Les Côtes 2, CH-2525 Le Landeron, Switzerland
Les Côtes 2, CH-2525 Le Landeron, Switzerland
Dimensional inspection of syringes, vials, ampoules, cartridges, insulin pens, and pharmaceutical production tooling. Non-contact measurement that meets GMP requirements for sterile manufacturing environments.
In pharmaceutical manufacturing, a dimensional deviation that would be insignificant in other industries can directly affect patient safety. A prefilled syringe barrel with an incorrect internal diameter changes the injection force, potentially making self-administration painful or impossible for patients. A vial with incorrect neck dimensions may not seal properly, compromising container closure integrity (CCI) and allowing microbial contamination of a sterile drug product.
The regulatory framework demands 100% traceability, documented measurement processes, and validated inspection systems. FDA (21 CFR Part 211), EU GMP Annex 1 for sterile products, and ISO 11040 for prefilled syringes all require that drug delivery devices meet dimensional specifications, and that measurement systems used to verify compliance are qualified and maintained under GMP.
The additional challenge: pharmaceutical containers are often made of glass or transparent polymers. They are fragile, they are produced in clean environments, and they must not be contaminated by the inspection process itself. Non-contact air gauging is uniquely suited to this requirement, it measures without touching, and the air flow itself is clean and dry.
PFL's air gauging technology measures pharmaceutical containers without physical contact, eliminating the risk of scratching glass surfaces, introducing particulates, or contaminating sterile components. The same compressed air that powers the measurement also cleans the measurement zone.
Air gauging measures by detecting air pressure changes in the gap between the gauge and the workpiece surface. No physical contact means no risk of introducing foreign particles into clean environments or scratching glass container surfaces, critical for GMP compliance in sterile manufacturing.
Many pharmaceutical containers, vials, ampoules, syringe barrels, are made of borosilicate glass or cyclic olefin polymer (COP/COC). These materials are difficult to measure with optical methods (transparency), but air gauging works regardless of material transparency, color, or surface reflectivity.
PFL measurement systems generate complete data records with timestamps, batch numbers, and operator identification, supporting the documentation requirements of GMP, FDA 21 CFR Part 11 (electronic records), and EU GMP Annex 11. Every measurement is traceable to calibration standards.
Pharmaceutical quality demands 100% inspection, not sampling. PFL automated gauging stations can inspect every container as it comes off the forming machine, measuring critical dimensions, classifying OK/NOK, and feeding data back to upstream processes for continuous improvement.
Dimensional inspection of drug delivery devices, primary packaging components, and pharmaceutical production tooling.
Internal bore diameter of glass and polymer syringe barrels, the dimension that determines injection force (glide force and break-loose force). Cone geometry for needle attachment (ISO 594 Luer), flange dimensions, and overall length. Air gauging measures the bore without contact, no risk of scratching the internal surface that contacts the drug product.
Neck diameter (critical for stopper sealing and container closure integrity), body diameter, overall height, bottom concavity, and wall thickness. Dimensional accuracy of the neck determines whether the crimp cap seals properly, a failure here compromises sterility. Air gauging can measure inside the narrow neck of vials as small as 2R without contact.
Internal bore diameter of glass cartridges for insulin pens, dental anesthetic systems, and auto-injectors. Bore diameter uniformity along the cartridge length affects plunger movement consistency, which directly affects dosing accuracy. Shoulder and neck dimensions determine compatibility with pen device mechanisms.
Diameter of tablet press punches and die bores determines tablet size and weight, which affects active ingredient dosing. Punch tip geometry (concavity, break line profile) determines tablet appearance and splitting accuracy. PFL measures these precision-machined tools to ensure uniformity across multi-station rotary presses.
Body and cap diameters of capsule mold pins, dosator tube bores, and tamping pin dimensions. These tooling components determine capsule fill weight and closure quality. Wear on mold pins leads to oversized capsules that don't close properly, regular dimensional verification ensures consistent production.
External diameter and compression zone dimensions of rubber stoppers, aluminum crimp caps, and flip-off seal components. The interference fit between stopper and vial neck creates the gas-tight seal that maintains sterility and prevents oxygen ingress, dimensional accuracy of both components is critical for container closure integrity.
Pharmaceutical dimensional inspection doesn't operate in a vacuum, it exists within a heavily regulated framework that dictates how measurements must be performed, documented, validated, and maintained. PFL systems are designed with these requirements in mind from the start.
Good Manufacturing Practice requires that measurement equipment is qualified (IQ/OQ/PQ), regularly calibrated against traceable standards, and operated by trained personnel following documented procedures. Every measurement must be recorded in a manner that ensures data integrity, the data must be attributable, legible, contemporaneous, original, and accurate (ALCOA principles).
PFL's SPC software and data acquisition systems support these requirements by automatically logging every measurement with timestamps, operator identification, batch references, and calibration status. Data cannot be modified without audit trail documentation.
International standard for prefilled syringe systems, defines dimensional requirements for glass barrels (Part 4), plunger stoppers (Part 5), and plastic barrels (Part 6). PFL measurement systems verify compliance with these specifications.
Current GMP for finished pharmaceuticals. Requires that laboratory instruments are calibrated, inspection procedures are documented, and production records include all test results.
Rules for manufacture of sterile medicinal products. Emphasizes container closure integrity, environmental monitoring, and process validation, all of which depend on accurate dimensional control.
Electronic records and electronic signatures. PFL software supports audit trails, user access controls, and data integrity requirements for electronic measurement records in GMP environments.
PFL product lines most frequently used in pharmaceutical and drug delivery device manufacturing.
