Short, direct answers to questions that come up on real cGMP process equipment projects. Each entry answers one question and stops – the longer treatments live in our technical guides, and the working tools in our calculators.
These are written from field practice rather than brochure copy, which means several say plainly where a widely repeated rule is a convention rather than a requirement, and where a specification that looks complete is actually unenforceable.
Cleaning, passivation and surface
- Can stainless steel be passivated in place? – why coverage, not chemistry, is the limiting factor in an installed circuit.
Fabrication and documentation
- What documentation should a sanitary piping contractor hand over? – the ten records, and the two questions that separate a real package from paperwork.
Qualification and documentation
- Is the three-batch rule for PQ actually required? – no, and it appears nowhere in 21 CFR 211. Where the number should come from instead.
Facilities and cleanrooms
- Can a cleanroom be installed in an existing building? – the four constraints that decide it, and the two that stop projects.
Need an answer that is not here? Ask us directly – if a question comes up more than once, we add it.