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.
Manufacturing Single Use Vape Cartridges

Manufacturing Single Use Vape Cartridges

Growing Vape Market

The vape market has been on the rise for several years and is projected to continue to grow at a rapid pace The global e-cigarette and vape market size was valued at USD 10,261.8 million in 2018 and is expected to grow at a CAGR (Compound Annual Growth Rate) of 24.9% from 2019 to 2025 1. Single use vape cartridges are used for both disposable and rechargeable vaporizers. Recent health concerns associated with the growing vape market will drive spur increased regulations for manufacturing vape cartridges. These increased regulations will drive demand for more accurate and reliable manufacturing equipment as seen in the Pharmaceutical manufacturing industry. Zaxis Inc. pumps are already being used to manufacture pharmaceuticals because of the eVmP’s exceptional precision and accuracy. The manufacturing of vape cartridges requires pumps that can handle highly viscous fluids while dispensing very precise doses in each cartridge. Zaxis Inc. metering pumps use positive displacement to pump fluids making them ideal for fluids with low or high viscosity. A natural progression for the vaping industry will be to convert their existing pump equipment to the Zaxis eVmP precision dispensing system.

Highly Viscous Fluids

Concentrated plant-based oils such as cannabis and hemp are known to be highly viscous fluids. Manufacturers use a number of different techniques to obtain the correct fluid viscosity for vape cartridges including distillates with thinning agents, cutting/infusing the oil with additives to thin the consistency, or infusing terpenes and strain-specific flavorings.

On a manufacturing production line all metering and dispensing pumps need to be able to overcome the backpressure the highly viscous fluids create. The Zaxis eVmP VS-Series was design specifically to deal with highly viscus fluids. The servo driven motor has nearly 4 times the torque of a traditional stepper motor and can handle flow rates near 2,000 mL/min and back pressure up to 200 psi. Meaning, the eVmP VS-Series can not only overcome the backpressure created by highly viscous fluids, is can dispense at a faster rate increasing product line throughput.

Precision Dosing

When manufacturing single use cartridges precision dosing is essential. In the Vape industry the FDA is particularly strict upon delivering exactly what is on the product label. Inconsistent dosing can upset end users if they receive a less than full product. Inconsistent dosing and overfilling can also have a damaging effect on the financial bottom-line of production.

The rising market has shined a spotlight on the Vape industry. Consumer safety is a top priority and with that comes higher quality control, including the repeatability of precision mixing ingredients. The FDA states that if you do not report your ingredients or changes to your ingredient quantities “your products may be deemed “misbranded” under federal law and therefore, subject to regulatory action, including seizure and injunction. Submission of false information is also punishable by criminal and civil law.2” If an e-liquid or “juice” mixture diverges from its label by the smallest percentage the FDA often requires destruction of the entire batch including video evidence of its destruction. Precision metering/dosing is vital to the successful and safe manufacturing of e-liquids.

The Zaxis eVmP system achieves +/- 0.5% full scale accuracy and 0.5 CV with 0.01 µL resolution through the use of a rotating and reciprocating positive displacement design. The use of positive displacement in the eVmP design helps reduce the risk of contamination or bleed over between packages. The difference between the external diameter of the piston and the internal diameter of the liner is near perfect. This means when the piston head is drawn away from the fluid path a vacuum is created ensuring volume remains constant through the entire cycle of operation. Furthermore, the eVmP rotating and reciprocating design renders highly repeatable results. With stainless steel pump head construction and sapphire hard, alumina ceramic, internals Zaxis eVmP pumps will last for millions of maintenance free cycles.

Not only is the FDA scrupulous when it comes to ingredients and dosages, the Vape industry also has a discerning customer base that is well informed about their products and often demand high standards that preserve a plant’s unique profile, flavor, and complexity. Precisely mixing each element of a juice as a distinct individual dose can be far more exact than big batch mixing producing a very high-quality product and reducing the margin of error and potential waste.

No One Wants a Leaking Pen

Many of the first Vape pens came with a warning not to lay them down or tip them over as the oil from the tank would often leak out. Cartridge design has evolved over the last few years and with the vape market on the rise the development and refinement of cartridge design is a continual process. There are several different leak tests that can be performed to validate a cartridge design. Closing off the vents and running a pressure decay test through the mouthpiece will validate all of the seals and ensure the tank is leak tight. Then opening the vents and running a mass flow test through the cartridge is especially helpful in validating that an atomizer filter design will not leak fluid.

The Isaac HD and Zaxis 7i are multi-function leak testers that have the capability of running multiple kinds of tests in the same unit. Both leak testers come with electronic regulators and up to 100 stored programs. This mean the air pressure setting will automatically adjust from test to test saving time and removing user error. Finding a desired flow rate for a cartridge is a delicate and precise task as the flow of air should be unimpeded while the flow of liquid should not pass through the saturated filter in full drops. The intuitive user interface makes test parameters easy to adjust and customize. The ability of the Isaac HD and Zaxis 7i to set and sense the difference between such tight parameters allows designers to develop cartridges that function perfectly without leaking.

Conclusion

The Zaxis eVmP VS-Series is ideal for handling the highly viscous fluid and extreme precision required for manufacturing single-use vape cartridges. The VS-Series servo motor technology is not only powerful enough to overcome the backpressure created by highly viscous fluids, but it also has the speed and accuracy to increase quality throughput. The Zaxis line of leak testers can validate the design of any vape cartridge as well as determine if there are any cartridge leaks or defects.

  1. Grand View Research. “E-cigarette And Vape Market Size, Share & Trends Analysis Report By Distribution Channel (Online, Retail), By Product, By Component, By Region, And Segment Forecasts, 2019 – 2025” Grand View Research, July. 2019 https://www.grandviewresearch.com/industry-analysis/e-cigarette-vaping-market
  2. FDA “ How Do I Comply with FDA’s Tobacco Regulations?” FDA  27, Aug. 2019 https://www.fda.gov/tobacco-products/compliance-enforcement-training/manufacturing 
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.