Clean Room Validation
At Praanomi Engineers Tech Pvt. Ltd., we understand the critical importance of maintaining cleanroom environments that meet the highest industry standards. Clean room validation is an essential part of ensuring that controlled environments, such as those used in pharmaceuticals, healthcare, electronics, and biotechnology, comply with stringent regulatory requirements. Our comprehensive clean room validation services guarantee that your facility operates under optimal conditions to protect the quality and safety of your processes and products.
Why Clean Room Validation is Essential
Validation ensures that your cleanroom is functioning correctly and maintaining the required environmental conditions, such as temperature, humidity, air quality, and particle control. It’s not only a regulatory necessity but also a key factor in maintaining product quality and operational efficiency. Without proper validation, your facility could be vulnerable to contamination, which could lead to compromised products, loss of credibility, or failed regulatory audits.
Our cleanroom validation services include:
- Airflow Testing: We measure the air volume flow rate and air change rate to verify that the cleanroom achieves the desired airflow to maintain its cleanliness class.
- HEPA Filter Integrity Testing: Our HEPA filter integrity tests ensure that filters are performing effectively to prevent contamination.
- Airborne Particulate Count Testing: We conduct particle count testing to measure and verify that your cleanroom meets required cleanliness levels.
- Pressure Differential Testing: Our team monitors and tests room-to-room pressure differentials to maintain contamination control between different classified zones.
- Temperature & Humidity Monitoring: Maintaining controlled temperature and humidity levels is crucial in sensitive environments. We provide precise monitoring to ensure consistent environmental conditions.
- Airflow Visualization Studies: These studies help visualize airflow patterns, ensuring the proper distribution of clean air and identifying any areas of turbulence or contamination risk.
- Recovery Rate Testing: We test the cleanroom’s recovery rate to ensure it can return to its clean state following contamination.
Expertise in Validation Documentation
At Praanomi Engineers Tech Pvt. Ltd., we not only perform thorough testing and certification but also provide complete validation documentation to satisfy regulatory body requirements. Our documentation process includes detailed reports on all tests performed, validation plans, and protocols, ensuring you have all the necessary records for regulatory audits and inspections.
We validate and certify:
- Cleanrooms (ISO 5 to ISO 9)
- Laminar flow units
- Pass boxes
- Biological safety cabinets
- Fume hoods
- Garment cubicles
- Isolators and other controlled environments
Why Choose Us?
With years of experience in cleanroom validation, we are known for our accuracy, professionalism, and strict adherence to industry standards. We use state-of-the-art instruments that are calibrated to international guidelines, ensuring that all measurements and test results are accurate and reliable.
Our technicians are highly trained and certified in the latest validation techniques, ensuring that your cleanroom operates within its design specifications and meets all regulatory requirements.
Validation and Documentation
At Praanomi Engineers Tech Pvt. Ltd., we specialize in delivering top-tier validation services and testing for cleanrooms and critical environments. Our comprehensive validation support ensures that all qualification documentation meets the stringent requirements of regulatory bodies. With a proven track record, we are leaders in providing third-party cleanroom validation services, leveraging cutting-edge instruments to offer independent certification and validation.
All our equipment is meticulously calibrated following the latest international standards, ensuring precision and reliability. Our team of trained and accredited validation technicians excels in testing various types of equipment, adhering to the highest business ethics and demonstrating our commitment to integrity in every service we provide.
Our Approach
- User Requirement Specifications: We collaborate closely with clients to document key user requirements and expectations for their facility, system, or critical process equipment, ensuring alignment with operational needs.
- Validation Plans: Every project begins with the development of a high-level validation plan. We work with clients to create an approach that is both efficient and effective, ensuring that all necessary steps are covered for successful validation.
- Qualification Protocols: Our risk-based approach to generating qualification protocols guarantees the accurate verification of critical systems, utilities, and equipment. We ensure the production of relevant and valuable protocols tailored to each specific project.
Cleanroom Validation Services
We offer a comprehensive range of validation services, including:
- Air volume flow rate and air change rate measurements
- Air and room pressure differential measurement
- HEPA filter integrity and leak testing
- Airborne particulate cleanliness counts
- Pressure gauge calibration
- Airflow visualization studies
- Recovery performance testing
- Temperature and humidity monitoring
- Lighting and noise level measurements
- Containment leak testing
Our team also ensures that all validation processes are thoroughly documented, providing our clients with a detailed record of testing and certification.
