April 10, 2018
To: All Bio-Rad Customers:
Re: Certificate of Analysis Changes for Ceramic Apatite Resins Products
Dear Valued Customer,
Bio-Rad strives to improve our customers’ experience and to standardize the formats for
the Certificates of Analysis (CofA) for our products. Bio-Rad is implementing changes
to the content of the CofA for our ceramic apatite products. There are no changes to
quality testing procedures, products or specifications.
Effective October 10, 2018, the following changes to the CofA for Ceramic Apatite
Resins will be implemented.
1. The FTIR spectrum will be removed from the CofA. The spectrum will be
available and customers will be able to obtain copies of the data per request by
contacting your local Bio-Rad support team.
2. There is no change from the current FTIR testing.*
3. The protein separation chromatogram will be removed from the CofA. The
chromatogram will be available and customers will be able to obtain copies of the
data per request by contacting your local Bio-Rad support team.
4. There is no change to the protein chromatography testing.*
5. Relating to Points 1 and 2 above, the following statement will be added to the
CofA: The FTIR spectrum and Protein Separation chromatogram are available
upon request by contacting your local Bio-Rad support team.*
6. The following statement indicating compliance to 21 CFR Part 11 will be added
to the CofA: This certificate is approved using a validated electronic system in
accordance with 21 CFR Part 11.*
7. The current wet signature is to be replaced with an electronic signature by Quality
Assurance as well as date/time stamp in compliance with 21 CFR Part 11.*
8. We will no longer provide a printed copy of the CofA with the shipment.
9. Customers will be able to download an electronic copy of the CofA at
www.bio-rad.com by providing the product catalog and control numbers. Refer to
Attachment 2 – Download Procedure for Certificates of Analysis to learn more.
The electronic CofA is to be approved by our QA organization.
A comprehensive listing of catalog numbers applicable to this change are found in
Table I - Catalog Numbers of Ceramic Apatite Resins products.
This change will enable our customers to obtain the CofA at their convenience. Also we
ensure Bio-Rad considers its environmental responsibility. Please direct any feedback to
Notification@bio-rad.com on or before July 10, 2018.
*Refer to Attachment 1 – CHT CoA Change Pictorial
Best regards,
Mario Vesnaver
QA Specialist
Bio-Rad Laboratories - Life Science Group
Table I - Catalog Numbers of Ceramic Apatite Resins Products
Ceramic Hydroxyapatite (CHT)
10 G
100 G
1 KG
5 KG
Type I, 20 µm
158-2000
157-0020
157-0021
N/A
Type I, 40 µm
158-4000
157-0040
157-0041
157-0045
Type I, 80 µm
158-8000
157-0080
157-0081
157-0085
Type II, 20 µm
158-2200
157-2000
157-2100
N/A
Type II, 40 µm
158-4200
157-4000
157-4100
157-4500
Type II, 80 µm
158-8200
157-8000
157-8100
157-8500
Ceramic Hydroxyfluoroapatite (MPC)
10 G
100 G
1 KG
5 KG
Type I, 40 µm
158-0200
157-0200
157-0201
157-0205
Ceramic Fluoroapatite (CFT)
10 G
100 G
1 KG
5 KG
Type II, 40 µm
158-5200
157-5000
157-5100
157-5500
Attachment 1
CHT CoA Change Pictorial
Page 1 Page 2 - removed
Page 3 - removed
Current
CHT CofA
New
CHT CofA
See expanded view of changes on next page
Remains
Unchanged
Remains
Unchanged
The FTIR spectrum and Protein Separation chromatogram are available upon request ..
This certificate is approved using a validated electronic system in accordance with 21 CFR Part 11.
Alice C Cheung__________________________________
This certificate has been verified and electronically
approved by an authorized Quality representative.
This e-s ignature is performed w ithin a secure system.
2017-08-24 / 19:07:35 UTC
Date/Time
Single Page
The FTIR spectrum and Protein Separation chromatogram are available upon request.
This certificate is approved using a validated electronic system in accordance with 21 CFR Part 11.
Alice C Cheung__________________________________
This certificate has been verified and electronically
approved by an authorized Quality representative.
This e-signature is performed within a secure system.
2017-08-24 / 19:07:35 UTC
Date/Time
New
CHT CofA
1. The FTIR spectrum and Protein Separation chromatogram
are available upon request via local Bio-Rad support team.
2. Statement indicating certificate is approved using a validated
electronic system in accordance with 21 CFR Part 11.
3. Electronic QA approval signature with date/time stamp in
compliance with 21 CFR Part 11.
April 10, 2018
To: All Bio-Rad Customers:
Re: Certificate of Analysis Changes for Chromatography Resins
Dear Valued Customer,
Bio-Rad strives to improve our customers’ experience and to standardize the formats for
the Certificates of Analysis (CofA) for our products. Bio-Rad is implementing changes
to the content of the CofA for our Chromatography products. There are no changes to
quality testing procedures, products or specifications.
Effective October 10, 2018, the following changes to the CofA for Chromatography
Resins will be implemented.
1. The current wet signature is to be replaced with an electronic signature by Quality
Assurance as well as date/time stamp in compliance with 21 CFR Part 11*.
2. The following statement indicating compliance to 21 CFR Part 11 will be added
to the certificates: This certificate is approved using a validated electronic system
in accordance with 21 CFR Part 11*.
3. We will no longer provide printed copy of CofA with the shipment.
4. Customers will be able to download an electronic copy of the CofA at
www.bio-rad.com
by providing the product catalog and control numbers. Refer to
Attachment 2 – Download Procedure for Certificates of Analysis to learn more.
The electronic CofA is to be approved by our QA organization.
This will enable our customers to obtain the CofA at their convenience. These changes
also ensure Bio-Rad considers its environmental responsibility. Please direct any
feedback to Notification@bio-rad.com on or before July 10, 2018.
*Refer to Attachment 1 – Sample CofA
Best regards,
Mario Vesnaver
QA Specialist
Bio-Rad Laboratories - Life Science Group
Bio-Rad Laboratories, Inc.
Certificate of Analysis
Material Description:
Chelex 100 Resin, 200-400, MB, Na, 50g
Material Number:
1421253
Control Number:
64167078
Manufacture Date:
2018-01-25
Expiration Date:
2020-11-15
Manufacturing Lot No.:
64151422
Characteristic Specification Results
pH
Lower Limit
10
Upper Limit
12
12 Pass
Copper capacity
0.3
0.3 meq/ml
Pass
Percent shrinkage: informational
46 %
Wet density: informational
0.68 g/ml
Particle size < 75 μm
5
0 % Pass
Particle size > 150 μm
10
0 % Pass
Total out of range
10
0 % Pass
T4 Ligation
Pass
This certificate is approved using a validated electronic system in accordance with 21 CFR Part 11.
Alice C Cheung
This certificate has been verified and electronically
approved by an authorized Quality representative.
This e-signature is performed within a secure system.
2018-01-25 / 17:48:50 UTC
Date/Time
3110 Regatta Blvd, Richmond CA 94804, USA
Page 1 of 1
Statement indicating certificate is approved using a
validated electronic system in accordance with 21 CFR
Part 11.
Electronic QA approval signature with date/time stamp in compliance with 21 CFR Part
11.
Attachment 2 - Download Procedure for Certificates of Analysis
