The cleanroom validation makes sure that the tools and surroundings meet the standards and certifications set by the government and work as they should. Validation of the cleanroom is necessary because of different checking criteria. The goal of cleanroom confirmation is to make sure that the people who use the space are safe. We do cleanroom validation at Ziebaq for all businesses that need to be careful with temperature and pressure, such as healthcare, aircraft, and all analytical labs.
In fields where cleanliness and quality of the product are very important, like medicines, science, and electronics manufacturing, clean rooms are very important. Clean Room Validation (CRV) services are available from Ziebaq to help your clean room facilities stay successful and in line with regulations.
In clean room validation projects, our experienced team follows well-known standards and processes to check things like particle count, temperature, humidity, and changes in pressure. They also look at things like air quality. When you hire Ziebaq for this service, you can be sure that the set-up in your controlled surroundings meets the rules set by global groups. In order to make the most money, this keeps both the quality of your goods and the value of your business safe.
When a cleanroom is first put into use or its design or intended use changes, it must be validated. We ensure that all of the proof programmes we create meet the rules and requirements set by regulators.
We can offer a full range of tools, cleanroom certification, and testing services because our techs are CETA- and NSF-certified and have much professional experience. Our team of experts provides Ziebaq certification services using calibrated tools and standard operating procedures (SOPs). The services include results and records that have been checked for quality.
You can use our extensive network of highly trained techs who can come to your place and get the job done quickly, so you don't have to worry about downtime or lost productivity.
We can fix, replace, and test containment equipment and parts, such as ULPA and HEPA filters, because we know a lot about them and have worked with top filter and equipment makers. Our experts can help you at every step of the equipment and cleanroom approval process. They can test and fix things on-site, deliver reports, and advise you on how to fix problems.
Ziebaq is an expert at testing and reporting cleanrooms that meet the requirements of the ISO 14644 list. After your test, you will get a report that meets the standards of ISO 14644 and, if asked, EU GMP. This makes sure that client sites are ready for audits and meet the needs of regulatory bodies.
There are three different ways to do the ISO certification test:
Cleanroom Qualification checks how well a cleanroom or piece of clean air technology works for its original purpose. Some things that a cleanroom needs to pass in order to meet BS EN ISO 14644 Parts 1, 2, 3, 4, and 7 are:
In addition to the above ISO standards, Annex 1 adds more tests for cleanrooms and clean air equipment (if needed for the design or running of the installation) if your process needs EU GMP certification.
Ziebaq can do all of these things except the tests for bacteria in the air and pollution on the ground. The tests above aren't just for people who work in EU GMP cleanrooms. There are times when an ISO 14644-validated cleanroom would need extra tests.
You can ask us to make a validation agreement for one year or more than one year that meets your needs. It may be necessary to fix HVAC systems, cleanrooms, and special clean air tools such as air handling units and laminar flow devices in order to meet HTM03-01 standards.
We can use data from year to year to make ideas and start a cycle of constant growth if we have a confirmation agreement. Plus, it helps you figure out how much money you need for repairs and other important things. You can also get service contracts for Ziebaq sites that cover the following:
We'll work with you to figure out the best amount of help to keep your important process safe.
We provide a variety of cleanroom validation, inspection, testing, and certification services to healthcare facilities, pharmaceutical production facilities, and server room facilities in line with ISO 14644. The parameters for the clean room test are:
We have detailed and auditable sterile certification paperwork. On the day of testing, you will get an intermediate report. Ten business days later, you will get the full report. Reporting is in line with GMP rules and ISO standards to meet your needs and the needs of any chosen regulatory body. You can select one of our testing packages, or we can create a plan just for you. Do not wait! For great cleanroom validation service, contact Ziebaq right away.
An outside group tests a cleanroom to make sure it meets the standards for its classification, which include particle counts and air changes per hour. You can also test the room pressure, temperature, humidity, live particles, light, and sound.
International Standards Organisation (ISO) 14644 sets cleanroom rules and other controlled settings. Part 1 (ISO 14644-1:2015) describes how to classify the health of the air by the number of particles present.
Clean room testing ensures that the air quality in a clean room meets test standards like ISO14644-1, ISO14644-2, and ISO14644-3.
Follows Good Manufacturing Practice (GMP) rules; this is a GMP cleanroom. Medical and pharmaceutical companies mostly use GMP, a quality management system, to make sure that processes take place in a controlled cleanroom setting.
There are three main types of acceptance factors for cleaning: chemical, bacteria, and physical. Each will have its own way of inspecting.
 (2).png)
.png){kind=logo}
 (1).png)
.png){kind=logo}
