Commissioning, Certification, and Validation Procedures
Cleanroom commissioning, certification, and validation are three distinct practices
usually performed by a multitude of test personnel and agencies. Though typically grouped into one folder they account for a
distinct series of testing and documentation of systems and procedures related to cleanroom air flow, particulate, equipment, microbial counts, and standard operating
procedures(SOP). They are typically undertaken to maintain compliance with regulatory agencies requirements for good manufacturing practices(GMP) and
Title 21 CFR Part 11 of the Code of Federal Regulations for compliance with the Food and Drug Administration(FDA).
Factory Acceptance Testing(FAT), Site Acceptance Testing(SAT), Installation Qualification(IQ), Operational Qualification(OQ) and Performance Qualification(PQ) are the typical order of testing
protocols for cleanroom certification, validation, and commissioning testing and documentations.
Cleanroom Commissioning Protocols:
Cleanroom Certification Standards:
- Factory Acceptance Testing(FAT)
a factory acceptance test (FAT) is conducted to determine and document the
equipment hardware and software operates according to its specification.
- Site Acceptance Testing(SAT) site acceptance tests verify
that the item performs as required by the user requirement specification or functional requirements.
Once an item passes SAT, it is ready for use, unless other contractual arrangements are made
between the user and the vendor.
- Installation Qualification(IQ) Installation Qualification as the name suggests
is carried out after, or concurrently with, the installation of the equipment or system at the user’s premises.
The purpose of the Installation Qualification is to provide documentary evidence that the system has been built
and installed correctly.
Operational Qualification(OQ) The purpose of Operational Qualification is to demonstrate that the newly acquired equipment (or facilities, services or systems)
functions as expected; that all parts and components operate correctly.
Performance Qualification(PQ) The intended purpose of Performance Qualification is to demonstrate compliance with all requirements given in the User Requirements Specification document.
Performance Qualification should follow on from successful completion of Operational Qualification (OQ).
Cleanroom Process Validation Protocols:
- IEST-RP-CC-006.3; Testing Clean Rooms
covers testing methods for characterizing the performance of cleanrooms. It is intended to assist planners, designers, manufacturers, and customers in preparing detailed specifications
for cleanroom procurement and for assuring cleanroom operational compliance.
- IEST-RP-CC-002.2; Unidirectional Clean Air Devices covers definitions, procedures for evaluating performance, and major requirements of unidirectional-flow,
clean-air devices. The RP may be used to define a basis of agreement between customer and supplier in the specification, procurement, and certification testing of unidirectional-flow, clean-air
devices with self-contained motor blower(s) and powered terminal units with replaceable filter.
- IEST-RP-CC-007.2; Testing ULPA Filters describes the equipment, aerosol properties, processes, and calculations for determining the efficiency of ultralow
penetration air (ULPA) filters, using particle counters. This test procedure covers production testing of filters for particle penetration and pressure drop of ULPA filters.
IEST-RP-CC-034.2; HEPA and ULPA Filter Leak Test covers definitions, equipment, and procedures for leak-testing high-efficiency particulate air (HEPA) filters and ultralow-penetration
air (ULPA) filters in the factory as they are produced, at the job site before they are installed, and after they are installed in cleanrooms and in unidirectional-flow, clean-air devices.
IEST-RP-CC016 provides a uniform method and basis for defining the rates of deposition of nonvolatile residue (NVR) and other forms of molecular contamination on surfaces in cleanrooms.
IEST-RP-CC023 provides guidelines for the control and quantitative measurement of viable contamination in the air and on surfaces in environments that require control of such contamination.
This includes areas designated as aseptic and those considered non sterile.
Process validation may be required by regulatory agencies. Process validation is a term used to indicate that a process has been subject to such scrutiny that the results of the process can be practically guaranteed. A comprehensive, well thought-out approach to validation is a key element
in assisting any company meet regulatory inspection requirements.
- Identification of the process to be validated
- Identification of device(s) to be manufactured using this process
- Objective and measurable criteria for a successful validation
- Length and duration of the validation
- Shifts, operators, equipment to be used in the process
- Identification of utilities for the process equipment and quality of the utilities
- Identification of operators and required operator qualification
- Complete description of the process
- Relevant specifications that relate to the product, components, manufacturing materials, etc.
- Any special controls or conditions to be placed on preceding processes during the validation
- Process parameters to be monitored, and methods for controlling and monitoring
- Product characteristics to be monitored and method for monitoring
- Any subjective criteria used to evaluate the product
- Definition of what constitutes non-conformance for both measurable and subjective criteria
- Statistical methods for data collection and analysis
- Consideration of maintenance and repairs of manufacturing equipment
- Criteria for revalidation