Balloon catheters and multi-lumen catheters are used throughout the medical industry. From administering essential intravenous medications to performing surgeries, catheters have no room for error, leaks, or compromised performance. When manufacturing balloon catheters, it is of the utmost importance to test extensively for air leaks to avoid critical consequences for patients during use.
Choosing the Right Balloon Catheter Leak Test System for Your Manufacturing Line
Balloon catheters are soft with an inflatable element near the tip, allowing doctors or other medical care providers to enlarge a narrow opening during angioplasty, tuboplasty, pyeloplasty, and other procedures. As an OEM or other manufacturer of balloon multi-lumen balloon catheters, it is imperative that you select the right non-destructive catheter test system to ensure that your components function safely, efficiently, and as designed. Make the following considerations before purchasing a leak test system:
What quality standards or official regulations do you need to meet?
Each of these non-destructive leak testing methods will deliver accurate results at an efficient pace. However, a better leak testing method is available for balloon catheter OEMs and manufacturers: Zaxis volumetric leak tester systems.
How Are Zaxis Volumetric Leak Testers Different from Traditional Test Systems?
Zaxis 7i volumetric leak testers are a non-destructive testing solution for balloon catheters. Featuring innovative designs and operations, our volumetric testing method is sometimes referred to as “airless,” describing the fact that no external air source is hooked up to the tester. Instead, the volumetric leak testing system uses a plunger to generate a pre-determined fixed volume of air to identify any leaks that may be present in your multi-lumen catheters.
While this air leak tester was initially built for performing pressure decay tests, it can also be applied for vacuum decay testing, chamber testing, and other multiple leak testing applications. Other benefits and features of our air leak testing system include:
High level of accuracy and sensitivity, allowing for the detection of leaks with 0.1cc balloon through 60 cc balloon testing capabilities
Non-destructive testing method, meaning no modifications must be made to tested balloon catheters and components can be used after testing without interrupting operations
Versatile performances, providing testing in applications where a fixed volume is needed and compliance is an issue
Straightforward operations, minimizing installation time, maintenance delays, and training requirements
Cost-effective design, maximizing your facility’s available budget
Compact construction, freeing up premium facility floorspace as no external house air supply is necessary
Contact Zaxis Today for Highly Sensitive Leak Test Systems
Your customers and end-users depend on you to deliver effective balloon catheters that function without leaking or disruption. Zaxis is here to help. Our highly sensitive volumetric leak testers for catheters and other medical devices are manufactured with your specifications in mind. Each of our non-destructive testing systems is designed, engineered, and built in the USA to deliver high-quality products that work for you. Ready to learn more about how the Zaxis family of products can enhance your balloon catheter manufacturing line? Contact us or call 801-264-1000 to discuss your needs and learn more about our services. Request a quote to start your order and receive pricing details specific to your planned use. A highly trained engineering representative will be in touch as soon as possible.
Leak testing is an essential step in any manufacturing process. It ensures your products meet guidelines set by the FDA, USDA, OSHA, FMCSA, and other regulatory bodies applicable to your industry. Leak testing also guarantees no problems have occurred during manufacturing and allows you to mitigate risk while delivering high-quality components.
Traditional leak tests involve submerging a component in water and visually checking for bubbles. However, according to Sandia National Laboratories, nearly 30% of leaks are missed when the results depend on a human inspector. Automated air leak testing for manufacturing systems can remove this risk. They enhance your OEM manufacturing process by collecting and analyzing data, streamlining repeatable testing to ensure quality, and eliminating the chance of human error.
The Problems with Traditional Water Dunk Testing Processes
Water dunking, also called bubble testing, remains the oldest leak test technique. Still used in manufacturing lines across sectors, water dunking is often inefficient as it takes a long time to complete, features low sensitivity, and requires an operator to visually identify leaks. Other challenges include:
Difficult to maintain consistent conditions
Water is easily contaminated
Viscous materials can mask leaks during testing
Time is lost due to long test times, cleaning, and drying a part after testing
Large water tanks use up valuable space on production floors
Automated Air Leak Testing During Manufacturing Processes Creates More Efficient Systems
Automated air leak testing used during manufacturing processes will enhance your system’s overall efficiency while improving the quality of your final products. Air leak testing is non-destructive as it uses dry air to check for defects and has a smaller physical footprint. Various types of automated air leak testing for manufacturing are available to match your specifications, such as:
If you need help determining which automated air leak testing system is best for your OEM production, contact Zaxis today. We’ll work with you to navigate your options and find the right solution for your processes.
