With global attention focused on new COVID-19 vaccinations, the importance of effective, safe pharmaceutical products has never been clearer.
Any erosion of consumer trust in the purity and safety of such products can spell disaster for pharmaceutical manufacturers—and even threaten public health. In addition, quality issues can cause manufacturers to run afoul of strict regulatory rules and standards, resulting in hefty fines. Manufacturers of pharmaceutical products need confidence that every process input and ingredient meets the highest standards for purity and traceability.
All U.S. Borax facilities are committed to producing exceptional products, but our operations team in Coudekerque, France are experts in high-quality, specialty borates. In particular, the Coudekerque team applies its collective expertise to refine and distribute numerous specialty products—such as high-purity boric acids, sodium metaborate, sodium pentaborate, sodium tetraborate decahydrate, potassium tetraborate, potassium pentaborates, and ammonium pentaborates—for use in highly-regulated industries, including pharmaceutical manufacturing and nuclear energy.
Innovation and application of refined borates at Coudekerque
From a technical standpoint, the processes in place at Coudekerque are unique. Our quality-tested refined borates are shipped from our plant in Boron, California to France, where they undergo a second
multi-step refining process to reach the highest levels of purity.
These specialty borates meet manufacturing specifications not just for purity but also for granulometry and chemical form, making them perfectly suited for high-stakes industries such as pharmaceuticals and nuclear power production:
- Pharmaceuticals: Borates produced in Coudekerque for the pharmaceutical industry conform to current European Pharmacopoeia (EP) standards. They are used in a range of applications, including skin care and moisturizing eye drops (artificial tears).
Borax decahydrate is a mild alkaline salt that excels as a gentle cleanser and buffering agent. Optibor® boric acids provide pH buffering and act as a cross-linking agent.
EP- and NF-grade pharmaceutical products manufactured at Coudekerque conform to the current edition of the European Pharmacopoeia (EP) or National Formulary (NF).
- Nuclear energy: U.S. Borax borates provide essential radiation absorption for shielding, control, and safety applications in nuclear reactors and certain medical therapeutics.
Optibor boric acids and sodium pentaborate are used as precursors for isotopically enriched boron-10 materials.
Taking the quality of specialty borates to the next level
To ensure that manufacturers—and eventually consumers—can trust the quality and consistency of the products they receive, our Coudekerque facility has developed a highly specialized quality management system.
We conduct a wide range of analyses, using a variety of methods to reach a product’s specified quantification limits. For example, standard borate products are measured in tens of parts per million.
High-purity borates measure down to the hundredth of parts per million
Measured controls include assay, granulometry, impurities, anions (such as chloride or sulfates), and cations (such as sodium or calcium).
Our quality management system has been developed in compliance with crucial industry standards and meets important certification requirements:
- Certificate of Suitability (CEP): A certificate of Suitability to the Monographs of the European Pharmacopoeia delivered by EDQM (European Directorate for the Quality of Medicines & HealthCare) enables pharmaceutical manufacturers to easily administer Marketing Authorization Applications (MAA) for their products and offers optimal cost management and control.
- Good Manufacturing Practices (GMP) of Active Pharmaceutical Ingredients certification: Ensures our manufacturing, laboratory, packaging, storage, and distribution processes all comply with important industry benchmarks. Processes for producing high-purity products at Coudekerque are validated against the GMP to demonstrate their ability to produce high-quality products. We regularly monitor critical production parameters to prevent process deviations that could affect product quality.
- 10 CFR 50 Appendix B of the U.S. Nuclear Regulatory Commission (NRC): Sets quality assurance criteria for nuclear power plants and fuel reprocessing plants.
- 10 CFR 21: Establishes expectations for reporting of defects and noncompliance.
- ISO 9001:2015: Specifies requirements for quality management systems. Our facilities in Boron and in Coudekerque hold this ISO certification for mining, processing, production, testing, sales, and shipping in Boron and for refining, production, and internal transfer in Coudekerque.
Traceability is another must for our customers. The Coudekerque facility has a full traceability system, recording product information spanning every step from production to shipping. We record:
- Product name
- Batch number
- Pallet number
- Bag number
- Production date and time
- Production operators for each process step
- Critical parameters
- Quality analyses results, including raw data
- Lab technician names
- Names and dates associated with batch release
- Any issues that occur, whether during production, testing, or at any other stage or location
This in-depth tracing process even enables us to track which customers received specific batches of product. Together, these records ensure full accountability to our customers.
Inside the lab: Ensuring purity for specialty borates
Serving the best interests and specific needs of our customers is a priority for U.S. Borax and the Coudekerque facility. Depending on the industry, these needs can be highly specialized and all require increased purity of product.
The Coudekerque portfolio comprises more than 60 SKUs and supports 10 production, milling, or packing lines. Only three lines are in operation at any time. The facility also features a room dedicated to performing high-purity analyses, using two ionic chromatographs and atomic absorption spectroscopy (flame and hoven). We also produce our own ultra-pure water for use in our processes and employ quality control and assurance teams staffed with ISO- and GMP-trained individuals.
Quality standards for borates and our customers
Our Coudekerque facility’s quality processes are only the beginning of our dedication to customer satisfaction:
- For customers who want to conduct their own testing before placing an order, we’re happy to provide samples.
- Our technical support personnel are available to answer any borate-related technical or laboratory service question—before or after purchase.
- Although U.S. Borax pharmaceutical products have no expiration date, the Coudekerque lab can retest products for pharmaceutical customers when product approaches the 3-year mark to verify product quality.