At Caldic, we support pharmaceutical manufacturers with a broad portfolio of pharma-grade solvents, combined with the capability to repack selected solvents under controlled cleanroom conditions. This allows us to deliver reliable, compliant, and flexible solvent solutions for both standard and highly regulated applications.
From sourcing and quality assurance to customized packaging and regulatory support, we help create clarity, continuity, and confidence across your solvent supply chain.
You can download our most up-to-date Pharma & Cleanroom Solvent List, including a clear overview of all available pharmaceutical-grade solvents and those suitable for cleanroom repacking, by completing the form at the bottom of this page.
Our operations are conducted in line with current Good Manufacturing Practice principles, supported by documented procedures, staff training, and robust quality systems governing solvent packing and holding. The facility operates in alignment with ISO 14644-1 cleanroom principles, ensuring strict airborne particle monitoring and validated performance.
We apply risk-based contamination control strategies consistent with EU GMP Annex 1 guidance, integrating facility design, equipment, and people management into a documented approach. In addition, our services are aligned with pharmacopeial and ICH guidelines for residual solvents and excipients, supporting global regulatory expectations.
Every batch of solvents begins with careful receipt and verification against specifications. Repacking then takes place in classified environments under GMP-approved procedures and in-process controls. To minimize contamination and operator exposure, we apply closed transfer systems such as dry-break couplings. Sampling is carried out in our GMP environment to avoid unnecessary product exposure on-site. Finally, each batch is supported by a full documentation package and delivered in IBCs, drums, or tailored packaging formats.
Take a closer look at how we operate. Our video provides an inside view of our GMP cleanroom facility in Belgium, showcasing the technology, protocols, and team behind our solvent repacking services.
Dry-break couplings automatically seal when disconnected, preventing leaks and minimizing residual loss. This technology not only protects product integrity but also enhances safety and efficiency during transfer.
With each delivery, customers receive comprehensive batch records covering line clearance, repacking, and traceability. Certificates of Analysis aligned to pharmacopeial monographs are included where applicable. Transparent records for change control and deviations support audits and supplier qualification processes. Environmental monitoring and cleaning validation data can also be provided to further support quality and compliance needs.
By combining advanced facilities with meticulous processes, Caldic sets a benchmark in solvent repacking. Our focus on safety, flexibility, and reliability ensures that pharmaceutical companies can depend on solvents of the highest quality, enabling them to deliver safe, effective medicines worldwide.
Learn how our GMP cleanroom services can support your production: contact our Benelux specialists or download the one-page overview for a concise summary of our capabilities. Together, we ensure solvent purity and a safer path to market for your medicines.
Cleanroom classes are defined by ISO 14644-1, which sets particle concentration and monitoring expectations. Our processes are aligned with these standards and with GMP requirements.
A documented CCS maps contamination risks across people, equipment, and facilities. By addressing them systematically, we reduce the risk of contamination and support consistent quality.
Yes. Our QMS and documentation are designed to support audits, and we provide the records required for supplier qualification.
They enable closed, spill-free transfers with minimal product loss, protecting both the solvent and the operator.
La industria farmacéutica y de salud opera en un entorno altamente regulado, donde la precisión, la seguridad, el cumplimiento y la confianza son esenciales. Caldic suministra ingredientes de grado GMP, apoyo regulatorio y suministro seguro desde el laboratorio hasta la producción. Te ayudamos a llevar soluciones al mercado más rápido, con confianza en calidad, cumplimiento y continuidad.
