Validation protocols are a method of establishing documented evidence that shows a high degree of assurance that a manufacturing process will consistently yield a product of repeatable high quality.
Cleanroom Validation is performed for a variety of reasons. To ensure that the design of the facility is fit for its intended purpose; to ensure that the facility, equipment, and environment meets User Requirement Specifications (URS); to ensure that the facility, equipment, and environment meet defined regulatory requirements; to ensure that the facility, equipment, and its environment function together as a system to meet defined standards.
Cleanrooms are validated and then certified according to its class. Each class has its unique requirements that must be made for a facility to be classified in the specified classification.
Validation and qualification of an HVAC system comprises integration of various technologies together. Anemometer, particle counter, LLM, SLM, filter integrity are some of the technologies that are combined together to develop an accurate result for validation. Tests that are performed during validation are:
Validation of a new cleanroom follows a specified lifecycle. The life cycle comprises five phases each of which accomplishes particular tasks to control variation in the modular environment. Cleanroom validation work is accomplished through five phases. It starts off with the design control phase and ends with monitor and control. Changes to equipment and control factors after the cleanroom has been validated are grounds for cleanroom re-validation.
Cleanroom validation starts with Design Qualification (DQ). The purpose of this phase is to prove through objective evidence that the design is fit for its intended purpose. Design Qualification is a verification exercise against requirements defined in the acceptance criteria of your DQ protocol.
The protocol should address the following:
The output of the Design Qualification phase is a phase report and an Standard Documentation List (SDL) file that documents the following:
The approval of the Design Qualification, DQ phase is a pre-requisite for the initiation of the Installation Qualification, IQ phase.
The purpose of this Installation Qualification (IQ) phase is to confirm through verification that equipment— as installed—confirms to user requirements and design requirements. Verification is focused on the following items that should be called for in your IQ protocol:
The output of this phase should be an IQ report addressing all the above elements, and an SDL file that documents the following elements:
IQ approval is a pre-requisite for the start of the Operational Qualification (OQ) phase.
The objective for this Operational Qualification (OQ) phase is to show through objective evidence that the cleanroom operates in conformance with design requirements and user defined requirements, and that it consistently operates within a defined range of conditions.
The OQ protocol should address the following:
The OQ phase should also address worst case scenarios.The worst case scenario is usually carried out at the specified High and specified Low parameters. Operation ranges, and extreme ranges, are set for each critical parameter and a worst case designed and documented. It should include the following:
The worst-case scenario is usually carried out at the specified High and specified Low parameters. The output of this phase is an OQ report addressing alarms and functional requirements of the cleanroom specified in the user requirement specifications.
The purpose of Performance Qualification (PQ) of the cleanroom is to demonstrate with objective evidence that the cleanroom consistently operates within defined parameters to produce the defined, desired environmental outcome. Cleanroom performance qualification involves testing and monitoring of the following:
The output of the PQ phase is a PQ report that analyzes the performance of the cleanroom using specified equipment parameters. PQ is a pre-requisite for certification.
Methods for evaluation and measurements for Certification are specified in ISO 14644-3. It calls out for the following ten tests.
Once certified to a particular class the cleanroom factors are monitored to ensure that parameters have not drifted, or changed, and that the environment is under control. A constant monitoring program is required after certification. Requirements for compliance are found in ISO 14644-2.
Statistical analysis for cleanroom parameters is encouraged as a tool for monitoring the cleanroom after certification to ensure compliance. The tool of choice is statistical process control, SPC.
