Standards & Compliance · 6 October 2026
Lot Traceability for Consumables: Building an Audit File That Closes
Traceability fails quietly: a box without a lot number, a certificate that does not match the delivery, a batch record that names a product family instead of a…
IEST-RP-CC004: What Wiper Test Methods Actually Measure
Biaxial shake, wet and dry particle counts, fibre release, sorption and extractables. A plain-language guide to what each wiper…
EU GMP Annex 1: Consumables in Grade A, Read Closely
The 2022 revision moved contamination control from a chapter to a strategy. For consumables, that means supplier qualification…
ISO 14644-1 in Practice: Choosing a Wiper for Each Class
The standard gives you a particle limit, not a consumable specification. How to translate a class into an edge finish, a fibre…