Cleanroom Biocontamination Control Training
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A compliant cleanroom is only as good as the bio-cleaning programme behind it. In one focused day, your teams learn to build, validate and run a bio-cleaning programme that meets EU GMP Annex 1, from the regulatory requirements through to hands-on practice.
Who it is for
Cleanroom operators and the production and quality staff responsible for disinfecting and bio-cleaning controlled areas.
What you will learn
- The regulatory requirements for disinfecting premises and equipment (EU GMP Annex 1, Biocidal Products Regulation, USP)
- The standards for evaluating disinfectants (NF EN 13697, SENS and TACT)
- The main families of disinfectant and how they work
- The equipment and consumables, and the rules for using them
- How to build a robust bio-cleaning validation plan
- How to run a bio-cleaning programme that meets cleanroom requirements
Format
One day, on site or remote, with a final assessment.
Standards
EU GMP Annex 1, NF EN 13697, Biocidal Products Regulation, USP.
Contact us to schedule a session.
| Medical International certifications | ANVISA (Agência Nacional de Vigilância Sanitária), CDSCO (Indian Central Drugs Standard Control Organization), DHA (Dubai Health Authority), FDA (Food and Drug Administration), ISO 13485, ISO 9001, MDSAP (Medical Device Single Audit Program), PMDA (Japonese Pharmaceuticals and Medical Devices Agency) |
|---|---|
| Product composition | One-day course (on site or remote): regulatory requirements, disinfectant evaluation standards (NF EN 13697, SENS, TACT), disinfectant families, equipment and consumables, validation plan, hands-on practice and a final assessment. |
| Power Source | Battery-powered |
| Environment of use | Clinic, Laboratory, Pharmacy |
| Private label | No |