Quality Leak Testing in Medical Manufacturing

Quality Leak Testing in Medical Manufacturing

Quality Leak Testing in Medical Manufacturing

Zaxis leak testers are configurable, accurate and repeatable. Perfect for quality leak testing in medical manufacturing.

Call: 801.264.1000
Email: sales@zaxisinc.com

Quality means seals that don’t burst; means joints that don’t break. Containing what needs to be contained & protecting what needs to be protected.

When your products are used to save lives, nothing less than the absolute best is acceptable. How do you ensure that you only produce the best? You test!

Zaxis leak testers have sensitivity and accuracy, purpose built for the medical manufacturing industry. The configurable design of Zaxis leak testers make them ideal for any application, from disposable supplies and diagnostic equipment, to large devices. Zaxis offers a broad selection of pressure ranges and flow rates as well as the ability to have multiple channels and multiple test types in a single tester. Zaxis can help you validate adherence to standards such as FDA or ASTM and beyond, to your own company standards of quality and peace of mind.

Speak to one of our sales engineers today about your application and how we can help ensure your production process is producing only the best.

Built for You

Contact us today to find the right solution for your needs.

Leak Testers

The modular design of Zaxis leak testers enables us to meet the demands of a wide variety of applications.

buffers and reagents for covid-19 testing

Medical Manufacturing Solutions

We have leak testing solutions for multi-lumen catheters, IV sets, implantable devices and much more.

Soft Gel Capsule Dispensing

Soft Gel Capsule Dispensing

Softgel manufacturing requires precise dispensing with excellent accuracy and repeatability. For example, Active Pharmaceutical Ingredients or APIs require the utmost precision so the dosage to consumers is not only safe but effective. In addition to stringent quality standards, pharmaceutical manufacturing must also be economical. Pharmaceutical manufacturing demands speed and convenience to achieve high throughput. In Softgel manufacturing the FDA has strict guidelines on batch uniformity1 that require any chemistry dispensing system to be fast sterile, repeatable and accurate.

Sterile Dispensing

An important feature of any dispense system that handles regulated recipes is the use of aseptic materials. The Zaxis eVmP Smart pump heads are made of chemically inert materials such as aluminum oxide, 316SS, or CKC (Ceramic/Kynar®/Ceramic).

Valveless Design

The rotating and reciprocating single piston design of the eVmP does not require any valves which limits the number of moving parts exposed to the fluid being dispensed. This allows the pump to be run for millions of maintenance free cycles and facilitates easy disassembly for cleaning. To remove an eVmP pump head, simply remove the two bolts (four on a VS6-Series) holding the head to its drive.

Other positive displacement pumping technologies that do not both rotate and reciprocate, require valves on the inlet and outlet of the ports. These ports can become clogged and affect performance. For this reason, the valveless design of the eVmP smart pump is a major advantage over traditional pumping technologies.

Electronic Adjustment

For a clean in place or CIP protocol, simply maximize the shot volume or displacement by pressing a single button. The eVmP Smart Pump System is controlled by a TSi (Touchscreen Interface) that can communicate up to 32 pumps at one time. Between batch runs, using the TSi, select all pumps and press the dedicated Max Shot button. The preferred cleaner or solvent is then passed through the pump heads cleaning the entire fluid path with zero disassembly required. Traditional pharmaceutical dispensing technology requires manual adjustment to change the shot volume. This is both imprecise and time consuming. The ability to dynamically adjust the dispense volume electronically is a huge advantage for pharmaceutical manufacturing and should not be overlooked.

When dispensing chemistry that precipitates or crystallizes, with exposure to atmosphere, it is best to a choose pump head with an integrated washport. The washport acts as an isolation gland between the dispense fluid and atmosphere. This gland introduces an inert fluid to the piston between the fill chamber and the head seals that acts as a piston lubricant and atmospheric barrier. This barrier prevents any crystallization of chemistry that can be caused by evaporation.

