Reliable filling of disposable syringes with highly viscous fluids and pastes.
Dosing syringes are an important option for the precise and clean application of pharmaceutical substances. However, the thin cylindrical cavities quickly become a challenge, especially when filling disposable syringes with highly viscous materials or semi-solids. Nevertheless, absolute precision filling of the syringe is a must. Conventional filling technologies in the pharmaceutical industry often reach their limits when it comes to semi-solid products.
ViscoTec has set itself the task of being able to fill a wide variety of products with just one dosing system. From watery to highly viscous, shear sensitive, abrasive, aggressive or toxic. This includes all viscous pharmaceutical or medical technology products and so-called semi-solids with or without highly effective substances: i.e. dermal fillers such as hyaluronic acid or depot medication drugs made of liposomes, filled with abrasive solids such as hydroxyapatite or shear-sensitive active ingredient crystals.
Flexible but high-precision filling of syringes The ViscoTec endless piston principle enables a precise, gentle, and pulsation-free product flow. The dispensers have a flow rate of 0.2ml/min to 700ml/min and are flexible to fill Luer Lock or Luer Slip syringes, for example, from 0.2ml to 50ml with a filling accuracy of ±1%. The net dosing time can be less than one second per syringe. A possible overfilling, but also underfilling, especially with self-medication of standard syringes, is therefore eliminated.
Even filling of small and very small batches with frequent product changes are possible thanks to the easy cleanability of the GMP-compliant Hygienic Dispensers. Cleaning is performed either by COP (Cleaning out of Place) or CIP (Cleaning in Place). Components in contact with the product can be autoclaved.
The special design of the filling pumps enables a programmable suck-back, which in turn ensures a defined thread break and therefore prevents unwanted dripping or thread pulling. This is done by the change of rotation direction in the dispenser, whereby the material is sucked-back into the dosing needle in a defined manner. The suck-back function can also be used for materials with difficult thread breakage. Dosing quantity, speed and acceleration can be individually adjusted according to the requirements of the product. The viscosity does not affect the dosing performance.
Another advantage of the volumetric filling pump is the absolute gentle handling of shear-sensitive or abrasive materials. There is no compression of the conveyed product during the filling process.
Changes to the fill quantity, due to a change in the container size, can be made without mechanical modification. This is ensured by the linear relationship between the quantity dosed and the servo revolution. Thanks to the compact design of the Hygienic Dispensers, they can be easily integrated into existing or newly designed fully automatic packaging systems. There are no limits as to the alignment of the dispensers. And in semi-automatic processes, the simple handling for the operator is a positive aspect - ideal for small batches or clinical trials.
Different filling processes depending on the application The filling process can be performed either via the stopper or via the syringe cone. When filling via the stopper, this is done by means of a Z-movement of the container or the filling needle in order to ensure a mirror filling. To avoid air pockets, the syringe can be placed under vacuum during filling. In this way, additional so-called "head spaces" can be avoided, which are known from conventional filling.
If the filling process is implemented via the syringe cone, a special needle or Luer connection is used for connection. This is possible thanks to the high-pressure stability of ViscoTec dosing systems. An advantage of this type of filling is that the "piston" can already be mounted in the syringe. During filling, this is then pushed backwards by the inflowing fluid. Subsequent placing of the piston under vacuum is no longer necessary.
Syringe filling application example For one customer, for example, syringes had to be filled to meet GMP conditions: Each 1 ml ointment with a dynamic viscosity of 160,000mPas. In addition, it was also a requirement to implement this without air bubbles and with a tolerance of ±1%. Due to the good preliminary results of dosing tests at the in-house technical center, the customer decided to use a ViscoTec Hygienic Dispenser 3VPHD8. The syringe is filled through the cone. Due to the viscosity of the material and the small opening, high dosing pressures occur here, which – as already mentioned - can be handled well due to the pressure stability of the endless piston technology. At the end of the filling process, the material is withdrawn from the syringe cone to keep it clean. During the first tests for the application, exceptionally good repeatability of 99.7% was achieved in addition to dosing tolerances of less than ±0.5%. This accuracy was also confirmed later during production.
Recent purchase of additional facility will increase critical tubing & molding capacities.
In May, NewAge Industries, the parent company of AdvantaPure, bought two of three units in a building within seven miles of its headquarters. NewAge recently purchased the remaining unit and now owns the entire seven-acre property consisting of over 90,000ft2 of future production, warehouse, and office space.
