Frequently Asked Questions

What accreditations and Certifications does CellSera Australia hold?

• ISO 13485:2016
• ISO   9001:2015
• EU accreditation 4133
• Granted a certificate of Suitability for Foetal Bovine Serum and Adult Bovine Serum by EDQM
• cGMP certification
• HACCP certification

 

What is the minimum amount of FBS I can purchase?

The smallest amount of FBS we sell is 1 x 50mL sample bottle.

 

Does CellSera have a freezer storage facility?

Yes, we can store frozen products for our costumers. Please contact us for further details.

 

What tests are included on the FBS Certificate of Analysis (CoA)?

A list of available tests can be found here. We can also add more tests if required.

 

What tests are included on the Pharmaceutical Grade FBS Certificate of Analysis (CoA)?

A list of available tests can be found here. We can also add more tests if required.

 

What is the difference between the Sterile Filtered FBS and Pharmaceutical Grade FBS

Pharmaceutical grade FBS is virus tested to the current EMEA guidelines, where as the Sterile Filtered FBS is not. The actual serum is identical.

 

Where does product testing occur?

All of our testing is done at independent accredited laboratories all around the world.

 

What other testing can I have done?

We have a large range of tests available, but more can be added upon request. 

 

What treatments does CellSera offer?

We offer heat treatment as well as gamma irradiation at any dose you require.

 

What shipping options are available?

Air freight (Foam cartons + dry ice) 
Sea freight (20 or 40 foot -20º refer container)

 

What paperwork is supplied with the serum?

Depending on where you are located, we will provide all of the necessary paperwork in order for you to import the serum. This includes but not limited to:
• Health certificate signed by the Department of Agriculture (Australian)
• A signed letter by the DA confirming Australia’s freedom of BSE/TSE
• Certificate of Australian Origin signed by the Australian Business Chamber
• Commercial Invoice (customs purposes)
• Packing List (customs purposes)
• Airway Bill / Bill of Lading
• We can also provide batch-manufacturing records that allow us to trace the origin of each individual bottle.

 

Can we arrange a customer audit?

Yes. Audits can be arranged at any time, please contact us for further information.

 

Do you sell serum from other countries?

We only produce and sell products of Australian and New Zealand Origin.

 

 

 

*Free 50mL sample will be issued at our discretion. Depends on how many bottles you would need to order from that batch. Otherwise 50mL samples can be purchased.