January 2025 Newsletter
1. What Does Medical Device Packaging Really Protect?
When most people think about “medical device risk,” their first instinct is: Will it fail? Will it break? In real-world use, however, the most critical concern for patients is infection. Many medical devices (such as catheters, surgical instruments, and implants) are terminally sterilized at the factory and then shipped to warehouses, logistics hubs, and hospitals—only to be opened at the point of use, often in the operating room.
The real challenge is this:
- From the moment sterilization is completed to the second the clinician opens the package
- Months—or even years—may have passed
- The product has gone through transportation, stacking, and temperature/humidity changes
If even a hairline gap forms during this journey—one that is nearly invisible to the naked eye—sterility can be silently compromised. So medical device packaging is not truly about “looking good”; it is about whether sterility can be delivered intact to healthcare professionals at the point of use.
2. Sterile Barrier System + Protective Packaging = A Complete “System”
In international standards, medical device packaging is not just “a pouch”—it is a system:
Sterile Barrier System (SBS)
- Provides a microbial barrier and allows aseptic presentation at the point of use
- Examples: Tyvek®/film pouches, paper/plastic laminate pouches, thermoformed trays with lidding, etc.
Protective Packaging
- An additional outer layer that helps the SBS withstand impacts, stacking loads, and other distribution stresses
- Examples: cartons, shipping boxes, etc.
In other words, a “medical device packaging system” is typically designed and validated as: SBS (inner sterile barrier) + protective packaging (outer protection).
3. ISO 11607, EN 868, MDR: Why Are They Mentioned So Often?
ISO 11607-1 / ISO 11607-2
- The core international standard for packaging of terminally sterilized medical devices
- 11607-1: Specifies requirements for materials, preformed sterile barrier systems, SBS, and packaging systems—how they should be designed and tested
- 11607-2: Specifies requirements for forming, sealing, and assembly processes, including IQ/OQ/PQ process validation
EN 868 Series
In Europe, EN 868 is still used in certain contexts, but many parts have been incorporated into or replaced by ISO 11607. The EN 868 series focuses on detailed requirements for specific sterilization packaging materials (for example, packaging paper and pouches used for ethylene oxide sterilization).
EU MDR 2017/745 (especially Annex I, GSPR)
- The overarching regulation for medical devices in the European Union
- GSPR 11.2: Requires devices to remain sterile under the manufacturer’s specified storage and transport conditions until the sterile barrier system is compromised
- GSPR 13: Requirements for labeling and information supplied with the device, including shelf-life-related information
- GSPR 15: Requirements specifically addressing the manufacture, packaging, and testing of sterile devices
A simple way to remember their roles:
- ISO 11607 & EN 868: tell you how to design and test packaging
- MDR: tells you what level of safety is required to place a product on the market
4. Three Key Questions: From both a practical and audit perspective, medical device packaging ultimately answers three simple questions:
Q1 | At the moment of sealing: Was it sealed properly? Is the seal strong enough? Could it split open during transport? If the seal is too strong, it may tear open abruptly when peeled, causing the device to spring out and compromising aseptic presentation.
Common development-phase tests include:
- Seal Strength (ASTM F88): Cut out the seal area and pull in opposite directions to evaluate peel strength consistency
- Dye Penetration (ASTM F1929, etc.): Apply dye solution along the seal to detect micro-channels
- Burst & Creep (ASTM F1140): Pressurize the package to burst or hold pressure for a defined period to verify how much pressure the structure can withstand
These align with ISO 11607-1 design and integrity requirements—allowing you to demonstrate that “it was sealed correctly from the start.”
Q2 | Over time: Will it still hold up through the end of shelf life?
Medical devices typically have a defined shelf life. That date cannot be arbitrary—it must be supported by scientific evidence. A common approach is Accelerated Aging (ASTM F1980).
- Use elevated temperature to simulate long-term aging
- Perform full integrity and functional testing both before and after aging
- Accelerated aging provides an estimated shelf life, which is later supported by real-time aging data over time
Q3 | After trucks and airplanes: Can it remain sterile after distribution?
In real distribution environments, cartons and trays are treated harshly—dropped, vibrated, stacked, and compressed. Temperature and humidity can also swing significantly during container loading/unloading.