Automated Leak Testing Saves Time & Money
Automating air leak testing during manufacturing saves you time, money, and labor hours. The leak tester will notify line operators if suboptimal conditions occur, making it easy for floor workers to quickly address issues, malfunctions, or problems. Product defects are identified faster, minimizing turnaround time. As less employee oversight is required, your manufacturing team is freed up to address higher-order concerns in your facility.
Accurate & Repeatable Methods for Precision Manufacturing
Compared to more traditional water dunking test methods, automated air leak testing delivers precision results with a higher degree of accuracy and repeatability. Reliable automated testers made by a trusted manufacturer—such as Zaxis, Inc—are designed to improve over time as more data is collected. Fewer defective products leave your facility as you refine, enhance, and create a more efficient manufacturing process using automated leak testing methods.
Scalable Automated Leak Testing Systems Fit Your Specifications
Digital leak testing systems used during manufacturing processes allow you to scale production and increase the speed of quality assurance testing. Multiple types of leak testers are available to match your needs, and automated leak testing systems are configurable to meet most specifications.
Call 801-264-1000 to speak with an automated air leak testing expert and find the best equipment for your manufacturing facility.
Automated Leak Testing Methods for Manufacturing in Any Industry
As manufacturing methods become more automated, advanced, and digitized, all aspects of your production must keep pace. Automated leak testing used during the manufacturing process is an excellent way to certify product quality while keeping up with demand. Automated leak testing maximizes efficiency across industries but is particularly useful in manufacturing:
Contact Zaxis to Order Automated Leak Testing Systems for Your OEM Outfit
Zaxis Inc is a leading USA-owned and operated automated leak testing system manufacturer. Our leak testers are explicitly designed for OEM assembly and manufacturing lines. We’ve engineered our products to support you as you build quality products that meet stringent regulations to satisfy your customers. Your success is our success, and we are ready to help you navigate our automated leak testing systems to find the best solution for your facility.
Contact us or request a quote today to get started. We’ll be in touch as soon as possible to discuss the right option for your manufacturing goals.
Figuring out which leak testing system is best for your manufacturing or assembly operation can be a challenge. Air leak testing for electronics, medical devices, automotive components, and more all have their own unique set of standards, regulations, and guidelines that must be met. Before investing in new non-destructive testing equipment for air leak detection, be sure that you are selecting the best standard type of air leak testing method for your industry, facility, and production.
Pressure & Vacuum Decay Leak Testing Methods
Pressure decay leak testing is commonly applied in manufacturing operations involving sealed components with an access port, such as catheters, implantable devices, and sensors or indicators. After the leak tester fills the component with pressurized air, the valve is closed to allow the pressure to reach equilibrium. If the air pressure decreases, then a leak is present and your component is rejected.
Vacuum decay air leak testing is the opposite of pressure decay. Instead of filling a component with air, the air is completely evacuated. If the pressure rises during testing, then a leak is present in your part. This type of leak testing method is commonly applied to locate leaks caused by external sources. It is also an ideal solution for automotive fuel injectors, medical catheters, and more.
Mass Flow Air Leak Detection
As the name implies, mass flow air leak detection equipment measures the amount of air that flows through a component or part. Mass flow testing can be used to test both small and large volume parts. For small parts, the extremely small internal volume allows for very low test times, generating a high throughput of production. In large parts, the flow rate can be adjusted to maximize the speed of the test. Standard applications for mass flow air leak testers include:
If blockages are a concern for your manufacturing production, then occlusion testing is one of your best options. Your product is filled with regulated air. All valves close after your preset pressure is reached. The downstream port is opened so you can measure the pressure loss. A lack of decay denotes an issue, and further steps must be taken. Occlusion non-destructive methods are standard when testing catheters, check valves, tubing, and similar parts.
Burst Pressure Leak Test
Burst pressure tests measure the maximum pressure your component can withstand before catastrophically failing, or, as denoted by the name, “bursting.” Your part is attached to the test port and pressurized. After pressure sensors measure the pressure ramp rate and burst event, you compare your test results to your pre-established parameters. Design engineers favor burst pressure leak tests as they help establish the best material for a part, component geometry, and more.