“This acquisition completes one plan and puts another in motion,” notes Ken Baker, CEO. “Our search for the right property landed us this convenient location, just fifteen minutes from our headquarters. Now that we own the entire building, the next steps begin.”
Investing in the building, which was purchased with cash, will allow NewAge to increase manufacturing capacity for its AdvantaPure high purity line of products. The facility will house additional tubing extrusion equipment and mold presses in a design planned to maximize workflows and optimize efficiencies.
NewAge recently started Phase 1 of renovations and is preparing areas for cleanroom manufacturing and offices for production and quality department personnel. The company will use the facility as an additional site for the manufacture of AdvantaSil silicone tubing and braid reinforced hose, weldable and sealable AdvantaFlex thermoplastic elastomer (TPE) tubing, and Single-Use molded tubing assemblies.
Demand for tubing, reinforced hose, and molded assemblies has increased considerably in recent months, with many of the products being used in COVID-19 applications such as virus detection test kits, laboratory work on antibodies, ventilators and vaccine development. NewAge Industries-AdvantaPure has hired new team members to keep pace with growth and continues to fill open positions.
“The new property will increase our manufacturing capacity a great deal,” Baker notes. “We expect to eventually produce two-to-three times the amount of platinum-cured silicone and TPE tubing we’re currently making at our headquarters.
“It’s important that we’re preparing for this now, because COVID-19 and all of its repercussions won’t be going away any time soon. We understand security of supply and the critical nature of the products we’re providing to our customers.”
Renovations will continue through 2020 and into next year. Extrusion equipment and injection molding presses, many of which are already purchased and on site, will be set up in stages as areas of the building are prepared. NewAge Industries-AdvantaPure anticipates testing and validation of manufacturing equipment and environments to occur in 2021. The facility will be ISO 9001:2015 certified.
Takumi USA and the new Set and Inspect app by Renishaw will drive manufacturing process improvements for customers.
Takumi USA has partnered with Renishaw to be the first CNC machine tool brand to offer Renishaw’s Set and Inspect app for the Fanuc control. Set and Inspect will help job shops of all sizes be more efficient and profitable by making it possible for anyone with a part probe to immediately add inspection probing to their process and reap the full financial benefit of probing on a machine tool. Unlike traditional programming software, Set and Inspect is easy to use: the software’s intuitive interface guides the user through the process of creating a probing cycle, automatically generates the required machine code for the probing cycle, and sends it to the control. The intuitive graphical user interface (GUI) of the Set and Inspect app allows for quick learning, inexperienced operators can learn how to use it in 30 minutes or less, to create routines for increased production efficiency, decreased operator intervention, decreased scrapped parts, and decreased re-work time with inspection probing.
Takumi USA, Renishaw collaboration The team at Takumi USA became aware of Renishaw’s new technology in early 2020 and immediately realized the benefits. While Set and Inspect is not loaded directly on the Fanuc control, Takumi engineers came up with a simple solution that provides a seamless integration of the app to the Fanuc control with the FOCAS 2 feature and added a tablet device to the control. With no need to learn macro programming, the machinist can easily program set-up probing routines or inspection routines and send them to the control memory with a single button press. The results are displayed on the same screen during the cycle. They can be used to develop experience data for tooling, track changes to parts, and monitor adjustments to tool wear to determine when the cutter should be replaced.
Sophisticated probing, inspection technology simplified With minimal training required, the operator jogs the probe into position using the handwheel, selects a probing cycle from the menu, and completes the user input fields. The Set and Inspect app does the rest – automatically generating the required machine code for the probing cycle and sending it to the control, which significantly reduces data entry errors and programming time.
Set and Inspect can automate a production cycle by inspecting features to determine tool wear and automatically adjusts the wear offsets. Features are available to define how many parts to inspect before adjusting wear offsets, what percentage of the error to apply as an adjustment, and a function to stop production if results are out of tolerance.
This feature is now available on the Takumi H-Series 3-axis high-speed double-column CNC machines, the Takumi V-Series 3-axis box way CNC machines, and the VC-Series 3-axis heavy-duty general purpose machining centers.
Online tools offer a look at new technologies, gives first-hand insight into the US machine tool industry amid the pandemic.
