What Leak Detection Associates does

Leak Detection Associates (LDA), operating commercially under the brand PTI Helium Leak Testing and as a subsidiary of PTI Inspection Systems, designs and manufactures custom-built helium-based leak detection systems for Container Closure Integrity (CCI) testing in regulated industries. The company's flagship product is the SIMS 1915+ (Seal Integrity Monitoring System), a helium mass spectrometer platform with sensitivity as low as 1×10⁻¹⁰ mbar·L/sec, oil-free pumping, and 21 CFR Part 11 compliant ETHOS-HLD software. The offering is modular, with the LT80/LT85/LT150 low-temperature add-on systems enabling CCI testing down to -160°C for cryogenic biologics, the HSAM Model VM-2 headspace analyzer, the Sniffer Probe for leak localization, custom-engineered package test fixtures, and a family of calibrated internal and external leak standards. LDA serves pharmaceutical manufacturers (vials, pre-filled syringes, ampoules), biotechnology companies working on cell and gene therapies requiring ultra-low temperature storage, and medical device manufacturers of sterile barrier systems and combination products. Food packaging is a secondary vertical.\n\nLDA generates revenue through a mixed model combining one-time equipment sales with recurring and project-based services. Instruments are quote-priced and custom-built to client specifications, with installation and qualification services (IQ/OQ/PQ) typically accompanying the sale. A recurring revenue layer is built around annual calibration services, annual service contracts (unlimited on-site repair, replacement parts, preventative maintenance, requalification), on-site training, and feasibility/method development studies frequently used as pre-purchase de-risking. Contract testing is offered both at LDA's two Centers of Excellence (Hawthorne, New York and St-Prex, Switzerland) and on client sites via deployable SIMS test units. The go-to-market is direct enterprise sales targeted at regulated quality and validation buyers, supported by content marketing around USP 1207, ASTM F2391-05, EU GMP Annex 1, and FDA 21 CFR Part 11 compliance rather than mass-market advertising.

Name

Leak Detection Associates

Legal name

Leak Detection Associates

Website

https://heliumleak.com

Company type

Private

Founded year

2018

Operating status

Operating

Headcount range

11–50 employees

Short description

Leak Detection Associates (PTI Helium Leak Testing) designs and manufactures custom helium-based leak detection systems, primarily the SIMS 1915+, for Container Closure Integrity testing in pharmaceutical, biotechnology, and medical device packaging applications.

Ownership category

akta.pro rank

Headquarters

HQ city

Egg Harbor Township

HQ country

United States

HQ region

North America

Offices2 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Personnel, Technology or R&D, Operations, Marketing or Sales, Infrastructure, Supply Chain

Revenue model

1. Helium Leak Detection Equipment Sales: Sale of SIMS 1915+ helium leak detection systems, LT low temperature add-on systems, and accessories including vacuum test fixtures, sniffer probes, and calibrated leak standards. Systems are custom-built to client specifications based on intended package types and testing requirements.
2. Installation and Qualification Services: On-site installation, IQ/OQ/PQ qualification services ensuring instruments meet regulatory standards. Pre-delivery site preparation and formal qualification processes for regulated environments.
3. Calibration Services: Annual calibration services for all components of helium leak detection systems including internal and external leak standards and HSAM probes. Scheduled calibration database with reminders to ensure compliance.
4. Service Contracts: Annual service contract programs including unlimited on-site repair, replacement parts, annual preventative maintenance, and comprehensive requalification and calibration services.
5. Training Services: On-site training specific to SIMS 1915+ helium leak testing instrument, covering leak testing fundamentals, advanced techniques, system maintenance, and method development and validation.
6. Feasibility and Method Development: Feasibility studies preceding instrument purchase to prove concept, method development using industry standard positive control practices, and validation services. Methods can be transferred to client site or used routinely at PTI's Center of Excellence.
7. Contract Testing Services: Client onsite or in-house testing at Centers of Excellence in Hawthorne, NY and St-Prex, Switzerland. Also offers SIMS test units for temporary deployment to client locations for validation studies or leak testing of critical components.

