Sterile Liquid Filling & Packaging—Precision That Powers Diagnostics and Care

n diagnostic, medical, and life science applications, even the smallest inconsistency in liquid fills can compromise test results, regulatory approval, and patient safety. That’s why sterile liquid filling and packaging is one of the most mission-critical processes in regulated manufacturing.

At Ciro Manufacturing, we offer sterile filling services backed by ISO 13485 certification, rigorous process validation, and full traceability. From small pilot runs to high-volume product launches, we help you deliver precisely filled, contamination-free, ready-for-market liquid components.

What Is Sterile Liquid Filling?

Sterile liquid filling is the process of dispensing aqueous or biological solutions—like buffers, reagents, and media—into sterile containers in a contamination-controlled environment. These filled containers are typically part of:

• Diagnostic reagent kits

• Sample collection and transport devices

• Molecular and PCR test kits

• Medical device subassemblies

These liquids often need to be:

• Filled accurately to strict volume tolerances

• Sterile or aseptic, avoiding microbial contamination

• Sealed and labeled for long-term stability and traceability

Ciro’s Liquid Filling Capabilities

1. Filling Systems and Volume Flexibility

Our equipment handles:

• Volumes from 0.5 mL to 100+ mL

• Semi-automated and fully automated lines

• High-viscosity and low-viscosity liquids

• Multiple container types: tubes, vials, bottles, syringes

2. Sterile Environment and Cleanroom Controls

All filling takes place in our ISO Class 6 cleanroom, under ISO 13485 guidelines. This ensures:

• HEPA-filtered airflow and particulate control

• Temperature and humidity monitoring

• Cleanroom gowning and operator training

3. Capping, Sealing, and Labeling

We support various closure systems and labeling options:

• Screw caps, snap tops, foil heat seals, and tamper-evident caps

• Inkjet, thermal, or laser-printed labels

• Barcode and data matrix serialization for traceability

4. Batch Control and Documentation

Every production run includes:

• Fill weight verification and real-time monitoring

• Lot-based tracking

• Documentation: Batch Records, COAs, MSDS, and QC signoffs

Why Choose Ciro for Sterile Filling and Packaging?

• Compliance Confidence: Our ISO 13485-certified quality system aligns with FDA, CE, and IVDR regulations

• Speed to Market: Integrated in-house tooling, molding, and filling services reduce lead times

• Customizability: Tailored filling setups for novel products, pilot batches, or large commercial runs

• End-to-End Service: Seamless integration with kitting, packaging, and logistics

Ideal Use Cases for Our Sterile Liquid Filling

• Viral transport media (VTM) and stabilizing agents

• PCR reagents, buffers, and wash solutions

• ELISA kit buffers and diluents

• Saline, pH solutions, and extraction fluids

• Biotech and clinical trial formulation kits

Whether your fill needs are routine or complex, we provide the sterility, scalability, and compliance you need.

Case Study: A Rapid Diagnostic Buffer Fill Program

A client launching a rapid antigen test needed:

• A low-viscosity buffer filled into 3 mL vials

• Tamper-evident caps

• 300,000 units filled and labeled within 4 weeks

Ciro executed the full fill-seal-label-pack workflow under ISO 13485 with 100% lot traceability, enabling the client to hit their EUA submission deadline.

Final Thought: Liquid Filling That Delivers Confidence and Control

Precision filling is about more than volume—it’s about regulatory trust, product performance, and the protection of end users. At Ciro, we don’t just fill containers—we deliver compliant, consistent, and market-ready liquid solutions.

👉 Contact us today to start your sterile filling project.