ISO 10555 Correlation to a Pressure Decay Test

ISO 10555 Correlation to a Pressure Decay Test

ISO 10555 Correlation to a Pressure Decay Test

Air to Liquid Correlation

Often a process or product has an ISO or similar standard for leak testing.  The following describes how a customer took the ISO 10555 leak test and correlated it to a pressure decay leak test using an Isaac HD pressure decay test.

The ISO 10555 process states that a product can leak no more than one falling drop of water in less than 30 seconds when pressurized to 3 ATM of liquid pressure.  The following describes the tests that were performed to correlate this to a nondestructive pressure decay test.

A group of parts were gathered that had been determined to be leak free.  Some of the parts were sent out to a company to have holes drilled through them in varying diameters.  The part was a catheter and the hole was drilled through the catheter hub directly into the eventual fluid path of the catheter.  The holes varied in size from 1 to 20 micron in diameter.  The parts were then taken and tested with air.  The customer wanted to use 15 PSI of air pressure as their test medium.  The laser drilled catheters were first put on a flow meter to determine the amount of flow through the hole.  Once a flow had been recorded the parts were put on an Isaac HD pressure decay tester to measure the amount of decay that they generated.  The pressure decay test was repeated four times with a one minute interval between tests.  Once this data had been recorded the parts were tested with water.  The parts were pressurized with water to 3 ATM and monitored for water drops forming.  Each part was timed and the timer stopped once the drop formed and fell off of the part.  The following chart shows the air flow, diameter and time for the drop to fall.  The study determined that for a drop to fall the hole size had to be 10 micron and the air flow at 15 PSI was greater than 2 SCCM.  A leak standard of 2 SCCM at 15 PSI was then created to be used for test development.

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Issac HD

The Isaac HD packs industry-leading capabilities into a small package. Isaac HD is an out of the box solution for your leak testing needs.

ISO 10555 Correlation to a Pressure Decay Test

ISO 10555 Correlation to a Pressure Decay TestAir to Liquid Correlation Often a process or product has an ISO or similar standard for leak testing.  The following describes how a customer took the ISO 10555 leak test and correlated it to a pressure decay leak test...

Electronic Variable Metering Pump Introduction

Electronic Variable Metering Pump IntroductionRotating and Reciprocating Valve-Less Ceramic Piston Design with Electronic Variability and Positive Displacement.Contact us today to find the right solution for your needs. Electronic Variable Metering Pump Introduction...

What is a Leak Standard

What is a Leak Standard? A slim, compact design that saves on valuable manufacturing space. Easy to concatenate together for automation. Contact us today to find the right solution for your needs.

Pressure and Vacuum in one iKit Leak Tester

Pressure and Vacuum in one iKit Leak Tester A slim, compact design that saves on valuable manufacturing space. Easy to concatenate together for automation. Contact us today to find the right solution for your needs.

Configure a Leak Tester

Contact us today to find the right solution for your needs.
Electronic Variable Metering Pump Introduction

Electronic Variable Metering Pump Introduction

Electronic Variable Metering Pump Introduction

eVmP Metering Pumps

Rotating and Reciprocating Valve-Less Ceramic Piston Design with Electronic Variability and Positive Displacement.

ISO 10555 Correlation to a Pressure Decay Test

ISO 10555 Correlation to a Pressure Decay TestAir to Liquid Correlation Often a process or product has an ISO or similar standard for leak testing.  The following describes how a customer took the ISO 10555 leak test and correlated it to a pressure decay leak test...

Electronic Variable Metering Pump Introduction

Electronic Variable Metering Pump IntroductionRotating and Reciprocating Valve-Less Ceramic Piston Design with Electronic Variability and Positive Displacement.Contact us today to find the right solution for your needs. Electronic Variable Metering Pump Introduction...

What is a Leak Standard

What is a Leak Standard? A slim, compact design that saves on valuable manufacturing space. Easy to concatenate together for automation. Contact us today to find the right solution for your needs.

