OPUS® 2.5 - 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.
To support customer filings, the OPUS® Columns Regulatory Support File contains the following sections:
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 component||Manufacturing Pre-GMP
OPUS® 2.5 - 80R
|Manufacturing GMP Run Ready
OPUS® 2.5 - 80R
|Certificate of Analysis||♦||♦|
|Actual column diameter||♦||♦|
|Actual bed height||♦||♦|
|Resin lot number||♦||♦|
|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||♦||♦|
|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)||♦|