Medical device packaging is conducted in an iso class 7 8 cleanroom.
Clean room certification levels.
Cleanrooms are used for manufacturing where high levels of cleanliness and sterility are required.
In theory for an entire room to reach iso 6 air cleanliness you need to enter the cleanroom via an iso 8 ante room then go through an iso 7 to finally get into the iso 6 as shown in the image.
Authoritative documents such as iso 14644 and fs 209e provide no specific instructions regarding activities carried out in medical device environments.
Maintaining clean air with low levels of particulates in your cleanroom is critical to meeting performance requirements and staying in compliance.
Broadly medical device manufacturing is conducted in an iso 5 8 cleanroom class 100 100 000.
A properly designed clean room must have a high rate of air changes to scrub the room of particulates.
Basic clean room requirements designs for gmp clean rooms what is a clean room.
Contact us for more information regarding clean room classifications requirements and iso 14644 1 cleanroom standards or call us at 888 984 8801 with any questions that you may have.
A clean room gmp cleanroom in my mind are a combination of engineering design fabrication finish and operational controls control strategy that are required to convert a normal room to a clean room.
The cleanroom classification standards fs 209e and iso 14644 1 require specific particle count measurements and calculations to classify the cleanliness level of a cleanroom or clean area.
Iso 14644 1 cleanroom standard eu guidelines to good manufacturing practice.
A cleanroom or clean room is a room that has hepa filtration to remove particles from the air.
In reality however you can reach an iso 6 clean room with 1 recommendation is 2 airlock.
Our certified technicians will use a variety of cleanroom testing equipment to verify your facility requirements and ensure compliance with relevant industry standards.
Pace holds a cleanroom performance testing certification from the national environmental balancing bureau nebb.
This process allows clean filtered air to continuously flows from clean to less clean spaces allowing for continual air movement.
Details of the used measuring method reference standard and deviations.
Acceptance criteria for the cleanroom or clean zone including the iso classification the occupancy state and the considered design criteria 5.
Room pressurization measurement purpose to check the specified room pressurisation to avoid cross.
Once the room is completed most specifications call for testing and certification.