That’s why distribution simulation testing is commonly performed:
- ASTM D4169: Simulates real distribution through sequences of drop, vibration, compression, and environmental cycles
- ISTA 3A: Simulates small-parcel and courier delivery scenarios
After simulation, ASTM F88/F1929/F1140 and other methods are used again to confirm: “After this ‘rough ride,’ did the seals or packaging develop any new leaks or damage?”
5. Taking It Further: Not Only Physical Integrity, but Also Microbial Barrier Performance
ASTM F88, F1929, F1140, F1980, and D4169 primarily evaluate physical integrity: Will it break? Will it leak? Will materials degrade? For certain higher-risk products, the next step is microbial barrier testing (for example, ASTM F1608 / DIN 58953-6). This uses live microorganisms to verify the packaging material’s microbial barrier performance—confirming that, under defined conditions and time, bacteria will not penetrate into the package. This enables you to demonstrate not only “the package is intact,” but also “the material itself provides adequate microbial barrier protection.”
6. Conclusion: Treat “Sterility” as the Real Product
To clinicians and patients, it looks like a catheter, a clamp, or an implant. From a safety perspective, what you are truly delivering is a complete sterile system—validated by design, process qualification, and long-term storage and distribution verification. Packaging is the final, yet critical, link in that system.
| Your Need | Related Tests & Standards | Recommended Instrument Types |
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| I want to monitor oxygen changes inside the package to confirm seal and barrier stability |
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| I need to verify seal strength and consistency to support ISO 11607-1 design validation and sealing OQ/PQ |
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| I need to demonstrate the package will not burst or slowly leak under pressure (burst/creep compliance) |
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| I want leak testing to find invisible leak paths for integrity validation and in-process sampling |
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| I need to establish shelf life and demonstrate sterility is maintained through the labeled expiry date |
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| I need to simulate distribution (drop, vibration, compression) to ensure packaging is not compromised during shipping |
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| I want to address ESG/sustainability and evaluate the biodegradability of packaging materials |
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Related Products
ECHO
ECHO Instruments is a global analytical instrumentation company with over 30 years of experience, dedicated to making the world a better and cleaner place. As a worldwide leader in automatic respirometric systems, ECHO provides advanced solutions for environmental biodegradation and compostability testing, wastewater and soil research, as well as optical oxygen analysis for pharmaceutical and modified atmosphere packaging applications.
Respirometer ER series
A system that measures CO₂ production (and O₂/CO₂ concentration in the flow) during biodegradation under controlled conditions; continuously monitors flow, temperature, pressure, humidity; software calculates CO₂ production and % biodegradation; additional gases can be measured.
Features
- Modular & upgradable; optional gas sensors (e.g., CH₄, H₂S, H₂, NH₃)
- Aerobic or anaerobic; temperature range about +3°C to +70°C
- Multi-channel (12/24/36/48/60); MFC per channel
- Plug & Play; compressor included; auto humidification; leakage alarm; remote control; Excel export
- Optional on-line δ¹³C isotope integration
Respirometer DRI Series
Measures O₂ to determine microbial activity in degradable organic matter under defined continuous airflow and adiabatic conditions; sealed adiabatic vessels create conditions defined by EU and other norms.
Features
- 1/3/6/12 channels; Plug & Play; temperature sensor in each vessel; automatic condensate removal
- Measures temperature/flow/pressure/humidity; O₂ range 0–25% (accuracy stated 2%)
- Multiple vessel sizes; remote desktop control; compressor included; Excel
Soil Flux
Portable/automatic analyzers for simultaneous gas flux measurements (CO₂, O₂, CH₄ and others on request) over a wide dynamic range on various surfaces; suitable for fields, forests, landfills, etc.
Features
- Portable or stationary (automated); lightweight
- Built-in GPS for map positioning
- Compatible with up to 5 different gas sensors (different ranges)
- Operable on tablets/phones/PCs; software allows for on-site flux calculation.
Plastic Disintegration Respirometer - DT
Determines the degree of disintegration of plastics under defined composting conditions in a pilot-scale test.
Features
- Single/Multi-channel: 1/3/6/12; Plug & Play
- Control unit integrated with PC; each reactor has a cooling system
- Measures temperature and flow rate; O2 measurement range 0–25% (accuracy indicated 2%)
- Multiple container sizes; remote desktop control; includes air pump/compressor; Excel export
Compact – Modular XC Respirometer
Compact respirometer for screening & R&D; can connect to existing hardware (stand-alone controller) or be delivered as a complete setup.