Note: Burst pressure tests are a type of destructive testing. However, for check valves and similar components, it can be run as a non-destructive test.
Pressure Cracking Air Leak Detection
Often compared to burst pressure tests, pressure cracking air leak tests detect leaks such as a valve opening. Using two ports, you set specifications for minimum and maximum pressures required to open your device. Crack tests then measure the success or failure of your part by measuring increases and decreases in pressure. They are often applied to industrial components with a small amount of weep (or leak) before the full opening, including check valves and needleless injection sites.
Chamber Air Leak Test
Applied to find air leaks in sealed packing or devices without an opening, chamber air leak tests are implemented by placing your product inside a sealed chamber. That chamber is pressurized. Any pressure drop signifies that your product has an air leak. Chamber air leak tests are non-destructive and used throughout a variety of industries, including for testing:
Medical implantable devices
Sensors and indicators
Radios, cell phones, watches, and other consumer goods
And many other components!
The Best USA-Made Air Leak Detection Equipment
Deciding which standard type of leak detection system is best for your production can be difficult, but Zaxis, Inc. is here to help. Since we first opened our doors, we have been dedicated to providing the best non-destructive air leak detection equipment for industrial manufacturers. Our air leak testing systems for electronics, medical devices, and other sectors are second to none, and we work hard to find the best solution for your unique production needs.
Ready to learn more about Zaxis and how we can support your manufacturing application through the market’s finest air leak testing for electronics and other devices? Contact us or call 801-264-1000 today. Our experts will be in touch as soon as possible.
Since batteries are the most costly part of EVs, leak testing throughout EV manufacturing is necessary to assure battery performance and safety.
The Traction Battery
Just as the combustion engine is the powerhouse of classic automobiles, the traction battery can be considered the same for electric vehicles (EVs). The electrolyte-filled battery cell is the smallest manufacturing unit in the traction battery. Three types of battery cells are frequently used in the industry that includes the round cells, prismatic cells, and pouch cells.
The individual cells are grouped into battery modules which are combined to form battery packs. The battery packs are jointly placed in a single housing at the end of the manufacturing process. Leak testing is important at every stage of the process.
Leak Testing throughout EV manufacturing
Below are the steps involved in battery installation in electric vehicles and the corresponding leak testing steps needed for each step.
Test methods for battery cells
To ensure an extended service life, very low leak rates must be maintained. This level of low leak rate allowance is possible with precise leak testing techniques like vacuum leak testing, burst leak testing, and accumulation chamber leaking testing.
Leak tightness of battery modules and packs and housings
Usually, battery modules and battery packs are cooled using a water-glycol mixture or refrigerant from the AC system of the vehicle. If there isn’t sufficient leak proofing, the cooling medium can leak and cause short circuits. Because battery packs housings, protect the battery cells and models, the housings must meet the IP 67 and IP-69K ingress protection standards.
Leak testing cooling components
The service life and operational safety of an EV battery depend on reliable cooling because batteries heat up during charging or driving mode. Modern batteries use passive air cooling and active liquid cooling using refrigerants. The refrigerant is routed in a cooling circuit around the cells to remove maximum heat from the circuit. If leaks are present, refrigerants can leak in the cells, causing short circuits.
Electric drive motor
The electric drive motors used in EVs also must be leak proof because they are frequently exposed to rainwater or water jets during cleaning. Leak testing ensures that neither water enters the motor from the outside nor the water inside the cooling jacket escapes into the motor. The motor housings are tested in accordance with the IP 67 and IP 69 standards.
In addition, modern electric motors are using a water-glycol mixture for active water cooling that ensures the optimum motor temperature. The cooling jacket must be leak tested to avoid water penetration into the electrical components of the engine. Similarly, a loss of coolant can occur if it seeps out of the cooling circuit.
To find out how Zaxis can help you leak test your EV batteries, contact us.
Zaxis Leak Testers
The modular design of Zaxis leak testers enables us to meet the demands of a wide variety of applications. Click to learn more
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Batteries are a costly and critical part of electric vehicles (EVs)
With batteries making up roughly 40% of the total cost of an electric vehicle and their role in determining range and performance, batteries are the most critical and expensive component of the electric vehicle. The importance of batteries, particularly lithium-ion, in EVs is driving the demand for improved performance and quality in EV battery production.
