How to Produce Regulatory-Compliant Color on Pharmaceuticals
Studies show consumers identify medications by color. Pharmaceutical manufacturers must ensure accurate and consistent color on active pharmaceutical ingredients (APIs) and the final product to confirm conformance with FDA CF24 part 11 for electronic record-keeping.
Challenge
Accurate color is necessary for consumer safety and to minimize the risk of counterfeiting but producing consistent color across different product types and materials is challenging.
- Color is an indicator of product quality, stability, degradation, and efficacy
- Color is difficult to match between liquid, gel, film, and solid products
- Incorrect color can lead to expensive product recalls
- Visual evaluation alone cannot quantify APIs
- Regulated products require compliance tracking, but electronic record-keeping is difficult to maintain
Solution
Digital color solutions enable manufacturers to effectively communicate with Life Science brands and efficiently control the color of pharmaceutical products during formulation and production. By implementing an end-to-end color workflow that includes a non-contact spectrophotometer, formulation software, quality control software, and a light booth, manufacturers can confidently formulate the correct ratio of API to additives and produce color-consistent pharmaceutical products. X-Rite digital color solutions meet FDA 21 CFR Part 11 for system access and electronic recordkeeping.
Results
A color control system offers fast ROI, usually within 6 months.
- Improve color communication and quality
- Formulate consistent recipes that account for API color, concentration, and haze
- Validate tolerance adherence and catch color drifts early
- Minimize errors caused by visual evaluation
- Reduce waste and recalls due to mismatched color
- Track, prove, and integrate conformance data into electronic record-keeping
- Scale from a single location to a global, multi-facility enterprise
How it Works
- The brand digitally communicates product color and acceptable tolerance.
- The manufacturer measures the color of API and uses formulation software to create a color recipe and establish the API/additive ratio.
- Throughout production, the manufacturer takes measurements using a spectrophotometer fitted with an attachment to hold powders, liquids, and other difficult to hold samples.
- The measurements are automatically loaded into quality control software which displays measurement results as numbers and graphs.
- The manufacturer can easily assess variations in color and opacity on pills, liquids, gels, capsules and more to ensure each product is within tolerance or reformulate if necessary.
- Quality control software digitally tracks conformance to FDA standards and creates a compliance audit log that details each event with operator ID, date, time, etc. for use in electronic record-keeping to validate compliance.
- If the brand supplies a physical standard or reference, the manufacturer can compare it against the production sample in a light booth to ensure color harmony under controlled lighting.
- Quality assurance software automatically verifies and optimizes spectrophotometer performance and corrects for drift for measurement confidence across global sites.
Featured Products
A benchtop sphere spectrophotometer that provides measurement flexibility with switchable reflectance and optional transmission apertures to evaluate color and haze on opaque, translucent, and transparent liquids, powders, films, small pills, and more. Ideal for supply chains, the Ci7800 offers industry-leading ≤0.08 dE* inter-instrument agreement and ≤0.01 dE* repeatability for operator confidence and consistent measurements.
The Ci7800 can be adapted with accessories, including a test tube holder and reflectance cuvette to measure liquid, a port up accessory feet kit to take vertical measurements on samples like powders, a 25 mm glass aperture to present specimens behind glass, and transmission kits to hold translucent and transparent samples and liquids for repeatable measurements. The Ci7800 integrates seamlessly with Color iMatch formulation software, Color iQC quality control software, and NetProfiler performance optimization software.
With a retractable location-aware sample positioner and aperture sizes ranging from 2mm to 12mm, the MetaVue VS3200 can capture precise measurements on a variety of samples without contact. Digital targeting and on-screen preview in Color iQC software enable precise alignment for repeatable spectral data, even on powders, liquids, curves and tiny pills and capsules.
To handle multiple sample shapes and sizes, the MetaVue VS3200 can be adapted with accessories, including a benchtop stand that converts the instrument with a sample arm for holding objects in place and sample cups to hold powder and liquid samples. MetaVue VS3200 integrates seamlessly with Color iMatch formulation software, Color iQC quality control software, and NetProfiler performance optimization software.
Formulation software to accelerate color development for thin plastics and capsules. Color iMatch achieves excellent first match performance, requires fewer correction steps, and generates audit and compliance logs for electronic recordkeeping.
Quality control software to receive digital color standards and tolerances from the brand, evaluate color and opacity adherence throughout production, and export audit and compliance logs for electronic recordkeeping.
A cloud-based blend of software and color standards that makes it easy to adjust and validate instrument performance, identify instruments in need of service, and reduce variation between devices so you can trust that measurement differences are accurate indicators of color change and not a result of instrument variability.
A top-of-the-line light booth to visually assess physical samples under 7 versatile light sources. The SpectraLight QC can help build standard operating procedures across the pharmaceutical supply chain with settings for every program, custom profiles based on brand owner requirements for light source, illumination, and other parameters, and unprecedented reporting and traceability.
Achieve Color Success
A digital color solution from X-Rite enables Life Science Brands and Pharma Manufacturers to produce consistent color across product types, track compliance, and generate an audit trail.