Features
- Configuration
- Stand-alone controller compatible with existing containers/boxes, etc.
- Complete package in one go (container, incubator, gas source, PC)
- Modular and upgradeable; new software features; multiple mixing options
- Advantages (Performance/Operation)
- Multi-channel: 6 / 12 / 18 / 24 / 30 / 36…
- Plug & Play; suitable for screening and R&D
- Measures O2, CO2, temperature, flow rate, pressure, humidity; multiple gas sensors with various ranges
- Remote desktop control; Excel export
B-O2 Oxygen Analyzer (Automatic Oxygen Analyzer)
Fully automatic optical O₂ analyzer for determining O₂ concentration in blister packs and other MAP pharmaceutical packaging for QC and production lines; measures 1–6 blisters at once, up to 72 points in one serial measurement.
Features
- Headspace measurement, no sample extraction required
- High precision, no O₂ consumption during measurement
- Automatic calibration
- Supports IQ/OQ files (verification files)
- Complies with 21 CFR Part 11 (requirements related to data integrity/electronic records and signatures)
Hand O2 Oxygen Analyzer (Portable Oxygen Analyzer)
Portable device for O₂ concentration in headspace of various MAP packaging; micro-invasive measurements enabled by <140 µm optical sensor tips; compliant with pharmaceutical standards and 21 CFR Part 11.
Features
- Measurable in gas or liquid phases
- No sampling or extraction required, high precision, measurement without O₂ consumption
- Supports salinity factor input for different salinity samples (vial)
- IQ/OQ files; provides 2 sterilizable sensors
- Quick calibration, user-manageable
- Battery or AC power powered
INDUSTRIAL PHYSICS
工業物理，我們為世界各地的製造商、生產線和實驗室確保包裝、產品和材料的完整性。我們在廣泛的專業應用中提供一流的測試和檢測解決方案。工業物理提供近 100 年的經驗、廣泛的設備組合以及將您的需求放在首位的全球服務。
材料測試 | 柔性包裝檢測 | 氣體及包裝密封檢測 | 鍍層-塗料-塗層測試 | 飲料罐裝檢測
Systech Illinois -氣體及包裝密封檢測
Systech Illinois成立於1983年，是一家來自英國，專為氣體測量提供品質控制設備的製造商，有近30年的感測器研發、生產和應用經驗，是全球微量氧和微量水檢測領域的技術和品質的領導者。Systech Illinois總部位於英國牛津，同時在美國和瑞士各擁有一個分工廠 Illinois Instruments，並在全球50多個國家和地區設銷售網路。
特點
- 7101水蒸氣透過率分析儀
- GS 6000 頂空氣體分析儀
- Lyssy L80-6000水蒸氣透過率分析儀
- GS Micro 微量頂空氣體分析儀
- 8101e 氧氣透過率分析儀
- MM500 微量水分析儀