Precision and Accuracy

The FDA has general drug manufacturing guidelines put in place “to assure batch uniformity and integrity of drug products.” 1

These guidelines cover things such as:

  • Tablet or capsule weight variation
  • Adequacy of mixing to assure uniformity and homogeneity
  • Dissolution time and rate
  • Clarity, completeness, or pH of solutions

To achieve the product consistency required by FDA guidelines, a Softgel dispense system must achieve high accuracy with a low relative standard deviation. Positive displacement pumps are preferred for pharmaceutical metered dispensing due to their high accuracy. Positive displacement pumps do not depend on back pressure for flow, they control flow rates by changing the speed at which the pump is driven.2

Most positive displacement pumps can be classified as rotating, such as a gear or screw pump, or reciprocating, such as a diaphragm or plunger pump. The eVmP uses a unique drive and piston design that both rotates and reciprocates to accomplish both valving and pumping, eliminating valves used in traditional piston pumps. eVmP Smart pumps have 1% or better full-scale accuracy as well as a 0.5 coefficient of variation resulting in accurate and repeatable metered dispensing without the use of valves.

Another feature created by Zaxis for the eVmP smart pump system is micro stepping. Positive displacement pumps are designed to be viscosity independent but in real world applications the viscosity of a fluid can minutely affect the desired dispense volume. Example: you have set your pump to dispense 50 microliters but during production the volume metered is consistently 49.8 microliters. The micro stepping feature makes slight adjustments to the volume metered allowing you to hit your desired target.

Achieving High Throughput

Manufacturing pharmaceuticals demands excessively high throughput and constant changeover. eVmP stands for Electronic Variable Metering Pump and the purpose of the systems patented design is the ability to change dose volume without the need to manually adjust the pump. Along with the stepper or a powerful 1500 RPM servo motor that drives the pump head piston, each eVmP contains a second stepper motor that controls the pump drives angle of articulation. This angle affects the travel distance of the pump heads piston thereby changing the dispense volume. This enables the electronic micro-stepping feature referred to above, the clean in place Max Shot feature and most importantly, the ability to easily and quickly change dispense volumes between batches/recipes.

Every eVmP Smart pump contains an onboard processor that can store up to 50 programs. These programs can be batch specific with different volumes, speeds, timing, etc…. A common saved program often set is a clean in place program. For example, at the beginning of a shift an operator can select the programs for every batch that will be run that day, with a clean in place program set to run between each batch. The pumps will automatically change over at the completion of every batch leaving the operator nothing to do but switch out the chemistry.

eVmP Smart Pump System Makes Pharmaceutical Dispensing Easy

The eVmP Smart Pump System is ideally suited for softgel dispensing. The aseptic materials that are easy to dismantle for an autoclave, or simply clean in place, combined with integrated washports and an auto-agitation feature make eVmPs optimal for handling pharmaceutical chemistry. The eVmP onboard processors are compatible with Digital I/O, RS485 and EtherNet/IP for easy integration into any manufacturing system. The micro stepping feature helps dial in your target for the perfect shot size. The programmable volume creates a highly accurate and highly versatile tool for any dispensing system. The high accuracy and excellent standard deviation attained by the rotating and reciprocating, positive displacement design will expand your pharmaceutical manufacturing core competencies.

  1. Food and Drug Administration. Code of Federal Regulations Title 21,   https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=211.110. Revised 1 Apr. 2019.
  2. Science Direct. Positive Displacement Pumps, https://www.sciencedirect.com/topics/engineering/positive-displacement-pumps. Accessed 14 May 2020.
Pressure Decay Leak Testing in Automation

Pressure Decay Leak Testing in Automation

Pressure Decay Leak Testing in Automation

In automated manufacturing many assembled products require leak testing to validate product viability and quality. A leak test is used to determine if an assembled object, product, or system functions within a specified leak limit. Leaks occur when gas or liquid flow through an object via an imperfection or manufacturing defect such as holes, cracks, weak seals, etc.

The automation of leak testing generates several key challenges, such as real estate on a production line, strict quality standards, efficient productivity, as well as communication and data sharing with the rest of the automation equipment.

Configure a Leak Tester

Contact us today to find the right solution for your needs.

Proximity is Key

Square footage on a production line is valuable and costly. Leak testers are often integrated into assembly lines however they best fit. Many standard pressure decay leak testers measure over 12” wide. A common solution for integration is to extend the connection hoses between the part under test and the leak tester which can be several feet away. The longer the connection tubing, the more volume is used in a leak test, which can have a devastating effect on productivity as well as the accuracy of leak tests.

The volume of air used in a leak test includes the internal volume of the tester, the volume contained in all of the connection tubing, as well as the volume of the product under test. The farther a leak tester is from the part under test the larger the test volume. The larger the volume the longer the volume takes to pressurize which negatively effects productivity and throughput.

