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OPUS® 5 - 80R Pre-packed Columns
GMP Manufacturing

For large-scale GMP manufacturing, OPUS® 5 - 80R Columns are packed in ISO 7 cleanrooms under a best in class ISO 9001 quality system.

Manufactured in ISO Class 7 clean rooms

OPUS® 5 - 80R 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.

Repligen develops and manufactures products for the biopharmaceutical industry under an ISO 9001 quality management system.  We focus on the timely delivery of high quality, consistent and robust products, to ensure business continuity for our customers.

about repligen manufacturing

  • Monitored weekly for viable and 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 used to maintain air quality
  • Required gowning procedures posted in all relevant areas 

Complete Regulatory Support File

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
  • Product contact materials

OPUS® Regulatory Support File

Certificate of Analysis for each column configuration

OPUS_columnpacking2.jpg

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.  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

Certificate component Manufacturing Pre-GMP
OPUS® 5 - 80R
Manufacturing GMP Run Ready
OPUS® 5 - 80R
Certificate of Analysis
Catalog number
Lot number
Serial number
Actual column diameter
Actual bed height
Resin type
Resin lot number
Shipping/Storage buffer
Packing date
Asymmetry result
Theoretical plate count (N/m) result
TSO 9001 Compliance Statement
Product Contact Materials Compliance Statement
(animal-free, EMEA 410/01, USP Class VI)
Copy of Resin Certificate of Analysis
Packing environment
QC chromatogram
Chromatography resin control statement  
Resin sample for QC analysis  
Endotoxin test result <0.25 Eu/ml (pass/fail)  
Bioburden test result <10 CFU/ml (pass/fail)