Ensuring solvent purity in pharmaceutical production

In pharmaceutical production, solvent purity is critical for patient safety and product efficacy. Even the smallest trace of contamination can create serious risks. To address these challenges, companies increasingly rely on partners that operate under Good Manufacturing Practice (GMP) standards. 

Caldic is a trusted partner in customized solvent repacking. At our state-of-the-art cleanroom facility in Belgium, we provide GMP-compliant services that ensure reliable quality and reduce contamination risks. 

Cleanroom advantages

  • Pharmacopeia-grade repacking

    Solvents that meet excipient and medicinal standards.

  • Risk minimization

    Secure handling in controlled cleanroom environments.

  • Flexible delivery options

    From bulk supply to IBCs and drums.

  • GMP-standard processes

    Supporting global API and intermediates producers with small-batch precision.

  • Regulatory compliance

    Documentation support in line with pharmaceutical requirements.

  • Consistent supply

    Reliable availability to safeguard production continuity.

Compliance and standards we align to 

Our operations comply with current Good Manufacturing Practice regulations, including documented procedures, staff training, and robust quality systems governing solvent packing and holding. The facility operates in line 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, integrating facility design, equipment, and people management into a documented approach. In addition, our services respect pharmacopeial and ICH guidelines for residual solvents and excipients, supporting global regulatory compliance. 

 

Our process at a glance 

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. 

Inside our cleanroom 

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. 

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Why closed transfer matters 

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. 

Documentation you can expect 

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. 

A partner in excellence 

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. 

If you would like to learn more about how our GMP cleanroom services can support your production, our team is here to help. Get in touch with our Benelux specialists through the contact form below, or download the one-pager for a concise overview of our capabilities. Together, we can ensure solvent purity and create a safer path to market for your medicines. 

Frequently asked questions 

What cleanroom standards are relevant to solvent repacking? 

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. 

How does a contamination control strategy support quality? 

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. 

Do you support regulatory audits and supplier qualification? 

Yes. Our QMS and documentation are designed to support audits, and we provide the records required for supplier qualification. 

What is the value of dry-break couplings for solvents? 

They enable closed, spill-free transfers with minimal product loss, protecting both the solvent and the operator.