The pharmaceutical industry is one of the most competitive, strictly regulated, and complex industries in the world. The manufacturers of pharmaceutical drugs are tasked with adhering to specific guidelines for the safety of their customers. If these guidelines are not followed precisely, companies risk drug recalls, lawsuits, extreme financial impacts and more. In an industry where brand image and trust are so important, these mistakes can have grave consequences for the future of a business.
Find out everything you’ve always wanted to know about the Drug Supply Chain Security Act (DSCSA) by downloading our infographic.
The development, manufacturing, and packaging of pharmaceuticals are labor-intensive due to the safety precautions required to meet regulations. These precautions can slow production and increase expenses. Fortunately, automation in pharmaceutical manufacturing is an incredibly efficient way to ensure that businesses are offering the best product possible while following safety guidelines and operating efficiently. By using cutting-edge automation technology, manufacturers can reduce expenses due to errors and increase production by increasing the speed of each process.
To maximize efficiency, it is essential to take advantage of automation in pharmaceutical manufacturing whenever possible. Below are some of the most effective types of automation to consider to increase profitability and assure quality products.
Due to the strict regulation of the pharmaceutical industry, it is important that every product that is produced is complete, non-defective, and accounted for. If one product does not meet the specific guidelines, the quality of the entire batch can come into question or be considered defective or incomplete.
For products with multiple parts such as a vial with a lid or stopper, the product needs to be complete with all pieces accounted for to ensure that there is no shortage during packaging and that the products are safe to use. The product also needs to be checked for quality and defects to ensure they meet safety and quality standards for the business. Abnormalities can include misshaped pills, products with holes or damage from production, as well as any products that do not belong and may become a safety hazard. This can be as simple as a differently sized vial or as dangerous as the wrong pill being mixed in.
To assure the safety of this process, an automated counting and inspection system can be put in place. These systems are tailored to be able to work with various product configurations which allows them to count, identify, and quality-check each product individually. This will enable companies to achieve consistently accurate results, removing the need for extra precautions and additional labor for testing.
Mislabeling is one of the leading causes of drug recalls, which is likely due to the incredibly strict requirements placed on labels of pharmaceuticals. Dosing, instructions, and ingredients are all included on the label, making the accuracy of the label vital for safe use. If one of these is omitted or incorrect due to a printing error, the product cannot be sold which can lead to costly and image-damaging recalls.
Additionally, pharmaceuticals are required to include serialization information on their labels. This consists of information such as the product id, production lot, date of manufacturing, and barcode to ensure that the individual product and batch can be identified if there is a recall. The serialization information also helps to combat tampering and ensure quality for the products, reassuring customers that the products are safe. Clarke Solutions offers Pharmaceutical Manufacturing consulting services.
Automated label printing and inspection systems offer the benefit of consistency for label printing and inspection. They are also able to print the necessary serialization information to protect the integrity of the products and comply with FDA regulations, reducing the risk of recalls and increasing productivity by speeding up text verifications.
Packaging ensures that your product can be transported and used safely without contamination or damage occurring. It is essential to check all aspects of the product’s packaging, from dimensions of the lid to the printing on the label, to ensure that everything is represented correctly.
When placed on the product, the label has a risk of misalignment that can be remedied by verifying the packaging quality to limit any imperfect products from leaving production. Additionally, once product packaging is filled and assembled, it is important to check that the packaging is secured and not able to spill, open, or be damaged leading to contamination.
Automation in pharmaceutical manufacturing allows for the process of verifying the overall quality of the product and packaging to be simplified to lower the risk of recalls. It ensures that the packaging is assembled correctly, the label adheres to the regulations, and that it is safe from contamination and safe to transport. In addition to the safety precautions the previous processes offer, automatic product verification allows for a near-total elimination of recall risk and ensures only high-quality products are released.
Being one of the most highly regulated and complicated industries, automation in pharmaceutical manufacturing offers unparalleled consistency, cost-efficiency, and recall risk mitigation. Partnered with our sister company, Acquire Automation, Clarke Solutions stands ready to provide you with the automation support you need in the areas of manufacturing and packaging.
To learn more about the Drug Supply Chain Security Act (DSCSA) download our infographic.