If you need to print pharmaceutical products, you’ll need the highest-quality printing solutions. You’ll need a pharmaceutical printer that is capable of producing crisp identifying marks on pharmaceutical products. Thankfully, there are several companies that provide pharmaceutical printing solutions. Here are a few: R.W. Hartnett Company, Axalta Pharmaceutical Solutions, and Xerox Pharmaceutical Solutions.
Regulatory Requirements
Pharmaceutical printing requires strict regulatory compliance. The FDA’s requirements are extremely stringent, requiring uncompromisable quality, crystalline legibility, and ultra-specific formatting. This makes it vital for manufacturers to ensure their labels are easy to read and contain the required information. To ensure compliance, manufacturers must know the printing practices of their label suppliers.
Printing is a complex process that requires analytical methods to ensure that the intended characteristics of the product are reproduced. The printing process requires that the printer’s internal parts are made of approved materials to minimize the risk of contamination. Unlike conventional manufacturing, 3D printing machines do not allow easy cleaning of the inside components. Pharmacies must develop standard operating procedures to ensure that the printer is sterile and free from contamination.
Auditable & Controlled
The document should be auditable and controlled, and revision history should be maintained. Documents must also be easily checkable and laid out in an orderly fashion. Reproduction processes must also avoid errors. Documents must not be outdated. Regulatory inspectors typically spend a great deal of time reviewing documents to make sure that everything is compliant.
The FDA’s requirements differ for medical devices. Some products are exempt, while others require premarket submission. The majority of medical devices go through a 510(k) review, which requires the manufacturer to show that the product is substantially equivalent to a current device. This reduces the need for extensive clinical trials, but manufacturers still need to submit a complete application for premarket approval.
Pharmaceutical manufacturers are trying to differentiate their products from their competitors. Labeling is an essential part of this process. In addition to making a product more unique, manufacturers must also ensure that it meets serialization requirements.
Costs
Pharmaceutics printing is a highly specialized field with many unique requirements. Not only must all medical information be legible and readable, but it must also be printed in the highest quality possible. Proper pharmaceutical printing is essential to the industry as mistakes in the printing process can lead to significant problems.
Currently, the most common pharmaceutical printing technology is the inkjet-based method. This method allows for the creation of complex dosage forms. It can be used to produce microcapsules, antibiotic-printed micropatterns, and mesoporous bioactive glass scaffolds. Pharmacies have to develop a standard operating procedure to clean the printers.
3D Printing
3D printing is an ideal way to manufacture personalized medicines. This process allows patients to select their specific dosage from a catalogue and choose flavours, textures, colours, shapes, and sizes. The ability to print specific dosages and other details helps increase patient engagement and adherence. It also allows for the manufacture of more precise dosages, which improves treatment efficacy. It also reduces the risk of adverse effects.
Costs of pharmaceutical printing vary according to the technology used. The more complex the printing process, the more expensive it is. Nevertheless, despite the costs, 3D printing is a valuable tool for the pharmaceutical industry. It improves the manufacturing process and reduces lead times for new products. In addition, it also reduces tooling costs.
Workload
Pharmaceutical printing companies have a heavy workload and are faced with numerous print jobs daily. The quantity of jobs can range from hundreds to thousands. Each print job has its own specifications and requirements. Labels used for pharmaceutical products often have a variety of sizes and finishes. It is important to know how to manage these jobs efficiently.
Pharmaceutical printing requires precision and high quality. Misprinted labels can lead to dangerous overdose or loss of license, which is why it is crucial for each label to be 100% accurate. Managed print services help pharmaceutical companies maintain high quality printing by automating processes and reducing paperwork. These services also monitor and schedule jobs to make the most efficient use of resources.
Managed Print Services
Managed print services ensure compliance with HIPAA standards and minimize the risk of fraud. For example, a managed print service can store pharmaceutical prints in secure locations that only employees can access. Then, they can hold the prints until someone physically present enters a special code before they can access them.
Pharmaceutical reimporters in Europe have specific print requirements. Parallel trade occurs outside the distribution network of the pharmaceutical manufacturer, so these products must be repacked to comply with local laws. In addition, pharmaceutical re-importers must maintain records of their shipments and ensure that all information is correct. This means that print plays a vital role in parallel trade of pharmaceuticals.
Applications
Pharmaceutical printing is an emerging technology for the production of pharmaceutical products. These products are manufactured through 3D printing and use of different types of materials, including inks and powders. Inkjet-based 3D printing is the main printing technology in the pharmaceutical industry. It has many applications, including the fabrication of new dosage forms, such as microcapusles and antibiotic-printed micropatterns.
Growing Pharmaceutical Industry
The pharmaceutical industry is growing, thanks to advances in medicine and technology. Inefficiencies in printing can pose significant problems to the business. VA Business Systems offers solutions to meet the printing needs of pharmaceutical companies. These include: (1) printing in high-quality and high-contrast color; (2) adherence to regulatory codes; and (3) ensuring consistent and high-quality print quality.
Among the advantages of pharmaceutical printing is its ability to produce precise dosage forms that contain precise drug concentrations. Pharmaceutical printing is an emerging technology that has many advantages. It can lead to personalized medicine and reduce lead times.
Media
Pharmaceutical printing requires consistency in quality, accuracy, and readability. Any mistake in these documents can have dire consequences. According to the CDC, drug overdose deaths have increased from 6.1 deaths per 100,000 people in 1999 to 21.7 in 2017.
Managed print services, or MPS, can streamline the entire printing process at a pharmaceutical organization. They handle the installation of in-house printing equipment, manage equipment maintenance, and monitor usage. This allows pharmaceutical teams to focus on their patients and improve their customer service. Managed print services are also ideal for the research and development process, and can lower costs and improve processes.
FDA Requirements
Pharmaceutical labels must be printed with precise data to meet FDA requirements. For this reason, the pharmaceutical industry relies on high-end labeling solutions. NeuraLabel offers several label printers with advanced features for flexible, high-volume production. The Sprint and Sirius label printers offer white label printing, which is critical in the pharmaceutical industry.
With these technologies, a pharmacy can print a customized dosage form. The formulation can be tailored to a patient’s pharmacogenetic profile and dispensed at the patient’s healthcare point. The personalized dose can also help improve patient compliance. It is also possible to use 3D-printed drug formulations to create personalized dosages.
