Principles of Cleanroom Validation

A clean room is a modular environment in which the following environmental factors are controlled; temperature, particles in the air, microbes, relative humidity, differential pressure and air flow.In Cleanroom validation is performed for various reasons.To ensure that the design of the facility is adapted to the intended use; ensure that the installation, equipment and the environment are the specifications of requirements of users (URS); ensure that the installation, equipment and the environment meet the defined regulatory requirements; make sure that the installation, equipment and its environment work together as a system that meets defined standards.Cleanrooms are validated and certified according to ISO 14644-1 class.Each class of ISO14544-1 has its unique requirements that need to be made so that a facility be closed within the specified classification.LIFE CYCLE of VALIDATION the validation of a new clean room air conditioning room follows a specified life cycle.The life cycle includes five phases which each performs specific tasks to control the variation in the modular environment.Validation in Cleanroom work is done in five phases.It starts with the control of design phase and ends with the control and the control.Changes to the equipment and control factors after the validation of the cleanroom justify the revalidation of the cleanroom.

PHASE one: QUALIFICATION of the design the cleanroom validation starts with the design qualification (DQ).The purpose of this phase is to prove by objective evidence that the design is suitable for the use for which it is intended.The qualification of design is an exercise in check against the requirements defined in the acceptance of your DQ Protocol criteria.The Protocol should address the following points: user (URS) Documents of the supplier requirements Specifications and specifications facilities buy online design Documentation (FAT) factory acceptance Tests as construction drawings data sheets out of the qualification of design phase is a phase report and a list of standard documentation file (SDL), which documents the following: design Conditions of auction purchase requirements and order documentation list of the documents provided by the supplier as construction drawings, lists of lists of inspection acceptance Tests components factory approval of the qualification of design phase, DQ is a prerequisite for the initiation of the installation qualification phase, QI

PHASE 2: QUALIFICATION for the INSTALLATION the objective of this phase of installation (QI) qualification is confirmed by the audit equipment, as installed, confirm the requirements of the user and design requirements.The audit focuses on the following which should be requested in your QI Protocol: calibration HVAC check loop P & ID data review of the integrity test of the filter HEPA State of calibration of critical equipment Tests acceptance of installation qualification Tests (SAT) site Documentation piping and welding audit of the utility of the system's standard operating Procedures and work instructions the result of this phase should be an IQ report dealing with all of the above, and an SDL file that documents the following: changes of project Tests of QI made calibration Documents supplied by the supplier certificate of equipment installation acceptance Tests goodwill of site (SAT) list of consumables list spare parts list of the documents operational environmental review report and teaching the approval of QI is a prerequisite at the beginning of the phase of operational qualification (OQ).


PHASE 3: QUALIFICATION of the operation the objective of this phase of operational qualification (OQ) is to show by objective evidence that the white room works in accordance with the design requirements and the requirements defined by the user and it works constantly in a defined range of conditions.OQ Protocol should address the following points: the function Test of HVAC (Heating-Ventilation-air conditioning) compared to the functional requirements specified alarms critics locking alarms operating parameters critics defined on the data sheet of the room the standard operation for the cleanroom filter integrity Tests the air velocity and airflow models of air pressure Difference flow phase OOW should also address the worst-case scenarios.To design the worst-case scenario for the functioning of the clean room, the critical operating parameters are identified from the data sheet of the cleanroom.The operating range and the extreme beaches are defined for each critical parameter and the worst case is designed and documented.It should include the following: maximum and minimum Temperatures, maximum moisture and minimum maintenance Contamination of the scenario staff schedules the worst is usually run with specified Low settings and High specified.The output of this phase is a report OQ alarms and functional the cleanroom requirements specified in the specifications of the user.PHASE 4: QUALIFICATION of the PERFORMANCE qualification (PQ) the cleanroom performance goal is to demonstrate with objective evidence that the white room works consistently with defined parameters to produce the result environmental wished and defined.The qualification of cleanroom performance involves the testing and monitoring of the following: levels of suspended particles in the air levels of surface particles particles viable microbial humidity relative pressure differential Temperature phase exit PQ is a PQ report that analyzes the performance of the clean room using equipment settings specified.PQ is a pre-requisite for certification

CLEANROOM CERTIFICATION validated cleanrooms are validated for a required cleanliness class.The level of cleanliness that is chosen is determined by the needs of the users.Cleanroom classes are defined in ISO1464-1: methods for evaluation and measurement for certification are specified in ISO14644-3.He calls for the ten following tests. Test count of particles in the air Test of air flow differential air pressure leak Test of the Filter Test of visualisation of flow Test of direction of air flow temperature humidity recovery leak Test Test Test Test of containment once certified for a particular class, Cleanroom factors are monitored to ensure that the parameters do not have derived or changed and that the environment is under control.MONITOR and control a program of constant surveillance is required after certification.Compliance requirements are in the ISO 14644 - 2. ' statistical analysis for the parameters of cleanrooms is encouraged as a tool for monitoring of the white room after certification to ensure compliance.The tool of choice is statistical process control,