Cleanroom validation service is conducted for various reasons. To make sure that the facility design best fits the intended purpose, ensure that the equipment, facility, and environment mitigates the URS (User Requirement Specifications), to make sure the equipment, facility and the environment mitigate or meet the defined regulatory needs, to make sure the equipment, facility, and environment function together as a system to mitigate the defined standards.
Validation is a crucial process for a cleanroom. This serves to ensure the cleanroom is installed properly and designed well for its ISO classification and that all the components like the environment, facility and equipment meet the regulatory needs, requirements, and other well-defined standards.
So, what exactly are cleanroom validation services?
Most cleanrooms are validated by the 3rd party agencies. It entails a thorough inspection and various tests, whereafter the classroom gets certified to a particular class showing its level of control, generally to an ISO 14544 – 1 class.
Validation has numerous phases, which starts with the design qualification process and ends with the final certification. Some tests performed in such phases involve velocity tests and airflow volume, ULPA/HEPA filter leak testing, smoke testing or air movement visualization, room recovery, room pressurization, relative humidity, airborne particle count tests, temperature, and numerous other test conditions.
Note that certification contains 3 major phases. Installation qualification is even referred to as Phase 1 or as-built testing. The testing was performed with all the services connected and pleasantly working but with zero material, production equipment or employee present, which prove that equipment is rightly installed.
Phase 2 is nothing but the operational qualification or the testing ‘at at rest’. Testing happens when the equipment is well installed but not functioning and zero employees are present. It proves the equipment works well to attain the needed environmental conditions.
In phase 3, you will see performance qualification. In such a phase, testing gets performed with all the equipment installed as well as operating and employees conducting their daily work duties/tasks. This kind of testing proves the cleanroom has the needed operation performance for cleanroom application.
Once the initial certification is done, it is crucial to recertify regularly to make sure that your cleanroom operates continuously as it previously did when it was formed. At a minimum, annual certification is considered. Based on the product and industry, semiannual or also quarterly certification might be needed.
How can cleanroom validation services help?
Regular cleanroom validation services assist to recognize and detect any harmful source of contamination and assure regulatory clients and bodies so that the controlled environment continues to mitigate the ISO class parameters. In short, it makes sure your crucial process stays protected.
In case the cleanroom does not have any current validation certificate to meet particle concentration limits that are set in the ISO 14644-1:2015 then this will certainly not be compliant with the ISO 14644-2:2015.
What exact risk is to your business in case you do not validate periodically your cleanroom?
While the guidance is in the right place for validating the controlled surroundings, frequency and scope of validation must be defined by your companies’ individual risk examination. Internals must be assigned in alignment with the risk identified. Any failure in doing so can lead to high maintenance expenses as well as operational time loss.
How often are you required to validate your cleanroom?
For ensuring that your cleanroom continues further to perform well as well as enhance your company process, it requires to be well validated to prove that it completely complies with the ISO 14644-1:2015 – classification of the air cleanliness by the particle concentration.
ISO 14644 – 2: 2015 – Monitors to cater evidence of the cleanroom performance linked to air cleanliness by the particle concentration, enlighten the customers to finish the risk assessment as well as monitor plans to determine the frequency of validation and testing to individual processes.
Above mentioned standards state the highest time interval between the airborne particle testing of a cleanroom of ISO class five and below is six months & ISO class six and above is twelve months.
Advantages of utilizing the connect two cleanroom validation service
- Save both money and time: Keep both the expense as well as loss of operational time to the least, which helps protect your investment.
- The brand you can rely upon: Validations are done by the CTCB qualified project engineers, which cater for you with peace of mind.
- Highly traceable validation as well as maintenance records for auditing purposes.
- Completely free validation reminder service based on the requirement as a part of long-term validation package.
- The connected two cleanrooms provide expert advice on cleanroom efficiency, which includes clothing, cleaning, and furniture.
What is the cleanroom validation services?
Connect 2 classrooms majorly advise on having periodical validation services performed by one of the CTCB qualified project engineers because it has knowledge about your cleanroom. It guarantees that the cleanroom solution that you have invested in would carry on working for you.
- Complete cleanroom validation involves airborne particle counts, air changes, airflow measurement and pre-filter change.
- Other additional cleanroom validation services filter the integrity test, smoke testing, recovery rate testing, containment leak testing, air pressure differential, lighting lux levels, particle counter calibration and sound levels.
Filter integrity testing
Filter efficiency and integrity are crucial. If the filter fails to work efficiently you may run the contamination risk entering your cleanroom, which potentially affects your processes and product quality and directly may impact your cleanroom classification.
The equipment using the HEPA or the ULPA filter must be tested at periodical intervals as well as the swift movement of your equipment to make sure zero damage owing to transportation.
In case your filter fails to work well you run the contamination risk entering your cleanroom, especially impacting your processes as well as your product quality.
This in turn impacts the classification of your classroom. DOP tests can thus lower the costly product recalls, save time, money and prevent any damage to your brand.