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What are the recommendations for the storage of collected extracts?

by Paul Phillips | Apr 23, 2020

Refrigeration may be good for the short-term storage of samples. Sample containers should be inert glass, Teflon or stainless steel. We also recognize that the sample storage issue is important, with many opinions. It is always a point of consideration because the...

What are the recommendations regarding the liquid/liquid extraction (LLE) method?

by Paul Phillips | Apr 23, 2020

The BioPhorum protocol published 2014 recommends three extractions with dichloromethane (DCM) at 1:1 (volume/volume) ratio. It is allowed to alter volume ratios or the number of extraction cycles to reach sufficient spike recovery and LOD of the standard(s) used in...

Why are no pure organic extraction solvents included in the BioPhorum protocol published in 2014?

by Paul Phillips | Apr 23, 2020

An extractable profile for pure organic solvent is sometimes overkill and not as representative of what is relevant to the processes, which BioPhorum members have been concerned with. Therefore, using a pure organic solvent is not relevant and not needed for our...

Will a user pay for extractables testing if the request falls outside of the BioPhorum protocol?

by Paul Phillips | Apr 23, 2020

Exceptions may arise from time to time. In these cases, an agreement should be reached between the single-use system (SUS) supplier and the customer regarding costs, e.g. the request can be performed as a fee for service by the supplier.

What is the recommendation when an end-user asks for an analysis not mentioned in either the BioPhorum protocol or the subsequent standard user requirements?

by Paul Phillips | Apr 23, 2020

Additional tests may be requested by an end-user where they deem it necessary for their product/process. In such cases, it will be for the user and supplier to reach an agreement on this testing and the related funding.
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