Best Practices for Coloring Medical and Healthcare Products

With an increasing demand in the medical 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 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 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 or 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

Some materials will also degrade or change during specific sterilization processes. Most 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 to prevent slumping or distortion.

Irradiation Two types of radiation for sterilization purposes include gamma rays and E-beam. Both methods can generate free radicals in a that can lead to degradation as polymer chains are damaged. But as long as the product sterilized is adequately resistant to ionizing radiation (all thermoplastics are, for example), the "absorbed dose" of radiation on each polymer is enough to destroy the DNA chain of microorganisms.

Gamma rays have higher penetrating power than E-beam, which allows for a denser, tighter packing of products in the sterilization chamber. The thicker the packaging, the more the edges of the items will absorb radiation. Each polymer type has a margin of error for ionizing radiation that may or may not account for excess radiation at the edges.

Ethylene Oxide Gaseous chemicals sterilize polymers such as Ethylene Oxide, or EtO, is a potent alkylating agent. The downside to EtO is that it is incredibly toxic, possibly carcinogenic, and is explosive when mixed with air.

EtO can be used on most polymer types because it does not degrade plastic and has no effect on heat-sensitive polymers such as thermoplastics. EtO can leave a toxic residue. Product guidelines require the residue removed from tools or devices before use.

Advancements In Sterilization Despite current sterilization requirements, a bacterial infection is still a significant issue around the world in polymer-based medical tools and devices. Because of the dangers of disease, scientists are continually working toward discovering better methods for sterilization.

One of the most promising experimental methods involves X-rays. X-rays penetrate deeper than both gamma and E- beam radiation and do so with a better dose uniformity ratio (DUR). The problem of gamma radiation over absorption does not exist with X-rays.

X-rays also trigger far fewer polymer reactions, allows for their use on some of the more fragile polymers previously sterilized with toxic EtO gas. Finally, X-ray sterilization accomplishes much quickly than either gamma or E-beam and X-rays, resulting in far less environmental impact. Radiation-resistant polymers make plastics stand up better and longer to ionizing radiation sterilization techniques.

Better anti-bacterial/bacteria-repellent, polymer-based biomaterials are in development to cut down on bacterial infections. Polymers and polymer additives (such as antimicrobial additives like MicroBlok) that resist bacterial accumulation on polymer surfaces are now available.

Use of Quality Materials Today, medical manufacturers are less concerned with the price of materials than the quality to align with the needs of the market and changes in government regulations.

High-caliber medical thermoplastics such as (PVC), polyethylene (PE) (PS), and elastomer (TPE) compounds made with FDA or biocompatible compliant ingredients remain critical to the medical device design process. At the same time, the market for , ABS, , and polyetheretherketones (PEEKs) is expanding.

Photo Caption: blue color concentrate from Chroma Color because it performed well, met our needs for being semi-transparent, and matched Aspire’s EMST150 product line.

Match Colors To Resins

One of the biggest challenges related to coloring plastic medical products is accurately matching the desired color with a specific resin. It is critical to establish a partnership with your color and additives supplier early on in the development process to ensure particular color and performance attributes.

The colorant supplier considers the unique resin, color, and performance requirements for the application because each resin viscosity, melt processing temperatures, natural resin color, etc. are distinct. Ask your color supplier to assist with critical application decisions from the onset regarding the carrier resin, pigment systems, stabilizers, and other additives.

Typically, your supplier will use color sample chips or Pantone color charts to pinpoint the desired color for each plastic product or part. During this selection process, colors may look different depending on gloss, grain, , resin type, light sources, and other factors.

Right Color Concentrate For The Job

The manufacturing of medical-grade polymers must minimize the risk of pathogenic microorganisms. Plastic compounding, masterbatches, and a wide variety of additives for plastics are available from Chroma Color to meet medical polymer specifications.

When it comes to pharmaceutical packaging, being the first and being the best are incredibly crucial. Focusing on the development and purity of a product is more important than ever. Two essential trends in pharmaceutical packaging, lab services, and clean compounding offer innovative solutions to safeguarding the purity of the product and staying ahead of your competition.

Lab Services — Success for every great product starts in the lab. Pharmaceutical packaging companies go to great lengths to make sure their labs are top-notch. This is why so many companies work on receiving their ISO 17025 accreditation. ISO 17025 ensures the lab's testing proficiency and calibration accuracy, as well as the staff's technical competency.

Labs are the nucleus for developing, formulating, and testing new and existing products. Independent validation of a company's people and processes give you a significant competitive advantage. Yet many companies were initially reluctant to seek ISO 17025 accreditation due to its stringent requirements. In recent years, more companies in the medical industry lean on the certification because it allows them to substantiate their claims of technical credibility and the knowledge of their staff.

Clean Compounding Center Purity and cleanliness are of the utmost importance in the pharmaceutical industry, particularly for applications that use antimicrobials in conjunction with their resin. After the 2012 multi-state fungal meningitis outbreak, the FDA ramped up its investigation of pharmaceutical companies. Leading to a record number of recalls: 2,061 in 2013-2014, compared to a total of 2,217 in the previous nine years combined (as noted by Regulatory Affairs Professionals Society). The massive outbreak also caught the industry's attention, spurring companies to seek a better way to protect them from the threat of contamination.

Clean compounding centers help fight contamination caused by sunlight degradation, particulates, and chemical and human interaction, which are constant threats in the pharmaceutical packaging industry. Built for enhanced quality control, these centers are the ultimate protection from outside infiltration, using U.V. filtration systems to help create a stable production environment. Moreover, pharmaceutical companies have millions (and potentially billions) of dollars invested in their products, which makes the need for clean compounding centers more imperative than ever before.

In medical plastics, vibrant and long-lasting colors are essential to patient and user safety. Companies that include Chroma Color Corporation have been developing technology that makes vibrant long lasting colorant less expensive without sacrificing quality.

BASICS Of PATENTED G2, G3 COLOR TECHNOLOGY

Chroma’s patented G2 and G3 Technologies deliver the ultimate solution for reducing the cost-to-color and for enabling sustainability without sacrifice

Designed for Cost Optimization

-G-Series masterbatches yield the lowest the cost-to-color available today

-G-Series masterbatches have the highest pigment loadings, highest dye loadings, and the highest additives loadings available in the industry today

-PP, PE & PET packaging produced with G3 does not compromise pigment dispersion and distribution in processing

-G-Series masterbatches offer all of the benefits of liquid colorants without the mess, hassle and waste

Designed for Sustainability

-Reduced Carbon Footprint

-Production requires low energy consumption

-3 Truckloads of traditional concentrate can be replaced by 1 truckload of G3

-Reduced Waste

-Zero waste vs. liquid color’s excessive waste

-Improved Coloration of PCR Resins

- Successful track record in coloring PCR PP & PE, Bio plastics, Ocean Plastics, PIR, and other sustainable resins

About Chroma Color Corporation Chroma Color Corporation is a technology-leading specialty color and additive concentrate supplier in the plastics marketplace. Chroma's extensive technical leadership and manufacturing expertise, coupled with its game-changing colorant technologies, have surprised and delighted customers for over 50 years. Chroma's wide-ranging markets include packaging, wire, cable, building, construction, consumer products, medical, healthcare, lawn and garden, durables, sanitation, recreation and leisure, transportation, and more. https://chromacolors.com/