Pressure and Vacuum in one iKit Leak Tester

Pressure and Vacuum in one iKit Leak Tester A slim, compact design that saves on valuable manufacturing space. Easy to concatenate together for automation. Contact us today to find the right solution for your needs.

Configure a Leak Tester

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

Electronic Variable Metering Pump Introduction Video Transcript

Hi, welcome to Zaxis’ video blog, today we’re going to talk about our eVmP product line. The eVmP, or electronic variable metering pump, is a pretty cool product. It’s a patented technology. Our patent relies around the electronic adjustment of this mechanical hinge. We are the only company that has this type of Technology. What’s really cool is that you can go from 0 to, let’s say, a hundred microliters, or anywhere in-between with a simple touch of a button. The precision made in ceramics that live inside the pump head have about a 1% accuracy over the whole range, as well as half a percent coefficient of variation. So it’s extremely repeatable and precise, which is ideal for your metering pump application. What’s really unique about this the eVmP is that in a manufacturing environment, if you want to change shot sizes, you just do it with the TSI, or via RS485, or EtherNet/IP. You simply change the shot volume and send the command to the pump without recalibrating the pump. You’re already set at 10 microliters, or whatever your application requires. Again, this is one of the only products in the market that has this precision, as well as convenience. Thank you so much for watching. If you have any questions, go to our website at zaxisinc.com or call us at 801 264 1000.

What is a Leak Standard

What is a Leak Standard

What is a Leak Standard?

Leak Standard

A slim, compact design that saves on valuable manufacturing space. Easy to concatenate together for automation.

ISO 10555 Correlation to a Pressure Decay Test

ISO 10555 Correlation to a Pressure Decay TestAir to Liquid Correlation Often a process or product has an ISO or similar standard for leak testing.  The following describes how a customer took the ISO 10555 leak test and correlated it to a pressure decay leak test...

Electronic Variable Metering Pump Introduction

Electronic Variable Metering Pump IntroductionRotating and Reciprocating Valve-Less Ceramic Piston Design with Electronic Variability and Positive Displacement.Contact us today to find the right solution for your needs. Electronic Variable Metering Pump Introduction...

What is a Leak Standard

What is a Leak Standard? A slim, compact design that saves on valuable manufacturing space. Easy to concatenate together for automation. Contact us today to find the right solution for your needs.

Pressure and Vacuum in one iKit Leak Tester

Pressure and Vacuum in one iKit Leak Tester A slim, compact design that saves on valuable manufacturing space. Easy to concatenate together for automation. Contact us today to find the right solution for your needs.

Configure a Leak Tester

Contact us today to find the right solution for your needs.
Pressure and Vacuum in one iKit Leak Tester

Pressure and Vacuum in one iKit Leak Tester

Pressure and Vacuum in one iKit Leak Tester

iKit

A slim, compact design that saves on valuable manufacturing space. Easy to concatenate together for automation.

ISO 10555 Correlation to a Pressure Decay Test

ISO 10555 Correlation to a Pressure Decay TestAir to Liquid Correlation Often a process or product has an ISO or similar standard for leak testing.  The following describes how a customer took the ISO 10555 leak test and correlated it to a pressure decay leak test...

Electronic Variable Metering Pump Introduction

Electronic Variable Metering Pump IntroductionRotating and Reciprocating Valve-Less Ceramic Piston Design with Electronic Variability and Positive Displacement.Contact us today to find the right solution for your needs. Electronic Variable Metering Pump Introduction...

What is a Leak Standard

What is a Leak Standard? A slim, compact design that saves on valuable manufacturing space. Easy to concatenate together for automation. Contact us today to find the right solution for your needs.

Pressure and Vacuum in one iKit Leak Tester

Pressure and Vacuum in one iKit Leak Tester A slim, compact design that saves on valuable manufacturing space. Easy to concatenate together for automation. Contact us today to find the right solution for your needs.

