AMI’s Medical Marking and Coding Solutions Used in Clean Rooms
The pharmaceutical and medical industry is one of the most closely scrutinized and strictly regulated sectors, particularly when it comes to marking and coding. Proper labeling is crucial for ensuring patient safety, maintaining product integrity, and complying with stringent regulatory standards. In this blog post, we’ll explore marking and coding medical and pharmaceutical products and how Automated Marking Inc. (AMI) can help manufacturers meet these critical standards.
Marking and Coding Medical Items Requirements
In the United States, the Food and Drug Administration (FDA) sets forth comprehensive guidelines for the labeling of medical and pharmaceutical products. These regulations often require the use of 2D codes and multiple lines of human-readable information. This combination ensures both machine readability for efficient tracking and human readability for quick identification by healthcare professionals and patients.
Key elements that may be required on medical product labels include product name and strength, lot or batch number, expiration date, manufacturer information, Unique Device Identifier (UDI) for medical devices, National Drug Code (NDC) for pharmaceutical products, and dosage instructions and warnings.
It’s important to note that labeling requirements can vary depending on the specific type of product and its intended use. Manufacturers should always consult the FDA’s website for the most up-to-date labeling requirements to ensure full compliance.
AMI’s Medical Marking and Coding Solutions
At Automated Marking Inc., we understand the critical nature of accurate and reliable marking in the medical and pharmaceutical industries. Our state-of-the-art Thermal Inkjet (TIJ) printers are designed to meet and exceed the stringent requirements of this sector. Our graphic printers offer resolutions ranging from 300 DPI up to 600 DPI, ensuring crisp, clear prints that meet regulatory standards for legibility. Our systems allow for simultaneous printing of essential information, including 2D codes, lot numbers, expiration dates, and other required details.
TIJ machinery paired with cartridge-based ink technology ensures your production environment remains pristine – a crucial factor in sterile medical and pharmaceutical settings. Many of these facilities require clean rooms which are highly controlled environments used for producing medical and pharmaceutical products. These rooms’ quality control is managed down to the number of particles permitted in the air to produce the safest products for consumers. Leaking heads or high maintenance equipment is not permitted in these facilities. Our printers are integrated into many clean room environments since the advanced, leak free, & zero-maintenance solutions provide reliable performance, without the mess which is critical for upholding the integrity of sensitive pharmaceutical operations.
Our equipment offers easier direct-to-product marking, reducing downtime and increasing productivity. AMI’s products support reliable traceability, regulatory compliance, product safety, quality assurance, and anti-counterfeiting measures. Our marking solutions work as hard as you do, providing consistent, high-quality results throughout your production runs.
