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Vacuum and Leak Detection in Pharma and Biotech

From development labs to final packaging, vacuum plays a decisive role in making medicines safe and compliant.

Pfeiffer Vacuum+Fab Solutions provides advanced laboratory solutions and deterministic integrity testing that ensure sterility, reproducibility, and regulatory conformity.

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Vacuum along the pharmaceutical value chain

Vacuum technology supports every step of drug development and manufacturing. In active pharmaceutical ingredient (API) and excipient production, it enables drying, distillation, and solvent recovery. During drug formulation and packaging, vacuum ensures reliable mixing, sterile filling, and airtight sealing.

Pfeiffer Vacuum+Fab Solutions focuses on the critical areas of laboratory applications and quality assurance. Our technologies provide reproducible vacuum for R&D and pilot plants, high-sensitivity container closure integrity testing (CCIT), precise helium leak detection, and advanced analysis with residual gas analysis (RGA) and mass spectrometry. These solutions safeguard sterility, compliance, and data integrity.

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Vacuum applications

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Solutions

Vacuum applications in pharma and biotech

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Container Closure Integrity Testing (CCIT)

Ensuring sterile packaging integrity is a core requirement in the pharmaceutical industry. Even the smallest leak can allow moisture, gas, or microbial ingress, compromising product quality, product sterility, and patient safety. At the same time, regulators demand deterministic methods with full data traceability to replace subjective visual inspection.

Pfeiffer provides CCIT systems based on helium mass spectrometry, Optical Emission Spectroscopy, and mass extraction with sub-micron sensitivity and repeatable results. These turnkey systems are 21 CFR Part 11 compliant and aligned with USP <1207>, offering automated processes, reproducible data, and full data traceability. This secures reliability, audit readiness, and long-term confidence in drug packaging quality.

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Laboratory vacuum

Stable and clean vacuum is a prerequisite for reliable research and development in pharmaceuticals. Every analytical instrument requires vacuum – mass spectrometers, for example, combine turbomolecular vacuum pumps with backing pumps to achieve the necessary high vacuum levels. Glove boxes and other laboratory equipment may operate with only a backing pump. In the past, rotary vane vacuum pumps were widely used thanks to their robustness and favorable cost-performance ratio, especially for handling vapors. Today, however, laboratories increasingly turn to dry vacuum technologies such as scroll and diaphragm vacuum pumps, which offer quiet operation, low maintenance, and reduced contamination risk.

Pfeiffer supplies the complete range of laboratory vacuum solutions, from backing pumps and turbomolecular vacuum pumps to modern dry technologies, ensuring reproducible results in R&D and pilot plants. This guarantees reliable operation for sensitive instruments while improving efficiency and working conditions in the laboratory environment.

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Quality control

Ensuring consistent product quality is a central task in pharmaceutical manufacturing, especially under the stricter regulations of GMP Annex 1. Residual gas analysis (RGA) plays a key role here by providing real-time insights into the gas composition of vacuum processes. In freeze drying, for example, RGA enables the detection of changes such as silicone oil contamination at an early stage and gives a clear signal for defining drying endpoints.

With these capabilities, RGA strengthens contamination control and provides reliable data for documenting compliance. Pfeiffer supports quality assurance with proven technologies that help manufacturers maintain sterility and safeguard product integrity throughout the production environment.

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Helium leak detection (spraying method)

Pharmaceutical equipment must remain leaktight to guarantee sterility and safe operation. Undetected leaks in seals, flanges, or valves can compromise cleanroom conditions, cause costly downtime, and threaten product safety. Traditional pressure decay methods are unable to locate leaks and often lack the sensitivity necessary to find them quickly and reliably.

Pfeiffer addresses this problem with helium leak detection using the spraying method. By introducing helium around potential leak points while monitoring the vacuum system, even the smallest leaks can be located with high accuracy. This proven approach helps manufacturers protect sterile environments, reduce downtime, and maintain compliance with GMP requirements.

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Our solutions for pharma and biotech manufacturers

Pfeiffer Vacuum+Fab Solutions supports pharmaceutical companies with laboratory vacuum, quality control, and packaging integrity testing - precise, compliant, and reliable. From reproducible R&D results to deterministic CCIT and helium leak detection, our solutions safeguard sterility and efficiency across these critical steps.

Scroll vacuum pumps

Oil-free backing pumps ideal for clean, quiet operation in laboratories and compact setups.
Scroll pumps
Diaphragm vacuum pumps

Compact and easy to operate – perfect for rough vacuum applications like filtration or degassing.
Diaphragm pumps
Multi-stage roots vacuum pumps

High pumping speed at low pressures – ideal for demanding rough vacuum processes.
Multi-stage roots pumps
Rotary vane vacuum pumps

Robust, versatile solutions for medium vacuum, with flexible operation and stable performance at low pressures.
Rotary vane pumps
Leak detectors

Quickly locate even the smallest leaks to ensure system integrity and uptime.
Leak detectors
Residual gas analyzers (RGA)

Monitor gas composition with mass spectrometers in real time to safeguard process stability and purity.
Residual gas analyzers (RGA)
Gauges

Accurate pressure measurement from atmospheric pressure to UHV.
Vacuum gauges

Tailored solutions

Pharmaceutical processes require vacuum and leak detection solutions that are precisely adapted to each step. Pfeiffer specializes in laboratory applications, quality control, and packaging integrity testing, offering systems that are customized to the specific needs of our customers.

Container Closure Integrity Testing

In Container Closure Integrity Testing, solutions are tailored to the chosen technology. This may involve

customized vacuum chambers for non-porous containers like syringes, vials, or blister packs,
software adjustments to ensure compliance,
complete documentation of the testing approach, and
acceptance testing to verify reproducibility.

Laboratory settings

In laboratory settings, the typical one-pump-per-device setup can be replaced by more efficient configurations. For example, multiple instruments can be connected to a single, larger vacuum pump. Alternatively, entire facilities can be supplied by a central vacuum system. These options reduce noise and service requirements while lowering operating costs because vacuum is only provided when it is actually needed.

Residual gas analysis

In residual gas analysis, mass spectrometers require high vacuum, which is normally not needed in pharma production. Therefore, solutions integrate turbomolecular vacuum pumps or additional vacuum pump stages to reach the required vacuum level and use inlet systems to handle vapors and particles. These systems enable real-time monitoring of gas composition during processes such as freeze drying, allowing for the early detection of contaminants like silicone oil. Thus, RGA systems support manufacturers in meeting the contamination control expectations of GMP Annex 1.

Looking for more?

For large-scale pharmaceutical production, Busch Vacuum Solutions contributes the full range of vacuum technologies needed for drying, distillation, solvent recovery, sterile filling, and packaging.

Busch adds value through extensive system building expertise, ATEX-compliant technologies, and a global service network that ensures long-term reliability. As part of the Busch Group, Pfeiffer and Busch combine precision in laboratories with robustness in production. Together, they offer manufacturers the most comprehensive portfolio of vacuum solutions along the entire pharmaceutical value chain.

Discover the full portfolio from Busch for pharma

About the Busch Group