Highly accurate metering pumps are necessary to guarantee quality production of Lithium-Ion batteries.
Lithium-ion batteries are the most popular type of batteries used in electric vehicles. They contain combinations of special materials such as oxidized nickel, cobalt, and manganese (NCM for short). The combination of these materials determines the service life, energy density, and the number of charge cycles in a battery. The preparation of these materials requires the mixing of various solutions in precise quantities. The reactions must be carried out within a specific time frame, at specified temperatures, and under stable conditions. The process must be strictly controlled to determine the purity of lithium, nickel, cobalt, and manganese. Using smart high-end metering pumps in this process ensures the dispensing of exact quantities of these materials and guarantees repeatability of the process with precision.
Multiple stages of EV battery manufacturing require precise metering pumps
During various stages of battery production, high-end metering pumps with ethernet capability allow for real time digital feedback and control throughout the manufacturing process. This ensures the dispensing of correct quantities of materials at specific times. First, pumps meter soluble liquid metal mixed with nickel, cobalt, and manganese elements into a solution to meet a precise predetermined total NCM ion concentration. Fluoride is then metered to remove impurities having calcium and magnesium ions. Next, pumps are used to meter the solutions of nickel, cobalt, and manganese into a reactor. Then to ensure stable carbonate or hydroxide, pumps are used to meter quantities of NaOH and ammonia solutions. Later, metering pumps are used frequently used in battery testing or quality assurance applications to ensure they meet EV industry standards. All these steps require state-of-the-art metering pump technology capable of handling a variety of chemical agents and executing precise dispensing of fluids.
The figure below shows the stages of battery production with an electronic variable metering pump
Figure 1: Different stages of battery procution
Zaxis Variable Metering Pumps expertly meet the needs of EV battery producers
EV battery production requires precise metering pumps to ensure quality and repeatability. Zaxis eVmPs (electronic variable metering pumps) are specifically designed for highly precise low-volume dispensing of slurries, lubricants, and electrolytes that are used in the manufacturing of EV batteries. Furthermore, battery manufacturing lines must be flexible and able to absorb changes in the assembly lines. Manufacturers often experiment with new slurries, alloys, and mixtures to increase battery quality and output. The eVmP has a simple electronic adjustment feature specially designed for ensuring flexibility in production lines. In addition, Zaxis eVMPs have ethernet IP capability for easy digital feedback and control. With built in Ethernet IP, the pump is part of a closed feedback loop and can be digitally controlled to make precise manufacturing adjustments in real time.
The internal pump components of the eVmP are made of chemically inert, sapphire hard ceramics. The materials used in manufacturing these pumps are free from contaminants like copper, zinc, and iron that can contaminate the cathode and anode slurry. The sapphire hard ceramics used in these pumps are ideal for dispensing corrosive electrolytes and as well as viscous, abrasive slurries. Moreover, the eVmP pump heads have been designed for millions of maintenance-free cycles to ensure flexibility and longevity in the production lines.
Contact Zaxis today to find out how we can help you in your EV production.
Zaxis offers solutions for your Automotive Leak Testing Needs.
The automotive industry is as demanding as ever with an ever-changing global economy, competition is fierce. Zaxis is here to ensure your automotive components pass the test.
Whether you are leak testing electronics, fuel injectors, transmissions, carburetors, or filters, Zaxis can provide a unique solution that fits all of your leak testing requirements. Take the image to the right for example. The image is an Isaac-HD leak tester connected to a custom Zaxis fixture designed specifically for an oil filter. The oil filter is a cast part that has a fair degree of compressive and thermal variability. Zaxis solved this customers complex testing requirements by leveraging our expertise and excellent manufacturing facilities. If you have a demanding application, choose the right partner, Zaxis, to support your leak testing needs.
Ingress protection is a critical part of product development particularly with the increased use of electronics in the automotive industry. Using IP Code is a standardized way to define just how leak proof a product is without using ambiguous terms such as waterproof. The issue with using the standard tests as laid out by the IP Code is the fact that these tests are very time consuming and destructive. Using pneumatic leak testing to validate IP ratings in place of physical water tests is time saving and non-destructive.
