Cleanroom-Ready CRS-300 Prefilled Syringe Filling Machine 3600 Pcs/Hour Switching Formats in 15 Minutes

• Sterile by design: the filling zone is a separate Grade A laminar flow tunnel with a 0.3 m per second downflow and a fully welded 316L stainless steel interior, so the machine is supplied ready for cleanroom installation and IQ/OQ documentation.
• 15 minute format changeover: tool-free quick release nest plates and magnetic stopper tooling allow operators to switch syringe volume, barrel length and cap type within a single shift, keeping a multi-product line productive.
• Validated line clearance: a built-in clearance checklist guides the operator through every step of the changeover and records the operator ID, timestamp and removed components, producing a printable clearance record for the batch file.
• Gentle handling of sensitive biologics: a low shear peristaltic filling path with a servo controlled pinch valve minimises foaming and shear stress when handling proteins, vaccines and viscous gels.
• Integrated weight check: an in-line checkweigher rejects any syringe outside the 1 percent tolerance band and sends the result to the batch report, so fill accuracy is documented rather than assumed.
• Cleanroom friendly footprint: the compact 2.2 metre frame, recessed cabling and IP65 rated control cabinet reduce cleaning time and allow installation inside an existing barrier system without major civil work.

The CRS-300 suits contract manufacturing organisations that produce small and medium batch sizes across many syringe formats, including hyaluronic acid fillers, saline and heparin flush syringes, vaccine diluents, ophthalmic viscoelastic devices, veterinary injectables and dental anaesthetics. Because the filling path is peristaltic and the format tooling is interchangeable, the same machine can run a 30,000 piece vaccine batch in the morning and a 2,000 piece batch of high value dermal filler in the afternoon without a mechanical rebuild. The downstream interface accepts standard labelling, visual inspection, plunger rod insertion and blister packing modules, and the upstream interface is compatible with nest denesters and tray loaders.

Before shipment, the CRS-300 is assembled, dry-run tested and then filled with placebo to confirm repeatability across the full speed range. The documentation package includes the IQ/OQ protocol, material certificates for all product contact parts, calibration certificates for the checkweigher and a cleaning validation guide. The machine is shipped in a plywood case with a vacuum barrier bag, desiccant and shock sensors, and lifting points are marked on the frame for cleanroom installation. A twelve month warranty covers mechanical, electrical and control components, and our engineering team provides remote commissioning support together with a spare parts list that keeps critical wear items, silicone tubing and nest plates available for five years.