- EC900 線上微量氧分析儀
- EC92D/IS 防爆認證便攜微量氧分析儀
- PM700 機械順磁氧分析儀
- EC9031 缺氧監測儀
- EC91 防爆認證微量氧分析儀
TM Electronics -氣體及包裝密封檢測
TM Electronics, Inc成立於1961年，是一家來自美國，測量包裝完整性，致力於生產先進且自動化的實驗室儀器設備製造商。產品包括檢漏儀、流量測試儀、壓力衰減儀、真空檢漏儀等專業檢漏設備。TME作為包裝完整性設備的世界領先者，服務於醫療、塑膠、包裝薄膜、食品、醫藥、電子和汽車工業等諸多行業的需要。
特點
- Worker Integra 檢漏儀
- 定制化夾具
- BT Integra Pack 檢漏儀
- Solution 密封性測試儀
- Integra Flex 檢漏儀
Eagle Vision -飲料罐裝檢測
Eagle Vision創立於1995年，總部位於荷蘭，是全球知名的線上機器智慧視覺檢測系統方案供應商。產品類型廣泛，包括金屬罐360°檢測、空罐檢測、罐外360°全檢及空瓶瑕疵檢測。Eagle Vision模組化的設計，既能滿足客戶當前檢測需求，又允許客戶添加其他檢測專案。
特點
- 360罐子視覺檢測系統
- 噴碼視覺檢測系統
- 瓶蓋視覺檢測系統
- 空罐檢測系統
CMC-KUHNKE -飲料罐裝檢測
CMC-KUHNKE成立於1971 年，工廠位於德國首都柏林，是一家金屬容器檢測儀器的專業研發製造廠商。CMC-KUHNKE一直是行業創新的引導者，先後發明電腦化卷封檢測、2片罐自動測量、無損卷封檢測及卷封緊密度測量技術。
特點
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United Testing Systems - 材料測試
United Testing Systems于1964年成立，總部位於美國，是世界一流的電子萬能材料試驗機、多工位元拉伸試驗系統和液壓萬能試驗機製造商之一。UTS有超過50年的試驗機研發和製造歷史，開創了第一個自動資料獲取和還原系統，能夠在不需要操作員參與的情況下連續測試多個樣品。這些突破使UTS 建立和保持了自己在材料測試技術領域的領先地位。
特點
- 臺式 DTM/ 落地式 DFM 電子萬能材料試驗機
- DHFM液壓萬能材料試驗機
- LCH Speedy 現場快速試驗機
- TruBlue II 洛氏硬度計
- Tru Blue μVT 顯微硬度測試系統
- Tru Blue 樣品切割機
- Tru Blue 樣品鑲嵌機
- Tru Blue 研磨拋光機
- 夾具及附件
- 環境試驗倉
- 引伸計
Ray-Ran -材料測試
Ray-Ran成立於1977年，總部位於英國伯明罕，專門為聚合物工業應用的使用者提供加工測試設備，被視為高分子行業測試設備的主要供應商之一。與全球大多數其他測試設備製造商相比，Ray-Ran可以提供更廣泛的產品範圍，涵蓋了原材料測試，樣品製備，樣品測試等全面的測試要求。Ray-Ran 始終保持其核心業務活動的強大工程和製造基礎，提供40多種不同的產品。主要產品包括密度梯度儀，擺錘衝擊儀，熱變形和維卡軟化點測試儀等。目前，Ray-Ran在39個國家/地區設有本地分銷商和代理商，使用者遍佈60多個國家和地區，獲得了良好的口碑。
特點
- PCP 氣動樣品沖切機
- CNC 樣品數控銑床
- MFR300 熔融指數儀
- DGA 自動密度梯度儀
- HDV熱變形/維卡軟化點六位測試儀
- IMT 擺錘衝擊試驗機
- 儀器化落錘衝擊試驗機
- FDT 落鏢衝擊試驗機
- X100 臺式萬能材料試驗機
- X250 單立柱臺式萬能材料試驗機
- X500雙柱高力值萬能試驗機
- X350雙柱臺式萬能試驗機
SpecMetrix®實驗室塗層厚度測量系統
SpecMetrix®高級實驗室塗層厚度測量系統為使用者提供了高標準的非接觸、非破壞性和即時塗層及樣品塗層厚度測量。SpecMetrix精確和創新的ROI增強光學干涉技術，使用者可以獲得樣品的完整塗層測量資料。允許您通過非接觸和非破壞性手段獲得塗層測量。
Quality By Vision 飲料罐裝檢測
如果您使用金屬包裝，那麼 Quality by Vision (QBV) 擁有可靠的檢測機器來檢查一切是否正常。無論您是罐頭製造商、罐頭灌裝機還是供應商，我們都擁有質量和流程控制系統，讓您的生活更輕鬆。
特點
- Buckle & Burst Tester: 氣溶膠罐
- 罐身塞徑規
- ENR-4000 數字搪瓷評估器
- MDA – 氣霧罐多維自動測量儀
- MDE – 氣溶膠端的多維自動測量儀
- 板厚儀
- QVIS-A1：氣溶膠的 100% 視覺檢測
- 分數殘留量規 - 氣溶膠
- SEAMetal HD：氣霧罐
- TBS-LSS：縫鋸、氣霧罐
C&W Specialist 鍍層、塗料、塗層測試
