Cleanroom Commissioning, Qualification & Validation Services
If you need decontamination but do not have the resources, time or equipment, Vibraclean has your solution. From the smallest enclosure to a large building, our skilled personnel provide the customised treatment you require:
Ideal for:
Bio Safety–Level Labs 2, 3 and 4
Post-Construction New-Area Commissioning
Additional Research Areas
Pharmaceutical Production Areas
Grade A-D ISO Class 5-8 GxP Cleanrooms
Pre-validation
Building out a cleanroom and adjacent environments is a multi-stage construction process.
Vibraclean GMP cleaners meet the standards outlined in the Scope of Work and complete their work in the agreed time frame to avoid project delays. All Vibraclean GMP cleaners arrive outfitted with the correct Personal Protective Equipment (PPE).
After post construction cleaning, the room is ready is for pre-validation cleaning. This further reduces particles and residue levels to within desired operating parameters.
Level 1
Clean Construction
To start, conduct daily and hourly cleanups using vacuums and start using a daily cleaning service. There should be no unnecessary trash or debris in the cleanroom area. We recommend using multiple rugs as well as sticky mats to prevent dirt from entering.
This is also the post construction cleaning stage to conduct particle counts.
Level 2
Pre Cleanroom Construction
First, establish a smock room/airlock for entry/exit with an air cleaner. Workers must wear booties in the area and use sticky mats on floors. In addition, no wood, cardboard or paper are allowed in the area.
A HEPA vacuum is required for cleanup after all cutting/drilling in the cleanroom.Further, the air systems should be on, but not the filter fan units.
Level 3
Active Cleanroom Construction
Includes all the precautions of Level 2, plus several additional steps. Workers must use a designated smock room and have limited access at this stage.
Before entering the cleanroom, workers must be fully smocked. This includes wearing lab coats or coveralls, hair/beard nets, booties and gloves and mask. The recirculation air system should also be employed to continuously clean the air.
Commission, Qualification & Validation
Pass certification the first time
Commissioning, qualification, and validation (CQV) of controlled environments is a process of ensuring that equipment, facilities, utilities, and processes meet specific requirements and operate consistently and reliably. CQV of controlled environments is important because it ensures that the conditions in which products are manufactured or stored are consistent and controlled.
Sterility is an important aspect of the CQV process. Maintaining sterility during the CQV process is critical because even a small amount of contamination can compromise the safety and effectiveness of the final product. To maintain sterility during the CQV process, it is important to use proper cleaning and disinfection techniques, as well as to follow strict guidelines. By maintaining sterility during the CQV process, companies can ensure the quality and safety of their products and protect the health of their customers.
Controlled Environments
Vibraclean specializes in sterility and maintenance of controlled environments
Not only do Vibraclean GMP technicians meet the standards outlined in the Scope of Work, they complete their work in the agreed time frame to avoid project delays.
All Vibraclean GMP technicians arrive outfitted with the correct Personal Protective Equipment (PPE) to conduct the pre-validation cleaning services. Vibraclean is capable and prepared to carry out effective clinical and medical lab cleaning in a variety of labs, including:
Validation of the work with biological and chemical indicators.
Testing and cycle development service is available.
Vibraclean works with trusted partners to ensure the success of your project.
Our core competency is in the execution of the work.
However we are involved in all steps and collaborate with stakeholders to ensure a positive outcome.
