Compliance Labeling
Key Factors in Choosing a Solution
GHS Labeling Compliance
The Globally Harmonized System of Classification and Labeling of Chemicals (GHS), created by the United Nations, provides guidelines for creating labels and safety data sheets that universally communicate information and warnings about hazardous materials Manufacturers, as well as importers, distributors, and users of chemical substances, are required to comply with the standards.
GHS labeling includes pictograms — one set for container labels and workplace safety warnings and another for use during transport of dangerous goods. They also include signal words such as “Danger” or “Warning,” and statements describing the nature of the hazard, whether they are to human health or the environment, and precautionary measures that handlers should take. There are additional requirements involving size, print media, and the use of color.
Information on US government’s implementation of the GHS standard can be found at the United States Department of Labor’s OSHA website.
Know and Follow the Regulations for Proper Labeling of Chemicals
Peak Technologies can ensure you are using the right label at the right time. Our expertise will guide you in determining the best solution based on factors including:
- Size of Label
- Number of SKUs
- Print Volume
- Existing Equipment
- Hot Printing System
- Software
Peak Technologies Has GHS Certified Solutions for You
- Preprinted certified labels using press Inks
- Certified blank labels
- Thermal transfer printing
- Laser printing
- Inkjet printing
- Media match
UDI Labeling Compliance
Regulations that Govern the Labeling and Identification of Medical Devices
Each medical device must have a Unique Device Identifier (UDI) on all levels of packaging including shipping boxes or crates. For device that can be used multiple times, the UDI must also be directly marked on the device itself. UDIs enable healthcare providers to collect device performance data, accurately track hospital inventory, track devices in the event of a recall, and reduce the risk of unapproved or counterfeit devices.
Ever since the FDA published its final rule in 2013 for labeling medical devices, manufacturers have been challenged to find the right solutions that address their particular products and that keep them in UDI labeling compliance.
The FDA website has more information about the benefits of UDI labeling and a timetable for compliance dates.
Using UDIs
Each UDI consists of two numeric or alphanumeric parts:
- The device identifier (DI) is assigned by one of three FDA-accredited issuing agencies and includes unique numbers indicating the manufacturer and the specific model or version of the device.
- The production identifier (PI) includes information such as lot or batch number, serial number, and manufacture or expiration dates.
Regulations give manufacturers some flexibility when they choose how best to incorporate this information on their labels, as long as it is readable both by human eyes (in plain text) and by automatic identification and data capture (AIDC) technology. Several types of 1D and 2D barcodes or RFID tags are acceptable, depending on product type and package size.
Find UDI-Compliant Solution Options at Peak Technologies
Peak Technologies offers several solutions that can address your UDI labeling requirements:
- Printers: We provide a wide range of printers that can produce the barcodes or RFID tags you need, providing crisp UDI labels that are durable and easily machine-readable. Our thermal transfer solutions offer the full breadth and depth of printing on a wide variety of specialized substrates. In addition, Peak provides full color on-demand label printing solutions from Epson for applications where the need for dynamic color is required or desired.
- Software: Peak Technologies can advise you on the best enterprise labeling software to facilitate compliance with FDA standards, in addition to making label production and management easier. For example, our partner TEKLYNX offers TEKLYNX CENTRAL CFR, which is designed to facilitate FDA label compliance.
- Labels and Tags: We carry a wide selection of labels, including custom media options, to fit UDI needs. In many cases, UDI labels must be able to withstand extreme environments. Our specialized labels can withstand sterilization, hold up against cleaning agents used in hospitals, last the life of product disposal, and meet UL standards.
Walmart RFID Compliance
If your goods are sold in Walmart stores across the U.S. or Puerto Rico, or on Walmart.com, beginning on September 2, 2022, several products entering stores must have RFID tags (radio frequency identification) and be 100% readable by RFID readers or you will be deemed noncompliant. The product categories impacted include, but may not be limited to, items in home goods, electronics, toys, sporting goods, and automotive. Our team of experts can help implement a solution for your business to meet Walmart’s RFID requirements.
