Cleanroom qualification and validation
Cleanroom
We understand the values we measure
if they are not correct, we find the cause
and fix it.
CARE OF AIR
Validation process
Accredited measurements
We adhere to STN EN 1822-1:2010-04, STN EN 1822-1:2010-04, GMP and other relevant standards.
Individual approach
We adapt the validation date and process to your operational and production processes.
Active communication
We keep you informed about all validation process steps in a timely manner, as well as explain them to you.
Successful completion
If we find a problem, we solve it. The work is finished only when the validation values are according to specifications.
Professional background
Validation specialists are also experienced technicians. They understand filtration technology and air conditioning.
Comprehensive solutions
After finishing the validation process, we provide cleanroom disinfection or monitoring, as well as qualification expiration reminders.
CARE OF AIR
What issue are you dealing with?
We need a validation of a new cleanroom or regular validations
- We plan the validation process together (contacts). During planning, but also when taking the measurement itself, we respect your production processes and requirements. Validations can be performed during outages, weekends or holidays.
- During validation, we inform you about each step of the measurement process. If some measured values show incorrect readings, we notify you in good time. Upon your agreement, we start looking for the cause. We analyze the entire space, check the air conditioning dimensioning and filter installation. Afterwards, we propose a solution to the situation and discuss it with you.
- You can find more details here what we do in case of a failed validation.
- After taking the measurements, we issue a validation protocol and a technical report, reflecting your requirements for processing the results.
- We monitor the validation expiration date for you and notify you when the cleanroom validation needs to be repeated.
- Following the validation, we also provide other services: filter management, cleanroom construction and reconstruction, cleanroom technical management, production and laboratory equipment validation and disinfection
Our cleanroom did not pass validation, we do not have the required results
- • There can be several reasons why your cleanroom failed to validate. In such a case, it is necessary to find out, whether your cleanroom has a microbiological, physical or design problem. We help you detect and eliminate the cause. We plan the date in advance (contacts).
- If the microbiological test values are bad, we focus on a thorough disinfection of the premises. We also disinfect hard-to-reach places, air conditioning and filters. We check the effectiveness of our solutions by repeating the measurements.
- We check the air conditioning dimensioning, as well as the quality and installation of the filters and air inlets. Our technicians have no problem to do the “dirty work”, such as checking the air conditioning from the inside, or working at heights.
- The identified shortcomings can be eliminated with additional filter technology or sophisticated filter management. We configure the filters with which you meet the required values. We professionally install the filters.
- We constantly consult with you regarding the adjustments we plan to implement, in order to improve the measured values. We take into account your budget, as well as the time frame. We guarantee a successful completion of the validation process. Traveling to repeat the control measurements multiple times is not a problem.
- After finishing the validation process, we issue a validation, or a technical report, in which we take into account your requirements for processing the results.
- We monitor the expiration date of the validation for you and notify you when the cleanroom validation needs to be repeated.
- • Following the validation, we also provide other services: filter management, cleanroom construction and reconstruction, cleanroom technical management, production and laboratory equipment validation and disinfection.
We need to design, construct or reconstruct a cleanroom
We take care of the entire process, starting with analysis, study and project design. Our designers know cleanrooms inside out, and they know how to design them properly. Cleanroom construction is provided as a turnkey service. You can be sure that the cleanroom will be functional, configurable, made of first-class materials and will not have difficulties successfully passing the validation process before commissioning.
More about the service
CARE OF AIR
Taking microbiological air samples
We take the air samples using biological air samplers (aeroscopes) in order to evaluate its microbiological profile (air bioburden) on various culture media according to client requirements. Our aeroscopes comply with the EU GMP standard and other devices comply with the GLP and other applicable standards. The sample evaluation is performed in an accredited laboratory for environmental hygiene.
Care of air
Validation measurements range
- Microbiological air samples using biological air samplers (aeroscopes), in order to evaluate its microbiological profile (air bioburden).
- DOP photometric methods of absolute filter integrity testing and HVAC components according to EN1822 and ISO 14644-3:2015, GMP and other standards. Filtration efficiency measurement on built-in devices and filters.
- Absolute filtration integrity test using isokinetic probes and particle counters.
- Particles measurement by laser particle counters.
- Air velocity measurements using thermoanemometers, microanemometers, propeller anemometers, or pitot and pressure probes.
- Distributed and exhaust air volumes and air exchange multiplicities measurements.
- Absolute and differential pressures measurements of rooms and equipment.
- Temperature and relative humidity measurements.
- Cleanroom recovery tests and derived recovery tests.
- Air flow visualizations.
- Particles in compressed gases measurements.
- CO2 and other gases measurements upon request.
- Speed measurements by optical and mechanical probes.
- Temperature measurement in various environments (incubation, sterilization, deep freezing, refrigeration and more).
- Sterilization tunnels validation.
- Sterilizers and autoclaves validation.
CARE OF AIR
