Cleanroom Validation Services
Cleanroom Validation Services In UAE, Saudi Arabia, Oman, Qatar, Kuwait, & Bahrain.
We are specialised in testing and re-qualification of cleanrooms as per ISO 14644 guidelines / EU GMP/IEST-RP-CC006.3/Federal Standard 209E/Other Corporate SOPs.
• Airflow volume flow measurement and air change rate calculation
• Unidirectional airflow velocity measurement
• HEPA Filter integrity testing (DOP and Particle Count)
• Room differential pressure measurement
• Non-viable airborne particulate monitoring
• Airflow visualisation
• Clean-up recovery test
• Temperature and humidity monitoring and uniformity mapping
• Containment and induction leak test
FTS Lifecare is a specialist in cleanroom validation. After the processes are successfully undertaken, we extend an audit-ready report that complies with the requirements verified by regulatory bodies. Pharmaceutical companies understand the importance of this validation. For pharma companies operating in countries like Saudi Arabia, Kuwait, UAE, Bahrain, Oman, Qatar, Sudan and Yemen, FTS Lifecare is most commonly the one-stop solution. Today, the top multinational companies in the Middle East are our clients.
Here at FTS, we understand that the needs of different pharma companies are distinct.
For a modern organization operating with current protocols, the importance of our service need not be explained.
The ISO Validation tests can usually conduct in 3 states
1. As-built – Simply the empty structure of the cleanroom without any furniture or equipment.
2. At-rest – The cleanroom has furniture and equipment, but they are not in use.
3. Operational – At this stage, the cleanroom operates entirely and with the necessary operating processes.
Your installer would probably test your cleanroom in the ‘as built’ state and, in other cases, ‘at rest’ state, but intelligent customers opt for the ‘Operational’ state. This ensures that your cleanroom is in the best form of cleanliness during validation, leaving no scope for mistakes in the future. Now, before you wonder what you should be your choice, let us extend a few tips and tricks your way.
ISO 8 Cleanroom Standards
The allowed particle counts for an ISO 8 cleanroom depend on the referenced standard and its measurements. According to US Federal Standard 209E, ISO 8 cleanrooms are also known as Class 100,000 cleanrooms.
What are the requirements for a cleanroom validation test?
In order to meet the overall level of adherence as is needed to choose a perfectly operational cleanroom, the room must stick to the following:
• The airflow measurement needs to be proper in terms of velocity and volume.
• The airborne particle count needs to fit within the limit.
While the ones mentioned above are the basic requirements, you can also choose to go for additional tests to ensure that your cleanroom and the equipment inside validate higher certifications. Their needs include the following:
• Measurement of the difference in air pressure
• Filter leakage and testing of the integrity
• Surface contamination and removal of airborne microbes.
• Airflow direction regulation.
• Measurement of relative humidity.
• Measurement of temperature.
• Recovery testing
• Leak testing
Why should you get FTS’s cleanroom validation services?
FTS Lifecare is interchangeable with cleanroom validation across all major countries today. Whether it is the allied services from our team or the cleanroom validation services we offer, we can assure you that we are worthy of your faith. Let’s take a look at why we are the best bet for you.
• In-depth knowledge of certifications and guidelines.
• More than 21 years of experience offering customized solutions to top pharma companies.
• We offer the best advice as per your individual needs.
• We conform to all popular industry standards like ISO, GMP, etc.
• We offer a comprehensive range of services for you to choose from.