Pfeiffer Vacuum+Fab Solutions

Leak testing plays a critical role in ensuring the safety and integrity of medical devices and pharmaceutical packaging. Pfeiffer Vacuum+Fab Solutions, part of the Busch Group, provides leak detection equipment designed to support container closure integrity and device testing using three deterministic technologies: mass extraction, helium mass spectrometry, and optical emission spectroscopy.

Pfeiffer has decades of experience supporting medical manufacturers and research institutions worldwide. Experience with highly sensitive medical applications enables the company to deliver tailored vacuum and leak detection solutions that support patient safety, regulatory compliance, and reliable performance throughout the medical product lifecycle.

From development to production, Pfeiffer provides high-sensitivity, non-destructive container closure integrity testing (CCIT) solutions capable of detecting extremely small leaks in container closure systems. These solutions help maintain sterile barrier integrity, support global regulatory compliance, and ensure consistent drug product quality.

CCIT verifies that parenteral packaging maintains a sterile barrier throughout its lifecycle. Even microscopic leaks can allow ingress of contaminants such as moisture, microbes, or reactive gases, which can compromise drug safety, shelf life, and patient protection. Modern CCIT methods follow deterministic testing approaches aligned with USP <1207>, EU GMP Annex 1, and FDA guidelines to detect even the smallest integrity breaches.

In the medical field, patient safety is paramount. Safety, precision, and reliability play a critical role in protecting lives. Vacuum and leak detection technologies are used in a range of critical applications, including sterilization, medical device manufacturing, diagnostic imaging, container closure integrity testing (CCIT), residual gas analysis (RGA), and medical accelerators.

As drug delivery systems continue to increase in complexity, so does the need for greater precision in packaging integrity. Whether working with pre-filled syringes, vials, auto-injectors, or IV (intravenous) bags, even microscopic defects in the container closure system can compromise sterility, patient safety, and regulatory compliance. Traditional leak testing methods such as dye ingress or microbial ingress testing have proven insufficient, often failing to detect defects smaller than 10 µm. As a result, regulators increasingly recommend deterministic, non-destructive test methods, and many pharmaceutical and biotechnology manufacturers are transitioning to these technologies.

Pfeiffer offers expertise in three advanced technologies: helium mass spectrometry, mass extraction, and optical emission spectroscopy, providing tailored solutions to meet the stringent demands of pharmaceutical and medical applications.

Cryogenic storage increases leak risk due to moisture, gas ingress, and material stress – especially in biologics.  The Dry Chiller Module from Pfeiffer enables real time container closure integrity testing under deep-cold conditions (–80 °C or –112 °F) as described in USP <1207.1>, supporting biologic and temperature-sensitive product profiles.

Selecting the Right Leak Testing Method for Your Packaging System

Selecting the appropriate leak test method depends on the packaging system and required sensitivity. Aligned with USP <1207.1>, Pfeiffer feasibility studies include positive and negative control samples and method development guidance based on MALL and product–package profiles. The studies evaluate three deterministic technologies: helium mass spectrometry, optical emission spectroscopy, and mass extraction.

Complete Solution Capabilities, Including Validation Studies, IQ/OQ, and CCIT per USP <1207>

Pfeiffer Vacuum+Fab Solutions operates a fully equipped ISO 17000 laboratory to support validation requirements. Our experts can assist with all aspects of qualifying a deterministic CCIT program. From start to finish, our team supports regulatory requirements and the overall CCIT validation process.

Pfeiffer supports 15 different leak testing methods in accordance with DIN EN 1779 and DIN EN ISO 20485. We also meet the requirements outlined in USP <1207> through four CCIT technologies: air-based testing, tracer gas methods, optical emission spectroscopy, and residual gas analysis (RGA).

Leak Testing for Medical Devices and Pharmaceutical Packaging, 21 CFR Part 11 Compliant

Pfeiffer Vacuum+Fab Solutions offers three CCIT technologies: helium mass spectrometry, optical emission spectroscopy, and air-based testing. Because no single method addresses every CCIT application, selecting the appropriate technology depends on package design, product characteristics, and required sensitivity.

A diversified CCIT portfolio supports a wide range of testing requirements. While many providers offer only one or two technologies, multiple deterministic approaches can be evaluated to identify the most suitable method for each application.

Mass Extraction, Helium Mass Spectrometry, and Optical Emission Spectroscopy Technologies

Pfeiffer Vacuum+Fab Solutions offers three CCIT technologies designed to support high-sensitivity leak detection. The ASM 2000 helium mass spectrometer can detect leaks several orders of magnitude below the maximum allowable leak limit (MALL) of 0.2 microns. The AMI 1000 optical emission spectroscopy CCIT system can identify defects as small as 0.4 microns, while the SpeedAir 3050 microflow tester, an air-based CCIT technology, can detect defects down to 1 micron.

Worldwide Service and Support for Custom and Standard Leak Test Solutions

With a network of more than 100 companies and agencies across over 40 countries, Pfeiffer Vacuum+Fab Solutions maintains a strong global presence. Local technical specialists provide custom-tailored support, backed by a global network of application expertise and service resources. This global infrastructure enables consistent support for leak detection solutions across development, production, and service operations worldwide.

Need Help with FDA CCIT Validation or Method Development?

Pfeiffer Vacuum+Fab Solutions operates a fully equipped ISO 17000 laboratory to support CCIT validation requirements. Application specialists assist with all aspects of qualifying deterministic CCIT methods, including method development, feasibility studies, and regulatory alignment.

From initial feasibility through full validation, the team supports manufacturers with the regulatory and technical requirements associated with CCIT programs. Testing capabilities include 15 leak detection methods in accordance with DIN EN 1779 and DIN EN ISO 20485. The laboratory also supports compliance with USP <1207> using four CCIT technologies: air-based testing, tracer gas methods, optical emission spectroscopy, and residual gas analysis (RGA).

Worldwide Integration and All-in-One Solution Capabilities, from Concept to Installation

Pfeiffer Vacuum+Fab Solutions provides integrated support across the entire CCIT implementation process, from initial concept and feasibility testing through system installation and validation. A fully equipped ISO 17000 laboratory supports validation activities and method development for deterministic CCIT programs.

Application specialists assist manufacturers with regulatory and technical requirements throughout the validation process. Testing capabilities include 15 leak detection methods in accordance with DIN EN 1779 and DIN EN ISO 20485. The company also supports compliance with USP <1207> through four CCIT technologies: air-based testing, tracer gas methods, optical emission spectroscopy, and residual gas analysis (RGA).

Reducing Scrap Caused by Destructive CCIT Methods

Destructive CCIT methods, such as dye ingress testing, can lead to significant product scrap and higher testing costs. Non-destructive technologies from Pfeiffer Vacuum+Fab Solutions help eliminate this waste while providing repeatable, measurable results. Because the packaging remains intact, tested products can remain saleable, with testing cycles as short as 15–30 seconds, helping manufacturers reduce scrap and improve throughput.