Small Volume Aseptic Parenteral Manufacturing

Our Focus

We specialize in supporting small pharma by producing small volume batches with a focus on aseptic production and providing quick turnaround for reduced lead times. Our facility is equipped with advanced technology and strict quality control measures to ensure the highest standards of safety and efficacy in aseptic filling. We offer tailored solutions, working closely with clients to accommodate their specific needs and adapt to changes in production plans. By partnering with us, small pharma companies can confidently bring their innovative products to market, relying on our commitment to excellence and our customer-centric approach to aseptic filling and production.

Singota specializes in providing cutting-edge aseptic manufacturing solutions tailored to meet the unique needs of our clients. Our state-of-the-art robotic aseptic filling technology operates within a completely gloveless workcell, ensuring highly repeatable and precise fills for small batch manufacturing. Ideal for the production of preclinical and clinical injectable products in vial, syringe, and cartridge formats, our system handles a wide range of formulations, including various proteins, biosimilars, peptides, oligonucleotides, other biologics, and small molecules. With completely automated filling, stoppering, and capping processes integrated within a single isolator, our approach ensures precision, repeatability, and eliminates the need for operator intervention. Additionally, we offer non-destructive fill weight verification, optional gas overlay during stoppering, and utilize standard container formats for vials, syringes, and cartridges to minimize line losses. Our comprehensive suite of onsite services includes analytical method development, validation and qualification, formulation development, and associated testing for identity, in-process, release (micro), and ICH stability. Moreover, Singota Solutions extends its support beyond manufacturing, offering finishing (labeling & kitting) and supply chain (storage & distribution) services to streamline the entire production process.

Equipped for Faster

Singota utilizes a Cytiva (formerly Vanrx) SA25 work-cell system consisting of automated filling, stoppering, and capping processes integrated within an isolator using VHP (Vaporized Hydrogen Peroxide) decontamination.

Our robotic aseptic filling is done in a completely gloveless environment that provides highly repeatable, precision fills for small batch manufacturing. Our System is ideally suited for the production of pre-clinical, and clinical injectable products in vial, syringe, and cartridge formats. Singota’s state-of-the-art equipment handles a wide range of small molecule, biological formulations and potent compounds.

Singota’s combination of capacity and capability is supported by deep regulatory knowledge. Clinical focus is a different sphere than commercial, and our familiarity with the regulatory process in that respect eliminates a time-consuming variable from our partnerships. We also have proven expertise in tech transfer for large-scale clinical needs and commercial manufacturing, to ensuring a smooth transition of validation of both manufacturing and analytical methods when our partners grow beyond us.

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The Process

Our aseptic manufacturing process is backed by a rigorous Quality Assurance (QA) program. We prioritize quality at every step to ensure the safety, efficacy, and sterility of our products. Our state-of-the-art cleanroom facilities, environmental monitoring, and qualified personnel uphold the highest standards of cleanliness. Thorough validation and qualification processes, along with comprehensive documentation, guarantee compliance and traceability. Quality control testing, including microbial and sterility tests, ensures the integrity of our pharmaceutical products. With our robust QA process, clients can trust us to deliver precision, reliability, and compliance in their manufacturing needs.

We are equipped to handle your project from start to finish, from developmental formulation services, aseptic production, inspections, to labeling and kitting

“Operating in the drug development space – primarily for small-batch aseptic manufacturing for preclinical and clinical use — Singota is keenly aware of the project scheduling challenges faced by our clients. We have built our business with the understanding that many factors affect drug development timelines, from the intricacies of cutting-edge chemistry to the unpredictable-at-times availability of raw materials, that are often beyond our clients’ control.”

Read our article on “Scheduling Aseptic Filling for Preclinical and Clinical Batches” along with our other blogs to gain insight from our experts on this process. 

Our State-Of-The-Art Aseptic Filling Technology Offers:

  Fast turnaround and shortened lead-times

  Standard container formats – nested, pre-sterilized configurations

  Vial, syringe, and cartridge filling 

  Single use, disposable components for product contact pathway

  Gloveless, robotic technology providing robust contamination controls

  Automated check weight capability and pump setting adjustments

  Minimized line losses, preserving scarce and expensive drug products

Singota focuses on small batch aseptic filling runs for:

Cytiva formerly Vanrx SA Aseptic Filling Machine Aseptic filling SA

  Preclinical Development

  Clinical Trials

  Reference Standards

  Placebo fills

Read about an aseptic filling project with an accelerated timelineTruly Focused on Faster – Case Study
More Information

Please utilize these resources for additional information about our Small Volume Parenterals Manufacturing:

Learn More About Aseptic Filling at Singota Solutions