Process chromatography primary container change for 5 L and 10 L chromatography resins

Date: 
2021-10-26

Chromatography Resins

This is a permanent change to the primary container of the product (see appendix 1 for list of products). The original containers will be substituted with HDPE Carboy (rectangular) with tamper evident caps with the same volume capacity. The new containers were evaluated by Material Review Board and conform to requirements and meet the product specifications. Drop and Leak tests were performed and passed to ensure product integrity during shipment. We will use the new containers, 10 L and 20 L, for the products listed in appendix 1 in Quarter 1 of 2022.*

 

Specification: Original Container New Container (Jerrycans)
Size 10 L 10 L
  20 L 20 L
Material construction Low Density Polyethylene High Density Polyethylene
Tamper evident seal Yes Yes

 

 

  • Current round containers (carboy)

    Current round containers
  • New 10 L/ 20 L container (carboy)

    New container

 

Summary of the outer Box change:

This is a permanent change to the outer, non- product contacting box (see appendix 2 for list of products). Bio-Rad Laboratories, Inc. to be more eco-friendly will begin shipping in Kraft brown box. Both the white (current) and Kraft (future) boxes have the same dimensions, thickness, and material. The only difference is the outer color, where the original box is bleached white, while the new box is not. This is not a product contacting box. This will not affect form, fit, function or intended use of the finished product.

See Appendix II for list of products impacted

If additional information is required, please reach out to your local Bio-Rad Laboratories representative or NorCal-Quality-Assurance@bio-rad.com

*Please note that the original container (round) could be substituted for the new container (rectangular) in the future if we encounter global supply shortages.

 

Appendix I: List of Products Impacted by the Primary Container
Product contained in 10L HDPE Carboy Product contained in 20L HDPE Carboy
Bio-Rad Part Number Product Description Bio-Rad Part Number Product Description
1560042-3HT 3HT Macro-Prep High Q 3HT, 5L 1560043-3HT 3HT Macro-Prep High Q-3HT, 10L
1300152 BIO-GEL HT, 5 L 1510451 BIO-GEL A-1.5M, FINE, 10 L
1537308 DEAE Affi-Gel Blue, 5 L 1510731 BIO-GEL A-5M, COARSE, 10 L
12004040 Nuvia IMAC Uncharged Resin 5 L 1510752 BIO-GEL A-5M, FINE, 10 L
1530024 Macro-Prep 25 Q, 25 µm, 5 L 1510741 BIO-GEL A-5M, Medium, 10 L
1530034 Macro-Prep 25 S, 25 µm, 5 L 12003686 Macro-Prep CM B.A. 10 L
12003676 Macro-Prep DEAE B.A. 5 L 1560073 Macro-Prep CM, 50µm, 10 L
1560022 Macro-Prep DEAE Support, 5 L 12003677 Macro-Prep DEAE B.A. 10 L
12003681 Macro-Prep High Q B.A. 5L 1560023 Macro-Prep DEAE Support, 10 L
1560042 Macro-Prep High Q, 50 µm, 5 L 12003682 Macro-Prep High Q B.A. 10 L
1560042 Macro-Prep High Q, 50 µm, 5 L 12003682 Macro-Prep High Q B.A. 10 L
12003671 Macro-Prep High S B.A. 5 L 1560043 Macro-Prep High Q, 50 µm, 10 L
1560032 Macro-Prep High S, 50 µm, 5 L 12003672 Macro-Prep High S B.A. 10 L
12003690 Macro-Prep Methyl HIC B.A. 5 L 1560038 Macro-Prep High S BPL 10 L
1560082 Macro-Prep Methyl HIC, 50 µm, 5 L 1560033 Macro-Prep High S, 50 µm, 10 L
12007380 Nuvia aPrime 4A 5L 12003691 Macro-Prep Methyl HIC B.A. 10 L
1563405 Nuvia cPrime 5 L 1560083 Macro-Prep Methyl HIC, 10 L
12003720 Nuvia cPrime Media B.A. 5 L 12003695 Macro-Prep T-BUTYL HIC B.A. 10 L
12006659 Nuvia HP-Q 5 L 1560093 Macro-Prep t-Butyl HIC, 10 L
12007033 Nuvia HP-Q B.A. 5 L 12007391 Nuvia aPrime 4A 10 L
12003725 Nuvia IMAC Ni-CHARGED B.A. 5 L 1563406 Nuvia cPrime 10 L
12003233 Nuvia IMAC Resin, 5 L 12003721 Nuvia cPrime Media B.A. 10 L
  12007023 Nuvia HP-Q 10 L
  12006994 Nuvia HP-Q B.A. 10 L
  12003715 Nuvia HR-S B.A. 10 L
  1560517 Nuvia HR-S, 10 L
  12003726 Nuvia IMAC Ni-CHARGED B.A. 10 L
  12002782 Nuvia IMAC Resin, 10 L
  12004039 Nuvia IMAC Uncharged Resin 10 L
  12003711 Nuvia Q B.A. Media B.A. 10 L
  1560417 Nuvia Q MEDIA,10 L
  12003707 Nuvia S B.A. 10 L
  1560317 Nuvia S, 85 µm, 10 L
  12003699 UNOsphere Q B.A. 10 L
  1560107 UNOsphere Q, 10 L
  12003703 UNOsphere S B.A. 10 L
  1560117 UNOsphere S, 10 L

