Solon Manufacturing Facility
Liquid manufacturing
Liquid and aseptic processing
Powder blending and processing
Cleanroom liquid manufacturing and fill/finish
Core Capabilities
- Manufacturing and supply of high-purity biochemicals, reagents, and custom services for life sciences
- Manufacturing, quality control testing, dispensing, finishing, assembly for regulated and non-regulated products and the appropriate quality system infrastructure
- Products provided as bulk, finished goods, private label, OEM, and VWR brand
- Supply chain and logistics solutions
Industry Segments and Applications
- Diagnostics
- Molecular Diagnostics
- Biopharmaceutical
- Molecular Biology
Major Products
- Product types: In Vitro diagnostic products, excipients and bioprocessing chemical materials, raw chemical materials for further manufacturing, finished goods and contract manufactured products for life science
- Chemical categories: inorganic salts, sugars, carbohydrates, buffers, chaotropic agents, amino acids, detergents and surfactants, dyes and stains, organics, and liquid and powder blends and reagents for these categories
- Specialty life science product categories: electrophoresis products, enzymes, PCR products, protein purification and detection, nucleic acid purification and detection, cell culture, bacteriological media, dyes/stains/indicators, histology
Quality Systems
- FDA Registered Facility for Contract Manufacturing of Medical Devices (21CFR820)
- ISO 13485
- ISO 9001
- ISO 17025 Accredited for select laboratory methods
- EXCiPACT certified (for scope of products)
Quality Control Capabilities and Instrumentation
- Analytical instrumentation capabilities: HPLC, ICP, AA, titration, spectrophotometry, Karl Fisher, Polarimetry, Melting point, pH, Conductivity, Osmolality, APHA, and more
- Analytical testing capabilities: Compendia specification testing (USP, NF, EP, JP, BP), general chemistry testing
- Molecular testing capabilities: PCR, qPCR, DNase, RNase, Protease,
- Microbiology testing capabilities: bioburden, sterility, and endotoxin
- Functional testing to variety of custom requirements, utilizing customer instrumentation, where applicable
- Technology transfer: method and instrument transfer for custom needs
- Method, equipment, and environment validation
- Environmental monitoring program
- Water system monitoring program
Major Production Equipment
- Automated cleanroom liquid dispensing, capping, torqueing, and labeling equipment
- Automated liquid dispensing, capping, torqueing, labeling, shrink sleeving, boxing, and palletizing
- Automated glass ampoule filling and sealing
- Liquid compounding up to 10,000L lot size capability with mixing technologies including re-circulating batch mixing
- Automated and semi-automated labeling systems for vials and bottles
- Semi-automated small volume powder dispensing
- Dedicated excipient and bioprocessing materials handling work center and dispensing equipment
- Powder blending and compounding up to 2 metric ton single lot capability
- Particle size reduction equipment
- Supersack handling equipment
- Multiple reverse osmosis high-purity water purification systems yielding USP and EP water qualities
- Small-scale tablet pressing and lyophilization
Controlled Environment Manufacturing Capabilities
- ISO classed, qualified cleanrooms
- Controlled cleanrooms for manufacturing and dispensing
- Controlled, dedicated excipient and bioprocessing handling work centers
- Controlled cleanrooms for nucleic acid handling with DNA contamination control
- Isolated booths with dedicated HVAC for segregation
- Temperature and humidity controlled areas
- Validated temperature controlled and continuously monitored warehouses, coolers, and freezers
- Light-sensitive handling areas
- Hazardous/flammables handling areas