ACIC Machinery / PBL S.r.l.

Coral Springs,  FL 
United States
http://www.acicmachinery.com

• Booth: 8023

We deliver turnkey equipment and automation solutions for radiopharmaceutical and bio/pharmaceutical manufacturing.

At ACIC Machinery, we deliver turnkey equipment and automation solutions for bio/pharmaceutical and radio-pharmaceutical manufacturing. We have extensive experience designing, building and commissioning both standard and custom projects.

Shielded hot cells with integrated robots or telemanipulators for the formulation, dispensing and inspection, packaging of nuclear/radio-pharmaceutical products.

Our global clients range in size from medium laboratories to large multinational pharmaceutical corporations.

Brands: ACIC Pharmaceutical Machinery| P.B.L. Srl (https://acicmachinery.com)

 Videos

 Press Releases

• Announcing our new robotic visual inspection machine (Apr 20, 2023)

  New inspection machine for RTF container

  We are thrilled to announce the launch of our cutting-edge robotic visual inspection machine for Ready-To-Use (RTU) containers. This state-of-the-art system employs advanced camera technology and Artificial Intelligence (AI) to deliver precise inspections for particulate matter and cosmetic defects.

  With a fully automatic format changeover and a compact, flexible design, the machine is capable of handling a wide range of containers with ease.

  Thanks to its sophisticated AI technology, our RTF ROBOX A/I guarantees unparalleled accuracy when it comes to detecting particle and cosmetic defects. As a result, the machine is able to overcome previous challenges such as air bubbles, silk-screening, and external defects that were previously difficult to detect.

  The RTF ROBOX A/I boasts a variety of features, including liquid particle control, LYO cosmetic control, cosmetic checks, vacuum decay, and high voltage methods, as well as integrated labeling heads and a user-friendly interface. The machine can inspect different types of containers – such as vials, syringes, and cartridges – with varying sizes and shapes, and has a speed range of 6 to 20 BpM.

  Main Features:

  • Manual or automatic container loading system
  • Robotic container handling system
  • 8 inspection stations (standard version)
  • Ability to vary the number of inspection stations to meet your specific needs
  • Manual or automatic camera system

• What is Artificial Intelligence? (Apr 26, 2023)

  What is artificial intelligence?

   Artificial intelligence (AI) involves using computers and software to do things that would traditionally require human intelligence. The difference? AI can consume and process large amounts of data. Levels of data and information that humans simply cannot process.

   The goals of AI technology and AI-supported machines are to:

  • Recognize patterns
  • Make decisions
  • Make judgments

   That mimics, and ultimately supersedes human behavior and intelligence.

   ACIC Machinery is proud to offer inspection machinery solutions for pharmaceutical products that are fully automated and supported by AI technology.

  AI-supported inspection machines quickly spot and identify problems in any part of the production line monitored by state-of-the-art cameras. Studies suggest that AI-supported solutions can increase defect detection rates by up to 90% compared to human inspection rates (Dorfman, 2022).

   Powered by AI, our automated inspection machinery greatly enhance the speed and accuracy of container inspection, as well as substantially reduce rates of false positives.

  So how does it work?

   The first level of the inspection system is comprised of standard inspection software, which mainly detects moving particles but can also detect some non-moving particles.

  The second level of the inspection system is comprised of AI software which has two main functions:

  1. Reduce false positives by distinguishing between real particles and false particles (eg. Bubbles)

  2. Capability to add new types of particles to the AI database for inspection. The AI database generates a new knowledge base when it undergoes training for new defects by qualified personnel. Previous versions of the knowledge base are stored and archived. Only qualified personnel can access training mode in the system.

  Contact us at ACIC Pharmaceutical Machinery to learn more about our AI-supported inspection equipment.  Let’s start designing an inspection system for your manufacturing facility that will increase the speed, accuracy, and performance of your operations.

  Learn more about our automatic inspection machines:

  https://acicmachinery.com/products/inspection-technologies/ 

  References

  1. Our partners

  2. Dorfman, E. (2022, April 19). How AI for Quality Control Enhances Yield in Manufacturing. Retrieved from https://postindustria.com/how-ai-for-quality-control-enhances-yield-in-ml-manufacturing/

• Improve Quality of Radiopharmaceuticals with Automation (Apr 26, 2023)

  In recent years, there have been major advances in automation equipment for the manufacture of radiopharmaceuticals.

  Creating modern facilities that incorporate automated manufacturing processes improves product consistency, quality, and operator safety.