幾十年來，C&W Specialist專業設備一直在製造旨在提供現代工業要求的嚴格環境測試的機械。C&W Specialist現在在汽車製造的所有主要部門以及油漆、表面和塗料、化學、電子、航空航天、軍事和海上工業中都受到依賴。
特點
- C&W 鹽霧腐蝕試驗箱
- 鹽霧冷凝箱
- 濕度調節櫃
- 濕度櫃
- 鹽霧櫃
Steinfurth
Steinfurth 產品線提供最高質量的機電測量測試儀器——讓您保護包裝、產品和材料的完整性。為飲料、食品和製藥行業的製造商提供創新的測試和檢測解決方案。提供二氧化碳測量儀器、記錄儀系統、碳酸化系統、實驗室搖床、分析儀器或包裝測試設備。
特點
- NICO 是市場上唯一的非侵入性手持式 CO2 分析解決方案。這是全球首創 - 提供了一種非破壞性方法來測量灌裝飲料容器中的 CO2。
Messmer Büchel 柔性包裝檢測
Büchel公司于1924年在荷蘭成立，主營紙張表面性能的測試設備，其合作開發的Bekk平滑度和PPS印刷粗糙度至今還是行業標準。1982年Büchel並購英國公司Messmer，並改名為Messmer Büchel。Messmer Büchel是包材（尤其是紙張物性）實驗室儀器設備的知名供應商，目前公司已擴大到為其他行業如包裝，印刷品質控制，紡織材料和塑膠薄膜提供測試設備。
Testing Machines, Inc. 柔性包裝檢測
Testing Machines, Inc 於1917年在美國紐約成立，在1931年開始業務轉為向美國造紙工業實驗室提供檢測儀器。多年來，TMI 作為實驗室儀器供應商把業務擴張到範圍更廣的行業，包括塑膠、紡織、粘合劑和橡膠。TMI 銷售辦事處和代理網路遍佈全球超過50個國家，能為全球客戶提供服務和校準。
SpecMetrix® ACS 金屬容器塗層厚度和重量測量系統
SpecMetrix® ACS 系統是先進、精確的塗層厚度和塗層重量測量系統，專為金屬包裝容器設計。該系統在塗層金屬罐製造商和支援它們的塗料供應商中有廣泛的應用，尤其適用於罐體的內部和外部塗層的測量。SpecMetrix® ACS 系統根據您的罐廠需求進行配置。我們提供從靈活的單罐測量型號，到適用於多罐測量的生產車間半自動非接觸解決方案，能夠提供高度精確的塗層重量資料，支援您的程式控制、品質保證或索賠審核。
SpecMetrix® In-line 線上塗層測量系統
SpecMetrix 提供獨家的線上塗層厚度測量系統，適用於塗層和生產線。這些系統旨在提供應用塗層的非接觸、非破壞性和即時厚度測量。SpecMetrix®線上塗層測量系統具有極高的適應性。不論您的塗覆基材為何，我們都可以為您的濕塗或乾塗工藝控制與品質保障需求，提供合適的塗層與膜厚測量解決方案。
OxySense5250i 氧氣和溶解氧分析儀 -氣體及包裝密封檢測
OxySense成立於上世紀80年代，總部位於美國，是光學氧氣測量系統領導者，主營包裝和加工行業的光學氧氣感測器系統，其創新的光學傳感系統可在許多世界先進的公司的研究實驗室和生產車間中找到。OxySense實驗室系統為滲透測試 (薄膜包裝和成品包裝)、貨架壽命研究、頂空分析、溶解氧研究及封閉表徵提供了一套完整的解決方案。
特點
OxySense的主要客戶涵蓋食品、飲料、包裝、製藥和生物醫學領域，包括可口可樂、雀巢、金寶湯、安姆科、日本可樂麗、美國莊臣等。
SYSTECH ILLINOIS
Systech Illinois offers advanced testing systems for oxygen, gas, and moisture analysis. Designed in compliance with industry standards, these instruments address critical analysis needs across various applications. Our high-performance headspace and permeation analyzers ensure packaging integrity in industries such as plastics, food, pharmaceuticals, and medical devices—delivering accurate, repeatable results you can rely on.
Gaspace Advance Micro
The Gaspace Advance Micro is a headspace gas analyzer designed for oxygen (O₂) and carbon dioxide (CO₂) measurement, ideal for the food and pharmaceutical industries. With automatic calibration, diagnostics, and control features, it delivers consistent, accurate results—critical for HACCP compliance.
