Knowledge Base & FAQ
This page is designed to give you fast, clear answers to the most common questions surrounding medical device packaging, pouch sealers, sterile barrier systems, and medical device pouch testing and inspection. Whether you are exploring ISO 11607 compliance, evaluating new packaging equipment, or learning about the science behind sterile barrier integrity, this FAQ serves as a comprehensive resource during your discovery process.
Here you can also learn more about who we are as a company. Van der Stähl Scientific has spent more than thirty years serving the medical device packaging community, and our values, experience, and technical depth are reflected in every product and service we provide. As you evaluate partners for your healthcare packaging project, we want you to have a clear understanding of our capabilities, our culture, and the level of support you can expect from our team.
We are always available to provide quick, accurate answers about our full dashboard of products and services, including pouch sealers, vacuum packaging systems, sterile barrier testing devices, and our ISO 11607 validation support programs. If you need immediate assistance or would like to speak with an application engineer, feel free to call us at 800-550-3854. We look forward to supporting your project and helping you strengthen patient safety through better packaging.
Pouch Sealers & Equipment
This section provides an overview of our medical-grade sealing hardware, including the differences between impulse and rotary systems. Learn about our precision thermal management, factory calibration through our ISO/IEC 17025 accredited laboratory, and how to request service or replacement parts for your equipment.
Van der Stähl Scientific provides a full range of medical pouch sealers engineered for sterile barrier integrity and repeatable performance. Our portfolio includes constantheat rotary sealers, impulse sealers, and advanced microprocessorcontrolled systems designed for healthcare packaging and medical device manufacturing. Each system is built to support ISO 11607 requirements for seal strength, consistency, and process control.
ISO 11607 requires that sealing processes be validated, controlled, and repeatable. Our pouch sealers are designed with precise thermal management, pressure control, and dwelltime accuracy to help users meet these requirements. Every system is sent to our customers, calibrated through our ISO/IEC 17025 accredited laboratory, ensuring that the equipment is ready for validation activities the moment it arrives.
Our sealers are engineered specifically for sterile barrier performance, not general industrial use. Features such as multi-zone thermal control, precision pressure regulation, and ISO/IEC 17025 certified calibration ensure that each seal meets the stringent requirements of medical device packaging. We also provide unmatched technical support from certified packaging professionals.
Most healthcare facilities and manufacturers calibrate their pouch sealers annually, although some highrisk applications require more frequent intervals. Because calibration is essential for ISO 11607 compliance, we provide factory calibration services through our accredited laboratory to ensure traceability and accuracy. We offer these services at a our service center and calibration laboratory in Southern California or on site at your facility.
Yes. We offer full service and repair, replacement parts, and technical support for all of our pouch sealers. Our team is trained to maintain the precision required for our medical device packaging equipment.
You can request a quote through our website or by contacting our sales team directly. Providing information about your packaging materials, device type, sterilization method, and throughput needs helps us recommend the right system.
We provide ongoing technical support, calibration services, training, and validation assistance. Our goal is to ensure that your equipment continues to perform at the highest level throughout its service life.
Yes. Every pouch sealer we ship arrives calibrated through our inhouse ISO/IEC 17025 accredited calibration laboratory at no additional cost. This ensures that your equipment is ready for validation and compliant operation the moment it arrives.
Our systems are engineered for sterile barrier performance, not general industrial use. Manufacturers rely on our precise process control, while hospitals value our ease of use, consistency, and ability to reduce sterile barrier failures caused by operator variability. Both environments benefit from our accredited calibration and expert support.
Vacuum Packaging
Explore the technical advantages of vacuum packaging for stabilizing delicate or sharp medical devices. This section highlights the features of the V46010 validatable vacuum sealer, explaining how it maintains sterile barrier integrity without the need for external air sources.
Vacuum packaging removes air from the pouch before sealing, which stabilizes the device during shipping, reduces movement that can damage sterile barriers, and helps preserve sensitive chemistries used in combination medical devices. Vacuum packaging is especially valuable for devices with sharp edges, irregular shapes, or components that must remain immobilized.
ISO 11607 requires that sterile barrier systems maintain integrity throughout distribution and storage. Vacuum packaging reduces internal stress on the pouch, minimizes abrasion, and helps prevent seal creep or delamination. By stabilizing the device, vacuum packaging supports stronger, more consistent sterile barrier performance.
The V46010 is a fully validatable vacuum pouch sealer engineered specifically for medical device packaging. It provides precise control of vacuum level, seal temperature, pressure, and dwell time. Every unit ships calibrated through our ISO/IEC 17025 accredited laboratory, ensuring it is ready for validation the moment it arrives. This unit also does not require any external air. It has a password lockout so validated settings can not be changed.
Devices with sharp edges, long profiles, delicate chemistries, or components that must remain immobilized benefit greatly from vacuum packaging. Orthopedic implants, combination devices, catheter systems, and diagnostic kits are common applications for the V46010.
