Aseptic Filling Equipment
Aseptic filling equipment is a crucial step in the drug manufacturing process. It sterilizes and hermetically seals the packaging, preventing harmful pathogens from entering the drug container.
Modern machinery offers high-efficiency, sanitary vial filling solutions without the risk of contamination caused by human intervention. RABS and isolator-barrier systems remove the need for labor-intensive cleanrooms.
Vial Loading Trays
The manufacturing process for pharmaceutical and biotech products is complex and requires the right equipment. One essential piece of this equipment is a vial tray that minimizes the wear on a filling machine while ensuring quality, uniform products. Hurst vial trays, distributed by Chemtech International, are made with injection molded plastic and feature an enhanced design that optimizes workflow. They’re lightweight and easy to handle, reducing physical strain on the operator, and they also offer exceptional resistance to corrosion, denting, and rusting.
A vial tray that’s compatible with the manufacturer’s chosen vial filling machine minimizes the wear to a machine, which reduces costs and maximizes efficiency. These plastic trays are also FDA-compliant and go through a rigorous quality control process to ensure the highest level of safety and performance for pharmaceutical and biotech manufacturers.
The Garvey Corporation AST RTL tray loader is a high-performance solution for cGMP production of sterile vials, syringes, and cartridges in an isolator-barrier system. This robust tray loader is built to withstand the high volume of vials that are processed on a daily basis and includes a tray accumulation system to increase your throughput by up to 30%. It’s a modular system that’s flexible enough for various application needs including R&D, niche products, and clinical and commercial production. It also supports a variety of trays and different packaging configurations for maximum flexibility.
Vial Selection
The vials and caps you use for aseptic aseptic filling equipment liquid filling will come into direct contact with your formulation during its entire shelf life, so choosing a compatible design is crucial. Vials are available in a wide range of shapes and sizes, as well as with a variety of septa materials. Choose a septa based on chemical compatibility with your solvent and the permeability of the PTFE liner that faces it.
Closed-system processing minimizes contamination from human intervention, preserving the integrity of pharmaceutical compounds. Single-use aseptic bag-in-box fillers let you spend less time switching between sterilization in place (SIP), production, and cleaning in place (CIP). Streamline your cleanroom operations with bag-in-box aseptic systems.
When working with potent powders, containment and isolation is critical to product safety. Isolators allow you to work with the powder in an isolated environment without exposing operators to the substance. They also ensure that hazardous ingredients are separated from the equipment, reducing risk of exposure and cross-contamination.
Whether you’re performing manual headspace analysis or using an autosampler, a vial rack provides convenient storage and handling. Several types of racks are available to fit different vial sizes. You can also select from a variety of caps, inserts, and mats for your aseptic vials. Several options are available to help maximize vial storage, including crimp caps with aluminum lids and a PTFE septum or snap caps that provide a moderate seal.
Vial Filling Machines
Vial filling machines sterilize vials, bottles, cartridges and syringes while providing precise liquid dispensation for sensitive pharmaceutical and biopharmaceutical products. They work within a controlled environment, so the product never touches human hands during its handling or processing. This reduces the risk of contamination by harmful pathogens and other contaminants.
Because brine and vinegar solutions are corrosive to equipment overtime, brine filling machines are explicitly designed aseptic filling equipment factory to manage these liquids effectively. These aseptic liquid filling machines are ideal for dispensing five-gallon pails of brine based on volume, while minimizing the clogs and buildup in the nozzles.
Ensure sterility in the bag and reduce downtime with Alfa Laval’s reliable aseptic bag-in-box fillers. Spend less time switching between sterilization in place (SIP), production and cleaning in place (CIP) because the process is self-contained in a single machine with a steam barrier to protect mechanical moving parts during the process.
Aseptic fill-and-finish systems offer class-leading precision, efficiency and flexibility for your pharmaceutical or biopharmaceutical production line. Integrated with an isolator, these systems maximize floorspace and minimize downtime, allowing you to bring drugs to market faster and ensure GMP compliance.
Isolators
For some applications, especially in pharmaceuticals, a single-use isolator can be used for aseptic filling equipment to provide an ultra-clean environment for the process. This is important because these processes typically involve a lot of microbial contamination during the filling and stoppering stages. TL Systems Corp. built a prototype isolation system that will be used by Eli Lilly for this purpose. This will enable the company to save on garments, utilities, environmental monitoring and cleaning costs, says the firms marketing manager.
A typical isolation device is an enclosed unit designed to enclose the operations of a small-scale filling machine. It is equipped with hinged “easy-lift” window panels and a special “mouse hole” for the exit of filled vials. It also offers a choice of positive or negative pressure, unidirectional laminar recirculating or total exhaust airflow regimes, depending on the product and production process.
It is also important that the system be designed to facilitate easy cleaning of all surfaces without major dismantling. This will reduce the risk of retained particles and liquids that can result in contamination or bacterial growth and help avoid any unnecessary shutdowns. Finally, the isolator should have a robust leak detection system, such as electronic particle counting and flow velocity measurement, with data logged and recorded at one-minute intervals. Ideally, this system can be integrated with a host computer for online batch production records and other data processing.