Key Features
- Analyzes headspace volumes as low as 1 mL
- User-friendly touchscreen interface
- Five configurable test methods
- Automatic calibration and self-diagnostics
- Customizable pass/fail criteria
- Built-in printer for results
- Documentation support for IQ, OQ, and PQ
- 21 CFR Part 11 compliant
AquaSense 7101 Water Vapor Permeation
The 7101 water vapor analyzer range uses a sensitive and stable P₂O₅ sensor for absolute moisture measurement. With a wide detection range of 0.002–1000 g/m²/day and precise control of temperature, humidity, and flow, it delivers accurate, repeatable WVTR (Water Vapor Transmission Rate) results for both R&D and quality control of packaging films.
Key Features
- Cost-effective, user-replaceable sensor
- Long sensor lifespan with low replacement cost
- Runs on a full Windows® OS for secure operation and network connectivity
- Anti-surge function protects sensor from high moisture levels
- Validation completed in hours using third-party certified, NIST-traceable gases
- Remote diagnostics and support available (with user permission), reducing service downtime
Lyssy L80-6000 Water Vapor Permeation Analyzer
The L80 series analyzers have been trusted by laboratories worldwide for decades. The L80-6000 represents the latest generation, offering a reliable testing principle, minimal maintenance, and excellent cost-efficiency. Designed for testing high-permeability materials with specialized sample cards, it delivers rapid and accurate results—the higher the permeability, the faster the test time. Along with a broad measurement range, it ensures high precision and ease of use.
Key Features
- User-friendly operator interface
- Highly automated for simple operation
- Fast and accurate test results
- Wide testing range for both low and high permeability materials
- Automatic equilibrium detection
- Automatic temperature control
- Easy setup of test parameters and sample data
- Convenient test sample holders
- Built-in printer for test documentation
- Low maintenance requirements
8101e OxySense® Oxygen Transmission Rate Analyzer
The OxySense 8101e is an expandable oxygen transmission rate (OTR) analyzer designed to reduce testing costs. As the only major provider offering satellite expansion, Systech Illinois allows labs to scale efficiently by adding capacity as needed—lowering cost per test while maintaining precision and reliability.
Key Features
- Completely redesigned system
- High-sensitivity, wide-range eMetric™ coulometric sensor
- Easy operation—load the film and press start
- Windows-based control software with Quickstart configuration and clear results display
- Q-Seal™ gas-free film loading system
- Automatic control of relative humidity and temperature
- “Test Condition Matrix” (TCM™) enables multi-condition testing (up to 10 conditions) with one click
- Expandable system—supports up to 32 test cells
GS6000 Headspace Analyzer
The Gaspace 6000 headspace analyzers combine advanced technology with user-friendly operation to meet the industry's highest standards for accuracy and reliability. These systems feature built-in sampling, durable zirconia and infrared sensors, and microprocessor control to ensure consistent, repeatable results.
Key Features
- Simple setup and operation
- AccuFlow transducer for precise flow control
- Intuitive menu interface
- One-touch calibration
- Customizable pass/fail testing
- Lightweight and portable design
- USB port for diagnostic software
- Optional external printer via RS232
- Can piercing station
- 45° adaptor for can piercing
- Waterproof protective case
- Syringe injection port capability
PM700 Process Oxygen Analyzer
The PM700 delivers best-in-class high-performance oxygen analysis. This advanced paramagnetic analyzer features intuitive software for accurate and reliable results. With an autoranging capability from 0.01% to 99.99%, it is ideal for oxygen purity measurements. Its non-depleting sensor ensures long-term, maintenance-free operation.
Key Features
- Paramagnetic sensor with PID temperature control for superior accuracy
- Optional barometric pressure compensation for enhanced purity analysis
- Auto calibration functionality
- Large autoranging LED display
- Dedicated to oxygen analysis
MM500 Moisture Detector
The MM500 moisture analyzer is designed for application-specific customization, delivering absolute moisture measurement in gases with high precision across a wide range—from 0.01 ppm to 1000 ppm (–110 °C to –20 °C dew point). Measurement units can be selected in ppmv or dew point (°C or °F).