Yes. The V46010 is designed for intuitive operation, rapid cycle times, and repeatable performance. Operators can quickly set validated parameters, and the system maintains consistent vacuum and seal conditions to support highvolume medical device packaging without the need for any external air sources.
Testing & Inspection
Learn about the science of seal integrity through our laboratory services and the PTT100V desktop testing system. This section covers peel strength testing, channel detection, and how routine monitoring prevents compromised devices from entering the sterile field.
Yes. Our ISO/IEC 17025 accredited laboratory provides a wide range of sterile barrier testing, including peel strength testing, burst testing, visual inspection as well as dye testing. These services support both initial validation and ongoing process monitoring for medical device packaging systems.
Common indicators include channels, weak spots, uneven seal width, delamination, or inconsistent peel strength. We offer seal testing services and can help diagnose the root cause, whether it is equipment, materials, or operator technique. We also provide testing and inspection machinery like our PTT-100-V Desktop medical pouch testing laboratory that allows our customers to test inspect their pouches throughout the day to prevent devices entering the sterile environment with compromised seals.
The PTT100V is a compact, desktop medical pouch testing system designed to evaluate seal strength, detect channels, and support ISO 11607 process validation. It provides precise, repeatable testing for healthcare packaging and medical device manufacturing.
The system is ideal for medical device manufacturers, hospital sterile processing departments, quality assurance teams, and any facility responsible for maintaining sterile barrier integrity. It is especially valuable for organizations performing routine seal verification or validation.
Visual inspection alone cannot detect many seal defects. Testing verifies that seals meet strength requirements, identifies weak spots, and ensures that packaging processes remain in control. Regular testing is essential for ISO 11607 compliance and patient safety.
ISO 11607 requires routine monitoring of sealing processes. The PTT100V provides quantifiable data on seal strength and integrity, helping users document compliance and maintain defensible validation records.
Yes. The PTT100V is designed for simplicity and accuracy. Operators can perform tests quickly with minimal training, and the system provides clear, repeatable results. Its compact footprint makes it ideal for both laboratory and production environments.
The system supports peel testing, channel detection, and seal strength evaluation. These tests help identify issues related to temperature, pressure, dwell time, and material compatibility.
Many facilities test seals daily as part of routine quality checks. Others test per batch or per shift. Frequent testing helps detect drift early and prevents compromised sterile barriers from reaching patients.
Yes. By analyzing seal strength and failure modes, the system can help identify issues related to equipment calibration, operator technique, or material selection. This makes it a powerful tool for continuous process improvement.
Validation & ISO 11607 Compliance
Navigate the complexities of regulatory standards with information on our Sterile Start® validation support program. We define the requirements for sterile barrier systems (SBS) and explain how our structured protocols help you achieve compliant, defensible, and repeatable sealing outcomes.
Sterile Start® is our structured validation support program that guides customers through the sealing process qualification required under ISO 11607. Our certified packaging experts assist with protocol development, equipment setup, material selection, and seal quality testing. The program is designed to help healthcare facilities and medical device manufacturers achieve compliant, defensible validation outcomes.
A visual seal may look acceptable but still fail under stress. A validated seal is produced under controlled, documented conditions that meet ISO 11607 requirements for strength, consistency, and repeatability. Our equipment and validation support ensure that seals are defensible and compliant.
A sterile barrier system is the minimum package configuration that prevents microbial ingress and allows aseptic presentation of a medical device. Our equipment is engineered to create strong, reliable SBS performance that supports patient safety.
We can assist with custom pouch sizes, specialized materials, and unique packaging configurations for novel medical devices. Our team works with manufacturers to ensure that custom solutions meet ISO 11607 requirements.
Sterile Start® is our structured, threetier validation support program designed to help customers meet ISO 11607 requirements. The program includes protocol guidance, equipment setup, seal testing, material compatibility review, and ongoing process monitoring. Each tier provides increasing levels of support to match the complexity of your packaging system.
ISO 11607 requires documented, repeatable, and controlled sealing processes. Sterile Start® provides the framework, testing, and expert guidance needed to establish defensible validation protocols. Our team helps ensure that your sealing process meets regulatory expectations and supports sterile barrier integrity.
Hospital & Sterile Processing
Designed specifically for clinical environments, this section addresses the unique challenges of hospital workflows. Discover how upgrading to modern, mechanized sealing systems can reduce operator variability, minimize reprocessing errors, and directly improve patient safety.
Yes. We provide hands-on training at our facility, virtual instruction, and onsite support for sterile processing teams and manufacturing personnel through our Sterile Start® program. Training covers equipment operation, seal inspection, ISO 11607 requirements, and best practices for healthcare packaging.
Absolutely. Many of our systems are designed specifically for healthcare packaging environments. They support the unique challenges of hospital workflows, including high throughput, variable operator technique, and the need for consistent sterile barrier performance.
