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Custom Buffer/Reagent Manufacturing and Filling Service

Along with component manufacturing services, we also offer reagent formulation, testing, filling, label control, inspection, and shipping.

Formulation

We can formulate any aqueous phase reagent from a few hundred milliliters up to several hundred liters.  Your team can decide the exact components required for your specific assay, kit, or reagent including buffering ingredients, detergents, and preservatives.  Reagents can be filtered to remove particulates.  Formulation will be performed in the cleanroom environment as required, either ISO 5, 6 or 7 depending on your needs.

Testing

We can perform testing per your standard operating procedures. All QC personnel receive extensive proficiency training prior to each project. Sample preparation and testing areas are separate to avoid contamination of test samples and to ensure accurate test results

Filling

Various filling methods are utilized at Ciro to meet your product needs. Automated filling and capping occurs in our cleanroom. Manual filling is performed with micropipettes, repeaters and peristaltic pumps and is performed in Laminar flow hoods under ISO 5 conditions. Manual filling for any volume from the microliter range to several liters is available.

Labeling, Label Control, and Inspection

Label design, label printing, and label application are all performed by trained personnel. Label reconciliation process in place to ensure all unused labels are accounted for and destroyed. Vial inspections are performed for all critical and noncritical defects

  • No/ Low Fill
  • Crooked/ Loose Cap
  • Label legibility
  • Damaged Vials/Caps

Packaging, Shipping, and Handling

Products can be stored in validated, temperature-controlled areas ranging from room temperature (15-25°C), 2-8°C, -20°C, or -70°C. Shipping validations can be performed as requested for customers to ensure the product arrives intact and maintains performance after delivery. We can assist you in selecting the appropriate types of packaging materials to ensure the safety of your product while in transit. We can arrange for warehousing your product and can fulfill and ship your orders upon receipt of a shipping request using the shipping courier of your choice.

Product Capacity

Depending on fill volume, we have internal capacity to produce 2,000,000 vial fills per week. Our systems are both semi-automated for lower production quantities, as well as full high-speed filling and capping automation. We are able to fill various liquids and volumes.

Please contact us today for a custom quote.