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Clean room validation requirements

UHS is inviting specialist and qualified suppliers to perform third party independent testing; balancing, validation and certification for the clean room in accordance with USP-NF <Chapter-797> As a minimum the below tests and documentations should be performed.

INSTALLATION QUALIFICATION

The purpose of this Installation Qualification (IQ) is to confirm through verification that clean room as was built confirms to user requirements and design requirements. Verification is focused on the following items:

HVAC calibration HEPA filter integrity test data review Critical equipment calibration status Installation Qualification tests System standard operating procedures and work instructions

The output of this phase should be an IQ report addressing all the above elements including the following documents: 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. Required changes if any. IQ tests performed Calibration Supplier supplied documents Equipment certificate Installation deviations Site Acceptance Tests Consumable list Spare part list Environmental review report List of Operational and Instructional documents

OPERATION QUALIFICATION upon successful conclusion of the Above IQ process; this Operational Qualification (OQ) will be conducted to show through objective evidence that the clean room 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:

Testing HVAC (Heating-Ventilation-Air Conditioner) system operation against specified functional requirements Critical Alarms Interlock Alarms Critical operating parameters defined on the room data sheet

Filter integrity tests Standard operation for the clean room Air speed and air flow Air flow patterns Pressure differential The OQ should also address worst case scenarios. To design the worst case scenario for the operation of the clean room, critical operating parameters are identified from the clean room data sheet. Operation ranges, and extreme ranges, are set for each critical parameter and a worst case designed and documented. It should include the following:

1. Maximum and minimum temperatures 2. Maximum and minimum humidity 3. Maintenance schedules 4. Personnel contamination 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 clean room specified in the user requirement specifications. PERFORMANCE QUALIFICATION

The purpose of Performance Qualification (PQ) of the clean room is to demonstrate with objective evidence that the clean room consistently operates within defined parameters to produce the defined, desired environmental outcome. Clean room performance qualification involves testing and monitoring of the following: 1. Airborne particulate levels 2. Surface particulate levels 3. Viable microbial particulates 4. Relative humidity 5. Differential pressure 6. Temperature 7. The output of the PQ phase is a PQ report that analyzes the performance of the clean room using specified equipment parameters. PQ is a pre-requisite for certification.

CLEANROOM CERTIFICATION

validated clean rooms are validated to a required class of cleanliness. The level of cleanliness required is as below:

We are aimed at creating ISO 5,7 and 8 environment (cleanliness). ISO 5 for LAFH, BSC, as it must maintain ISO 5 during Dynamic conditions and unidirectional flow of air is required. ISO 7 in Buffer area and ISO 8 Ante area, and it must maintain ISO 7 or 8 during Dynamic working conditions and Air Flow Balance Testing required at the instillation site.

Methods for evaluation and measurements for Certification are specified in ISO14644-3. It calls out for the following ten tests. 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. Airborne particle count test Airflow test Air pressure differential test Filter leakage test Flow visualization test Airflow direction test Temperature test Humidity test Recovery test Containment leak test

Once certified to a particular class the clean room factors are monitored to ensure that parameters have not drifted, or changed, and that the environment is under control.