The Importance of Validating Your Cleanrooms

1. The The Importance of Importance of Validating Your Cleanrooms Validating Your Cleanrooms A cleanroom is a highly regulated environment used in industries like medical devices and pharmaceutical manufacturing. Cleanrooms are costly to develop and maintain due to the sensitive nature of the materials generated in these environments, which necessitate particular conditions to reduce the possibility of contamination. To operate efficiently, both in terms of process and expense, the environment must comply with clean air safety laws in addition to getting the essential equipment while establishing a cleanroom. independent cleanroom validation services entail doing a series of tests to see if these standards, such as ISO 14644:2015 and the Medicines and Healthcare Products Regulatory Agency's (MHRA) requirements, are being followed. Cleanroom validation services should be conducted regularly and can help detect and identify any harmful contamination sources, as well as reassure regulatory bodies and clients that your controlled environment meets ISO class criteria. In a nutshell, it ensures that your critical process is safeguarded. A cleanroom will not be compliant with ISO 14644- 2:2015. Validation of cleanrooms is done for a variety of reasons. The facility, equipment, and environment must meet user requirement specifications (URS). This is to ensure that the facility, equipment, and environment meet defined regulatory requirements, and to ensure that the facility, equipment, and its environment work together as a system to meet defined standards. Cleanrooms are evaluated and then ISO 14644-1 certified to a specific class. Each ISO14544-1 class has its own set of conditions that must be met for a facility to be categorized in that class. 1.Design Qualification Design Qualification (DQ) is the first step in cleanroom validation. Its goal is to demonstrate that the design is suited for its intended purpose using objective evidence. DQ is a verification exercise against the standards mentioned in your Cleanroom Verification protocol's approval criteria. The protocol should have the following elements,

2. •Specifications for User Requirements (URS) •Documents and specs from vendors •Purchase orders are placed according to the layout of the facility. •Factory Acceptance Tests Design documentation (FATs) •As-built blueprints •Sheets of data The Design Qualification phase produces a phase report as well as a Standard Documentation List (SDL) file that contains the following information, •Requirements for design •Conditions for bidding •Documentation for purchases and orders •List of vendor-supplied papers As-built drawings •Lists of components •Lists of inspections •Factory Acceptance Examinations 2.Installation qualification The Installation Qualification (IQ) phase validates that the equipment, when installed, complies with user and design criteria through verification. Verification is centered on the items listed below, which should be included in your IQ protocol, •P&ID loop verification •HVAC calibration •Review of results from HEPA filter integrity tests •State of critical equipment calibration (SATs) •Site Acceptance Tests •Qualification tests for installation •Documentation for piping and welding •Verification of utility •Work instructions and standard operating procedures for the system This phase should result in an IQ report that addresses all of the aforementioned elements, as well as an SDL file that documents the following, •Changes to the project •IQ tests were carried out. •Calibration •Documents from the supplier •Installation discrepancies according to the equipment certificate •Acceptance Tests on the Site (SAT) •List of consumables •List of spare parts •Report on the Environmental Assessment •Documents for Operational and Instructional Use 3.Operation Qualification

3. The goal of the Operational Qualification (OQ) phase is to demonstrate that the cleanroom performs following design and user-specified requirements and that it does so consistently over a given range of conditions, using objective evidence. The following issues should be addressed by the OQ protocol, •Testing the operation of an HVAC (Heating, Ventilation, and Air Conditioning) system against stated functional requirements •Alarms of Critical Importance •Alarms that interlock •On the room data sheet, critical operating parameters are defined. •Tests for filter integrity •The cleanroom runs regularly. •Air velocity and flow •Patterns of airflow •Differential pressure Worst-case situations should also be addressed during the OQ phase. Critical operating parameters are identified from the cleanroom datasheet to create the worst-case scenario for cleanroom operation. For each key parameter, operation ranges and extreme ranges are established, as well as a worst-case scenario that is planned and recorded. The following items should be included, •Temperatures at maximum and minimum. •Humidity maximum and minimum. •Maintenance schedules. •Contamination of personnel. 4.Performance qualification The cleanroom's performance qualification procedure (PQ) includes testing and monitoring of the following, •Particulate matter concentrations in the air. •Particulate levels on the surface. •Microbial particles that are alive. •Humidity, relative to the temperature. •There is a pressure difference. •Temperature. The PQ phase produces a PQ report that examines the cleanroom's performance using specified equipment characteristics. Certification requires a minimum of PQ. 5.Testing for filter integrity The integrity and efficiency of the filter are critical. If your filter isn't working properly, you risk contamination entering your cleanroom, which could have an impact on your processes and product quality, as well as your cleanroom classification.

4. Equipment with a HEPA or ULPA filter should be examined regularly and whenever it is moved to ensure that no damage has occurred due to transportation. What can we do to assist? In addition to containment laboratories and hospital operating theatres, we provide totally unbiased and completely independent cleanroom validation services. Our technical service engineers are certified by the Cleanroom Testing and Certification Board (CTCB-I) and are stationed across your facility, providing important specialist coverage. From small hospital pharmacies to major pharmaceutical production units, we can conduct unbiased validation on a variety of cleanroom facilities. Cleanroom procedures must be performed regularly at predetermined intervals to assure complete compliance. For example, for unidirectional flow, airflow velocities should be measured every 6 months, and for non-unidirectional flow, every 12 months. Contact our team immediately if you need to schedule service for your cleanroom or clean air environment, require spare parts such as filters, require lab fumigation, or are due for validation tests.