Testing & Validation of Critical Equipment
In addition to cleanrooms, we provide testing and validation for:
- Laminar air flow units
- Reverse air flow units
- Pass boxes
- Bio-safety cabinets
- Fume hoods
- Garment cubicles
- Isolators
With Praanomi Engineers Tech Pvt. Ltd., you can be confident that your facility and equipment meet all regulatory standards and perform at the highest level. We are dedicated to ensuring that every aspect of your cleanroom and controlled environment is validated and compliant with industry guidelines.
HVAC & AMC
HVAC
Designing, installing, commissioning, and qualifying HVAC systems for clean rooms is a critical aspect of cleanroom facility construction. The HVAC system ensures that environmental conditions such as temperature, humidity, and air quality meet the strict standards required in cleanroom environments.
The design of the HVAC system is tailored to the specific needs of the cleanroom, factoring in the number of rooms, layout, equipment, and the precise environmental conditions that must be maintained. A well-designed HVAC system ensures the cleanroom achieves optimal performance, meeting both operational and regulatory requirements.
Annual Maintenance Contract (AMC)
We offer customized maintenance and certification packages to ensure your facility stays fully compliant with all state and federal regulations. Our flexible services are designed to prolong the lifecycle of your facilities, keeping them operational and efficient.
With regular inspections, we identify and address any discrepancies, ensuring that your facility is always up to GMP (Good Manufacturing Practice) standards. Should your facility require renovation or upgrades, we carry out all work adhering strictly to GMP guidelines to ensure compliance.
Our Approach
- We offer comprehensive and standard AMC services, tailored to your facility’s design and operational needs.
- Scheduled maintenance programs are created to align with your specific requirements, ensuring optimal facility performance.
- Our team monitors the facility continuously and implements corrective measures when necessary, supporting regulatory compliance audits.
- All maintenance activities are executed following approved Standard Operating Procedures (SOPs), with strict adherence to safety and statutory regulations.
- We provide detailed documentation for every maintenance activity and are available 24/7 for customer support to ensure uninterrupted service.
Our team’s approach guarantees not only compliance but also the efficient, long-term operation of your cleanroom and facility.
Electrical
We have capabilities to provide high quality engineering services in line with applicable global engineering standards and practices.
We provide engineering consultancy services utilizing the rich experience of our team on a wide range of sectors which include:
- Universities, Residential & Commercial High-Rise buildings, Townships & Public Buildings
- Power Plants
- Cement Plants
- Oil & Gas
- Petrochemical and Refineries
Our team having been involved in many prestigious projects in the past across India and abroad providing services in Basic Engineering, Pre-bid Engineering, Detail Engineering and As-built Engineering Services, we are very confident that will serve to meet / exceed our customer's expectations and become the most proffered engineering consultants to our customer.
Electrical Design and Power System Studies
Concept- Feed- Primary & Detailed Engineering Services
- Load Schedule
- Single Line Diagrams
- Equipment Sizing & Selection
- Electrical Layouts
- Specifications – Electrical Equipment
- Transformer Sizing
- Substation Engineering
- Lighting / Earthing / Lightning / Grounding Calculation
- Voltage Drop & Cable Sizing
- Cable Schedule & Tray Layouts
- Adequacy Checks of Equipment and Cables
- Protection and Metering SLD
- Substation Layout Plan and Sections
- Substation Clearance Diagrams
- Erection Key Diagram
- Earthing & Lightning Protection
- Lighting System Design
- Procurement Support
- Conduit Layouts
- Cable Routing and Schedule
- Drum Schedule
- Control Room Equipment Layout
- SCMS, PMS and SCADA System
- Project Bill of Materials
Power System Studies
Using Latest ETAP Software Package, Power system studies covers the following
- Load Flow Studies
- Short Circuit Studies
- Transient Stability
- Relay Co-ordination
- Dynamic Stability
- Motor Starting Analysis
- Harmonic Analysis
- Arc Flash Analysis
Prebid Engineering:
- Preliminary Design Calculations
- Conceptual Layouts
- MTO
Review Engineering:
- Review of Design Calculations
- Review of Design Drawings
- Coordination with Owner / EPC / Vendor
Distribution System:
- 33/11kVHT/LT Substation and Distribution line upto consumer metering
- Supply of equipment
- Construction including erection, testing and commissioning as EPC contractor
- 132kV, 66kV ,33kV & 11kVUG cable distribution works
- 66kV, 33kV & 11kV over headline works
Substation Projects:
- Substation projects executed from 33kV to 132kV
- Supply contracts for major equipment & auxiliary system of S/S
- Construction including erection, testing and commissioning as EPC contractor
- Our work includes civil construction / control room building / fire fighting system etc.
- Substation modification and bay extension works