Leak Testing for Ingress
There are many reasons, from basic product functionality to marketing, that manufacturers test their parts for ingress. In design and development processes common terms such as dust tight or waterproof are used to describe a products level of protection against ingress, however these terms are rather vague. Considerations such as a part or product function, form and even environment need to be taken into consideration.
Function: Are you trying to keep particulates or liquid out or in?
Form: Does product have multiple parts; do they all need the same or varying levels of protection?
Environment: Is the product meant for indoor or outdoor use, will it be submitted to high pressure or low-pressure situations?
Backup camera on a car requires testing to IPXX standards
IP Standards and What They Mean
The International Electrotechnical Commission (IEC) has published its standard 60529, otherwise known as Ingress Protection Code (IP Code). This code is comprised of the letters IP followed by two digits (example: IPXX). The first digit of the IP Code corresponds with protection against solid ingress and ranges from 0, meaning no protection, to 6, meaning dust tight. The second digit refers to liquid ingress and ranges from 0, meaning no protection, to 9, meaning protected from powerful high temperature water jets. Either digit may be populated with an X which can mean the protection level is 0 or the protection rating is not applicable thus not tested.
Effective Against Object Size
Dripping Water when Tilted up to 15º
Powerful Water Jets
Immersion up to 1m
Immersion beyond 1m
Steam Jet Cleaning
The most common IP rating in medical device assembly and electronics is IP67. This ensures the product is dust tight with no particulate ingress. IP67 also validates that the product can remain submerged under 1 meter of water for up to 30 minutes with no water ingress.
The standard tests as laid out by the IP Code are very time consuming and destructive, particularly when testing for liquid ingress. IP Code testing for liquid is also incredibly expensive and not ideal for large scale manufacturing. These moisture tests require specific testing environments that include precisely oriented, often high pressure, spray nozzles with rotating platforms as well as water tanks that can hold a large amount of water. The apparatus must be able to spray water at a consistent specified pressure for an extended period of time to determine the item under test’s specific ingress protection level. The test is then validated through disassembly as the item under test is physically inspected for ingress of water.
Every product is different so deciding what IP rating a particular product needs and how to test it is highly specialized. Form, Function and Environment not only helps a designer determine a correlating IP rating but also how to test.
Product Testing Considerations:
Is the product’s goal to keep things in or out?
What pressure will the product have to face?
Is the product in an enclosure or is it an external component?
Pneumatic Leak Testing
An alternative to the standard physical IP Code tests is pneumatic leak testing. Air molecules are smaller than water molecules, therefore testing for the ingress of air can determine the ingress of water without directly submitting the item under test to water. Pneumatic leak tests also negate the need to disassemble the item under test for validation.
Zaxis has been using pneumatic leak testers to validate ingress protection for many years. The term leak tight is a veritable spectrum and the engineering team at Zaxis have designed tests across the entire gamut. They can help product designers and developers understand the leak tight spectrum and develop custom tests to validate for IP rating.
In order to streamline IP rating validation through the entire product development process Zaxis has designed their family of leak testers to all use the same components. This means the benchtop leak tester used by R&D during a products design stage has the same components as the leak testers on the production floor, making validation of IP ratings simple and consistent. Test validation is critical especially when dealing with regulated standards such as IP Code.
For more information about the International Electrotechnical Commission visit there website at https://www.iec.ch/. For more information about the Zaxis family of leak testers or how to create a pneumatic leak test to IP rate your products contact email@example.com or call 1 (801) 264-1000.
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See how one customer integrated a Zaxis leak tester into a robotic application? Zaxis leak testers are configurable, accurate and repeatable. Perfect for quality leak testing in the manufacturing process for a variety of applications.
Here at ZAXIS we have been designing and building precision leak testing equipment for over 20 years. As a result of all those years we understand that our high-quality customers are just as important as our high-quality products. We are problem solvers at heart and for that reason we have innovated some of the world’s leading leak testing and dispensing equipment around.
Our company is just big enough to make a dent in the world and just small enough to remember where we came from and what we stand for. Consequently, we have been able to maintain relationships with manufacturers big and small for years and years. Above all, we are grateful for all of the loyalty and friendship and will continue to put your needs as our top priority. We are always here to help and can’t wait to see our new customers join our growing family here at Zaxis.
