OPUS® Columns (10cm - 60cm) delivery time: 6-8 weeks

OPUS® 5cm-60cm columns are packed in controlled classified clean rooms which meet ISO Class 7 non-viable particulate (NVP) standards. Buffer preparation occurs in a room which meets ISO Class 8 NVP standards.

  • Monitored weekly for viable as well as non-viable particles
  • Monitored for viable contaminants during packing operations while dosing chromatography resin into the columns
  • Restricted access area dedicated to the production of OPUS® columns only
  • Routine cleaning and disinfection schedule
  • Monitored room pressure differentials, 100% HEPA filtered air is used to maintain air quality
  • Required gowning procedures posted in all relevant areas 

LEARN MORE ABOUT REPLIGEN MANUFACTURING

To support customer filings, the OPUS® Columns Regulatory Support File contains the following sections:

  • Product specifications
  • Manufacturing procedures
  • Extractables and leachables
  • Shipping qualification
  • User instructions
  • Material certificates
  • Example Certificates of Analysis

OPUS® Regulatory Support File

OPUS® Pre-packed Column Configuration Options

In order to provide the most flexibility, OPUS® Pre-packed Columns are available for non-GMP and GMP applications. In general, OPUS® non-GMP and GMP Columns are identical except as noted in the table below.  Resin samples are not provided with OPUS® non-GMP Columns. OPUS® GMP Columns come with a resin sample for incoming resin identity testing at the end-user's facility. 

Certificate of Analysis example

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