Configure a Leak Tester

Contact us today to find the right solution for your needs.
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.
Leak Testing Ventilator Tubes & Assemblies

Leak Testing Ventilator Tubes & Assemblies

With the outbreak of the novel coronavirus, Covid-19, in 2020 the demand for medical ventilators has skyrocketed. Production of these medical devices have ramped up so high that some companies are retooling their production lines to help meet this increased demand. With the increase in production, quality control of these life sustaining devices and assemblies cannot be overlooked. In this article we will go over leak testing the consumable parts of a ventilator, primarily the ventilator tubing set assembly.

What is a Ventilator

A medical ventilator is a life support system sometimes referred to as a breathing machine. The ventilator is designed to blow gas into a patient’s lungs via an endotracheal or ET tube. 1 The gas is a mixture of air and measured amounts of oxygen. The amount of oxygen is dependent upon the patient’s oxygen saturation and can be adjusted at any time. The pressure of this gas is also closely monitored. The pressure that is applied by the ventilator at the end of each breath is known as PEEP or Positive End Expiratory Pressure. PEEP is the pressure in the lungs above atmospheric pressure that exists at the end of expiration. 2 Medical ventilators, as well as CPAP machines, use PEEP to help hold the lung open so the alveoli (air sacs) don’t collapse.1

The ET tube is part or a tubing assembly that connects the patient to the ventilator. This tubing assembly is made up of many components. Corrugated hoses for maximum controlled air flow. Pitot tubes to measure air pressure coming out of the patient to ensure enough PEEP pressure is being applied by the machine to keep the lungs from collapsing. Soft valves on the exhalation tube to ensure the patient is taking in the controlled gas. Air filters protect the machine from contamination. All these components are assembled using a myriad of fittings, adhesives, and ultrasonic welds.

A Clinical Background

Mechanical ventilators are used as interventional therapy when a patient has a condition or incident that has or will threaten their ability to breathe. Also known as Acute Respiratory Distress Syndrome (ARDS), which can occur for numerous reasons.  Ventilators are responsible for assisting the patient with gas exchanges (up taking oxygen, ridding of CO2), keeping an open airway (ie: from someone who has a severe allergic reaction and their airway closes), to protect against choking (ie: pneumonia patient choking on saliva), or if the patient has some sort of trauma or life threatening illness that would eventually lead to respiratory failure.
 
 
Mechanical ventilators control the rate, depth, mixture of air, flow rates, tidal volumes, total pressures, and min and max pressure limits. Depending on the patients history of illness and specific needs, a clinician can program the ventilator to suit the individual needs of each patient. For example, if a patient has a lung injury or a preexisting respiratory condition (COPD, pneumonia, etc.) it is vital to control the total and min and max peak pressures of the air a ventilator is pushing in and out of the lungs, as well as the pressure on the lungs, to ensure that the ventilator doesn’t cause any further lung complications to the already compromised patient. Also, for patients with pneumonia, ventilators are incredibly instrumental in not only providing airway protection and breathing assistance, but also allowing the clinician to program the min and max pressures to fully inflate and deflate the lungs, which assists in moving debris (sputum, phlegm) out of the lungs, allowing for uptake of more oxygen, which typically results in more ventilator-free days. These two examples are an the numerous ways that a programable ventilator can meet the exponentially changing needs of critically ill patients.
 
 
Click Here for more information describing the ins and out of ventilator management in further detail. 3

How Do You Leak Test Ventilator Tubes and Assemblies?

When leak testing a ventilator tubing assembly there are two primary defects to look for:

  • Proper (non-leaking) Seals Between Assembled Parts
  • No Obstructions in the Airway

The fastest and most inexpensive way to test tubing walls and assembly connections is a Pressure Decay test. In a PD test, one side of the tube or tubing set is attached to a leak tester while the other side is sealed. The assembly is pressurized to set value. With the incoming supply shut off, the part settles to reduce the thermodynamic and elastomeric effects on the part. During the test step, any decrease in air pressure over time signifies a leak. If the assembly does not leak/decay past its predetermined reject value, it is a good part.