Go-to-market motion1 record

Distribution channels4 records

Marketing channels5 records

Core offering

Leak Detection Associates (operating as PTI Helium Leak Testing) designs, manufactures, and sells custom-built helium-based leak detection systems — principally the SIMS 1915+ Seal Integrity Monitoring System — used to perform quantitative Container Closure Integrity (CCI) testing on pharmaceutical, biotechnology, medical device, and food packaging. The company complements its hardware with installation/qualification, calibration, training, annual service contracts, feasibility/method development, and onsite or in-house contract testing delivered through Centers of Excellence in Hawthorne, NY and St-Prex, Switzerland.

Product overview

Leak Detection Associates (LDA), operating as PTI Helium Leak Testing, offers a modular helium-based leak detection system portfolio centered on the SIMS 1915+ as the core platform. The system integrates specialized add-on modules including the LT80 Low Temperature Test System for cryogenic testing (-160°C), the HSAM Model VM-2 for headspace helium concentration analysis with optional vial filler, and the Sniffer Probe for leak site localization. Custom package test fixtures are engineered to client specifications for each container type. Supporting accessories include calibrated internal and external leak standards (E-6, E-7, E-8). The complete offering is complemented by services including installation/qualification (IQ/OQ/PQ), calibration, annual service contracts, training, feasibility/method development, and client onsite or in-house testing. The system tests pharmaceutical packaging including vials, pre-filled syringes, bottles, blister packs, foil pouches, and combination products, supporting package design, production validation, and quality monitoring.

Differentiator

Problem solved

Functional benefit

Products and services

• SIMS 1915+ (Seal Integrity Monitoring System) Advanced custom-built helium-based leak detection system with sensitivity as low as 1×10⁻¹⁰ mbar·L/sec, oil-free pump, dual test port manifold, and ETHOS-HLD 21 CFR Part 11 compliant software. Used by pharmaceutical and medical device manufacturers for deterministic CCI testing of vials, syringes, cartridges, blister packs, bottles, tubes, and foil pouches.
• LT80 Low Temperature Test System Temperature conditioning and helium leak testing add-on enabling package integrity testing at temperatures from 0°C down to -80°C, using SP Corporation Chiller. Designed for biologics, cell and gene therapies, and other temperature-sensitive drug formulations.
• LT85 and LT150 Low Temperature Add-on Systems Ultra-cold CCI testing add-on systems for temperatures ranging from 0°C to -160°C, enabling package integrity testing under deep cryogenic storage conditions for biologics, cell and gene therapies.
• HSAM (Head Space Analyzer Module) Model VM-2 Device that measures helium concentration in container headspace with integral calibration chamber, calibrant gas flow control valve, and universal holder. Used to detect leaks in sealed vials.
• Sniffer Probe Handheld probe that detects helium escaping from defects by systematically scanning suspect leak locations in pressurized systems; can detect location-specific leaks over 100 times smaller than the bubble method.
• Custom Package Test Fixtures Custom-engineered fixtures tailored to specific container/package types and materials of construction, including vacuum clamps, O-ring seals, and chamber gaskets, designed by PTI's engineering team.
• Calibrated Leak Standards (Internal and External) Internal and external calibrated helium leak standards (E-6, E-7, and E-8 models) in various leak rate ranges for daily performance verification, system suitability checks, and qualification activities.
• Vial Filler (HSAM Attachment) Optional vial filling assembly for the HSAM that enables test preparation of already-sealed vials by replacing headspace gas with 100% helium.
• Installation and Qualification Services Full-service delivery including Installation Qualification (IQ), Operation Qualification (OQ), and Performance Qualification (PQ) performed by engineering technicians, ensuring site readiness with necessary gas and electrical supplies for regulated environments.
• Calibration Services Annual calibration services for all components of helium leak detection systems, including internal and external leak standards and HSAM probes, with a scheduled calibration database and reminders.
• Annual Service Contracts Tailored annual service contract programs including unlimited on-site repair, replacement parts, annual preventative maintenance, and comprehensive requalification and calibration services.
• Training Services On-site training specific to the SIMS 1915+ helium leak testing instrument, covering leak testing fundamentals, advanced techniques, system maintenance, and method development and validation.
• Feasibility and Method Development Feasibility studies preceding instrument purchase to prove concept, method development using industry-standard positive control practices, and validation services; methods can be transferred to client site or used routinely at PTI's Center of Excellence.
• Client Onsite or In-House Testing Helium leak detection contract testing services delivered at client facilities (using SIMS test units deployed temporarily) or at PTI's Centers of Excellence in Hawthorne, New York and St-Prex, Switzerland; includes cold storage testing capabilities.

