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Solon Manufacturing Facility

Our manufacturing facility in Solon, OH include two buildings totaling 275,000 sq. feet .
  • 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: 2003
  • ISO 9001 : 2008
  • 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