MCRT Consulting in the fields of pharmaceuticals and medical technique
In the field of pharmaceuticals a maximum of security is required.
Each step of the production can only be done with qualified systems and validated processes. The MCRT supports you with its specialists in the qualification of new and old cleanrooms systems by:
- Risk analysis in air technical systems
- Providing qualifying master plans (incl. re-qualifying plans)
- Design qualification for cleanroom systems incl. all ventilation and air-conditioning systems
- Installation qualification (FAT und SAT)
- Operational qualification (SAT)
- Customer support during process qualification regarding cleanroom systems
- Re-qualifications in compliance with the time intervals of ISO 14644 - 2
We use the following measurement techniques:
- Filter challenge test following ISO 14644 – 3 respectively VDI 2083 – 3
- Measuring of all physical parameters of a cleanroom system (temperature, humidity, pressure, noise level, air velocity and -volume and other parameters)
- Verification of cleanroom classifications according to ISO 14644 - 3, VDI 2083 - 3 or GMP Annex 1
- Recovery time control according to ISO 14644 - 3 respectively VDI 2083 - 3
- Verification of the correct observance of pressure cascades in cleanroom systems
- Flow visualisation
- Planning and execution of monitoring systems for pressure, temperature, relative humidity and particle concentration as well as other physical parameters