Occlusion testing checks for blockages (or occlusions) in test parts. Measuring the air flow through the test part determines whether the test part is blocked.
General techniques for identifying occlusions/blockages
Several techniques are used to identify occlusions/blockages in test parts. These techniques include:
Air flow occlusion testing
Back pressure occlusion testing
Pressure drop occlusion testing
Air Flow Occlusion Testing
In this method, the test part is pressurized to a predetermined target pressure. After the target pressure is reached, the flow sensor records the flow rate of air through the part. If the flow rate is below the set limit a blockage is present, and the part fails the test. If the flow rate is greater than the set limit at the desired pressure, the part passes the test.
This technique is often used to identify blockages in open terminal test parts such as medical catheters or refrigeration tubing.
Back Pressure Occlusion Testing
In this method, a test part is pressurized to a specific flow rate and air pressure in the part is measured. Since more pressure is required to force air flow through the test part with a blockage, the test instrument measures this input pressure to determine a blockage. If the required input pressure exceeds the acceptable set limits, the part is occluded and fails the test.
Pressure Drop Occlusion Testing
In this test method, the test part is pressurized and then vented through a downstream port and pressure loss is measured.
The test part is pressurized for a set time to reach a target pressure. After the fill time is complete, the system moves on to the measurement step where the downstream port is opened to vent and there is a drop in pressure. If the pressure drop reaches the predetermined minimum pressure drop value, the test part is considered non-occluded. If the pressure drop is less than the minimum pressure drop value, the part is occluded and fails the test.
The iKit, Isaac HD,Zaxis PD, and Zaxis 7i testers are capable of air flow occlusion testing, back pressure occlusion testing and pressure drop occlusion testing to test parts for occlusions. Zaxis’ line of instruments can be used to reliably detect occlusions in catheters, IV sets, tubing, and check valves.
To find the right occlusion test and the right instrument for your specific application, contact Zaxis to discuss your project.
Leak testing medical devices is crucial to any medical equipment manufacturing operation. Zaxis is here to help. Our experts discuss medical devices that benefit from leak testing, outline our leak testers for medical equipment, and help you deliver the best medical devices to your clients. All our testers are FDA/ASTM compliant and provide high-quality leak testing for medical equipment.
Leak Testing Medical Devices for Critical Applications
Medical devices must meet stringent regulatory guidelines while meeting client demands to do more in less time and at a higher level than previous models. Leak testing can help you meet these demands to create precision medical components for potentially life-saving applications, such as:
Bags and filters
Blood dialyzers and devices
And many other essential medical devices!
Leak Testers for Medical Devices
Leak testers for medical equipment must be highly sensitive, accurate, and purpose-built for the medical manufacturing industry. Many feature configurable designs, making them ideal for any medical application, from disposable supplies to diagnostic equipment to large devices and beyond.
To keep your medical equipment delivering quality results, it’s essential to find a leak tester manufacturer you can trust and who offers a broad selection of pressure ranges, flow rates, and the ability to have multiple channels or test types in a single tester. Zaxis is proud to offer a variety of FDA/ASTM-compliant leak testers that can be used to confirm quality medical devices are leaving your facility. We offer:
Zaxis PD. A wall-mounted, low-cost, single-channel alternative for manufacturing cell configurations.
iKit. Save on space with this tester’s slim, compact design with enhanced automation abilities.
Isaac HD. Features a modular design and hardworking capabilities.
Zaxis 7i. The large feature capacity includes an easy-to-use color touchscreen.
All our leak testing products for medical devices are configurable, accurate, and repeatable. We are your perfect solution for quality leak testing in medical manufacturing.
Your Top Source for FDA/ASTM-Compliant Leak Testers for Medical Equipment
Zaxis is your top provider of leak testing equipment for medical devices and other industries. We only offer the highest quality products, meaning seals that don’t burst, joints that don’t break, containing what needs to be contained, and protecting what needs to be protected. When your products are used to save lives, nothing less than the best is acceptable. How do you ensure that you only produce the best? You test!
To learn more about how Zaxis can take your medical device manufacturing operation to the next level through our quality leak testing products for medical equipment, contact us or call 801-264-1000 to speak to one of our sales engineers today. We’re ready to show you how we can help ensure your production process only generates the best.
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