Yes. We work closely with sterile processing departments to improve sealing consistency, reduce rework, and support better patient outcomes. Our SPDS selfseal pouch support system is one example of how we help hospitals reduce sterile barrier failures caused by inconsistent hand sealing.
Outdated pouch sealers and manual sealing techniques increase the risk of sterile barrier failure. Modern systems provide controlled temperature, pressure, and dwell time, which are essential for producing consistent, ISO 11607compliant seals that protect patients from infection.
Weak seals, channels, and inconsistent hand pressure can compromise sterile barriers. Upgraded systems create uniform, validated seals that reduce the likelihood of microbial ingress. Better packaging directly supports safer surgical outcomes.
Common indicators include inconsistent seal width, temperature drift, operator complaints, frequent rework, or failed peel tests. If a sealer cannot maintain stable parameters, it cannot support sterile barrier integrity.
Yes. Mechanized sealing systems reduce operator variability, one of the leading contributors to sterile barrier failure. Automated or guided sealing processes help ensure that every pouch receives the correct pressure and dwell time.
Absolutely. Modern sealers reduce rework, shorten cycle times, and provide more predictable results. This helps sterile processing departments keep pace with surgical demand while improving patient safety.
About Van der Stähl Scientific
Discover the history and "country store" culture that defines our family-owned business. This section details our thirty-year legacy, our Six Sigma trained technical team, and our commitment to building long-term relationships through expert guidance and honest accountability.
Our systems are used by medical device manufacturers, hospital sterile processing departments, biotech firms, pharmaceutical companies, and government agencies. We proudly support organizations such as NASA, the Centers for Disease Control, and many of the nation’s leading medical device companies.
Yes. Our team can provide guidance on selecting Tyvek®, medicalgrade films, foils, and laminates that are compatible with your sterilization method and sealing equipment. Proper material selection is critical for maintaining sterile barrier integrity and supporting successful validation.
Our pouch sealers and sterile barrier materials support a wide range of sterilization modalities, including steam, ethylene oxide, hydrogen peroxide gas plasma, and radiation. We can help you determine the best material and sealing parameters for your specific sterilization process.
With more than three decades of experience, an ISO/IEC 17025 accredited laboratory, and a team of certified packaging experts, we offer unmatched expertise in sterile barrier science. Our equipment, testing services, and validation support are all designed to help protect patients and support regulatory compliance.
Van der Stähl Scientific has served the medical device packaging industry for more than thirty years. Our company is built on solid sterile barrier science, ISO 11607 compliance, and realworld packaging performance. We provide technology forward sealing systems, accredited calibration, and expert support that help protect patients and reduce risk for manufacturers and healthcare facilities.
Three decades in medical device packaging has allowed us to refine our equipment, testing methods, and support programs to meet the evolving demands of healthcare packaging. Our long history means customers receive proven technology, deep regulatory understanding, and guidance from a team that has supported thousands of validation projects.
Our calibration and technical support are performed by Six Sigma trained technicians who specialize in medical device packaging systems. Their training ensures precise calibration, accurate diagnostics, and processdriven support that aligns with ISO 11607 and industry best practices.
Yes. We provide ongoing calibration, technical support, training, and validation assistance throughout the life of your equipment. Our goal is to ensure that your sealing systems remain accurate, compliant, and reliable for years to come.
Weak or inconsistent pouch seals can compromise sterile barriers and increase infection risk. Our validated sealing systems, accredited calibration, and Sterile Start® support help ensure that every seal meets the strength and consistency required to protect patients.
Our combination of accredited calibration, Six Sigma trained technicians, deep regulatory expertise, and three decades of sterile barrier science makes us uniquely qualified to support medical device packaging. We do not simply sell equipment; we provide complete sterile packaging solutions backed by expert guidance.
Yes. Van der Stähl Scientific is a family owned company, and that identity shapes everything we do. Our family pride drives our values, our work ethic, and our commitment to serving customers with honesty, accountability, and genuine care. Because we are not a large corporate machine, every customer interaction matters to us. We take the time to understand your needs, support your team, and deliver solutions that protect patients and strengthen sterile barrier performance. Our family values translate directly into better customer experiences, longterm relationships, and a level of service that is increasingly rare in the medical device packaging industry.
The heart of our company operates much like a country store where calls are answered, promises are kept, and decadeslong relationships are formed. Customers are never pushed into automated systems or left waiting for support. Instead, they speak with real people who know the equipment, understand sterile barrier science, and genuinely care about their success.
Behind this warm, personal customer interface is a highly technical organization that provides industryleading medical device pouch sealing systems and advanced pouch testing and inspection devices. We are a hybrid company: approachable and relationshipdriven on the outside, yet deeply technical and standardsfocused on the inside.
In addition to our equipment, we support customers with two ISO/IEC 17025 accredited laboratories that provide calibration and empirical pouch testing services. This combination of personal service and accredited technical capability is rare in the industry and is a major reason customers stay with us for decades.
If you would like to learn more or speak with our team, we would love to meet you. Call us at 8005503854
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