To check for obstructions in a ventilator tubing set, it is best to use a Back-Pressure Flow test. The BP Flow test measures the back pressure created by the part at a specific flow rate. Obstructions will cause the pressure to increase or decrease from the nominal value. This pressure change is compared to the programmed tolerance for pass/fail status. These flow values are very specific to each tubing set design. Variables like filters, tube diameter, and tube length can affect what an acceptable value is for one tube design but not for another.

How to Save Time

Unlike the ventilator device itself that can be used multiple times with many patients, the tubing assembly is a consumable product that can only be used by one patient. This makes high throughput essential to production.

The two best ways to reduce leak test cycle time for ventilator tube sets are:

  • Minimizing the test circuit volume
  • Use a multi-function leak tester that has both pressure decay and back-pressure flow as well as multiple test ports.
  • Ensure that the part is the choke of the system, not the test pneumatics.
  • Establish accurate but efficient test times.

The nearer the leak tester is to the part under test, the faster the test can run. By eliminating excess volume contained in connection hoses and fittings, the sensitivity to pressure change increases. Geometric differences in the test lines and fittings (diameter changes) can cause pressure drops in the system.

A multi-tester is a leak tester that can perform multiple test types in a single machine. Zaxis pioneered this technology with the first ever multi-function tester. The Isaac HD by Zaxis can attach to a ventilator tube assembly, pressurize the part, run a PD test and immediately run a back-pressure flow test. The tubing set doesn’t have to go to a second testing cell for the second test, it is all done by one machine in a matter of seconds.

Conclusion

A global pandemic involving the spread of a novel virus that can severely affect the respiratory system has woefully increased the demand for medical ventilators and consumable tubing sets. Quality leak testing these life sustaining parts is critical. A Pressure Decay test coupled with a back-pressure Flow test can validate a parts functionality. Using a multi-tester such as the Isaac HD by Zaxis can save time and improve production throughput. Lastly minimizing the test circuit volume and optimizing test configuration parameters can decrease test times yielding a more efficient production process.

 

  1. Am J Respir Crit Care Med Vol. 196, P3-4, 2017 ATS Patient Education Series © 2017 American Thoracic Society – https://www.thoracic.org/patients/patient-resources/resources/mechanical-ventilation.pdf
  2. Positive end-expiratory pressure (PEEP)”. com. Citing: Saunders Comprehensive Veterinary Dictionary. 2007.
  3. Andres L. Mora Carpio; Jorge I. Mora,  Ventilator Management,  National Center for Biotechnology Information,  June 2, 2019,  https://www.ncbi.nlm.nih.gov/books/NBK448186/

FDA Approves New Faster Coronavirus Test by Roche

FDA Approves New Faster Coronavirus Test by Roche

Reports are coming in on the FDA’s approval of a new test for Covid-19 that has been developed by Roche.

“U.S. health regulators have approved a new coronavirus test that will speed up by tenfold the ability to test patients, helping solve a significant obstacle to American efforts to contain the virus.

The Food and Drug Administration granted “emergency use authorization” to the test, which runs on Roche Holding AG’s cobas 6800/8800 systems. The 8800 system is capable of testing 4,128 patients a day, and the 6800 version can test as many as 1,440. The tool also is available in Europe and countries that accept its CE marking for medical devices.”

https://www.bloomberg.com/news/articles/2020-03-13/roche-gets-clearance-for-coronavirus-test-that-s-10-times-faster.

 

“A new, high-speed coronavirus test has been granted emergency clearance by the Food and Drug Administration, the latest effort to expand capacity to diagnose the fast-spreading pathogen.

