This article was originally published on October 17, 2022, and updated on June 16, 2025.
Precision and cleanliness are critical aspects of pharmaceutical and biotechnology manufacturing. From sterile production environments to aggressive chemical processes, pressure instruments must deliver consistent performance while supporting stringent regulatory requirements.
Ashcroft has been manufacturing pressure instrumentation for pharmaceutical and biotechnology applications for generations. Over the past 10 years with the company, I have helped customers find the best solutions for their specific needs, drawing on trusted industry practices and proven instrumentation examples.
Read this article to get a comprehensive overview of common instrument applications, industry challenges and primary considerations for selecting the product that will deliver the most accurate results. You will also find links to additional information that can help deepen your knowledge.
Where are pressure instruments used in the pharmaceutical and biotech industries?
Pressure measurement instruments, including sanitary pressure gauges and pressure transducers, play a critical role in maintaining control, consistency and compliance across several pharmaceutical and biotech processes, such as:
Hygienic Processes
Instruments used in sanitary production areas—such as pharmaceutical manufacturing suites, biologics processing lines, vaccine filling systems, and CIP/SIP skids—must meet rigorous 3-A sanitary standards. In these environments, product contact areas must be kept free of microbial contamination to ensure patient safety and regulatory compliance.
To support these conditions, pressure instruments must feature smooth, cleanable surfaces, be constructed with electropolished stainless steel and offer sanitary connections for easy integration and sterilization. Compatibility with clean-in-place (CIP), sterilize-in-place (SIP) and autoclaving procedures is also important to avoid process interruptions during routine cleaning and validation.
The Ashcroft® 1032 Sanitary Pressure Gauge is a good example of a 3-A approved instrument designed to meet sanitary demands. It features an electropolished seal with a 12–15 microinch surface finish to support hygienic applications with ease. Plus, the Ashcroft® E2 Sanitary Pressure Transducer is also 3-A approved.
Cleanroom and Critical Environment Monitoring
Maintaining precise pressure levels within cleanrooms, isolation rooms and other controlled environments is essential for preventing contamination and ensuring one-way airflow. These spaces often require instruments with ultra-low differential pressure measurement capabilities, as well as in-place calibration features and traceable calibration certificates to meet stringent compliance, safety and validation standards.
Effective monitoring in these environments depends on pressure instruments that can detect extremely small fluctuations, integrate seamlessly with building management systems, and be serviced without process disruption. For instance, differential pressure sensors such as the Ashcroft® GXLdp and DXLdp provide highly accurate low-range measurement, along with built-in SpoolCal® technology that enables in-place calibration—ideal for minimizing downtime and preserving environmental integrity.
Fume Hoods and Containment Systems
In environments where hazardous substances are handled, such as compounding labs, biocontainment hoods, or clean-air enclosures, accurate differential pressure monitoring is essential to ensure that air is flowing in the correct direction and that harmful agents remain contained.
Similar to cleanroom and critical environment monitoring, these systems require extremely sensitive instrumentation to detect minute changes in pressure and must include traceable calibration certificates to meet compliance requirements from regulatory agencies and internal validation processes.
Chemical and Bioprocessing Operations
Biopharmaceutical and chemical manufacturing processes—such as fermentation, buffer preparation, chromatography, and media filtration—often involve high-pressure flows, aggressive chemicals, and elevated temperatures. These systems require pressure instruments that can withstand mechanical stress, resist chemical attack, and deliver stable, accurate readings under dynamic conditions.
Instruments such as all-welded pressure gauges or chemically compatible transducers are ideal for these environments.
Calibration and Validation Activities
Good Manufacturing Practices (GMP) require pressure instruments to undergo routine calibration and performance validation to ensure they meet regulatory and quality assurance standards. This is especially important in systems that influence critical processes.
However, removing instruments for calibration can be time-consuming, introduces the risk of contamination and may require costly process revalidation. That’s why instruments that support in-place calibration are increasingly preferred in pharmaceutical and biotech facilities.
The Ashcroft® ATE-2 Handheld Digital Calibrator is a practical and portable solution for performing on-site, in-place pressure calibration. With it, maintenance teams can quickly verify instrument accuracy without disrupting validated systems.
Additionally, as mentioned earlier, differential pressure sensors like the Ashcroft® DXLdp and GXLdp feature the patented SpoolCal® actuator, which enables in-place calibration directly within cleanrooms or air handling systems. This design saves time, maintains sterility and supports compliance with FDA, EU Annex 1, and internal validation protocols.
Key considerations for selecting the right pressure instrument for your pharmaceutical and biotech applications
When evaluating pressure measurement instrumentation for pharma or biotech applications, consider these primary factors:
1. Accuracy, Repeatability & Long-Term Stability
Precision and stability over time are critical for validated processes. Instruments must maintain their calibration to avoid drift-related issues.
The Ashcroft® 1032 Sanitary Pressure Gauge, in addition to its sanitary credentials, offers consistent performance across a wide range of applications, making it well-suited for long-term use in critical environments. Another great option for accuracy, reliability and long-term stability is the Ashcroft® 1033 Sanitary Pressure Gauge with our PLUS!™ Performance option.
2. Material Traceability and Regulatory Compliance
The materials you use depend on the specific application and compatibility with the media used, especially in hygienic applications where there are strict regulatory standards. A good way to ensure safety and reliability is to use instruments with traceable materials and 3-A certification.
Material traceability certifies that the materials used in your application have records chronicling their creation, so you have precise knowledge of the origin and composition of the materials you receive. Note: Transducers do not have material traceability unless they have a sanitary seal.
3. Pressure Range and Media Compatibility
Matching the correct pressure reference (gauge/vacuum, absolute or differential) and selecting compatible wetted materials for your process media are critical to preventing premature instrument failure and ensuring long-term reliability.
For applications involving aggressive cleaning agents or specialized process media, consider stainless-steel-based transducers designed for chemical compatibility. Before making your selection, check out our material selector and corrosion guide.
4. In-Place Calibration Capabilities
Minimizing process disruptions is also a key advantage in regulated environments. Using instruments that support in-place calibration will reduce downtime and lower operational risk.
As previously stated, the Ashcroft® GXLdp and DXLdp differential pressure transducers feature the exclusive, patented SpoolCal® actuator, which enables accurate in-place calibration without disconnecting the sensor from the system. This feature helps you save time and reduces the risk of contamination.
Additionally, the Ashcroft® ATE-2 Handheld Digital Calibrator is a field-proven device that supports simple and traceable on-site calibration, helping maintain compliance with validation protocols.
Ready to learn more?
Now that you know the factors to consider when choosing the right sanitary pressure instruments, you can research the solution that’s best for your pharmaceutical and biotechnology application. For your reference, here are additional articles that can answer additional questions about measurement instruments for your needs.
- Choosing a Pressure Transducer for Critical Environments
- How Does Temperature Affect Pressure Gauge Performance?
- Product Review: GXLdp Differential Pressure Transducer
- Product Review: 1032 Sanitary Pressure Gauge
- How Accurate Are Your HVAC System’s Pressure Instruments?
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