Aseptic Manufacturing
Singota Solutions specializes in supporting companies of all sizes with flexible, small‑batch aseptic manufacturing for injectable products. Our customer‑centric approach focuses on collaboration, adaptability, and quality to help innovative programs progress efficiently from bench to batch.
Aseptic Injectable Manufacturing
Our aseptic injectable manufacturing platform leverages state‑of‑the‑art gloveless robotic filling technology and rigorous quality controls to ensure the highest standards of safety and efficacy. Designed for preclinical and clinical programs, we specialize in aqueous‑based parenteral aseptic filling with flexible formats and adaptable fill volumes, supporting batch sizes from 200 to 20,000 units per batch while working closely with clients to meet evolving program needs and project‑specific timelines.
What We Offer
Formats: Pre-Filled Syringes, Vials, and Cartridges
Capabilities: Preclinical Development Services, Reference Standards, Clinical Trials, and Placebo Fill
Small-Batch: 200 to 20,000 Units per Batch
- Automated Check Weight Capability & Pump Setting Adjustments
- Standard Container Formats: Nested, Pre-Sterilized Configurations
- Minimized Line Losses, Preserving Scarce & Expensive Drug Products
Robotic Filling Technology
Our SA25 workcell technology, developed by Cytiva (formerly Vanrx) and first implemented in North America by Singota Solutions, delivers fully automated filling, stoppering, and capping within a gloveless isolator. This advanced design supports exceptional precision and repeatability, eliminates operator intervention in Grade A environments, and enhances sterility assurance through a pre‑sterilized, single‑use flow path and sterilized components.
Explore Our Robotic Filling Technology
Inspection Capabilities
- USP Compliant Manual Visual Inspection
- Parenteral & Non-Parenteral Products
- Primary & Secondary Packaging
- Support of Shipping Validation Activities
Finishing Capabilities
- Label Development: De-Labeling & Re-Labeling
- Kitting for Clinical Trials
- Tailored Labeling for: Ambient (15 – 20°C), Refrigerated (2 – 8°C), Frozen (-80°C), & Cryogenic applications (-150°C)
Explore Our Clinical Distribution Finishing Services
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