  Many radiopharmaceuticals are produced under aseptic conditions to ensure they meet all purity and quality standards. There can be multiple manual processes in the manufacturing of sterile drugs, and each manual process during the aseptic assembly has the potential to introduce contamination. In addition to product safety, operator safety can be improved when introducing automation by reducing radiation exposure to personnel.

  Automation in Hot Cells
  Most operations in the hot cell are accomplished by using manipulators and robotic arms. Robotic arms can be programmed to automate processes inside and outside the hot cell including the opening of lead pots, the handling of lead pots and vials, automatic filling, and automatic visual inspection of labeling and cartoning. These automated processes can increase production speed, product quality, and reduce radiation exposure to operators.

  Solution
  ACIC Pharmaceutical Machinery and our partners have extensive experience in the design and commissioning of state-of-the-art equipment and turnkey solutions for the manufacture of radiopharmaceuticals.

  If you have any questions regarding automation in radiopharmaceutical manufacturing, please contact us or read more on our radiopharmaceutical equipment.

  References
  1. FDA. Sterile Drug Products Produced by Aseptic Processing — Current Good Manufacturing Practice. September 2004. https://www.fda.gov/media/71026/download
  2. IAEA. Radioisotope Handling Facilities and Automation of Radioisotope Production. December 2004. https://www-pub.iaea.org/MTCD/publications/PDF/te_1430_web.pdf
  3. U.S. Pharmacopeia. <1015> Automated Radiochemical Synthesis Apparatus. USP 32, NF 27, 2009. https://www.drugfuture.com/Pharmacopoeia/USP32/pub/data/v32270/usp32nf27s0_c1015.html
  4. Our Partners.

• How It Works: Radiofrequency and Thermocontact Welding (Apr 26, 2023)

  Radiofrequency Welding

  Radiofrequency (RF) welding, also known as high-frequency welding, is an effective sealing process for the manufacture of medical bags such as ostomy bags, urine bags, and blood bags.

  Radiofrequency welding works through the simultaneous application of a pressure force and an electromagnetic field with a frequency of either 27.12, 13.56, or 40.68 MHz on materials (for example, two films of PVC), which causes the material to melt, and the molecules to bond. This process makes the material weldable at relatively modest temperatures (for example, 30˚C) and results in a robust seal that is leak-proof and consistent.

  

  

  Why use RF Welding?

  RF welding results in a strong, leak-proof bond without the use of additional materials such as adhesives. The welds are durable, consistent, and ensures the integrity of the bag, which is crucial for pharmaceutical products. RF welding optimizes energy consumption, does not generate fumes, and does not require the use of additives. These aspects are beneficial for both operators and environmental protection.

  RF Welding can be performed on materials including polyvinylchloride (PVC), polyurethanes, polyethylene terephthalate (PET), and acrylonitrile butadiene styrene (ABS).

  Thermocontact Welding

  Thermocontact welding uses external heat and pressure to bond materials. Thermocontact welding can be a good alternative when materials are not suitable for RF welding. Materials for thermocontact welding include polypropylene (PP), polyethylene (PE), and PVC-free plastics.

  

• Controlling Leakage of Radioactive Containment in Automated Environments (Apr 26, 2023)

  Automation in radiopharmaceutical manufacturing is a great thing for all stages of the supply chain. In the manufacturing of radiopharmaceuticals, for example, the automation process can prevent accidents caused by human error. But leakage of contaminants still happens due to various factors that can exist in the process. Precautions can be taken that will help control or mitigate radioactive leakage that can occur.

  1. Safe Surfaces
  Machinery with areas that materials can easily get caught and exist, such as trims and corners, for example, increase the occurrence of radioactive contamination. The materials forming the surface of machinery, and the casing for the machinery should be easy to decontaminate. During design, non-porous, corrosion-resistant materials should be specified. For example, the use of rounded edges enables the user to easily wash away contaminants from spaces where they might normally get stuck.

  2. Air Filtering
  Radioactive particles in the air quickly spread through a building, unless precautions are taken. Be proactive by preventing particles from accumulating in the first place. Taking steps to maintain extreme cleanliness at all time, filtering the air, and setting up the ventilation system so that air from a controlled area is not re-circulated back into the building, are all proactive measures that will ensure only the cleanest environment. Integrating HEPA filtration systems contributes to a controlled ISO Class 5 environment.

  3. Disposal of Waste
  When there is contamination, and it has been dealt with, the radioactive waste (say, from decontaminating a room) needs to be disposed of safely. This will necessarily involve transporting the waste away from where it is. So, when planning an automated environment, think about the path that this waste will travel when leaving the building and ensure that it will not spread contaminants further during the disposal.

