Best Practices for Coloring Medical and Healthcare Plastic Products

Best Practices for Coloring Medical and Healthcare Plastic Products With an increasing demand in the medical plastics market globally, manufacturers are pioneering high-quality resins that raise the standards of excellence in health care. Advancements in plastics are curbing medical costs and enhancing patient safety. The current USD market was 22.2 billion in 2017, anticipated to grow at a Compound Annual Growth Rate (CAGR) of 6.1% during the forecast period through 2026. The medical plastics industry also continues to make advancements that are improving product performance and design. Medical-grade plastics are designed to meet many stringent regulatory requirements and can be chemical, corrosion- and temperature-resistant. Color helps users to recognize tools, remember instructions, and identify instruments. Typical medical and pharmaceutical applications include packaging, medicine bottles, dental and surgical tools, catheter tubing, and others. Best Colors For Medical and Healthcare Products It is often overwhelming to choose the best color for your medical or healthcare products. Imagine that you are in an emergency room, hospital room, or a medical professional's office. Most colors are used for a specific usage (color-coding), and in many cases, define the application. For example, reds, oranges, and yellow hues help the medical staff more easily locate "Start" or "Off" buttons. They also help the maintenance staff find an entry to repair equipment and help them locate life-saving devices in the dark. Color also delivers the aesthetics desired by a medical device brand, such as corporate logos or a brand's unique colors. It sets their equipment apart from its competitors. Medical devices in the U.S. fit into three classes depending upon critical risk factors: Class I, Class II, and Class III. Each device class requires a different level of regulation and compliance. When you decide on the product classification, you can then find the rules for color and communicate them to your color supplier. One good example is the color guide for medical caps and closures. Colors For Caps and Closures in the Medical Industry The colors on phlebotomy test tubes contain information not only about what's inside, but also where the containers should be in a laboratory. Tubes marked with either 1-D or 2-D scannable barcodes indicate what coagulants or anticoagulants are present inside with the blood samples. But color-coded caps speed up storage and retrieval times, reduce the risk of lost or misplaced samples and eliminate laboratory errors. Standard tube closure colors include: Purple or lavender: Utilizes EDTA as an anticoagulant, which helps prepare plasma, whole blood, and bone marrow specimens. Light blue: Contains sodium citrate that acts as an anticoagulant to prepare citrated plasma for coagulation testing. Red: Contains no anticoagulant or other additives, typically used for serum or clotted whole-blood specimens. Gold: Mixed samples with a clot activator and serum gel separator for chemistry, serology, and immunology tests. Gray: Utilizes potassium oxalate and sodium fluoride to prevent coagulation and preserve the glucose in whole blood for specific chemistry tests. Drug Master Files (DMF) Save Time And Money An essential concern for any molder of medical devices is for components to meet the necessary FDA registrations for the production and distribution of medical devices for commercial shipping in the United States (U.S.). Medical and pharmaceutical companies also have a responsibility to ensure that their products meet safety guidelines and protect consumers against harmful substances and reactions. Drug Master Files (DMF) provide a way to communicate information on the facilities, materials, and elements used to manufacture and package drugs and medical devices. The FDA does not require DMFs for raw materials or components used in the preparation of drug substances. If one is on file, the FDA may reference it in new drug applications as an indication that all sites, processes, and materials are safe for use with pharmaceutical products. About Drug Master Files: Drug Master Files, or DMFs, are submissions to the Food and Drug Administration to provide confidential, detailed information about facilities, processes, and other specifics used to manufacture, process, pack or store drugs intended for human use. They streamline the process of securing FDA approval for medical and pharmaceutical plastics applications, which can help a manufacturer or brand owner get products to market faster. DMFs fall into five categories, according to the FDA: Type I for manufacturing facilities and procedures Type II for drug substances and preparation Type III for packaging materials Type IV for excipients, flavors, and colorants Type V for FDA accepted reference information. DMFs are confidential, allowing a manufacturer to disclose important safety-related information without disclosing proprietary business information. Pharmaceutical businesses and associated firms and vendors often look for suppliers whose products are pre-packaged with DMFs to cut down on delays in getting their products to market. Companies that maintain up-to-date DMFs tend to be viewed as more credible by customers and clients. “API (Active Pharmaceutical Ingredients) manufacturers with a large number of DMFs are often considered more reliable in terms of quality, regulatory standing, and ability to meet Current Good Manufacturing Practice (cGMP) requirements,” according to Balance.com, a financial website. Having an up-to-date DMF is an indication of both credibility and reliability. Chroma Color offers a catalog of colors, additives and concentrates packaged with FDA- accepted DMFs. The Primary Benefits of Drug Master Files -All materials used for the storage or packaging of drugs and medical supplies fall under the FDA’s Type III designation. Filings are not required, but maintaining DMFs offers a range of business advantages, including: -Faster FDA Approval: Having up-to-date DMFs for drug containers, bags, closures, and other components dramatically reduce the time required for FDA approval. A speedier review process means that products can get to market more efficiently. -Confidentiality: DMFs provide a way to maintain transparency with the FDA while protecting proprietary manufacturing processes and procedures. DMFs are required when two or more firms work together to manufacture a product. -Flexibility: Supplier-maintained DMFs allow for greater flexibility when changing vendors and packaging partners. - A pharmaceutical company that uses Chroma Color for colorants, compounds, or masterbatches can contract with any molder or packaging facility without having to re-file a DMF. Type III DMFs and Drug Packaging Materials Type III DMF files also apply to stored devices with components exposed to drug substances, including individual and pressurized containers, bulk containers, cap closures, liners, inner seals, resins/elastomers, and valve closure systems, according to APG-Pharma.com, a European laboratory, and pharmaceutical packaging company. Components manufactured with polyethylene or polypropylene resins, both of which are compliant with food additive regulations (FAR). Certain colorants and functional additives may also chemically affect drug substances, so they, too, need DMFs on file. The FDA also takes into consideration any material properties that might affect the safe use of plastics with drugs or medical supplies, including: - Light exposure - Reactive gases - Moisture permeation/water vapor transmission - Extractables - Child resistance Any such properties could interact negatively with certain drugs and materials, which could, in turn, cause severe harm or result in reduced effectiveness of the product. Sterilization Techniques and Impacts on Polymers Some materials will also degrade or change during specific sterilization processes. Most thermoplastics can withstand exposure to sterilization without any significant changes to their properties or color. But there are exceptions, so it is best to have your team work with a reputable company early in the product development stage to work to ensure your product maintains the sterile barrier, and meets all assembly/ distribution requirements. The following sterilization techniques can be used with plastics, though each has advantages and disadvantages. Dry Heat Dry heat sterilization takes place in an oven chamber. Sterilization occurs through convection – the surrounding air heats the surface of the items. Hot air is either heated slowly, replacing cooler air (gravity convection) or blown into the chamber (mechanical convection). Although somewhat effective at killing pathogenic organisms, dry heat sterilization is unable to reach every part of a product with temperatures high enough to kill pathogens. Also, most plastics degrade quicker when exposed to dry heat regularly. Autoclaving Autoclave sterilization involves injecting saturated steam into a sealed chamber. Temperatures, times, and chamber pressure differ depending on the situation. Steam penetrates nearly every part of a tool or device and takes even less time to complete than the dry heat process. Depending on the type of plastic, autoclaving can get hot enough to cause a product to lose its structural integrity. Silicones, most fluoropolymers, polypropylene, and other polymers designed for high heat exposure handle autoclaving well. Thermoplastics, PET, nylons, and acrylics will not and may need to be supported during autoclaving

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