area of USP <1207> Container Closure Integrity Testing, the CS Analytical team has played an active role in the education of industry stakeholders worldwide on this unique but critical topic. No better example exists than Brandon’s commitment to continuous accumulation and exchange of ideas and information in the niche of pharmaceutical, biotech, and medical device container and package testing. He has served as an organizer, staff trainer, and speaker at a wide variety of global public and private training programs, workshops, conferences and trade shows. Examples of Brandon’s far-reaching communication of the USP <1207> platform include:
- Young, J., & Zurawlow, B. (2019). Parenteral Product Container-Closure Integrity Testing. In Parenteral Medications(pp. 511-534). CRC Press.
- PDA Technical Report No. 86 (TR 86) Industry Challenges and Current Technologies for Pharmaceutical Package Integrity Testing
- Optimized CCI Test Method Development and Validation Approaches. PDA Europe Parenteral Packaging Conference: Frankfurt, Germany. Mar, 2015.
- USP Container Testing: A Contract Lab’s Perspective on Industry Confusion. PharmaPack North America: NY, NY. Jun, 2015.
- CCIT: Current Trends, Regulatory Updates, and Test Technology Overview. Institute of Packaging Professionals Drug and Pharmaceutical Packaging Committee Annual Meeting: Pearl River, NY. Jun 2015.
- The Effects of a Plunger Surface Roughening Treatment on CCI: Evaluation of Inherent Package Integrity by Helium Leak Detection in the Vacuum Mode. PDA Europe Parenteral Packaging Conference: Barcelona, Spain. Mar, 2017.
- Considerations for Container Closure Integrity Method Selection and Development: Impact of the Product, Package and Study Goals. PDA Container Closure Performance and Integrity Conference: Bethesda, MD. Jun, 2018.
- CCIT Trends, Updates, and Explanations. PDA Advancing Science in Drug, Device, & Primary Packaging Conference: Vadodara, India. Aug, 2018.
- CCIT Regulatory Landscape: Moving Toward Prevention. PDA Container Closures For Injectables: Technologies, Properties And Practices Workshop: Pune, India Jan 24-25, Pune, India. Jan, 2019.
- Preventative Studies: Critical Dimensions and Capping. PDA Container Closures For Injectables: Technologies, Properties And Practices Workshop: Pune, India Jan 24-25, Pune, India. Jan, 2019.
- CCIT Regulatory Landscape: Moving Toward Prevention. ISPE Annual Meeting and Expo: Las Vegas, NV. Oct, 2019.
- CCI Method Selection through the Product Lifecycle. Making Pharmaceuticals: Coventry, United Kingdom. Oct, 2021.
Public Training Courses, Workshops, and Webinars:
- Original PDA Container Closure Integrity Training Course, developed and implemented in 2014 as the platform for future PDA CCI Training courses.
- Lighthouse Instruments CCI Workshop: Amsterdam, Netherlands. May, 2019.
- PDA CCI Training Course: Gothenburg, Sweden. Oct, 2019.
- PDA CCI Training Course: Basel, Switzerland. Feb, 2020.
- Packaging Technologies and Inspection (PTI) CCI Webinar Series.
- CCIT Regulatory Guidance: Past, Present, and Future. Oct, 2020.
- Searching for a Silver Bullet: CCI Method Selection and the Toolbox Approach. Oct, 2020.
- How Good is Good Enough? Applying CCIT in the Real World. Nov, 2020.
- Packaging Technologies and Inspection (PTI) Helium Leak Detection Webinar Series.
- Helium Leak Detection: History, Principles of Operation, and Methods for Pharmaceutical Packaging. April, 2021.
- Helium Leak Detection: USP <1207> Lifecycle Approach and Real-World Applications. May, 2021.
Despite industry contribution and engagement, perhaps the most notable attribute of the CS Analytical team is the vast array of hands-on experience developing, validating, and implementing container closure integrity test methods and strategies for products and clients across the globe. Having been involved from the beginning of what is now referred to as deterministic CCI testing, conceptualizing the modern CCI lab in the process, CS Analytical team members have witnessed and contributed to advancement in leak test technology, developed and validated leak test methods for standard, emerging, and cutting-edge package and drug delivery systems, and influenced and navigated a changing regulatory landscape in service and advancement of our clients and the broader industry. At CS Analytical, continuous advancement and application of our field is core to our mission, enabled by collaboration with our industry partners and clients.