Why a dead-clean sterile filter can pass pyrogen straight through
The limit for a parenteral product is calculable from the dose and the body weight in two lines. Almost nobody in this trade performs the calculation.
Fill & finish
Page 7 of 11 of this archive, newest first.
Who signed this, and what did they undertake by signing it
What the Journal asks when a document arrives unsigned, and what the answers have been.
Who signed this, and what did they undertake by signing it
Two signatures — one who performed the work, one who approved its release — are the ordinary regulated convention and are almost unknown here.
Everything on the page, in the order a chemist would read it
The purity figure is the least informative line on a well-constructed certificate and the only line most buyers read.
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.
The last mile is the warmest mile
The honest finding is more nuanced than the alarm: a lyophilised cake tolerates a brief warm excursion far better than a reconstituted solution does, and the trade’s real…
The retest date and the expiry date are not the same document
We asked twenty companies three questions about stability data and print every answer, refusal and non-response.
Oxidation, and the peroxide that came in with the surfactant
We describe each pathway in enough chemical detail to explain why it is invisible to the method the trade uses, because that is the part which has practical consequences.
The empty half of every certificate of analysis
Every certificate circulating in this market answers a question about molecules. Almost none answers a question about organisms, pyrogens, or the integrity of the seal.
Why FGP 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.
Reading a certificate for what it does not say
The most consequential features of most certificates in this market are the tests that do not appear on them at all.
Freezing a reconstituted vial: the ice-water interface problem
An in-use period is established by a dedicated study on a specific formulation in a specific container at a specific concentration. Borrowing one from a marketed product is…
Benzyl alcohol is a preservative, not a sterilising agent
We set out what is known, what is inferred and what is simply assumed about the fortnight after a vial is opened.
Reading a certificate as a document rather than as a score
The header identifies the batch, the table records the tests, and the footer says who is answerable. Two of the three are usually incomplete.
One vial, four weeks, and the data that does not exist
Every degradation pathway accelerates by orders of magnitude on reconstitution, because the solvent that lyophilisation removed is the reagent most of them need.
We asked four laboratories for a sterility test. Here is what came back.
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.
How far back does this document actually reach?
What happens to traceability when bulk material is subdivided, repackaged and relabelled two or three times before sale.
Benzyl alcohol is a preservative, not a sterilising agent
At low concentrations a measurable fraction of peptide can adsorb to glass and plastic surfaces, and the loss is largest exactly where it is least expected.
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.
Two documents, two disciplines: purity and sterility are not the same trade
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.