You are using an unsupported browser.
Some features of this site may not function properly. For optimal user experience, please view this site in Chrome, Firefox, Safari, or Edge.

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在ISO 9001质量管理体系下开发和生产用于生物制药行业的产品。我们专注于及时交付高质量、一致且稳健的产品,以确保我们客户的业务连续性。

关于Repligen生产

  • 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
分析证书
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)