Quantifiable outcome

• Sensitivity as low as 1×10⁻¹⁰ mbar·L/sec enables detection of leaks too small for traditional methods
• +2 more outcomes

Segments4 records

Ideal customer profiles4 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature7 records

Scale indicators3 records

Recent moves6 records

Expansion highlights5 records

Direct peers

• AMETEK Mocon: AMETEK's Mocon division provides packaging integrity and permeation testing instruments for food, pharmaceutical, and medical device applications. It is a direct peer in package integrity testing equipment, though it focuses more on permeation analysis rather than helium mass spectrometry leak detection.
• INFICON: INFICON is a major manufacturer of leak detection solutions, including helium sniffers and mass spectrometer leak detectors, serving HVAC/R, automotive, and industrial customers. It overlaps with LDA in helium-based leak detection technology and competes for industrial and emerging pharmaceutical packaging applications.
• Pfeiffer Vacuum: Pfeiffer Vacuum is one of the world's leading manufacturers of helium leak detection systems and mass spectrometers, directly competing with LDA's SIMS 1915+ in industrial and laboratory leak detection applications. Both serve regulated industries with high-sensitivity vacuum-based leak testing instrumentation, making them the closest direct competitor in core technology.
• LACO Technologies: LACO Technologies manufactures helium and vacuum leak testing equipment and fixtures for industrial and laboratory applications. It competes with LDA in custom-engineered leak detection solutions, particularly for smaller-volume and specialized testing requirements.
• Leybold (Atlas Copco): Leybold, part of Atlas Copco, manufactures vacuum and helium leak detection equipment including mass spectrometer leak detectors. It directly competes with LDA's SIMS 1915+ platform in laboratory and industrial leak detection markets, particularly in European regulated environments.
• Testing Machines Inc. (TMI): TMI manufactures physical testing instruments for packaging, paper, plastics, and similar materials, including package integrity testing equipment. It is a direct peer in packaging testing instrumentation, though its portfolio emphasizes physical/mechanical testing rather than helium-based mass spectrometry.

Broad incumbents

• Agilent Technologies: Agilent Technologies is a global analytical instrument leader that both supplies the mass spectrometer technology integrated into LDA's SIMS 1915+ and offers its own helium leak detection product line. It is a critical technology partner and a broader incumbent whose own leak detection portfolio competes in the same end markets.
• Eurofins Scientific: Eurofins Scientific is a global leader in bioanalytical and pharmaceutical testing services, including pharmaceutical product and packaging testing for regulatory compliance. It is comparable to LDA's Centers of Excellence contract testing service, though it operates at significantly broader scale across multiple scientific disciplines.
• SGS: SGS is the world's largest testing, inspection, and certification company, offering packaging integrity and CCI testing services to pharmaceutical and medical device manufacturers. It is comparable to LDA's contract testing services revenue stream (Centers of Excellence) but operates at a much larger scale across many test categories.
• Thermo Fisher Scientific: Thermo Fisher Scientific is a global analytical instrument leader with a portfolio that includes mass spectrometers and laboratory testing equipment relevant to pharmaceutical packaging and CCI applications. It is comparable to LDA as a broad analytical instrument incumbent whose mass spec and laboratory technologies overlap with the SIMS 1915+ platform.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat6 records

Key highlights7 records

Customer concentration

Compliance3 records

Revenue estimate

Valuation estimate

Number of profiles

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Leak Detection Associates