The test was developed by diagnostics giant Roche Holding AG and is designed to run on the company’s automated machines, which are already installed in more than 100 laboratories across the U.S. It will be available immediately.”

https://www.wsj.com/articles/fda-grants-new-coronavirus-test-emergency-approval-11584090078?mod=e2tw

 

“Medical diagnostics giant Roche  (RHHBY)  said it received “Emergency Use Authorization” to begin mass-producing coronavirus testing kits and also processing the results from the U.S. Food and Drug Administration.

The Geneva-based pharmaceutical company said the FDA has given it the go-ahead for what it formally called the cobas SARS-CoV-2 Test for the qualitative detection of SARS-CoV-2, the novel coronavirus”

https://www.thestreet.com/world/roche-coronavirus-test-kits-fda

 

“A new, high-speed coronavirus test has been granted emergency clearance by the Food and Drug Administration, the latest effort to expand capacity to diagnose the fast-spreading pathogen.

The test was developed by diagnostics giant Roche Holding AG and is designed to run on the company’s automated machines, which are already installed in more than 100 laboratories across the U.S.”

https://www.marketwatch.com/story/roche-coronavirus-test-gets-emergency-fda-approval-2020-03-13

Press Release – Zaxis PD Entry Level Leak Tester

Press Release – Zaxis PD Entry Level Leak Tester

Press Release: Zaxis presents its entry level leak tester, the Zaxis PD, specifically designed for an introduction to pressure decay leak testing.

Download Press Package

SALT LAKE CITY, UT. (March 10, 2020) – Zaxis Inc. launches their newest leak tester, the Zaxis PD, available for purchase through any Zaxis Sales Representative. The combination of a color touchscreen interface and a wall mountable design creates a leak tester ideal for entry level pressure decay.

The Zaxis PD leak test system specializing in Pressure Decay and Vacuum Decay. In a development and manufacturing environment the Pressure Decay test is a versatile leak test method. In a pressure decay test, a product is attached to a leak tester and filled with air. Once pressurized, the air source is closed off and the pressure is allowed to settle. During the test any decrease in air pressure over time signifies a leak.

The Zaxis PD has been designed as an entry level leak tester that is easy to use and affordable. The intuitive touchscreen interface has been created to simplify operation and communication with automated equipment. The wall mount brackets are designed to attach to standard extrusion channels with either M6 or 1/4” fasteners. The Zaxis PD can store up to 4 programs which allows the user to set up and easily switch between different test programs. A built-in electronic regulator automatically controls pressure, allowing multiple tests to run at varying pressures without manually adjusting the regulator.

The simple set-up, and reliable communication (options include USB, RS232, I/O, and Ethernet TCP/IP) are invaluable for elevated production quality and throughput.

The Zaxis PD works as an entry level leak testing system designed to handle the most common leak test types. For production engineers and R&D engineers, the Zaxis PD is a great introduction to leak testing.

Download Press Package

Leak Testing for IP Standards

Leak Testing for IP Standards

Ingress protection is a critical part of product development particularly in the medical device assembly and electronics industries. 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?

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.

1st Digit Effective Against Object Size 2nd Digit Protected Against
0 0 Not Protected
1 >50mm 1 Dripping Water
2 >12.5mm 2 Dripping Water when Tilted up to 15º
3 >2.5mm 3 Spraying Water
4 >1mm 4 Splashing Water
5 Dust Protected 5 Water Jets
6 Dust Tight 6 Powerful Water Jets
    7 Immersion up to 1m
    8 Immersion beyond 1m
    9 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.

Challenges

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.

Ambiguity

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 sales@zaxisinc.com or call 1 (801) 264-1000.

Visit Our Downloads Page for Individual Product Data Sheets and Full Product Catalog

Flexible Automated Dispensing

Flexible Automated Dispensing

Flexibility is a valuable attribute in automated production systems. Many automation systems can be described as Fixed or Hard, meaning they have been designed for a single product or specific task. These specified systems are often too rigid to be reused or adapted to any purpose outside of its original design. Metered dispensing in automation often faces the same flexibility issues. An automated dispensing system with the ability to dynamically adjust volume is key to a lean production line.