  4. Double Containment
  Double containment should be used as a fail-safe in case the first line of defense fails. Be sure to plan for larger problems that involve more than a single machine or area. Consider the spread of contamination in the event of a large accident – don’t just think about the machine and its immediate vicinity, but about where radioactive contaminants might spread through contact, waste disposal, or airflow. For example, if the container around the machine is negative pressure, and springs a leak, radioactive particles in the air will not spread. So far so good, but if there is a larger accident, this may not be enough, and contaminants will spread from the room throughout the building. By making the entire room negative pressure, you can contain more serious leaks with relative ease.

  In the manufacturing process that involves radioactive elements, a thorough consideration beyond the obvious decontamination plan and process is not just smart but should be mandatory. Steps can be taken in stages, such as in the design of the hot-cell automation process. Early design considerations will not just save time and money, but will also create a safer environment and a more efficient way of dealing with potential harm.

  If you have any questions regarding automation in radiopharmaceutical manufacturing, please contact us.

• Filling and Sealing: A Summary of Our Filling and Sealing Solutions (Apr 26, 2023)

  ACIC Machinery is a leading provider of filling and sealing solutions ranging from small and large volume parenteral products to sterile and non-sterile filling. Applications include ampoules, vials, syringes, cartridges, glass/plastic bottles, and soft bags. These machines can process liquid, semi-solid, and powder products (freeze-dried). Let’s take a closer look at a few of our machines:

  STERILE & NON-STERILE FILLING

  Filling & Closing Machine for Nested Containers

  The filling and closing machines have been specifically designed to process pre-sterilized nested containers such as syringes and cartridges. Despite its compact design, it can accommodate different filling systems to treat liquid, freeze-dried, suspension, emulsion, and oil-based products.

  

  Vial Filling Machine for Aseptic Processing

  This machine is used for the filling, stoppering, and sealing operations of injectables in glass vials for aseptic conditions. These machines are suitable for both liquid and freeze-dried products.

  

  Closing & Sealing Machines for Bottles & Vials

  Fully automatic closing/capping and sealing machines are designed for the application of different closures on glass and plastic vials and bottles.

  

  Filling & Closing Machines for Pharmaceutical Processing

  Filling and closing machines are specifically designed for filling, plugging, and capping both sterile and non-sterile products such as syrup, ophthalmic solution, and nasal spray in either glass or plastic containers.

  

  PARENTERAL FILLING

  ISBM (Injection, Stretch, Blow, Molding) Filling Line

  ISBM technology is the modern manufacturing trend for IV solutions and irrigation products. Complete processing lines for polypropylene (PP) bottles forming, filling, and closing starting from the raw PP granules.

  

  Filling machine for pharmaceutical bags

  Filling and closing machines are made to treat IV bags. These machines can fill a single chamber bag as well as a dialysis multi-chamber bag. The machine design allows a high level of flexibility in means of productivity and bag shapes.

  

  Our Solution

  ACIC Machinery brings you many solutions for your pharmaceutical filling and sealing needs.

• Fast Turnaround for 7M2 and 30M2 Freeze Dryers (May 17, 2023)

  Fast Turnaround for 7m2 and 30m2 Freeze Dryers

  These two freeze dryers were meticulously engineered to adhere to FDA 21 CFR Part 11 and cGMP standards for both pilot and commercial batch production. As of now, the 7m2 unit is 70% mechanically complete, while the 30m unit is 40% mechanically complete.

  Since the freeze dryers are not yet fully completed, this presents an opportune moment to incorporate any necessary adjustments to suit your specific requirements. We are receptive to discussing your production needs in order to customize the machine to your satisfaction.

  In collaboration with our clients, we maintain a close working relationship with our research, validation, and production teams to ensure optimal machine layout and processes that fulfill all customer specifications.

  Prior to equipment installation, our state-of-the-art research facility conducts pilot tests to validate the theoretical conditions of our clients’ processes. This meticulous process is carried out to guarantee optimal outcomes from each and every freeze dryer we produce.

  Simply reach out to us at 1.833.ACICMAC (1.833.227.2622) or contact us here,  and we’ll gladly discuss with you how our freeze dryers can be tailored to your specific requirements, provide you with additional information about our fast delivery models, and guide you through the purchasing process. We are committed to providing you with the best price and service possible, and our team is enthusiastic about assisting you in any way we can.

  https://acicmachinery.com/products/pharmaceutical-freeze-dryers/

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