The Taipei International Machine Tool Show (TIMTOS) will be held on March 15-20, 2021, in Taipei Nangang Exhibition Hall 1 and Hall 2 and World Trade Center Exhibition Hall 1. Since a meeting for booth allocation among exhibitors will be coordinated in late October, it is expected that TIMTOS 2021 will maintain the same size of nearly 7,000 booths as the previous edition. Fully supported by industry people, the show organizers, Taiwan External Trade Development Council (TAITRA) and Taiwan Association of Machinery Industry (TAMI), have been making every effort to organize and promote the event, both virtually and in person combined. Meanwhile, with an online exhibition being launched, the TIMTOS 2021 will be the world's first machinery trade show in the post-pandemic era.
The outbreak of COVID-19 has made digital promotion a mainstream. Thus, TAITRA has presented both TIMTOS Salon webinars and TIMTOS Glimpse for new product launches since this August. Both online programs have helped breakthrough the restrictions of physical boundaries while reaching out to the world. In the TIMTOS Salon, high-profile professionals of the world’s machine tool associations will comment on their local markets respectively, while the TIMTOS Glimpse highlights elite exhibitors with choice products. It is believed that TIMTOS will continue to raise its brand image as a world-class trade fair worthy of the attention of global machinery industry.
The TIMTOS Glimpse launched in October continues to catch buyer’s eye around the world with innovative R&D technologies exclusively from exhibitors. For example, aired on October 8 was a video featuring the AccuteX Technologies, a leading brand in cutting machines based in Taiwan, who will demonstrate its wire cut EDM machine, highlighted by high efficiency and precision. And the video airing on October 22 will be the Chin Fong Machine, one of the world's top five punch equipment manufacturers. Chin Fong will introduce its iS1 series servo presses, ST1 series straight column type single crank universal presses and iForming intelligent management system, all of which are to provide customers with solutions for smarter management.
The fourth episode of TIMTOS Salon had Douglas K. Woods, Chairman of the Association for Manufacturing Technology (AMT) sharing his perspectives on the current status of the U.S. machine tool industry amid the pandemic. At a time when Taiwan-U.S. economic and trade relations are heating up, this episode may provide Taiwanese manufacturers with the most real-time market information for their business endeavors in the US market.
As the organizers of TIMTOS have strived to make the in-person trade fair happen as scheduled in March 2021, they are also integrating online and offline resources catering to the global trend, and will put forward the TIMTOS Online Exhibition in November, which will be arranged by an online to offline (O2O) mode, aiming to breakthrough time zones and geographical restraints, help serve local and overseas exhibitors and buyers, and connect Taiwanese manufacturers with global buyers.
LexaGene expects the MiQLab to penetrate several markets where it can detect harmful pathogens.
LexaGene, a manufacturer of medical testing equipment, has hired Exothermic Molding Inc. to help in complete its MiQLab, a genetic analyzer. Officials at LexaGene describes the machine’s advantages of purifying and analyzing genetic material, testing for 27 targets simultaneously, delivering results in about an hour to a computer or mobile device, and offering one button operation.
Exothermic’s Production Manager Jorge Perez remarked that the MiQLab is the perfect complement to our portfolio of client products. Exothermic has been producing parts for specialized medical testing equipment for years. He further indicates how Exothermic was chosen for the project and the company’s role in helping LexaGene complete the product roll-out.
“LexaGene supplied us with aluminum parts for their prototypes of The MiQLab that required CNC machining, silk screening with specialized colors, and skilled painting capability. The assembled prototypes were slated for shipment to a photo shoot and to a show with extremely tight deadlines. Exothermic’s Assistant Production Manager James Patnaude shepherded this project through in record time. We had to take the finishing operations from concept to delivery in just three days. We had to ship the job out as soon as the paint dried. Patnaude had the courier service standing by and the product was delivered from our New Jersey plant to LexaGene’s CEO at his home on a Saturday,” Perez says.
Exothermic has quoted on producing parts for the MiQLab with their RIM plastic molding capability once a production run is required.
Founded in 1971, Exothermic Molding, Inc. has remained a family-owned privately held business. The company is known for both its innovative use of manufacturing processes and materials. The first known adopter of Reaction Injection Molding (RIM), Exothermic has taken that process a giant step further with the advent of a Nobel Prize winning polymer known as Proxima.
According to Exothermic’s management, Proxima has unique and superior properties over other polymers, such as its high durability and lighter weight. The company has torture tested the material with excellent results – driving over it with a vehicle and even attacking it with a sledgehammer. Neither test showed any damage. Proxima’s lighter weight can help reduce shipping costs, as well.