Hygiene control and validation of clean rooms
Micans performs hygiene inspections and clean room validation including particle counting. We adapt the sampling program in collaboration with you regarding the needs and requirements you must meet.
Analyzes
We perform, among other things, the following standardized analyzes.
- Particle count: Sum of all particles ≥0.5 µm/m3, ≥1 µm/m3 and ≥5 µm/m3
- Passive air sampling: Sedimentation plates for bacteria, yeast and mold. Detection limit 1 colony forming unit per 4 hours of each group of microorganisms.
- Active air sampling: Bioaerosol sampler for bacteria, yeast and mold. Detection limit 1 colony forming unit per m3 of each group of microorganisms
- Surface sampling: Contact plates. Detection limit 1 colony forming unit per 17 cm2.
Advice
Micans can provide advice and instructions on how to take samples and analyzes. It can, for example, be about how often you should test, how many positions should be tested and how you choose them.
Guiding documentation
When hygienic inspection of clean rooms, we start from these standards and recommendations:
- ISO 17141: 2020 Purity technology - Clean rooms and associated purity-controlled environments - methods for microbiological contamination control.
- SS-EN ISO 14644-1: 2016 Purity technology - Clean rooms and associated purity-controlled environments - Part 1: Classification of air purity based on particle concentration.
- EudraLex. The Rules Governing Medicinal Products in the European Union, Volume 4 EU Guidelines to Good Manufacturing Practice, Medicinal Products for Human and Veterinary Use. Annex 1 Manufacture of Sterile Medicinal Products (corrected version 2008)
- Procedures defined by customer
Micans' laboratory is:
ISO 17025: 2018 (SS) accredited by Swedac (id 10351)
ISO 9001: 2015 certified by A3 cert (id 1565)
ISO 14001: 2015 certified by A3 cert (id 1565)
For details, see Quality and environment
Micans' laboratory complies with OECD principles of good laboratory practice (GLP), ENV / MC / CHEM (98) 17
Feel free to contact us for questions, prices and more details.