Key Features
- Auto-ranging from 0.01 to 1000 ppm (–110 °C to –20 °C dew point)
- RS232/485 output
- Selectable units: ppmv, °C, °F dew point
- No calibration required
- Remote sensor available
- Fault alarm function
EC92DIS ATEX Portable Oxygen Analyzer
The EC92DIS is a portable oxygen analyzer approved for use in hazardous environments (II 1G Ex ia IIc Ga T4 – Zone 0 ATEX). It measures oxygen concentrations from as low as 1 ppm to high-percentage levels and is compatible with most industrial gases and atmospheres. The maintenance-free fuel cell and easy calibration using ambient air or standard gases make it highly convenient for field use.
Key Features
- Unique fast purge system
- Simple and quick calibration
- Maintenance-free measuring cell
- Intrinsically safe certification for hazardous areas
- Selectable oxygen ranges in % and ppm
- Powered by 2 × PP3 batteries
EC91 ATEX O2 analyzer
The EC91 is an intrinsically safe online oxygen analyzer designed for ppm and percent-level measurements in hazardous area gas streams. It detects oxygen concentrations from 1 ppm to high percent levels and is compatible with a wide range of industrial gases and atmospheres. The maintenance-free fuel cell offers long-term operation, and calibration is simple using ambient air or certified calibration gases.
Key Features
- Maintenance-free sampling cell with 5-year lifespan
- Certified safety for Zone 0 hazardous areas
- Easy air calibration
- 3-year warranty on electronics
- 36-month overall warranty covering workmanship and component reliability
EC9031 Oxygen Deficiency Monitors
The EC9031 is one of the most advanced and feature-rich oxygen monitors available. It includes adjustable alarm contacts for early warning of oxygen level changes, continuous data transmission to control systems or PLCs, and complete event logging. The unit uses a diffusion-type electrochemical sensor that requires no sample pumping and supports remote mounting for added flexibility.
Key Features
- 4.7" touchscreen with data logging, graphing, and event tracking
- Two adjustable oxygen alarm levels with audible and visual alerts
- 5-year sensor life
- Simple installation
- 3-year warranty
- High measurement accuracy
- IP65 wall-mount enclosure with optional bracket
- Pressure-compensated measurements
- Continuous data logging of oxygen, temperature, and pressure
- Date- and time-stamped measurements
- Sensor life warning alert
- All functions controlled via touchscreen, including alarm mute option
- Large, clear display of oxygen concentration and system status
EC900 Process Oxygen Analyzer
Brought to you by Systech Illinois, the world-leading brand in gas, oxygen, and moisture analysis, the EC900 series oxygen analyzers deliver fast, accurate measurements—detecting oxygen levels as low as 20 ppm from ambient air within two minutes.
These advanced instruments feature user-friendly software and high-quality sensors for reliable, repeatable results. Designed for use in a wide range of industrial gases and environments, EC900 analyzers are unaffected by hydrocarbons or volatile compounds—making them ideal for wave soldering, reflow ovens, and more. With multiple sensor options, the EC900 series offers a solution to fit every measurement need.
Key Features
- Long-life, maintenance-free disposable oxygen sensor
- Robust construction with three sensor configuration options
- Calibration via ambient air or certified gas
- Microprocessor-controlled operation
- Large, autoranging LED display
- Fast response time
- Vibration-resistant design
- Includes warranty coverage
Systech Illinois ZR800 Oxygen Analyzers
Invest in a powerful ZR800 Series Oxygen Analyzer and gain the ability to measure oxygen levels across most industrial gas streams—from as low as 0.1 ppm up to 100% volume.
Key Features
- Non-depleting, maintenance-free oxygen sensors
- Calibration via ambient air or traceable gas
- Microprocessor-controlled functions
- Large, autoranging LED display
- Extremely fast oxygen response time
- Vibration- and position-insensitive performance
- Robust design with three mounting options
- 24VDC version available
- Panel or bench-top mounting
- NEMA 4X / IP66 waterproof and weatherproof enclosure
- Operator interface with diagnostic tools and read-only mode
- Comprehensive diagnostics and fault alarms
Sampling & Control Options
- Bypass flowmeter
- Pressure regulator
- Sample pump
- Flow alarm
- Auto calibration
- Cartridge filter kit
Communication & Output
- RS232 / RS485 communication
- Analog outputs
- High/low alarms
- Flow and fault alarms
Gaspace Advance Head Space Analyzer
The Gaspace Advance oxygen (O₂) and carbon dioxide (CO₂) headspace gas analyzer is ideal for food and pharmaceutical applications. It offers automatic calibration, diagnostics, and control for accurate, repeatable results—critical for HACCP compliance. The intuitive touchscreen interface with large buttons makes testing simple and error-free, requiring no special training and helping maximize production efficiency.
