What the four services actually offer, test by test
Four independent services underpin confidence in this market. All four are competent at chemistry. Microbiology is a different accreditation, a different facility and a…
Fill & finish
Page 3 of 11 of this archive, newest first.
Sterility is not a percentage, which is the whole difficulty
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.
Mean kinetic temperature is not the average temperature
A single-use logger records the air adjacent to itself at a fixed interval. Where it sits in the package, and how often it samples, determine what it can possibly detect.
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…
The reviewer, the approver, and why regulated documents carry two names
Somebody has to be answerable for a release document. On most certificates in this market, nobody is named at all.
Date of analysis, date of manufacture, and the gap between them
A document is only as good as the chain that connects it to the material, and most chains here are two or three links longer than the paperwork admits.
What happens in solution that does not happen in the cake
Every degradation pathway accelerates by orders of magnitude on reconstitution, because the solvent that lyophilisation removed is the reagent most of them need.
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…
The pyrogen question has a price, and it is not the price of a purity run
A compendial sterility test takes fourteen days of incubation and consumes the containers tested. That timescale is incompatible with the business model that made…
Specification and result are two columns, and only one of them is a measurement
The arithmetic of significant figures, applied to a document that routinely reports four of them.
Adsorption, and the dose that stayed on the glass
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…
Asparagine, glycine, and the two residues that decide a shelf life
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.
Sterility is not a percentage, which is the whole difficulty
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.
What we asked twenty suppliers about stability data
Storage instructions in this market are close to uniform and almost never accompanied by the study that would justify them. Uniformity is a sign of convention, not of…
How to check a certificate in ten minutes
What each missing test would cost to add, and which of them a buyer should actually want.
What a batch number is supposed to mean
What happens to traceability when bulk material is subdivided, repackaged and relabelled two or three times before sale.
LAL, kinetic chromogenic, recombinant factor C: three ways to the same figure
The masking phenomenon known as low endotoxin recovery means a formulation can return a clean result while containing endotoxin the assay cannot see.
Container closure integrity, and the tests that actually probe it
A sterile product is sterile only for as long as its container closure system excludes the outside world. Integrity is testable, and the tests are cheap by the standards of…
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.