Medical and pharmaceutical production processes are among the most strictly regulated in the world. Products must meet uncompromising standards for safety, sterility, and integrity, and failure to do so can result in regulatory penalties, product recalls, and—most critically—patient risk. At Nolek, we develop and deliver high-performance leak testing solutions for pharmaceutical and medical manufacturers, ensuring that your packaging, devices, and components meet the highest quality benchmarks. We offer:
Automated leak test machines for packaging like blister packs, ampoules, vials, and infusion bags.
Testing systems for closed-system medical devices such as catheters and respiratory units.
Expert guidance in leak test methodology, validation, and compliance from early-stage R&D through to full-scale production.
The pharmaceutical and medical sectors demand zero-compromise quality control, and that begins with effective leak testing. At Nolek, we support manufacturers at every stage:
Prototype Verification: Ensuring your designs are leak-proof before entering production.
Inline Integrity Testing: Fast, repeatable leak tests with minimal cycle times for seamless production integration.
Comprehensive Project Support: From system design and validation documentation to regulatory compliance and post-installation support.
Our systems are built to meet the rigorous expectations of international standards, including FDA, EMA, and ISO 11607. And with full data traceability, you’ll have complete confidence in your quality assurance processes.
Expert perspectives, industry trends, and technical insights from leaders shaping the future of pharmaceutical and medical manufacturing.
Accumulation leak testing for rigid pharmaceutical vials and ampoules
Container closure integrity testing (CCIT) of sterile pre‑filled syringes, vials & bottles
Non‑destructive leak detection of blister packs and foil‑foil medical packaging
Inline pressure‑decay leak testing for high‑throughput medical device production
Vacuum decay leak testing of lyophilised drug containers and parenteral systems
Helium tracer‑gas leak detection for ultra‑high‑sensitivity pharmaceutical packaging
Flexible‑pack seal integrity testing for pouches, sachets and sterile barrier systems
Real‑time 100% package integrity monitoring for continuous pharmaceutical manufacturing
Micro‑flow leak testing of IV bags, infusion sets and other fluid‑handling medical components
Seal strength and leak rate testing of induction‑sealed bottles and tamper‑evident closures
The most accurate method for leak testing sterile pharmaceutical containers such as vials, syringes, and ampoules is often helium leak detection or vacuum decay testing, both of which offer non-destructive and highly sensitive results.
CCIT evaluates the seal quality of containers like vials and pre-filled syringes to ensure sterility is maintained. Techniques such as vacuum decay, high-voltage leak detection (HVLD), and laser-based headspace analysis are commonly used to detect micro-leaks without compromising the container.
Accumulation testing is a non-destructive leak detection method that uses a tracer gas (often helium) to measure leakage from sealed pharmaceutical packages in a sealed test chamber. It’s ideal for ensuring the integrity of containers such as blister packs, IV bags, and rigid bottles.
Yes. Non-destructive methods such as vacuum decay, headspace gas analysis, and high-voltage leak detection allow parenteral drug containers like IV bags, vials, and syringes to be tested without damaging the container or product inside.
Leak testing in pharma and MedTech is governed by regulatory standards such as USP <1207>, ISO 11607, FDA 21 CFR Part 211, and Annex 1 of EU GMP. These require validated, reproducible, and often non-destructive methods to confirm container closure integrity (CCI).
Yes, leak testing systems—such as inline pressure decay testers or automated vacuum leak detection machines—can be fully integrated into pharmaceutical production lines to enable 100% testing, high throughput, and compliance with data integrity requirements.
We have built machines that test several different medical packages including:
- Blister packages
- Medicine bottles
- Medicine cans
- Sachets
- Plasma bags
- Flexible packages/pouches
- Parental vials
- Filled syringes
Automated leak detection ensures consistent, repeatable testing of components like catheters, valves, and respiratory circuits. Benefits include reduced human error, faster cycle times, integration with MES systems, and comprehensive data logging for regulatory traceability.
How Can We Support You?
Your Partner in Leak Testing for Medical and Pharmaceutical Applications
- From early-stage product development to validated production testing, our experts are here to help you find the right leak detection solution for your pharmaceutical or medical application.
- Whether you need support with container closure integrity testing (CCIT), regulatory-compliant methods, or selecting the optimal non-destructive leak test equipment, we’re ready to assist.
- Get in touch to discuss your application and discover how our customised leak testing systems can help you improve quality assurance, reduce risk, and ensure regulatory compliance.