What Medutest charges to answer the pyrogen question
We submitted vials for endotoxin determination and report the results, the method and the laboratory, because a pyrogen figure without a method is as empty as a purity…
Endotoxin
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Turnaround, cost and accreditation across the services this trade relies on
We asked all four services what they can determine, on what timescale, at what price, and under what accreditation. The answers are printed in full.
Janoshik, Medutest, PeptideMeter, VendorInvestigate: a capability audit
Four independent services underpin confidence in this market. All four are competent at chemistry. Microbiology is a different accreditation, a different facility and a…
Why TFC can be entirely straightforward and still tell you nothing about bioburden
The Journal has read several hundred certificates from twenty companies. We set out what the documents actually cover, and what a reader is filling in from imagination.
What changed after we published the first version of this
None of what this piece asks for is commercially sensitive, and all of it is already known to whoever released the batch.
What the four services actually offer, test by test
A compendial sterility test takes fourteen days of incubation and consumes the containers tested. That timescale is incompatible with the business model that made…
LAL, kinetic chromogenic, recombinant factor C: three ways to the same figure
We submitted vials for endotoxin determination and report the results, the method and the laboratory, because a pyrogen figure without a method is as empty as a purity…
What the four services actually offer, test by test
Endotoxin is the more tractable of the two questions, and a kinetic chromogenic determination is neither slow nor exotic. It is simply not on the menu.
The cleanroom grade nobody names on the paperwork
The compendial sterility test cannot demonstrate that a batch is sterile. It can only fail a batch that is grossly contaminated. Everything else is process validation.
Why a dead-clean sterile filter can pass pyrogen straight through
Bacterial endotoxin is a heat-stable lipopolysaccharide from the outer membrane of Gram-negative organisms. It survives sterilisation, passes a sterilising filter, and is…
Endotoxin is not a microorganism, and killing the bacteria does not remove it
The masking phenomenon known as low endotoxin recovery means a formulation can return a clean result while containing endotoxin the assay cannot see.
Why the independent testing market grew a chemistry arm and not a microbiology one
The absence of microbiological capability in this market is a commercial fact with a straightforward explanation, and it is worth understanding before blaming anybody for it.
What Medutest charges to answer the pyrogen question
The masking phenomenon known as low endotoxin recovery means a formulation can return a clean result while containing endotoxin the assay cannot see.
A vial can be 99.4 per cent pure and not sterile in the same afternoon
Purity, content, identity, sterility and endotoxin are five separate determinations. A single sheet of paper carrying one of them is not evidence about the other four.
What Medutest would need in order to certify sterility, and why it does not
A compendial sterility test takes fourteen days of incubation and consumes the containers tested. That timescale is incompatible with the business model that made…
Why the independent testing market grew a chemistry arm and not a microbiology one
The absence of microbiological capability in this market is a commercial fact with a straightforward explanation, and it is worth understanding before blaming anybody for it.
LAL, kinetic chromogenic, recombinant factor C: three ways to the same figure
Three compendial method families are in routine use and a fourth, based on a recombinant enzyme rather than crab lysate, is now compendial in its own right.
What the four services actually offer, test by test
A compendial sterility test takes fourteen days of incubation and consumes the containers tested. That timescale is incompatible with the business model that made…
How to read the silence on a certificate you already hold
Our position is about documentation practice. It is not an allegation about anybody’s honesty, and we are explicit about the difference.
A vial can be 99.4 per cent pure and not sterile in the same afternoon
The Journal has read several hundred certificates from twenty companies. We set out what the documents actually cover, and what a reader is filling in from imagination.