Solon Manufacturing Facility

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

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

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)

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 a 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

Automated cleanroom liquid dispensing, capping, torqueing, and labeling equipment
Automated liquid dispensing, capping, torqueing, labeling, shrink sleeving equipment, 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

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