Aseptic Injectable Manufacturing
We specialize in supporting small pharma by producing small volume batches with a focus on 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 offered in our aseptic filling services. 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 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 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 automation, 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.
Our Focus
We specialize in supporting small pharma by producing small volume batches with a focus on 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 offered in our aseptic filling services. 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 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 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 automation, 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.
State of The Art 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
Formats and Capabilities:
- Syringes 1 mL Long, 1 mL Standard, 2.25 mL Standard, 3mL Standard
- Vials 2R, 4R, 6R, 8R, 10R, 15R, 20R, 30R
- Cartridges 1mL, 1.5mL
- Typical Batch Size 0.5L – 100L
Singota Focuses on Small Batch Runs For:
- Preclinical Development Services
- Clinical Trials
- Reference Standards
- Placebo fill