Precision leak detection for pharmaceutical packaging
Proper and secure packaging of pharmaceuticals is crucial to prevent devastating consequences from potential leaks. Oxipack’s leak detection systems are built with precision and adhere to the strictest standards for pharmaceutical packaging, making sure every life-saving dose remains sterile and protected.
We have spent nearly twenty years developing its vacuum decay leak detection to perfection. The changing requirements in the pharmaceutical sector have created the need to help companies and manufacturers navigate the changing landscape as Oxipack enters more forcefully the pharmaceutical sector. In this dynamic setting, we bring experience and cater to the needs of clients who are newly setting up operations.
There is increasing demand for validated Container Closure Integrity Testing (CCIT); therefore, we have presented two machines for the pharmaceutical industry that are based on our proven vacuum decay technology.
Fully compliant non-destructive vacuum decay testing for pharmaceutical applications
Our Stationary Leak Tester Pharmaceutical (SLTP) is made for flexible packaging, including MAP sachets and pouches. It utilises a non-destructive vacuum decay method compliant with ASTM F2338 and is suitable for testing multiple units at the same time. It features an intuitive interface with pass/fail lighting, integrated vacuum and control systems, and is fully compliant with 21 CFR Part 11. The SLTP is already proving central for high-throughput pharma uses where traceable, quantitative testing is needed.
Our Container Closure Integrity Tester (CCIT) offers a compact and highly sensitive solution for rigid containers such as capsules, vials and bottles. This technology also complies with ASTM F2338 and 21 CFR Part 11 and uses change parts specifically tailored for different container format applications. Its user-friendly touchscreen and minimal measuring space enable easy operation and precise, non-invasive outcomes, while also being suitable for pharma and biotech operations that need product integrity and regulatory compliance.
Versatile leak detection solutions for pharmaceuticals
Oxipack’s leak detection technology works with a wide variety of pharmaceutical packaging that ranges from vials to blister packs. Our solution is versatile and can be adapted to serve different materials and shapes. This helps ensure quality and efficiency for all intended pharmaceutical products.
For many pharmaceutical startups and contract manufacturing organisations (CDMOs), this simplicity is particularly useful, since these clients require fully compliant products and services that can seamlessly be integrated into their production processes without the need for an excessive amount of training, special requirements, or expensive lifecycle service agreements.
Leak detection may be something new to many of these clients, and our solutions help by providing features such as high intuition when it comes to leaks and challenges, full validation packages, traceable calibration, as well as easy and clear onboarding. By partnering with us, regulatory compliance is made easier and achievable.
Our systems produce audit-ready quantitative test data that is compliant with 21 CFR Part 11, seamlessly meshed into electronic batch records, and applicable in every production cycle. This allows organisations to retain and enhance process control.
Comprehensive client support with precision leak detection technology
Our offerings do not end at delivery. We provide support through every step of the process. URS (User Requirement Specification) is handled by our pharma customers as they validate the process with their packaging, but we are there to support them for the whole procedure. More specifically, we are:
- Helping with the drafting of the URS, especially around delicate requirements and packaging scope.
- Providing full calibration reports using traceable standards.
- Offering tailored solutions for accurate validation and reliable verification, including appropriate tools and expert guidance.
- Assisting with FAT/SAT, IQ/OQ/PQ, and advising on best validation processes.
With our support and expertise, we help businesses such as CDMOs and startups with tasks like scaling up or establishing their first Annex 1-compliant line, turning complicated compliance challenges related to CCIT into a smooth working procedure that can be repeatedly applied.
Our relevant whitepaper, titled “Validation of Leak Sizes for Vacuum Decay Testing”, has been a reference point for pharma QA teams because of the wide scope of product and process information it offers. The whitepaper covers:
- Positives and negatives of various kinds of artificial leak types
- Tools for machine verification vs product validation
- The importance of traceable flow rate over hole size
- What elements auditors want to see in a validation package
About Oxipack Leak Detection
Through manufacturing experience and regulation expertise, Oxipack continues to grow in the pharmaceutical space and recognises its learning journey while supporting customers through decades of vacuum decay expertise. Our confidence in our solutions, coupled with our drive to listen to our customers’ needs, ensures we build lasting partnerships by promoting safe, compliant pharmaceutical manufacturing.