Miniature air plugs for syringe barrel bores, vial neck internal diameters, and cartridge bores. Non-contact measurement eliminates contamination risk. The air flow cleans the measurement zone — ideal for GMP environments.
Explore Air Gauging → PrecisionPRETEC probes for external dimensions: vial height, stopper diameter, cap dimensions, punch tip geometry. Low measuring force options for soft elastomer stoppers and thin-wall glass containers.
Explore PRETEC Probes → IntegrityContainer closure integrity testing using pressure decay methods. Verify that vials, syringes, and cartridges maintain sterile barrier integrity. PLC-controlled with automatic pass/fail classification and data logging.
Explore Leak Test → InspectionDedicated inspection benches for pharmaceutical components. Manual or semi-automatic operation with touch screen HMI, SPC data acquisition, and GMP-compatible documentation. Designed for clean environment compatibility.
Explore Test Benches → 100% InspectionFully automated inline inspection stations for 100% dimensional verification of pharmaceutical containers. Integration with forming machines and filling lines. Production statistics and closed-loop process feedback.
Explore Turnkey → ComplianceSPC software with audit trail functionality, user access controls, and electronic signature support — aligned with 21 CFR Part 11 and EU GMP Annex 11 requirements for electronic records in pharmaceutical manufacturing.
Explore Displays & Software →Technical answers about precision measurement for pharmaceutical manufacturing.
Need measurement solutions for pharma?
Contact Our EngineersAir gauging measures dimensions using controlled air flow and back-pressure detection — there is no physical contact between the gauge and the container surface. The measurement air is clean, dry, filtered compressed air. This eliminates the two primary contamination pathways in contact measurement: particle generation from gauge-to-workpiece contact (metal or carbide particles shed from contact tips), and surface damage (scratches on glass surfaces that can harbor microorganisms or weaken the container). For pharmaceutical applications, the air supply can be further filtered to meet specific cleanliness requirements.
Yes. PFL manufactures miniature air plugs designed to measure the internal bore of prefilled syringe barrels — typically 6–11 mm diameter depending on syringe size (1 mL long, 2.25 mL, 5 mL). The air plug enters the barrel through the open end and measures bore diameter, straightness, and ovality along the barrel length. This is a critical dimension: the bore diameter directly affects the glide force and break-loose force of the plunger stopper, which determines how easy or difficult it is for a patient to perform an injection. ISO 11040-4 specifies the dimensional requirements that PFL systems verify.
PFL supports the IQ/OQ/PQ qualification process required for measurement equipment in GMP environments. Installation Qualification (IQ): PFL provides equipment specifications, installation requirements, and installation verification checklists. Operational Qualification (OQ): PFL performs functional testing and documents that the system operates within specified parameters. Performance Qualification (PQ): PFL supports your team in demonstrating that the system performs reliably with your actual production parts under real operating conditions. All qualification documentation is provided in formats compatible with pharmaceutical quality management systems.
Automated PFL inspection stations measure multiple dimensions per container in under 2 seconds, enabling 100% inline inspection at pharmaceutical production rates. For glass vial forming machines running at 40–80 vials per minute, PFL inline gauging stations keep pace with the forming output. For syringe barrel inspection at lower volumes (fill-and-finish rates), semi-automatic benches measuring 4–6 features per barrel achieve cycle times of 5–8 seconds per part. PFL engineers design the inspection speed to match your specific production rate — never becoming the bottleneck in your manufacturing line.
PFL's data acquisition and SPC software includes features that support 21 CFR Part 11 compliance: user authentication with individual login credentials, audit trail recording every data modification with timestamp and user ID, electronic signatures for batch release and calibration acknowledgment, role-based access controls (operator, supervisor, administrator), and secure data storage with backup. PFL does not claim Part 11 certification (this is a customer-level compliance determination), but our software architecture is specifically designed to enable pharmaceutical customers to achieve and maintain compliance within their quality systems.
Yes. PFL Antralux manufactures leak test machines using absolute and differential pressure decay methods — suitable for testing container closure integrity (CCI) of pharmaceutical vials, cartridges, and assemblies. We can combine dimensional gauging and leak testing in the same inspection station: first measure the critical dimensions (bore, neck, height), then perform the leak test, then classify the container as pass or fail. This reduces handling steps and provides comprehensive quality data from a single station. Data from both tests is logged together for complete traceability.
PFL measurement systems can be designed for clean room compatibility. Key considerations include: sealed enclosures with smooth, wipeable surfaces (no exposed fasteners or trapped contamination points), stainless steel and anodized aluminum construction that withstands chemical cleaning agents, filtered compressed air supply for the air gauging circuits, and cable management that prevents particle accumulation. For inline applications near forming machines (which are typically in controlled but not classified environments), standard PFL equipment is usually suitable. For fill-and-finish environments (ISO Class 7 or better), PFL can provide clean-room-compatible configurations. Discuss your specific cleanroom classification requirements with our engineers.
PFL's SPC software calculates and displays real-time process capability indices (Cp, Cpk, Pp, Ppk) for every measured dimension. Data is exportable in Q-DAS AQDEF format and CSV for import into plant-level quality systems. For pharmaceutical customers, this capability data supports: process validation (demonstrating that the forming or machining process consistently produces containers within specification), continuous monitoring (detecting process drift before it causes out-of-spec production), and annual product quality reviews required by GMP. Batch-level summaries with statistical analysis can be generated automatically at the end of each production run.
Tell us about your container type, critical dimensions, production volume, and regulatory requirements — we'll design a measurement solution that meets your GMP needs.