We clean to all relevant Orange Guide, ISO, FDA and BMA standards for both cleanrooms and Isolators. These limits help refine the production process by standardising the environment and therefore combating contamination and cross-contamination. Production efficiency increases as a result and customer satisfaction is achieved.
Isocleanse stand out from the rest of the available cleaning services because we are prepared to prove the clenliness of the room. In order for us to establish a level of trust with our new customers we will offer free micro testing* of the cleanroom and isolators in order to prove how effective our work is.
*Micro testing through TSA and SDA contact plates can be carried out for free on the first clean only. After the first clean micro testing and particulate testing can be performed for a small fee.
Cleanrooms are all designed to provide different grades of cleanliness depending on what is being carried out in the cleanroom. Cleanrooms are defined by the level of contamination within them.
The MHRA Grades are demonstrated in the table below:
Maximum permitted number of particles/m³ equal to or greater than measured by a particle monitoring system:
- “in operation” state is a condition where the clean room is functioning fully with the use of equipment and personnel.
- “at rest” state is a condition where installation is complete with production equipment installed & operating but with no personnel present
Recommended limits for microbial contamination:
Levels of particulate contamination are measured through particle counting systems. These systems will count the amount and size of particles in a specified amount of air. Levels of microbial contamination are demonstrated through microbiological testing of the cleanrooms surfaces, walls, floors, hatches, and any other area deemed appropriate within the cleanroom. Microbiological testing is the use of agar plates to capture microbes in the room. This can be in the air (through settle plates), on any surfaces (through contact plates), or on any operators (though exit monitoring with contact plates).
* This information is taken from the MHRA’s ‘Rules and Guidance for Pharmaceutical Manufacturers and Distributors 1997 – The Orange Guide’.
All operations and staff in the cleanroom can potentially cause contamination if procedures are not adhered to. Cleanroom procedures and cleaning schedules and techniques are essential in controlling the level of contamination. If contamination levels were to rise it greatly increases the risk of the product being contaminated. This can lead to decreased profits and productivity.