A higher test volume can also impede the leak testers ability to detect a leak. Think of this in terms of tires. You have a car tire which holds a large volume and a bike tire which holds a small volume. If both tires run over the same nail, what happens? The bike tire flattens almost immediately while the car tire slowly loses air over time. The smaller the test volume the faster and easier it is to detect a leak. The larger the test volume the longer it takes to identify if there is a leak, meaning extended test times with a lower accuracy of detection.

In terms of instrumentation, when running a pressure decay test, the value attributed to the pressure decay is the digital signal from the pressure sensor. When testing objects with the same size hole, such as a bike and car tire, the object with the larger test volume (car tire) will translate into a smaller signal than an object with a smaller test volume (bike tire). The pressure decay value is directly proportional to volume. Smaller signals require more time to detect a leak. Electrical, pneumatic, thermal or atmospheric effects, or noise, can mask small signals as well as influence the pressure decay value which has a negative impact on repeatability. A smaller total test volume yields a larger relative pressure decay value/signal and requires less test time. The greater the magnitude of the signal above zero, the better signal to noise ratio, which directly results in higher test accuracy and repeatability.

Moving the leak tester closer to the part under test will decrease test time and increase accuracy which raises both quality and throughput. The challenge is how to narrow that proximity when space is so limited? The answer is the iKit by Zaxis. At 1/4th the size of most pressure decay leak testers the iKit was designed specifically to fit within close proximity to the product under test on an assembly line. At only 3” wide the iKit can be mounted right on tooling saving valuable space and reducing excess test volume that is created by the use of extended hoses.

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Communication

Effective automation relies on effective communication. There are many components that go into an automated production line, all of which need to be able to talk to each other. Once a leak tester runs its test it needs the ability to communicate results or trigger events such as Pass=Next, Fail=Eject or Fail=Halt Production.

There are many forms of communication commonly used in factory automation including Modbus, Ethernet TCP/IP, and EtherNet/IPTM. The most dynamic of these communication systems is EtherNet/IPTM as it combines traditional Ethernet infrastructure and hardware with both of the most commonly used collections of Ethernet standards, the Internet Protocol suite and IEEE 802.3, and integrating the Common Industrial Protocol. EtherNet/IPTM is the preferred communication system for Allen-Bradley automation equipment.

With factory automation in mind, the purpose-built design of the iKit has the option to include EtherNet/IPTM. Other communication systems such as discrete I/O, RS232 and Ethernet TCP/IP are also available.

EtherNet/IP in Factory Automation

iKit Automation Solution

Zaxis has designed the iKit to be the ideal leak tester for factory automation settings. With the smallest footprint of any pressure decay leak tester on the market combined with integrated Allen-Bradley connectivity, the iKit by Zaxis is an excellent leak test solution for factory automation.

iKit by Zaxis

EtherNet/IP in Factory Automation

EtherNet/IP in Factory Automation

Data communication is a vital component in factory automation. The ability to have real time communication between a sensor-actuator network of devices and the controller/enterprise network is essential for maximizing quality and throughput. Zaxis has implemented EtherNet/IP in both our automated leak testers (Zaxis PD, and iKit) and our Electronic Variable Metering Pump (eVmP).

EtherNet/IP is an industrial network protocol designed for real time communication between all devices, not just those connected to controllers. This is accomplished by utilizing the traditional Ethernet infrastructure including hardware and both of the most commonly used collections of Ethernet standards, the Internet Protocol suite and IEEE 802.3, and integrating the Common Industrial Protocol.

 

What Does That Mean?

  • Ethernet Hardware: Most commonly, when someone thinks of Ethernet they think of that cable plugged into their desktop or the printer at work. An Ethernet cable is one of the most common network cables, used to connect devices, such as computers and routers, together enabling them to share files with each other or connect to the internet.
  • Internet Protocol suite: A standard set of transport and control protocols that handle the communication of information which is commonly used in the internet and most PCs
  • IEEE 802.3: A commonly available flexible network architecture that can incorporate IP67-rated industrial connectors.
  • Common Industrial Protocol: A communications protocol used to transfer automation data between devices. CIP utilized objects defined by each device on the network (required objects, application objects, and vendor objects). This created predefined device types with specific behaviors. CIP also contains messages and services tailored to factory automation including motion, control, safety and energy applications.

 

Put Them Together, What Do You Get?