 

Appendix II: List of Products Impacted by the Outer Box Change
Bio-Rad Part Number Product Description Bio-Rad Part Number Product Description
1300152 BIO-GEL HT, 5 L 1510451 BIO-GEL A-1.5M, FINE, 10 L
1537308 DEAE Affi-Gel Blue, 5 L 1510731 BBIO-GEL A-5M, COARSE, 10 L
12004040 Nuvia IMAC Uncharged Resin 5 L 1510752 BIO-GEL A-5M, FINE, 10 L
1530024 Macro-Prep 25 Q, 25 µm, 5 L 1510741 BIO-GEL A-5M, Medium, 10 L
1530034 Macro-Prep 25 S, 25 µm, 5 L 1560073 Macro-Prep CM, 50 µm, 10 L
12003686 Macro-Prep CM B.A. 10 L 1560023 Macro-Prep DEAE Support, 10 L
12003677 Macro-Prep DEAE B.A. 10 L 1560043 Macro-Prep High Q, 50 µm, 10 L
12003676 Macro-Prep DEAE B.A. 5L 1560043-3HT Macro-Prep High Q-3HT, 10 L
1560022 Macro-Prep DEAE Support, 5 L 1560038 Macro-Prep High S BPL 10 L
1560042-3HT Macro-Prep High Q 3HT, 5 L 1560033 Macro-Prep High S, 50 µm, 10 L
12003682 Macro-Prep High Q 3HT, 5 L 1560033 Macro-Prep High S, 50 µm, 10 L
12003681 Macro-Prep High Q B.A. 5 L 1560093 Macro-Prep t-Butyl HIC, 10 L
1560042 Macro-Prep High Q, 50 µm, 5 L 12007391 Nuvia aPrime 4A 10L
1560042 Macro-Prep High Q, 50 µm, 5 L 12007391 Nuvia aPrime 4A 10 L
12003672 Macro-Prep High S B.A. 10 L 1563406 Nuvia cPrime 10 L
12003671 Macro-Prep High S B.A. 5 L 12003721 Nuvia cPrime Media B.A. 10 L
1560032 Macro-Prep High S, 50 µm, 5 L 12007023 Nuvia HP-Q 10L
12003691 Macro-Prep Methyl HIC B.A. 10 L 12006994 Nuvia HP-Q B.A. 10 L
12003690 Macro-Prep Methyl HIC B.A. 5 L 12003715 Nuvia HR-S B.A. 10 L
1560082 Macro-Prep Methyl HIC, 50 µm, 5 L 1560517 Nuvia HR-S, 10 L
12003695 Macro-Prep T-BUTYL HIC B.A. 10 L 12003726 Nuvia IMAC Ni-CHARGED B.A. 10 L
12007380 Nuvia aPrime 4A 5L 12004039 Nuvia IMAC Uncharged Resin 10 L
1563405 Nuvia cPrime 5 L 12003711 Nuvia Q B.A. Media B.A. 10 L
12003719 Nuvia cPrime Media B.A. 1 L 1560417 Nuvia Q MEDIA,10 L
12003720 Nuvia cPrime Media B.A. 5 L 12003707 Nuvia S B.A. 10L
12006659 Nuvia HP-Q 5 L 1560317 Nuvia S, 85 µm, 10 L
12007033 Nuvia HP-Q B.A. 5 L 12003699 UNOsphere Q B.A. 10 L
12003725 Nuvia IMAC Ni-CHARGED B.A. 5 L 1560107 UNOsphere Q, 10 L
12002782 Nuvia IMAC Resin, 10 L 12003703 UNOsphere S B.A. 10 L
12003233 Nuvia IMAC Resin, 5 L 1560117 UNOsphere S, 10 L