Automating any production line comes with a number of inherent risks such as substantial pre-planning and initial set-up costs. For many High-Volume/Low-Mix (HVLM) manufacturers the benefits easily outweigh the risks. For Low-Volume/High-Mix (LVHM) manufacturers a great deal of flexibility in automation systems is desired but often difficult due to the diversity of the products being manufactured. In metered dispensing, automation is a necessity for both LMHV and HMLV manufacturers in order to attain the high throughput, precision, and repeatability that most metered applications require.

Automated dispensing is not without its own challenges. Traditionally, if multiple volumes are required multiple pumps are necessary; each programmed with a fixed volume and purpose. Changeover between products often require extended down time to flush out each pump and mechanically adjust them to their new parameters.

 

Common Challenges of Flexible Automated Dispensing:
  • Fixed Displacement – Changing the dispense volume often requires manual adjustment
  • Complicated Maintenance – Pumps that contain valves can be difficult to clean/maintain which disrupts product changeover and often leads to a short lifespan
  • Poor Communication – Transparency of information on the manufacturing floor is often hindered by the number of pumps that can be contained in a single production cell.
Fixed Displacement

The majority of metering pumps in automated dispensing systems require manual configuration and adjustment to change the volume being dispensed. This requires both time and skilled labor. The eVmP (Electronic Variable Metering Pump) Smart Pump System by Zaxis uses patented technology that integrates electronically controlled volumetric adjustment which eliminates the need for manual adjustment.

The Zaxis eVmP Smart Pump System adds flexibility to automated dispensing by storing multiple programs, containing distinct volumes and speeds, directly on eVmP metering pumps. Creating a product changeover program can streamline product changeover, which can be accomplished through the use of EtherNet/IP and the eVmP Detachable TSi (Touchscreen Interface).

Changeover Process for eVmP Smart Pump System
  • After batch completion change to a product changeover program, or simply select Max Shot on the Touchscreen Interface, which will adjust the pump volume to max displacement.
  • Run a sterilant such as alcohol through the wetted path.
  • Change to the next stored program or enter the desired variables (volume, RPM etc.) for the next batch.

The flexibility of the eVmP Smart Pump System is beneficial to LVHM manufacturers who have a high degree of changeover that must be accommodated. Superficially this may not appear to be an issue to some HVLM manufacturers who have little product changeover, however electronic volume adjustment can also be a great asset when only one product is being manufactured. Think of a simple wooden toy that is being glued together; the same adhesive is being used on the entire product but the surface area that requires adhesive changes. Rather than using multiple pumps for each volume of adhesive the eVmP Smart Pump can use its stored programs to automatically cycle through the different volumes needed to assemble the toy with extremely high volumetric accuracy.

Complicated Maintenance

Many of the positive displacement pumps used in manufacturing automation systems use valves which can clog and require routine disassembly for cleaning and maintenance. The eVmp Smart Pump System uses a valveless rotating and reciprocating piston pump design which enables the eVmP to run for millions of maintenance free cycles.

Poor Communication

Good communication is extremely important in flexible automation systems. The ability to see, at a glance, how the processes are being performed on a production line is an enormous benefit for efficient manufacturing. Often a group of fixed displacement metering pumps are placed together on a production cell and not much information is communicated about that cell. In the eVmP Smart Pump System each pump contains an onboard processor that communicates through EtherNet/IP (other communication options include Ethernet TCP/IP and RS485) to the rest of the automated system. The eVmP Detachable TSi can control up to 32 pumps and can be detached from the pumps and stored during production or used as a status screen for production transparency on the manufacturing floor.

Conclusion

Flexibility is a critical aspect in automated dispensing systems for both HVLM and LVHM manufactures. The patented eVmP Smart Pump System by Zaxis has been designed specifically for flexible automation. The eVmP Smart Pump System is the most dynamic solution for the lean manufacturing of applications that require metered dispensing.

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