“Data anytime, anywhere” says ODVA1, the global standards development group that manages EtherNet/IP. With the combination of traditional Ethernet and CIP, devices can communicate directly with each other rather than through routers or switches. With EtherNet/IP the automation or sensor-actuator network can be integrated into the enterprise network. No more dressing up for a clean room production floor or pulling on your steel toe boots just to make one minor adjustment, make whatever device adjustments you want from your desk.

The robust hardware, by itself, is optimal for a factory environment. Often on factory floors electronics have to withstand extreme temperatures, vibrations, or particulate matter. The Ethernet cable also saves time and frustration during set up. I/O network configuration can be daunting and time consuming as it requires the individual stripping and configuring of each wire whereas an Ethernet cable is simply plugged in.

I/O networking requires time consuming physical integration.

EtherNet/IP integration involves simply plugging a device into the network.

EtherNet/IP can transfer basic I/O data, or it can upload and download parameters and programs, monitor state-of-change and more. The versatility of EtherNet/IP allows you to set up your facility customized to your needs with a wide range of system designs such as unicast (one-to-one), multicast (one-to-many), and broadcast (one-to-all) communication.

EtherNet/IP is a complete suite of network functionality that implements physical, data link, network, transport, session, presentation and application. Its quick response time provides greater throughput, couple this with its market saturation and continued vendor support, EtherNet/IP is an excellent factory automation solution for years to come.

 

  1. ODVA “EtherNet/IP” Oct. 2015, https://www.odva.org/Technology-Standards/EtherNet-IP/Overview
Manufacturing Diagnostic Reagent Kits

Manufacturing Diagnostic Reagent Kits

The manufacturing of diagnostic reagent kits can be challenging and in the face of the 2020 Coronavirus (COVID-19) epidemic, quality reagent kits are in high demand. These reagent kits contain all of the major components necessary to perform designated diagnostic tests or procedures. Applications for these kits include in vitro and molecular diagnostics, biomarkers, clinical chemistry, diabetes, polymerase chain reaction (PCR), test strips, and illicit drug testing. They can be used in a laboratory, at the point of care (POC), or for personal use in cases like pregnancy tests, glucose strips, or at home DNA ancestry tests.

The manufacturing of these reagent kits usually calls for the dispensing of very small–very precise amounts of fluid of varying chemical make-up. The eVmP Micro Pump is ideal for integrated, turnkey, or laboratory applications that require metering and dispensing of liquid enzymes, buffers, diluents, standards, calibrators, and controls used in diagnostic test kits.

The chemical make-up of each reagent can have its own unique challenges for pumps. The eVmP relies on ceramic internals, no-valves, and synchronous rotation and reciprocation to keep the pumping motion simple and inert. The lack of valves and synchronous motion allow the eVmP to dispense neatly, and without drips, by creating a dynamic suck back. This can improve precious up time and keep nozzles clean, even with the most demanding isotonic buffers.

The other challenge is the unique amount or volume of each reagent. The eVmP Micro Pump can be set up to deliver nanoliter, microliter and milliliters through our patented variable metering pump system, with better than 1% accuracy and precision. The eVmP’s patented design utilizes two precision stepper motors, integrated controller and drivers, and can dynamically change dispense volume and flow rate.

Each eVmP can store up to 100 programs, and has immediate run controls that include speed, volume, and pumping direction. Advanced controls include suck-back, fine adjustment, acceleration, deceleration and linking of programs. All of the run controls are accessed through the latest in PLC and CPU communication over Ethernet/IP, or RS485. The eVmP can also be controlled from our Touch Screen Interface, up to 32 pumps with one screen.

Using a chemically inert fluid path, high accuracy and precision dispensing technology, the ability to make high resolution adjustments dynamically, and offering the latest in factory automation controls, makes the eVmP ideal for manufacturing diagnostic kits.

Isaac HD Multi-Function Leak TesterOnce the diagnostic kit is created, packaging is of the upmost importance. Creating a tight, leak proof seal is especially important when dealing with complex chemicals and precise fluid measurements. A chamber test performed on the reagent kit packaging with the Isaac HD leak tester by Zaxis will ensure quality and repeatability in the manufacturing process. For more information on leak testing for diagnostic reagent kits, CLICK HERE.

For questions please contact a sales rep via email at sales@zaxisinc.com or phone at +1 (801) 264-1000, or CLICK HERE to request a quote.