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BioPharma Services >> Resources >> FAQS

Frequently Asked Questions

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Below are FAQs that are normally asked by our customers about the different services we provide.

TESTING SOLUTIONS

I am sending my products in for testing at Eurofins | ams and am told that a validation test needs to be performed. Why is a validation test necessary?

For any new (previously not tested by Eurofins | ams) products that are sent in for testing (i.e. TGO 77 testing, PET, Sterility, Endotoxin, etc), a validation of the product for that particular test will need to be performed. The objective of the validation test is to demonstrate the suitability of an analytic method for its intended purpose on a particular product . This is a one-off test. 

Do you perform the various tests that is required to meet the Therapeutic Goods Order No. 77 (TGO 77) requirement?

Yes we do. We perform these tests regularly for our customers from the Pharmaceuticals industry. You can read more about these tests here.


Do you perform the tests required by Therapeutic Goods Order No. 54 (TGO 54) for registration of disinfectants with Therapeutic Goods Administration (TGA)?

Yes we do. We perform these tests regularly for our customers who are Consumer products manufacturers. You can read more about these tests here.


Why must I provide the Endotoxin Limit of the sample for LAL testing?

Endotoxin limit for the sample is required for our staff to calculate the Maximum Valid Dilution (MVD) of the product.
A majority of the substances tested for endotoxin interfere with the LAL test to some degree. Fortunately, the LAL test is usually more sensitive than necessary to detect the endotoxin limit for a given product or material. It is often possible to overcome interference by diluting the sample to a point at which the interfering factor ceases to affect the test, but at which the endotoxin limit concentration is still detectable. The greatest dilution at which the endotoxin limit can be detected is the MVD. 


We need to conduct environmental monitoring for our facility but we do not know how to do it, can you help us?

Yes we can certainly help. We perform a range of tests on environmental monitoring samples that our customers have. The list of tests are shown here. We also can work with our customer to develop and execute a validation or monitoring plan for their facility. Contact us to discuss further.

In the AS/NZS 4020 Test, what happens during the cold water application?

Products are tested at 20°C and covered up to <40°C


In the AS/NZS 4020 Test, what happens during the cold and hot water application?

Products are tested at a temperature between (40 – 100)°C

Do you perform any food testing?

No, we do not. Our business focus is on Pharmaceutical Products testing. Therefore, we are NOT NATA accredited for Food Testing.
 

SURCHARGES

What is the surcharge for urgent testing?

This depends on the type of test required, the quantity and nature of the samples, the urgency of the testing (starting same day or next day). If we are able to make changes to our operation schedules to fit in your test and perform it as per standard, no surcharge will be incurred. However, a surcharge is incurred when additional test apparatus, reagents or manpower is needed beyond the standard test requirements. Please contact us to discuss about your tests schedule to avoid such a scenerio.

 

SAMPLE SUBMISSIONS

What is the minimum quantity required for my samples?

The minimum quantity required for your samples varies depending on the tests that is being performed. You can find out about the amount of samples required by going to the respective test write-ups found on the testing solutions page here. Otherwise, please contact us to make an enquiry.


How and when should we send the samples in?

Samples must be delivered to the laboratory between 0900hrs and 1700hrs, Mondays to Fridays. For all samples send to Eurofins | ams for analysis or testing, please include a completed copy of the Sample Submission Form. You can find out more about this on our Sample Submission Forms page.