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About Singota
- Singota’s facility is in Bloomington, IN
- We are ~90 minutes from major FedEx & UPS hubs
- Serving 200+ clients with active projects
- Large Pharma
- Virtual Pharma
- Consulting Firms
- Animal Health
Supply Chain
- 15-25°C
- 2-8°C
- -20°C
- -80°C
- Hazardous storage
- Open bonded warehouse location in Switzerland
- We offer temperature, relative humidity, and differential pressure monitoring where applicable
- We do not offer liquid nitrogen, cell bank, human tissues, beta-lactams, or cephalosporins storage currently
- Yes, Singota is FDA registered to handle storage of controlled substances (Scheduled CIII-CV).
- FDA Registration
- EU GMP Certificate
- Drug Distributor Accreditation
- Japanese PMDA
- DEA Licenses (Analytical, Distributor, Manufacturing)
- 3PL Licenses
- Singota is a ~72,000 ft² facility with a range of storage options. We have domestic and international partnerships to meet our client’s logistics and storage needs. Please contact us for specific open capacity and capability.
- Single use-disposable product contact items
- Utilize electronic documentation for weigh & dispense
- Sampling and Dispensing services cover:
- Powders and liquids
- Flammable, toxic, and potent materials
- Light, humidity, and static sensitive materials
Aseptic Manufacturing
- Cytiva (formerly Vanrx) SA25 workcell, an automated filling, stoppering, and capping process integrated within a gloveless isolator
- No human exposure to Grade A areas, no human intervention
- Pre-sterilized single use flow path, component sterilization
- Pre-sterilized, nested, Read-to-Use (RTU) components
- Syringes: 1mL Long, 1mL – 3mL standard
- Vials: 2R-30R
- Cartridges: 1.5mL
- We do not fill bags or bottles currently
- Aqueous based, parenteral aseptic filling
- We have experience from Pre-clinical to Phase 3
- Batch Sizes: <100 to 10,000 units
- Fill volumes: We have flexibility of formats and fill volumes
- We have a flexible schedule; We can work with our clients to meet their timeline(s).
Development and Testing
- Yes
- Sterility Testing USP <71>
- Bacterial Endotoxin Testing USP <85>
- Microbial Enumeration/Bioburden USP <61>
- Specified Microorganism Testing USP <62>
- Yes, ICH storage conditions and excursion capabilities
- For full list of services, please download our Service Offering fact sheet
- API and Drug Product release testing
- Raw material testing
- Infusion and material compatibility studies
- Container closure integrity testing (CCIT)
- Reconstitution studies
- Post packaging ID
Finishing Services
- Yes, we support development and clinical trial labeling and kitting needs.
- Services we offer:
- Labeling/De-labeling
- Re-labeling
- Kitting
- Blinded
Quality Status
- QOH – Quantity on hand / released status; this is the only status that permits material transactions (aliquot, ship, etc.)
- QC – Quarantine status
- QR – Quality hold status
- REJ – Reject status; this is for materials deemed unacceptable for use and/or destined for disposal.
- RESEARCH – Non-GMP status; this status indicates the material is only for non-GMP/not for human use.
- RETAIN – Retention status; designates the material is part of the retention program at Singota.
- STAB – Stability status; designates the material is part of a stability study at Singota.