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, Revised 1 Apr. 2019.
  2. Science Direct. 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.


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 –
  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,

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.”


“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.”


“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”


“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.”

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.

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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.

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