Principles Of Cleanroom Validation

Temperature, airborne particle count, microbes, relative humidity, differential pressure, and airflow are all precisely managed in a clean room's modular design. There are several purposes for conducting validation in cleanrooms by Ziebaq. Adapting the facility's design to its intended use is one goal; meeting user requirements specifications (URS) in terms of installation, equipment, and environment is another; complying with regulatory requirements is yet another; and lastly, meeting systemic standards requires that all three components function as intended. Certified and validated cleanrooms meet the requirements of ISO 14644-1 class. A facility must adhere to its specific requirements if it wants to close under a certain class of ISO14544-1.

Ideas for a Cleanroom's Layout

Medical device, pharmaceutical, and printed circuit board (PCB) manufacturers operate in highly regulated environments that require validating controlled environments for critical process execution. It is essential to prove the following to validate a cleanroom:

• The air circulating within the cleanroom is high enough to either partially or completely disperse any contaminants that may have been there.
• The air quality of the cleanroom's supply ensures that it will not contribute to the contamination levels within.
• The air flows from more pristine to less pristine regions.
• The cleanroom's air circulation system reveals that no part of the room has particularly high levels of contamination, and
• Production can take place in a setting that is free of microbiological contaminants.

Life Cycle Of Validation 

A defined life cycle exists for validating a new clean room air conditioning system. Each of the five life cycle stages controls a different aspect of the modular environment's variability. There are five steps to validate work in a cleanroom by Ziebaq. The process begins with the design phase control and concludes with the control and control. Justifying the need for a cleanroom revalidation are modifications to the equipment and control factors that occurred after the initial validation.

Phase 1: 

Assurance of the plan Design qualification (DQ) is the first step in the cleanroom validation process. During this stage, you should gather evidence to support your claim that the design fits its intended purpose. To ensure that your design meets the standards outlined in the DQ Protocol acceptance criteria, you must perform a qualification of design exercise. Here are some points that the protocol should cover: 

• Things that the protocol needs to take into account are:
• User Requirement Specifications (URS)
• Details and paperwork from vendors
• Layout of the facility
• Orders for purchasing
• Technical specifications
• Factory Acceptance Tests(FATs)
• Concerning construction plans
• Documents including data

A phase report and an SDL file documenting the following are outputs of the Design Qualification phase:

• Standards for design
• Specifications for bids
• Documentation for purchases and orders
• List of documents provided by the vendor
• Concerning construction plans
• Arrays of components
• Evaluation protocols
• Acceptance Testing at the Factory

Starting the Installation Qualification (IQ) phase requires approval of the Design Qualification (DQ) phase.

Phase 2:

Installation Qualifications The goal of this installation phase is to ensure that the audited equipment confirms the user and design requirements, as well as the objective of the installation itself, which is known as qualification. You should request the following in your QI Protocol, and that is what the audit focuses on: 

• HVAC calibration
• Verification of P&ID loops
• Data review for HEPA filter integrity tests
• Important status update on equipment calibration
• Satisfaction Testing at the Site
• Qualification tests for installation
• Technical records for welding and piping
• Verification of utility

Work instructions and standard operating procedures for the system

An IQ report covering all of the topics above and an SDL file detailing the topics above should be the end products of this phase:

• Updates to the project
• IQ evaluations conducted
• Calibration
• Materials provided by the supplier
• Product certification
• Disparities in installation
• Site Acceptance Tests (SAT)
• Items for consumption
• Product Inventory
• Report on the evaluation of environmental impacts
• Documents about operations and instructions

IQ approval is required to begin the Operational Qualification (OQ) phase.

Phase 3:

Operational qualification during this stage of operational qualification (OQ), we the Ziebaq aim to provide concrete proof that the white room functions as expected under specified conditions, meeting both the design and user specifications. The points that the OQ Protocol ought to handle are: 

• Important Warnings
• Secure Locking Devices
• Key operational characteristics specified in the room's datasheet
• Checks for filter integrity
• Maintaining a clean atmosphere
• Venturi velocity and airflow
• The dynamics of airflow
• The difference in pressure

Additionally, the OQ phase needs to cover the worst-case scenarios. Using the cleanroom data sheet, we the Ziebaq can identify the critical operating parameters and create a worst-case scenario for the cleanroom's operation. We the Ziebaq establish operation and extreme ranges for every key parameter and create and document a worst-case scenario. Ensure that it contains:

• Highest and lowest points in time
• Extremes of humidity, both high and low
• Timelines for maintenance
• Contamination by employees

Executing the worst-case scenario with the High and Low parameters as specified is common practice.

Phase 4: 

The cleanroom's performance goal is to prove, through evidence, that it consistently works within specified parameters to achieve the desired and defined environmental outcome. When evaluating cleanroom efficiency, it is necessary to check and record data on the following: 

• Levels of airborne particles
• Levels of surface particles
• Microorganisms that are still viable
• Relative humidity
• Variable stress
• Celsius level

Using the parameters set by the equipment, the PQ report evaluates the cleanroom's performance. 

Cleanroom Certification

To be considered validated, a cleanroom by Ziebaq must meet certain standards of cleanliness. User needs dictate the selected level of cleanliness. As stated in ISO1464-1, cleanroom classes are here.

Standards defined in ISO 14644-3 outline evaluation and measurement procedures for certification. It requires the following ten tests:

• Counting particles in the air
• Evaluation of airflow
• Testing the difference in air pressure
• Check for filter leakage.
• Visualization of flow evaluation
• Test for the direction of airflow
• Checking the temperature
• Test for Humidity
• Evaluation of functional recovery
• Leak detection and prevention evaluation

Supervise and manage

Certification is only complete with an ongoing monitoring program. Conformity criteria are detailed in ISO 14644-2. An effective tool for monitoring the cleanroom after certification to ensure compliance is a statistical analysis of cleanroom parameters. Statistical process control, or SPC, is the preferred method. 

Conclusion

Validation in a cleanroom by Ziebaq goes beyond just counting particles. It comprises a battery of tests that, when run in different cleanroom states, must confirm that the cleanroom is suitable for its designated purpose and complies with the classification requirements for that space.