Key Features
- Easy-to-use touchscreen interface
- Five selectable test methods
- Quick setup with intuitive menu navigation
- Auto calibration and self-diagnosis
- Customizable pass/fail test parameters
- Built-in printer
- PC software integration
- Waterproof protective case
- Can piercing station with optional 45° adaptor
- Syringe injection port compatibility
- Microprocessor-controlled touchscreen system
- Can calculate nitrogen gas concentration based on O₂ and CO₂ levels
TME
TM Electronics has been designing and manufacturing precision measuring instruments for over 60 years. With a legacy of innovation, we deliver solutions that enhance both quality and productivity across industries.
Originally focused on metal fabrication, we specialized in that field for two decades. In the early 1980s, we expanded into medical device manufacturing, which led to a broader portfolio of advanced measuring solutions. Since then, our engineering team has developed technologies that serve the automotive, electronics, pharmaceutical, and food production sectors.
Today, TM Electronics is a leader in automated, high-performance testing equipment, including leak testers, flow testers, and package integrity testers.
Integra Flex
TME’s Integra Flex instruments provide an affordable and flexible solution for leak testing across a variety of environments. The rack-mount model is ideal for integration into OEM systems with data and connectivity support, while the benchtop version suits smaller production lines and R&D labs.
Key Features
- Easy LAN connectivity for streamlined communication
- Rack-mountable design for OEM system integration
- Standard XML data output for seamless data handling
- Compact footprint suitable for space-limited environments
- Remote control capabilities for enhanced factory automation
- Built-in PLC controls and I/O for customized user operations
- Simple integration with Quality Control and IOT systems
LT-V/L WORKER Integra
The smart TME WORKER Integra is an advanced instrument designed to simplify and streamline all aspects of leak testing. From programming and test execution to data review and reporting, this intelligent system improves the overall efficiency and usability of the testing process.
Key Features
- High-resolution measurement capability (0.0001 psi)
- Minimized internal volume ensures excellent sensitivity, repeatability, and reliability
- Icon-based touchscreen color display for intuitive control of test parameters and on-screen statistical result analysis
- USB connectivity for direct connection to a PC
- Multiple USB ports support peripherals including keyboard, mouse, printer, and barcode reader
- LAN capability for remote instrument control, data transfer, and automated operation
- Optional electronic pressure regulator available for enhanced control
PA-2096 TME Pressure Bubble Tester
The TME Pressure Bubble Tester delivers low pressure and precise flow to test pouches in accordance with ASTM International F-2096, the standard method for detecting gross leaks in packaging using internal pressurization bubble testing.
Key Features:
- Complies with ASTM F-2096 standards
- Quick and easy setup
- Open screen retainer offers full visibility from all sides
- Retainer locks securely to hold the pouch underwater during testing
- Digital pressure display with backlit screen and selectable measurement units
- Low-pressure control at 2" H2O
- NIST-traceable gauge calibration
BT-IP BT Integra Pack: Smart Package Tester
Smart BT Integra-Pack – Package Tester for Burst, Creep, Creep-to-Failure, and Leak Integrity Testing
Key Features:
- Compact bench-top instrument with high resolution (0.001 psig)
- Small footprint with intuitive operation for ease of use
- Electronic pressure and flow control ensure precise, repeatable test conditions
- Automatic high-flow output suitable for testing large porous packages
- Supports a variety of package types including flexible, rigid, porous, non-porous, open, and sealed packages
- Compliant with industry standards for Burst, Creep, Creep-to-Failure, and Leak Integrity testing
- Automatic Burst Test Mode delivers fast results without lengthy setup
- Pre-fill sensing automatically adjusts for package size
- Manual Burst Test Mode offers detailed control over test parameters
- Customizable settings for Ramp Rate, package type, acceptance limits, and pressure drop sensitivity
- Smart user interface with USB compatibility for keyboard, mouse, and barcode reader
- Low Power Stand-by Mode supports energy-efficient operation
- Real-time graphical test plots for burst, creep, and leak tests
- Flash drive export for convenient data transfer to PC
